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我們的服務性與專業度

◎ 曾與政府單位合作
◎ 與多家工業局財團法人合作，如：金屬中心、PMC、鞋技中心、ETC
◎ 協助工業局鞋類暨運動休閒中心推廣CE、RoHS & WEEE
◎ 經常與國外驗證公司溝通協調，如：BSI, TUV, DNV, AMTRI, LGA, IG, SGS等
◎ 台灣唯一有CE英文網站的顧問公司
◎ 本公司擁有相當多的系統產品之標準書與輔導資料
◎ CE認證及ISO認證，皆受到客戶的青睞與推崇
◎ 採用團隊經營方式輔導解決顧客的問題
◎ 無其他顧問公司之外包狀況

CE簡介
	何謂 CE MARK?
		歐盟各會員國有鑒於語言、文字、貨幣、法律、制度背景上的差異，所以進行各會員國內整合的工作，制定貨品、勞務、人力資源及財務資金的各項標準規範，促進各項商品於歐盟會員國內自由流通，所以制訂出各種安全指令，規定出需要貼 CE 標誌的產品。在機械方面，成立歐盟標準委員會及歐盟電工標準委員會，來制定共同的機械安全規範；無論是歐盟各會員國所製造的，或是外國所製造而銷售至歐盟境內的機械，都必須符合相關的歐盟規範，且在機械本體上必須黏貼 CE 標誌，表示本機械已符合相關的安全規範，才能合法地在歐盟各會員國販賣及使用。
	歐盟包含那些會員國 ?
		● 歐盟會員國︰奧地利、比利時、丹麥、芬蘭、法國、德國、希臘、愛爾蘭、義大利、盧森堡、荷蘭、葡萄牙、西班牙、瑞典、英國、塞浦路斯、捷克、愛沙尼亞、匈牙利、拉脫維亞、立陶宛、馬爾他、波蘭、斯洛伐克、斯洛文尼亞、保加利亞、羅馬尼亞，共27國。 ● 非歐盟會員國，但仍需要 CE 標誌：冰島、列支敦斯登、挪威。歐洲自由貿易協會的 4 個成員國中，除瑞士之外，其它 3 個成員國：。 ● 半歐盟國家︰土耳其。因宗教等原因不被歐盟接受，但其決心要加入歐盟，所以把 CE 標誌列為進入土耳其的強制性要求。
	歐盟的立法型態大致上有下列四種：
		1. 規定：具有直接的強制性，制定後則適用於所有會員國，不必轉換為會員國的國內法規。此項立法只需由決策的理事會或執委會同意即可。 2. 指令：具有強制性，只是會員國會採取什麼方法或措施來達成指令的要求，完全由會員國自行決定。通常會員國必須擬定一項國內法規來配合進行。 3. 決定：不對歐盟會員國產生的約束力，只是對某些特定會員國的特定事項，作為一種法律約束。 4. 建議或意見：不必經過歐盟立法程序、也不具歐盟的法律約束，只是歐盟對某一會員國的某事件表示其觀點，以促使會員國完成歐盟希望達到的目的。
	歐盟已制定的指令：
		90/396/EEC Appliances burning gaseous fuels( 氣體燃燒設備 ) 00/9/EC Cableway installations designed to carry persons( 纜道系統 ) 89/106/EEC Construction products( 營建產品 ) 2004/108/EC Electromagnetic compatibility( 電磁相容性 ) 94/9/EC Equipment and protective systems in potentially explosive atmospheres(ATEX 防爆指令 ) 93/15/EEC Explosives for civil uses( 一般民用爆炸物 ) 95/16/EC Lifts( 電梯指令 ) 2006/95/EC Low voltage equipment( 低電壓 ) 98/37/EC Machinery safety( 機械 ) 2004/22/EEC Measuring instruments( 量測儀器 ) 90/385/EEC Medical devices: Active implantable( 主動植入式醫療器材 ) 93/42/EEC Medical devices: General( 醫療器材 ) 98/79/EC Medical devices: In vitro diagnostic ( 體外診斷醫療器材 ) 92/42/EEC New hot-water boilers fired with liquid or gaseous fluids (efficiency requirements) ( 新熱水鍋爐 ) 90/384/EEC Non-automatic weighing instruments ( 非自動衡器 ) 94/62/EC Packaging and packaging waste( 包裝及包裝廢料 ) 89/686/EEC Personal protective equipment ( 個人防護設備 ) 97/23/EC Pressure equipment ( 壓力設備 ) 99/5/EC Radio and telecommunications terminal equipment( 無線及通信終端設備 ) 94/25/EC Recreational craft( 休閒裝置 ) 87/404/EEC Simple pressure vessels ( 簡單壓力容器 ) 88/378/EEC Toys safety( 玩具安全 )
	機械產品必須符合那些規定才可黏貼 CE 標誌？
		機械指令 (98/37/EC) 低電壓指令 (2006/95/EC) 電磁相容性指令 (2004/108/EC)
	如何建立技術文件 (TCF)
		● 引用之指令及標準技術文件必須列出產品符合 CE 標準所需引用之指令及標準產品於機械指令所必需引用之標準 ● 系列產品差異說明 ● 機械產品之各種圖表機械全圖及其尺寸 ( 長 X 寬 X 高 )。機械爆炸圖及其零件表。電路圖及其零件表。氣、油壓圖及其零件表。機械各部連結之方塊圖 ( 系統圖 ) ，並標註各外接線之編號。機械產品之型錄。 ● 各計算式說明 ● 所需之技術及測試報告基本衛生與安全要求機械安全危險評估原則機械安全標準基本觀念及一般設計原則 ( 基本術語、方法 ) 機械安全標準基本觀念及一般設計原則 ( 技術原則及說明 ) 工業機械電氣設備安全規範 LVD 測試 EMC 測試噪音測試溫度測試 ● 實施品保制度 ● 產品符合性聲明 (DOC) 產品符合性聲明之內容，至少應包含下列各項資訊：製造商或代理商之公司名稱、住址等資訊產品名稱、型號引用之指令引用之標準測試結果報告所載編號公司負責人簽署
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CE機械
	何謂機械 ?
		機械指令 (MD 98/37/EC ) 。依指令規定，凡是由零組件組合而成的組合體。當中至少有一部分是為了原料加工、處理搬運或包裝之目的，需透過適當的致動器、控制器或電路而作動者，都稱之為『機械』。此外，一些組裝在機械上保障安全的零組件，也屬本指令所包含廣義之機械。 - 零組件和組件之連結，透過致動器、控制或動力迴路而作動，進行材料之加工、處理、搬運和包裝床。 - 經由排列及控制整合的機械群組。 - 可替換零組件。 - 安全零組件。
	不屬於機械指令範圍的產品：
		• 僅靠人力為直接動力的機械，除非該機械用於貨物升降。 • 與病患直接接觸之醫療用機械。 • 用於露天廣場或遊樂園之特殊設備。 • 蒸汽鍋爐、槽或壓力容器。 • 為核能用途而特別設計或應用的機械，如遇意外事件會導致輻射能外洩。 • 運輸工具：是指藉著公路、鐵道、水道及空中等公共交通網路來運輸人員及 / 或貨物的運輸工具及其拖車。採礦工業所用的運輸車輛則包含於本指令中。 • 配備相關設備之船隻與近海機動設備。 • 用於公共或私人運輸之載人纜車，包含電纜車。 • 農業及森林用曳引機。 • 特別為軍用或警用之所設計與製造的機械。 • 用於特定高度的大樓或建築的升降服務設備，具有堅固的載車，其與水平面之傾斜角超過 15° ，且設計用來運送： - 人員 - 人員與貨物 - 貨物，但人員容易進入。 • 用於載人，以齒狀鐵軌及齒輪支撐之車輛。 • 礦坑用之捲揚傳動裝置。 • 劇場用升降梯。 • 建築工地現場用於載人或同時載人與貨物之起重機。 • 此外，指令所述及之機械或保安機件的有關危險，如果全部或部分為歐體其餘指令涵蓋，並且需要受這些指令之施行之情形下，則本指令便不再適用或須停止適用於這些產品。
	各類機械安全標準
		依歐盟標準可大致分為三類： A 類標準：主要在於解說基本概念、設計原則及名詞解釋、應用方法等大原則、大方向的標準，適用於所有機械的基本要求。 B 類標準：主要針對可廣泛應用於多種機械的安全觀念的標準。 C 類標準：主要針對每單一機器或機器群的標準。

如何挑選CE機器

文／莊文山
By Chuang Wen Shan

　　受到國外大廠的要求，有許多 OEM 廠，被迫需購置有 CE 標誌的機器，才能較有機會得到大廠的訂單，因此都會或多或少購買 CE 機器，然而有眾多機械廠只採行自我宣告方式，貼上 CE 標誌，在品質功能、設計是否符合歐盟 CE 規範，往往由該家廠商自由心證。乃造成購置的設備是否合乎 CE 規定，都令大多數的鞋廠一頭霧水，不知如何判斷。甚至聽聞有些 CE 證書，是台灣證書，並非是歐盟認可之驗證機構所發出的 CE 證書。
　

因此以下的說明，將教導如何挑選 CE 機器的粗略方法：

壹、判斷購買的機器是否為危險機器

　　自 1995 年 1 月 1 日起，歐盟規範，輸入歐洲單一市場的機械產品都必須貼 CE 標誌，才能在歐盟市場上銷售，並且規定需由製造商承擔機械安全的責任，一些高危險性的機械，更要先經過歐盟認可的驗證機構（ Notified Body ）檢驗合格，才能銷售。因此首先先核對所要的產品是不是屬於危險機械，像木工機械、衝剪機械就要特別注意。如果是以下， 89/392/EEC ： 1989 指令所規範的機械，請注意，一定需提出歐盟驗證機構所發的符合證明書。才能代表該廠的機械已符合 CE 規範，才能貼上 CE 標誌。

一、所列危險機械如下：
　1. 加工木材及類似材料或加工肉類類似材料之單片或多片圓鋸機。
　　1.1 操作時帶有固定式刀具的鋸木機，有一個以手抽送料方式進給之固定床台或採用可拆
              卸式動力進給裝置。
　　1.2 操作時帶有固定式刀具的鋸木機，採用有手操作之往復運動鋸木工作檯或托架。
　　1.3 操作時帶有固定式刀具的鋸木機，採用內藏式工作進給裝置及採用人工方式上下料。
　　1.4 操作時帶有移動式刀具的鋸木機，採用機械式進給裝置及人工方式上下料。
　2. 手押送式鉋木機
　3. 人工上、下料之木工用單面鉋
　4. 加工木材及類似材料或肉類及類似材料，採用固定式或移動式床台及移式承架，以人工
       上下料之帶鋸機。
　5. 由 1 至 4 點及第 7 點所提及加工木材及類似材料之機械所組合成之複合機械。
　6. 手進給式多刀具夾持頭之木工作□機。
　7. 加工木材及類似材料之立軸鉋花機。
　8. 木工用手提式鏈鋸。
　9. 採用人工上下料金屬冷作加工用沖壓床，包括摺床，其移動之工作的行程超過 6mm ，速
        度每秒超過 30mm 。
　10. 人工上下料式之塑膠射出或壓縮成型機。
　11. 人工上下料式之橡膠射出或壓縮成型機。
　12. 下列地下工程用機器設備
　　　─軌道上之機械：動力車頭及制動車
　　　─液壓式隧道頂支撐設備
　　　─地下工程用機械所採用之內燃機
　13. 安裝有壓縮機械，及採用人工收集裝載家庭垃圾之卡車。
　14. 附件一之 3.4.7 節中所提萬向接頭之防護裝與可分離式傳動軸。
　15. 維護車輛用頂高機
　16. 包括可能從三公尺以上垂直高度掉落之危險之人員舉升裝置。
　17. 製造煙火的機械。

二、非危險機械：
　　如果您所採購的機械，不是附件四所規定的機械也非其他規範的保安零組件，或者不是危險機械，則可請製造廠提出 CE 合格聲明書（ EC 合格聲明書），而這份合格聲明書，製造商是可以經過一系列 CE 規範流程而自我宣告的，不需一定要經過驗證公司審核過。

　　這點可能很多公司並不瞭得，製造商有此點優點可自行宣告符合 CE 。可省去驗證費用，但是製造商是否會因自我宣告，而降低安全呢！因此本文將說明如何簡易判斷。

貳、從外觀、目視來判斷是否符合 CE

一、資訊的完整性：
二、危險區是否加防護罩或光罩，或其他安全裝置：
三、面板是否符號化，或英文：
四、電控箱是否合乎 CE 規範： EN60204-1 ： 1992
五、按鈕顏色：
六、指示燈顏色：
七、一般在電源開關都有 0.1 。
八、說明書是否跟隨著機器。

參、從使用說明書，來判斷是否符合 CE

一、機械概要：
二、安全說明書：
三、安裝說明書：
四、操作說明書：
五、維護說明：

肆、CE模式選擇

　在 CE 規範中，關於產品欲附加上 CE 標示，可選用下列三種模式的其中一種程序，完成指令與標準所指定的工作與必須準備的相關文件資料：

1. Module Aa (Internal Production Control) ：自我宣告
‧廠商需準備使用說明書與技術文件
‧廠商需準備符合聲明書
‧產品需由國外認可驗證機構 (Notified Body) 執行測試與核發合格測試報告
2. Module B + C (EC type-examination + Conformity to type) ：認證
• 製造商需向國外認可驗證機構申請型式試驗
• 廠商需準備使用說明書與技術文件
• 廠商需準備符合聲明書
• 產品需由國外認可驗證機構 (Notified Body) 執行測試與核發合格測試報告
• 由國外認可驗證機構核發 EC 型式試驗證明書 (EC type-examination certificate)
3. Module B + D (EC type-examination + Production QA) ：認證
• 製造商需向國外認可驗證機構申請型式試驗
• 製造商需向認可驗證機構申請品質系統評鑑
• 廠商需準備使用說明書與技術文件
• 廠商需準備符合聲明書
• 產品需由國外認可驗證機構 (Notified Body) 執行測試與核發合格測試報告
• 由國外認可驗證機構核發 EC 型式試驗證明書 (EC type-examination certificate)

Module A
內部製程控制

Module B
EC 型式試驗

製造商準備技術文件

↓

認可驗證機構報行測試或不定期採樣測試

↓

製造商
- 附加 CE 標示
- 附加認可驗證機構之識別符號
- 起草書面符合聲明書

製造商向認可機構申請型式試驗

- 製造業者的姓名及地址，若由授權代表申請，則須另外提出授權代表之姓名及地址。
- 未向任何認可驗證機構提出申請之書面聲明認可驗證機構
- 審查技術文件以確定樣本符合技術文件
- 是否採用相關標準
- 是否符合選用標準

Module C
符合型式

Module D
製程品質保證

認可驗證機構
- 就產品之特定項目作試驗
- 不定期抽驗產品

製造商
- 附加 CE 標示
- 附加認可驗證機構之識別符號
- 起草書面符合聲明書

製造商於製程及最終產品檢驗執行合格之品質系統

製造商向認可驗證機構申請品質系統評鑑
- 產品類別相關資料
- 品質系統文件
- 合格型式之技術文件及 EC 型式試驗證明書影本

↓

認可驗證機構
- 評估其品質系統是否符合 EN 29002
製造商
- 附加 CE 標示
- 附加認可驗證機構之識別符號
- 起草書面符合聲明書

↓

認可驗證機構不定期稽核 (EC surveillance)

伍、從證書或 EC 合格聲明書來獲得資訊

• 一台機械最終一定有 EC 合格聲明書，也就是一般所稱之自我宣告書。
• 證書是歐盟驗證公司所發出的證書，詳細情況可問驗證公司或輔導單
　位。

以下指令將告知 EC 合格聲明書上所列的資訊

1.98/37/EC ： 1998 各會員國有關機械法律之調和
2.PREN1050 ： 1993 機械安全、風險評估
3.89/392/EEC ： 1989 各會員國有關機械法律之調和
4.ISO12001 ： 1995 噪音測試規範
5.ISO/DIS 11202-1993 噪音測試規範之草擬與表達法則
6.EN60204-1 ： 1992 機械安全─機械的電機設備
7.EN1050 ： 1996 機械安全─風險評估
8.EN292-1 ： 1991 機械安全─基本概念、設計通則─第一部基本術語、方法
9.EN292-2 ： 1991 機械安全─基本概念、設計通則─第二部：技術原理和規格
10.73/23/EEC ： 1995 低電壓指令
11.89/336/EEC 電磁相容指令
12.N574 ： 1997 機械安全─雙手同動式控制裝置─功能方面設計原則
13.EN418 機械安全─緊急停機設備、功能方面設計原則
14.CEI.IEC 617-1 ～ 13 國際標準電控符號
15.ISO7000 國際標準操作面板圖形
16.93/68/EEC CE 標誌黏貼及符合評估程序之修正指令
17.EN457 ： 1992 機械安全─聽覺性的危險訊號一般要求設計與測試
18.85/374/EEC 產品責任指令
19.EN1088 ： 1996 機械安全─結合護罩之互鎖裝置─設計及選取原則
20.EN60529 ： 1992 機械安全─以防護為條件的保護等級
21.EN1037 ： 1996 機械安全─意外啟動之防止
22.91/368/EEC 機械之修正指令
23.EN811 ： 1997 機械安全─防止下肢伸及危險區域之安全距離
24.EN294 機械安全─防止上肢伸及危險區域之安全距離
25.EN349 機械安全─避免人體各部位遭受擠壓之最小間隙
26.90/683/EEC CE 標誌符合評估程序
27.EN982 ： 1996 機械安全─流體動力系統及其組件之安全要求─液壓
28.EN983 ： 1996 機械安全─氣壓動力系統及其組件之安全要求─氣壓
29.EN693 ： 1997 油壓機械之一般安全要求
30.EN894-1 ： 1997 機械安全─設計顯示器控制制動器人因工程要求
31.PREN953 ： 1996 機械安全─固定、移動式護罩之設計及建構要求
32.EN954-1 ： 1997 機械安全─控制系統有關安全的部件─設計原則
33.EN563 ： 1994 機械安全─可接觸表面溫度的極限值
34.EN60947 ： 1997 機械安全─低電壓開關與控制安全要求
35.PREN1005-1 ～ 4 ： 1998 機械安全─人因工程的安全要求
36.EN61310-1 ： 1995 機械安全─指引標誌致動─視聽觸覺符號的要求
37.BS5378 ： PARTL ： 1980 安全標誌與顏色
38.EN1845 ： 1999 製鞋機械─射出成型機械之一般安全要求
39.EN931 ： 1998 製鞋機械─前幫機械之一般安全要求
40.PREN12653 ： 1997 製鞋機械─釘跟機械之一般安全要求
41.EN344 ： 1993 安全鞋之測試與一般安全要求
42.EN930 ： 1997 製鞋皮革人造皮機械─打粗磨光修邊機械安全要求
43.PREN12044 ： 1997 製鞋機械─裁剪機械之一般安全要求
44.PREN ： 12203 ： 1995 FOOTWEAR; leather and imiation leather goods manufacturing 　
　machine-shoe and leather presses-safety requirements.
45.PREN ： 13457 ： 1999 FOOTWEAR, leather and imitation leather goods manufacturing
　machine-splitting, skiving, trimming, cementing and cement drying machine-safety
　 requirements.

陸、結論

經由以上的介紹，相信這些粗略可目視的方法。已能提供採購者，基本認知。也由這些資料，可看出一部 CE 的機器是多麼繁複程序而完成的，其遵行的指令、條款又有它的規定，有時指令不足乃須至國外查詢，因此為何國外大廠會指名要求購置 CE 機器必有它的安全性的考量。　　本文所提供簡易的 CE 機器判斷方法，只是粗略，基本的規範如預知詳細細節，最好還是跟有研究 CE 的相關單位研討，會更明瞭。

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CE低電壓
	低電壓指令 (LVD 2006/95/EC )
		除了機械指令及電磁相容性指令外，還有一項必須要符合的指令「低電壓指令」，一般是指以電力作動的設備。
	機械產品必須符合的低電壓指令標準
		當考慮機械之電氣安全時，通常採用 EN 60204-1 作為評估及設計之標準。該標準明列了機械之電氣安全規定，例如電源安全、電擊防護、設備的防護、控制電路安全要求、操作介面或控制介面安全要求、導線或馬達安全要求、配線實務安全要求、對附屬品的安全要求、標示及警告標誌的使用等，都有非常詳細的規定。
	哪些產品不在低電壓指令規範內？
		部份設備雖然使用電力作定，但指令的附件二列出了一些排除條款，這些設備另有專屬之指令或法規規範，以下為本指令範圍外之產品： • 使用於易爆炸環境內之電氣設備 • 為放射線及醫療目的使用之電氣設備 • 貨物、乘客升降機之電氣零件 • 電表 • 家用之插頭及插座 • 電力系統控制器 • 無線電電氣干擾船隻、飛機或鐵路使用之特殊電氣設備
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CE電磁相容
	電磁相容性指令 (EMC 2004/108/EC )
		除了針對機械安全制定規範外，歐盟為了調合歐盟各會員國有關電磁干擾的容許程度，歐盟理事會公佈了各會員國間關於電磁相容性相關法律之調合指令。
	何謂電磁相容性 (EMC) ？
		一個設備或裝置與其它裝置同時操作時，不受電磁干擾而影響本身正常的工作能力，也就是說一個設備或裝置在操作過程中，有不利訊號出現時，此訊號是會影響原本的工作，而這訊號可可能來自自己；或一個設備或裝置在操作過程中，不受外界電磁干擾而影響其工作能力。
	哪些設備需符合電磁相容性指令？
		依指令規定適用的對象，包含所有易於產生電磁干擾的設備，或是本身的功能易受電磁干擾的設備。指令的附件三列出以下儀器或設備： • 家用無線電及電視接收器 • 工業製造設備 • 行動收音機 • 行動收音機及商用行動電話機 • 醫療及科學設備 • 資訊科技設備 • 一般電器及家用電器 • 航空及航海用無線設備 • 教育用電子設備 • 電信網路及儀器 • 電台及電視發報機 • 照明燈及螢光燈 ※ 工業產品必須依其適用的相關標準進行檢測
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CE 標誌營建產品指令 (89/106/EEC)

壹：

　　本指令基於各會員國應維護其境內建築及土木工程之品質水準以保障人民生命財產的安全，乃制定有關建築物安全、能源、環境保護及經濟考量等要求的規定。

　　本指令之「營建製品」係指任何為永久合併於營建工程而製造的產品，營建工程包括建築及土木工程。對營建製品之基本要求，包括其產品抗力、穩定程度、防火性、衛生、健康環境、使用安全、噪音防止等。基本安全要求應由執委會提出全是文件以包含不同地理環境及不同氣候狀況所可能產生的差異性。

　　歐洲技術可 (European technical approval) 係對無調和標準或無認可之國家標準等可茲遵循的產品和調合標準或認可之國家標準有很大差異的產品，所發給之許可證明，其有效期間為五年。

　　技術許可之給予須依據基本安全要求之詮釋文件對產品執行檢查、測試及評估。　　

　　各會員國應將核發技術許可、符合證書、執行檢驗及測試的驗證機構及試驗室名冊提交執委會。

　　

符合系統證明 (AOC)
根據相關的技術規格，符合系統證明 (AOC) 與產品符合評估的第三部份有關
Six (6) AOC 系統在建築物生產指令 (CPD) 規範中使用，如下：

系統 1+ 產品符合證明，包含審查測試。
系統 1 產品符合證明，不含審查測試。
系統 2+ 工廠品管證明 (FPC) ，包含連續的監控。
系統 2 工廠品管證明 (FPC) ，不含監控。
系統 3 原始的型式測試 ( 檢驗 ) 。
系統 4 僅製造商的任務。

在建築生產指令規定下，符合系統證明需具備的事項
符合證明 (權責系統編號)	1+	1	2+	2	3	4
製造商的職責
- 工廠生產管理	◎	◎	◎	◎	◎	◎
- 根據規定的測試計畫做進一步樣本測試	◎	◎	◎
- 原始型式測試			◎	◎		◎
認可機構的職責
- 原始型式測試	◎	◎			◎
- FPC 證書	◎		◎
- FPC 監控	◎	◎	◎
- 樣本的審查測試	◎
◎ = 所需的職責

貳、輔導產品生產管控注意事項內容：

＊產品 CE採行的步驟模式：

1. 判定產品是否在各指令規範的範圍內	→	2. 選用適當的符合評鑑模式	→	3. 參考歐洲調和標準(編號於歐體公報中公告)
4. 自我宣告或認證	→	5. 準備技術文件	→	6. 附加CE標示

合作的國外認可驗證機構：

--- LGA (Notified Body) ：發證單位、測試單位 ---
• 核發合格證書
• 執行防火測試
• 執行承載測試
• 執行耐久性測試
--- DANISH ：測試單位 ---
• 執行防火測試　

参、輔導實績

輔導上市之建材公司 ( 生產產品有 T Bars, Ceiling 等 ) ，採用 Aa 模式進行廠商自我宣告，將產品樣本寄送給國外認可驗證機構 (LGA) 做測試，並輔導製造商準備相關文件與草擬自我宣告書。

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GS 認證
GS 標誌為德國自願性安全標誌，依據「德國產品安全法」進行測試，通過測試並證明其安全性，是歐洲市場公認的德國安全認證標誌，目前約有 60 多家認證公司核發 GS 標誌。
GS 標誌的評估是依據低電壓指令、電磁相容性指令、及機械指令，並以調和的 (harmonized) 歐洲標準 (EN) 為基礎，以德國標準為輔，另有人體工學的特別要求，以考慮到消費者關於安全、健康與符合電磁相容等各項法令。此外，認證公司為確保產品的安全水準，依規定在測試前需做工廠檢查，及取得證書後之工廠後續檢驗。
雖然 GS 標誌並非為法律強制規定，但極受消費者重視。許多產品，包括電動工具、資訊產品、家電產品、電氣及電子辦公設備、工業機械、其他與安全有關的產品等，如果沒有 GS 標誌，便難以在德國或歐盟其他會員國地區銷售。所以， GS 標誌是強有力的銷售工具，能增強消費者的信心及購買意願。
※ 關於 GS 認證相關流程及細節，請洽本公司。

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CB 認證
「 CB Scheme 」是一些國際驗證機構 (National Certification Bodies, 簡稱 NCB) ，藉國際認證機構對測試產品的互相認可可以促進國際貿易， CB Scheme 是由國際電工協會 (IECEE) 所提出，由 IECEE 運作的 CB 體系，為一申請特定產品安全認證的國際性機構，並提供多個國家地區，現行約有 45 個會員國，內容涵蓋電子及電器產品符合性測試和認證系統。
「 CB Test Certificates 」是由「 CB Scheme 」會員國的國際驗證機構核發的證明文件。依據相同之 IEC 產品安全標準對產品作測試後，隨同 CB 測試報告，知會其他會員國，該產品已符合 IEC 產品安全標準的 CB 測試證書。
當產品取得「 CB Scheme 」會員國其中之一所核發的「 CB Test Certificates 」及該機構的驗證標誌後，若欲再申請其他「 CB Scheme 」會員國的驗證標誌，只須以此「 CB Test Certificates 」向該機構提出申請，該機構會認同此「 CB Test Certificates 」，不再執行額外測試。差別在於，該機構可能有工廠檢查或指定責任代理商的規定，還有年費規定的不同。
絕大部份的驗證機構對 CE 指令的測試要求，幾乎與 CB Test Certificates 的測試要求完全相同，故當取得 CB Test Certificates 時，通常可同時取得 CE 標誌，能為申請者節省許多費用。
※ 關於 CB 認證相關流程及細節，請洽本公司。

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UL 認證
UL 認證由 UL (Underwriters Laboratories, Inc.) 進行相關產品測試及認證，是美國第一家產品安全標準發展與認證的機構。
UL 認證顧慮到所有具有潛在危險性產品的安全問題，包含有關材料、工具、產品、設備、結構和系統等對生命財產的危險性進行測試，認證產品涵蓋廣泛，包含海運用品、救生器材、防火設備、化學產品、塑膠、照明、家用產品、視聽用品、通訊設備、資訊技術設備、醫療和實驗設備、電源、電纜電線、電子零件、工業控制設備、機械、家電產品及汽車設施等。另外，服務範疇不只在測試產品危險性，也為了產品的防盜防火性及設備是否正確安裝作評估。
原則上， UL 認證為自願性，製造商自願性地將產品進行測試及安全認證，所以，目前無特別的法令規定一定要附上 UL 標誌，但仍需視當地的地方政府的法令規定。
無可爭議地， UL 認證為美國產品安全認證的領導者，現在更被認為是全球性權威及信譽良好的認證指標，因此，對製造商而言，登錄申請 UL 標誌可為產品安全提供更有公信力之保證。
※ 關於 UL 認證相關流程及細節，請洽本公司。

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CSA

CSA 認證
CSA 認證是加拿大最具規模、年代最久遠的認證，其認證機構內包含文書、發證、測試及審查等部門，是加拿大最大的安全認證機構，也是一獨立之非營利事業機構，處理各個產業中與公共安全及其發展相關之事宜，能對機械、建材、電器、電腦設備、辦公設備、環保、醫療防火安全、運動及娛樂等方面，所有類型的產品提供安全認證，經 CSA 測試和認證的產品，被確定為完全符合標準規定，才可以銷往北美市場。
CSA 認證是針對申請人所申請的產品，不是針對申請人本身。申請人只能在經過 CSA 認證，才能在獲得授權的產品上黏貼 CSA 標誌，不能在其他未經 CSA 認證的產品上黏貼 CSA 標誌，即使是同一類型、同一系列但不同型號的產品，未經 CSA 認證不能黏貼 CSA 標誌。
CSA 認證的責任及權益屬於申請人，申請人可以是製造商，也可以是經銷商、代理商或其他單位。當申請人是製造商時，其附有 CSA 標誌的產品，可以自行銷售，也可選擇由經銷商或代理商銷售。當申請人是經銷商或代理商時，其附有 CSA 標誌的產品，應該在申請認證時所指定的工廠內生產，申請人可以依據自己需要，隨時向 CSA 提出申請要求增加、減少或變更製造商，該產品必須送 CSA 測試檢驗合格和進行工廠審查後，才能在產品上黏貼 CSA 標誌。
※ 關於 CSA 認證相關流程及細節，請洽本公司。

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大陸 3C

3C 認證
「 3C 」即為「中國國家強制性產品認證」，是一種法定的強制性安全認證制度，如未通過中國國家強制性產品認證，不得輸入中國或在中國內銷，負責「 3C 」認證的管理和組織實施工作為中國國家認證認可監督管理委員會。主要特點是國家公佈統一的目錄，然後統一適用的國家標準、技術規則和實施程序，並製訂統一的標誌，及規定統一的收費標準。
範圍為涉及人類健康和安全，動植物生命和健康，以及環境保護和公共安全的產品，管制約 19 類 132 種產品。凡列入強制性產品認證範圍之產品，沒有獲得指定認證機構的證書，沒有依照規定黏貼認證標誌，一律不得進口、不得出廠銷售和在經營服務場所使用。只有通過「 3C 」認證的產品才能使用「 3C 」認證標誌。 3C 認證標誌共分四種： Safety 、 EMC 、 Safety & EMC 及 Fire ，以各類認證的英文字母標誌。
※ 關於 3C 認證相關流程及細節，請洽本公司。

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PED 材料製造證明

輔導內容

一、序言：
1.1 範圍
1.2 驗證等級
1.3 品質系統認證標準與計劃

二、評估程序：
2.1 符合系統評估
2.2 符合系統證明
2.3 評估文件

三、重新評估：
3.1 重新評估與週期性查核
3.2 評估報告

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FDA
	美國食品藥物管理局(FDA)醫療器材上市前通告510(k)申請送件簡介
		前言 △ 醫療器材種類繁多，技術發展日新月異，需多加控管方能保障使用者安全。 △ 醫療器材認證兩大組織： (1)美國聯邦法規(21CFR) (a)FDA-510(k)上市前通告－Class I & II (b)PMA－Class III (2)CE-Mark－歐盟醫療器材認證 <note>PMA：Premarket Approval Application CE：Conformity European
	FDA組織簡介
		△ 隸屬於US Department of Health & Human Services (HHS) FDA－Center-Offices-Divisions/Offices 中心-辦公室-部/辦公室 OC (Office of the Commissioner) 局長辦公室 CDER (Center for Drug Evaluation & Research) 藥品相關 CBER (Center for Biologics Evaluation & Research) 生物製劑 CVM (Center for veterinary Medicine) 動物用藥 CFSAN (Center for Food Safety & Applied Nutrition) 食品 NCTR (National Center for Toxicological Research) 毒理 ORA (Office of Regulatory Affairs) 法規 CDRH (Center for Devices & Radiological Health) 醫療器材相關
	美國醫療器材法規簡介
		△ FEDERAL FOOD, DRUG, and COSMETIC ACT △ 1997 Modernization ACT △ Medical Device User Fee and Moderization ACT (MDUFMA) of 2002 Code of Federal Regulations (CFR) 1. 聯邦法規為美國聯邦政府行政機關編碼登錄公告發行之一般與現行法律規定。 2. 聯邦法規第21款(Title 21；簡稱為21CFR)專為FDA所保留之法律規定專冊，每年更新改版一次，約於每年4月1日公告。
	美國醫療器材分類簡介
		Class I －一般管制(ex：拐杖、口罩、眼鏡片) 管制項目：(1)禁止粗製濫造與不當標示 (2)通報產品危害性、修理與置換等善後事項 (3)廠房實施GMP(不一定需要) (4)製造商、進口商及銷售者都必須向FDA註冊列管 Class II －特別管制(ex：血壓計、醫療手套、電動輪椅) 管制項目：(1)同Class I (2)產品須通過FDA或工業界公認的標準測試 Class III －上市前許可(ex：心律調整器、保溫箱) 管制項目：(1)同Class I & Class II (2)產品必須通過PMA認證與臨床測試
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標準資料庫

◎ 歐盟指令

編號	指令名稱
73/23/EEC	Low voltage
87/404/EEC	Simple pressure vessels
88/378/EEC	Safety of toys
89/106/EEC	Construction products
89/336/EEC	Electromagnetic compatibility
89/686/EEC	Personal protective equipment
90/384/EEC	Non-automatic weighing instruments
90/385/EEC	Active implantable medical devices
90/396/EEC	Appliances burning gaseous fuels
92/42/EEC	Hot-water boilers
93/15/EEC	Explosives for civil uses
93/42/EEC	Medical devices
94/9/EC	Equipment and protective systems intended for use in potentially explosive atmospheres
94/25/EC	Recreational craft
95/16/EC	Lifts
96/48/EC	Interoperability of the Trans-European high-speed rail system
96/98/EC	Marine equipment
97/23/EC	Pressure equipment
98/37/EC	Machinery
98/79/EC	In vitro diagnostic medical devices
99/5/EC	Radio and telecommunications terminal equipment
99/36/EC	Transportable pressure equipment
2000/9/EC	Cableway installations designed to carry persons
2000/14/EC	Noise emission in the environment by equipment for use outdoors
2001/16/EC	Interoperability of the trans-European conventional rail system
2004/22/EC	Measuring Instruments

◎ 機械標準

編號	歐市標準	名稱 ( 英文 )
MD0001	EN 201 1997 +A2 2005	Rubber and plastics machines — Injection moulding machines — Safety requirements
MD0002	EN 289 1994	Rubber and plastics machinery- Compression and transfer moulding presses- Safety requirements for the design
MD0003	EN 292-1 1991	機械安全 ─ 基本概念、設計通則 ─ 第一部基本術語、方法
MD0004	EN 292-2 1991	機械安全 ─ 基本概念、設計通則 ─ 第二部 : 技術原理和規格
MD0005	EN 294 1992	Safety of machinery — Safety distance to prevent danger zones being reached by the upper limbs 25.8.1993 — EN 294:1992/AC:1993
MD0005	EN 294 1992	防止上肢伸及危險區域之安全距離 (1992)
MD0006	EN 344 1993	安全鞋之測試與一般安全要求
MD0007	EN 349 1993	Safety of machinery — Minimum gaps to avoid crushing of parts of the human body
MD0007	EN 349 1993	機械安全 ─ 避免人體各部位遭受擠壓之最小間隙
MD0008	EN 418	機械安全 ─ 緊急停機設備、功能方面設計原則
MD0009	EN 422 1996	Rubber and plastics Machines - Safety - Blow moulding machines intended for the production of hollow articles - Requirements for the design and construction
MD0010	EN 453 2000	Food processing machinery — Dough mixers — Safety and hygiene requirements
MD0011	EN 457 1992	機械安全 ─ 聽覺性的危險訊號一般要求設計與測試
MD0012	EN 563 1994	機械安全 ─ 可接觸表面溫度的極限值
MD0013	EN 692 1996	Machine tools — Mechanical presses — Safety
MD0014	EN 693 1999	Machine tools — Safety — Hydraulic presses
MD0014	EN 693 1999	油壓機械之一般安全要求
MD0015	EN 792-1 2000	Hand-held non-electric power tools — Safety requirements — Part 1: Assembly power tools for non-threaded mechanical fasteners
MD0016	EN 792-2 2000	Hand-held non-electric power tools — Safety requirements — Part 2: Cutting-off and crimping power tools
MD0017	EN 792-3 2000	Hand-held non-electric power tools — Safety requirements — Part 3: Drills and tappers
MD0018	EN 792-4 2000	Hand-held non-electric power tools — Safety requirements — Part 4:Non-rotary percussive power tools
MD0019	EN 792-5 2000	Hand-held non-electric power tools — Safety requirements — Part 5:Rotary percussive drills
MD0020	EN 792-6 2000	Hand-held non-electric power tools — Safety requirements — Part 6:Assembly power tools for threaded fasteners
MD0021	EN 792-8 2000	Hand-held non-electric power tools — Safety requirements — Part 8:Sanders and polishers
MD0022	EN 792-9 2000	Hand-held non-electric power tools — Safety requirements — Part 9:Die grinders
MD0023	EN 792-10 2000	Hand-held non-electric power tools — Safety requirements — Part 10: Compression power tools
MD0024	EN 792-11 2000	Hand-held non-electric power tools — Safety requirements — Part 11:Nibblers and shears
MD0025	EN 792-12 2000	Hand-held non-electric power tools — Safety requirements — Part 12:Small circular, small oscillating and reciprocating saws
MD0026	EN 792-13 2000	Hand-held non-electric power tools — Safety requirements — Part 13:Fastener driving tools
MD0027	EN 809 1998	Pumps and pump units for liquids — Common safety requirements 15.10.1998 —
MD0027	EN 809 1998	N 809:1998/AC:2001
MD0028	EN 811 1997	Safety of machinery — Safety distances to prevent danger zones being reached by the lower limbs
MD0028	EN 811 1997	機械安全 ─ 防止下肢伸及危險區域之安全距離
MD0029	EN 894-1 1997	機械安全 ─ 設計顯示器控制制動器人因工程要求
MD0030	EN 930 1997	製鞋皮革人造皮機械 ─ 打粗磨光修邊機械安全要求
MD0031	EN 931 1998	製鞋機械 ─ 前幫機械之一般安全要求
MD0032	EN 954-1 1997	Safety of machinery — Safety-related parts of control systems — Part 1: General principles for design
MD0032	EN 954-1 1997	機械安全 ─ 控制系統有關安全的部件 ─ 設計原則
MD0033	EN 957-1 1998	通用性安全需求與測試方法
MD0034	EN 982 1996	Safety of machinery — Safety requirements for fluid power systems and their components — Hydraulics
MD0034	EN 982 1996	機械安全 ─ 流體動力系統及其組件之安全要求 ─ 液壓
MD0035	EN 983 1996	機械安全 ─ 氣壓動力系統及其組件之安全要求 ─ 氣壓
MD0036	EN 1037 1996	Safety of machinery – Prevention of Unexpected start-up 機械安全 ─ 意外啟動之防止
MD0037	EN 1050 1996	機械安全 ─ 風險評估
MD0038	EN 1088 1996	Safety of machinery – Interlocking devices associated with guards – Principles for design and selection 機械安全 ─ 結合護罩之互鎖裝置 ─ 設計及選取原則
MD0039	EN 1114-1 1996	Rubber and plastics machines — Extruders and extrusion lines — Part 1: Safety requirements for extruders
MD0040	EN 1218-2 2004	Safety of woodworking machines — Tenoning machines — Part 2: Double end tenoning and/or profiling machines fed by chain or chains
MD0041	EN 1417 1997	Rubber and plastics machines- Two roll mills- Safety requirements
MD0042	EN 1612-1 1997	Rubber and plastics machines- Reaction moulding machines- Part 1: Safety requirements for metering and mixing units
MD0043	EN 1672-2 2005	Food processing machinery – Basic concepts- Part2: Hygiene requirements
MD0044	EN 1845 1999	Footwear manufacturing machines — Footwear moulding machines — Safety requirements
MD0044	EN 1845 1999	製鞋機械 ─ 射出成型機械之一般安全要求
MD0045	EN 1985 1999	Walking aids- General requirements and test methods
MD0046	ISO 10821 2005	Industrial sewing machines — Safety requirements for sewing machines, units and systems
MD0047	EN ISO 11111-1 2005	Textile machinery — Safety requirements — Part 1: Common requirements (ISO 11111-1:2005)
MD0048	EN 12012-1	Rubber and plastics machines - Size reduction machines –
MD0048	EN 12012-1	Part 1: Safety requirements for blade granulators
MD0049	EN ISO 12100-1 2003	Safety of machinery Basic concepts, general principles for design
MD0049	EN ISO 12100-1 2003	Part 1: Basic terminology, methodology
MD0050	EN ISO 12100-2 2003	Safety of machinery Basic concepts, general principles for design
MD0050	EN ISO 12100-2 2003	Part 2: Technical principles
MD0051	EN 12182	Technical aids for disabled persons- General requirements and test methods
MD0052	EN 12409 1999	Rubber and plastics machines - Thermoforming machines - Safety requirements
MD0053	EN 12622 2001	Safety of machine tools – Hydraulic press brakes
MD0054	EN 13060	Small steam sterilizers
MD0055	EN ISO 14122-2 2001	Safety of machinery
		Permanent means of access to machinery
		Part 2: Working platforms and walkways
MD0056	EN ISO 14122-3 2001	Safety of machinery Permanent means of access to machinery - Part 3: Stairways, stepladders and guard-rail
MD0057	EN 12417 2001	Machine tools — Safety — Machining centres 14.6.2002 —
MD0057	EN 12417 2001	EN 12417:2001/A1:2006
MD0058	EN 12601 2001	Reciprocating internal combustion engine driven generating sets — Safety
MD0059	EN ISO 14122-2 2001	Safety of machinery — Permanent means of access to machinery — Part 2: Working platforms and walkways (ISO 14122-2:2001)
MD0060	EN ISO 14122-3 2001	Safety of machinery — Permanent means of access to machinery — Part 3: Stairs, stepladders and guard-rails (ISO 14122-3:2001)
MD0061	EN 60095	Lead-acid battery, starter battery, identification, labeling, electrical characteristics, mechanical characteristics, test conditions, test methods, tests
MD0062	EN 60204-1 1992	機械安全 ─ 機械的電機設備
MD0063	EN 60204-31 1998	Safety of machinery- Electrical equipment of machines-
MD0063	EN 60204-31 1998	Part 31: Particular requirements for sewing machines, units and systems
MD0064	EN 60204-32	Safety of machinery-Electrical equipment of machines-Part 32: Requirements for hoisting machines
MD0065	EN 60529 1992	Degrees of protection provided by enclosures (IP code) 機械安全 ─ 以防護為條件的保護等級
MD0066	EN 60601-2-38	Medical electrical equipment Part2-38: Particular requirements for the safety of electrically operated hospital beds
MD0067	EN 61310-1 1995	機械安全 ─ 指引標誌致動 ─ 視聽觸覺符號的要求
MD0068	EN 60204-31 1998	Safety of machinery — Electrical equipment of machines — Part 31: Particular safety and EMC requirements for sewing machines, units and systems (IEC 60204-31:1996 (Modified))
MD0069	EN 60947 1997	機械安全 ─ 低電壓開關與控制安全要求
MD0070	prEN 415-3 1998	Safety of packaging machines. Form, fill and seal machines
MD0071	prEN 693 1999	hydraulic
MD0071	prEN 693 1999	工具機 - 安全 - 液壓壓機
MD0072	prEN 792-8 1992	Hand-held non-electric power tools — Safety requirements — Part 8: Sanders and polishers
MD0072	prEN 792-8 1992	手提非電動動力工具 - 安全需求拋光及砂磨機具
MD0073	prEN 953 1996	機械安全 ─ 固定、移動式護罩之設計及建構要求
MD0074	prEN 1005-1 ~ 4 1998	機械安全 ─ 人因工程的安全要求
MD0075	prEN 1050 1993	機械安全、風險評估
MD0076	prEN 1672 1994	Food processing machinery- Safety and hygiene requirements- Basic concepts-
MD0076	prEN 1672 1994	Part 1: Safety requirements
MD0077	prEN 12044 1997	製鞋機械 ─ 裁剪機械之一般安全要求
MD0078	prEN 12182	Technical aids for disabled persons- General requirements and test methods
MD0079	prEN 12203 1995	Footwear, leather and limitation leather goods manufacturing machines- shoe and leather presses – Safety requirements
MD0080	prEN 12653 1997	製鞋機械 ─ 釘跟機械之一般安全要求
MD0081	prEN 13457 1999	FOOTWEAR, leather and imitation leather goods manufacturing achine-splitting, skiving, trimming, cementing and cement drying machine-safety requirements.
MD0082	BS5378 : PARTL : 1980	安全標誌與顏色
MD0083	CEI.IEC 617-1	國際標準電控符號
MD0084	CEI.IEC 617-2	國際標準電控符號
MD0085	CEI.IEC 617-3	國際標準電控符號
MD0086	CEI.IEC 617-4	國際標準電控符號
MD0087	CEI.IEC 617-5	國際標準電控符號
MD0088	CEI.IEC 617-6	國際標準電控符號
MD0089	CEI.IEC 617-7	國際標準電控符號
MD0090	CEI.IEC 617-8	國際標準電控符號
MD0091	CEI.IEC 617-9	國際標準電控符號
MD0092	CEI.IEC 617-10	國際標準電控符號
MD0093	CEI.IEC 617-11	國際標準電控符號
MD0094	CEI.IEC 617-12	國際標準電控符號
MD0095	CEI.IEC 617-13	國際標準電控符號
MD0096	IEC 204-31	Electrical equipment of industrial machines-Part 31: Particular requirements for sewing machines, units and systems
MD0097	IEC 60034-1	Rotating electrical machines —
MD0097	IEC 60034-1	Part 1:Rating and performance
MD0098	ISO/DIS 3746.2	Acoustics — Determination of sound power levels of noise sources using sound pressure — Survey method using an enveloping measurement surface over a reflecting plane
MD0099	ISO 12001 1995	噪音測試規範
MD0100	ISO/DIS 11202 1993	噪音測試規範之草擬與表達法則
MD0101	ISO 7000	國際標準操作面板圖形
MD0102	EN 574 1997	機械安全 ─ 雙手同動式控制裝置 ─ 功能方面設計原則
MD0103	EN 289 2004	Plastics and rubber machines — Presses — Safety requirements
MD0104	EN 693 2001	Machine tools — Safety — Hydraulic presses
MD0105	EN ISO 11111-1 1996	Safety requirements for textile machinery
MD0106	IEC 60204-1 1997 +A1 1999	Safety of machinery – Electrical equipment of machines – Part 1: General requirements
MD0107	prEN 1672-1 1994	Food processing machinery - Basic concepts - Part 1: Safety requirements
MD0108	prEN 12417 1996	工作母機 - 安全 - 切削中心機
MD0109	EN 1034-1 2000	Safety of machinery - Safety requirements for the design and construction of paper making and finishing machines Part 1: Common requirements
MD0110	EN 1034-3 2000	Safety of machinery - Safety requirements for the design and construction of paper making and finishing machines Part 3: Winders and slitters, plying machines
MD0111	ISO 13849-1 2006	Safety of machinery — Safety-related parts of control systems — Part 1:General principles for design
MD0112	EN 12198-1 2000	Safety of machinery — Assessment and reduction of risks arising from radiation emitted by machinery — Part 1: General principles
MD0113	EN 12198-2 2002	Safety of machinery - Assessment and reduction of risks arising from radiation emitted by machinery - Part 2: Radiation emission measurement procedure
MD0114	EN 12198-3 2002	Safety of machinery - Assessment and reduction of risks arising from radiation emitted by machinery - Part 3: Reduction of radiation by attenuation or screening
MD0115	EN 201 1997 +A1 2000	Rubber and plastics machines — Injection moulding machines — Safety requirements
MD0116	EN 201 1997	橡塑膠機 – 射出成型機 – 安全要求
MD0117	IEC 60204-1 2005	Safety of machinery – Electrical equipment of machines – Part 1: General requirements
MD0118	IEC 60204-1 2000	Safety of machinery – Electrical equipment of machines – Part 1: General requirements 機械安全 – 機器的電氣設備 – 第一部份：一般要求
MD0119	IEC 60204-1 1997	Safety of machinery – Electrical equipment of machines – Part 1: General requirements 機械安全 – 機器的電氣設備 – 第一部份：一般要求
MD0120	EN 12415 2001	Safety of machine tools – Small numerically controlled turning machines and turning centres
MD0121	prEN 12415	工具機 - 安全 - 小型數控車床及車削中心機
MD0122	EN 12478 2001	Safety of machine tools – Large numerically controlled turning machines and turning centres
MD0123	prEN 12478	工具機 - 安全 - 大型數控車床及車削中心機
MD0124	EN 12840 2001	Safety of machine tools – Manually controlled turning machines with or without automatic control
MD0125	prEN 12840 1998	機器工具安全 - 包含或不包含自動控制之手控旋轉機器
MD0126	EN 12717 2001	Safety of machine tools – Drilling machine
MD0127	EN 1032 1997	Mechanical vibration - Testing of mobile machinery in order to determine the whole-body vibration emission value - General
MD0128	EN 1387 1997	Machine readable cards - Health care applications - Cards: General characteristics
MD0129	EN 50144-2-7 1996	Safety of hand held electric motor operated tools - Part 2-7: Particular requirements for spray guns
MD0130	EN 60335-2-64 1994	Specification for Safety of household and similar electrical appliances - Part 2: Particular requirements - Section 2.64 Commercial electric kitchen machines
MD0131	EN 741 2000	Continuous handling equipment and systems - Safety requirements for systems and their components for pneumatic handling of bulk materials
MD0132	EN 745 1999	Agricultural machinery – Rotary mowers and flail-mowers - Safety
MD0133	EN 774 1996	Garden equipment — Hand held, integrally powered hedge trimmers — Safety
MD0134	EN 848-1 1999	Safety of woodworking machines — One side moulding machines with rotating tool — Part 1: Single spindle vertical moulding machines
MD0135	EN 859 1998	Safety of woodworking machines - Handfed surface planning machines
MD0136	EN 1218-3 2001	Safety of woodworking machines — Tenoning machines — Part 3: Hand fed tenoning machines
MD0136	EN 1218-3 2001	with sliding table for cutting structural timbers
MD0137	EN 1218-4 2004	Safety of woodworking machines — Tenoning machines — Part 4: Edge banding machines fed by chain(s)
MD0138	EN 1218-5 2004	Safety of woodworking machines — Tenoning machines — Part 5: One side profiling machines with fixed table and feed rollers or fed by chain
MD0139	EN 1493 1998	Vehicle lifts
MD0140	EN 1870-2 1999	Safety of woodworking machines — Circular sawing machines — Part 2: Horizontal beam panel saws and vertical panel saws
MD0141	EN 1870-3 2001	Safety of woodworking machines — Circular sawing machines — Part 3: Down cutting cross-cut saws and dual purpose down cutting cross-cut saws/circular saw benches
MD0142	EN 1870-5 2002	Safety of woodworking machines — Circular sawing machines — Part 5: Circular sawbenches/up-cutting cross-cut sawing machines
MD0143	EN 1870-7 2002	Safety of woodworking machines — Circular sawing machines — Part 7: Single blade log sawing machines with integrated feed table and manual loading and/or unloading
MD0144	EN 1870-8 2001	Safety of woodworking machines — Circular sawing machines — Part 8: Single blade edging circular rip sawing machines with power driven saw unit and manual loading and/or unloading
MD0145	EN 1870-15 2004	Safety of woodworking machines — Circular sawing machines — Part 15: Multiblade cross-cut sawing machines with integrated feed of the workpiece and manual loading and/or unloading
MD0146	EN 13411-1 2002	Terminations for steel wire ropes — Safety — Part 1: Thimbles for steel wire rope slings
MD0147	EN 13411-2 2001	Terminations for steel wire ropes — Safety — Part 2: Splicing of eyes for wire rope slings
MD0148	EN 13411-3 2004	Terminations for steel wire ropes — Safety — Part 3: Ferrules and ferrule-securing
MD0149	EN 13411-4 2002	Terminations for steel wire ropes — Safety — Part 4: Metal and resin socketing
MD0150	EN 13411-5 2003	Terminations for steel wire ropes — Safety — Part 5: U-bolt wire rope grips
MD0151	EN 13411-6 2004	Terminations for steel wire ropes — Safety — Part 6: Asymmetric wedge socket
MD0152	EN 14886 2008	Plastics and rubber machines — Bandknife cutting machines for block foams — Safety requirements
MD0153	EN 15067 2007	Plastics and rubber machines — Film converting machines for bags and sacks — Safety requirements
MD0154	EN 50144-2-7 1996	Safety of hand held electric motor operated tools — Part 2-7: Particular requirements for spray guns
MD0155	EN 60204-1 2006	Safety of machinery – Electrical equipment of machines – Part 1: General requirements
MD0156	EN 60335-2-64 1994	Specification for Safety of household and similar electrical appliances — Part 2: Particular requirements — Section 2.64 Commercial electric kitchen machines
MD0157	EN 60745-1 2003	Hand-held motor-operated electric tools — Safety Part 1: General requirements
MD0158	EN 60745-2-1 2003	Hand-held motor-operated electric tools — Safety — Part 2-1: Particular requirements for drills and impact drills
MD0159	EN 60745-2-2 2003	Hand-held motor-operated electric tools – Safety Part 2-2: Particular requirements for screwdrivers and impact wrenches
MD0160	EN ISO 10821 2005	Industrial sewing machines -- Safety requirements for sewing machines, units and systems
MD0161	ISO 10218-1 2006	Robots for industrial environments -- Safety requirements -- Part 1: Robot

◎ 低電壓標準

編號	歐市標準	名稱 ( 英文 )
LVD001	EN 50083-1 1994	Cable networks for television signals, sound signals and interactive services - Part 1: Safety requirements
LVD002	EN 50085-1 2005	Cable trunking systems and cable ducting systems for electrical installations - Part 1: General requirements
LVD003	EN 50266-1 2001	Common test methods for cables under fire conditions - Test for vertical flame spread of vertically-mounted bunched wires or cables - Part 1: Apparatus
LVD004	EN 50266-2-1 2001	Common test methods for cables under fire conditions - Test for vertical flame spread of vertically-mounted bunched wires or cables - Part 2-1: Procedures - Category A F/R
LVD005	EN 50266-2-2 2001	Common test methods for cables under fire conditions - Test for vertical flame spread of vertically-mounted bunched wires or cables - Part 2-2: Procedures - Category A
LVD006	EN 50266-2-3 2001	Common test methods for cables under fire conditions - Test for vertical flame spread of vertically-mounted bunched wires or cables - Part 2-3: Procedures - Category B
LVD007	EN 50266-2-4 2001	Common test methods for cables under fire conditions - Test for vertical flame spread of vertically-mounted bunched wires or cables - Part 2-4: Procedures - Category C
LVD008	EN 50266-2-5 2001	Common test methods for cables under fire conditions - Test for vertical flame spread of vertically-mounted bunched wires or cables - Part 2-5 Procedures - Small cables - Category D
LVD009	EN 50267-2-1 1998	Common test methods for cables under fire conditions - Tests on gases evolved during combustion of materials from cables - Part 2-1: Procedures - Determination of the amount of halogen acid gas
LVD010	EN 50267-2-2 1998	Common test methods for cables under fire conditions - Tests on gases evolved during combustion of materials from cables - Part 2-2: Procedures - Determination of degree of acidity of gases for materials by measuring pH and conductivity
LVD011	EN 50267-2-3 1998	Common test methods for cables under fire conditions - Tests on gases evolved during combustion of materials from cables - Part 2-3: Procedures - Determination of degree of acidity of gases for cables by determination of the weighted average of pH and conductivity
LVD012	EN 50363-1 2005	Insulating, sheathing and covering materials for low voltage energy cables - Part 1: Cross-linked elastomeric insulating compounds
LVD013	EN 60034-1 1998	Rotating electrical machines - Part 1: Rating and performance
LVD014	EN 60034-1 2004	Rotating electrical machines - Part 1: Rating and performance
LVD015	EN 60065 2002	Audio, video and similar electronic apparatus - Safety requirements
LVD016	EN 60065 2002 +A1 2006	Audio, video and similar electronic apparatus - Safety requirements
LVD017	EN 60335-1 2002	Safety of household and similar electrical appliances - Part 1: General requirements
LVD018	EN 60335-2-24 1999	Household and similar electrical appliances - Safety - Part 2-24: Particular requirements for refrigerating appliances, ice-cream appliances and ice-makers
LVD019	EN 60335-2-24 2001	Household and similar electrical appliances - Safety - Part 2-24: Particular requirements for refrigerating appliances, ice-cream appliances and ice-makers
LVD020	EN 60335-2-30 2002	Household and similar electrical appliances - Safety - Part 2-30: Particular requirements for room heaters
LVD021	EN 60335-2-34 2000	Household and similar electrical appliances - Safety - Part 2-34: Particular requirements for motor-compressors
LVD022	EN 60335-2-35 1995	Household and similar electrical appliances - Safety - Part 2-35: Particular requirements for instantaneous water heaters
LVD023	EN 60335-2-44 1998	Household and similar electrical appliances - Safety - Part 2-44: Particular requirements for ironers
LVD024	EN 60335-2-45 1991	Household and similar electrical appliances - Safety - Part 2-45: Particular requirements for portable heating tools and similar appliances
LVD025	EN 60335-2-53 1991	Household and similar electrical appliances - Safety - Part 2-53: Particular requirements for sauna heating appliances
LVD026	EN 60335-2-53 1997	Household and similar electrical appliances - Safety - Part 2-53: Particular requirements for sauna heating appliances
LVD027	EN 60335-2-84 1999	Household and similar electrical appliances - Safety - Part 2-84: Particular requirements for toilets
LVD028	EN 60335-2-85 1998	Household and similar electrical appliances - Safety - Part 2-85: Particular requirements for fabric steamers
LVD029	EN 60400 1996	Lampholders for tubular fluorescent lamps and starterholders
LVD030	EN 60432-2 1995	Incandescent lamps - Safety specifications - Part 2: Tungsten halogen lamps for domestic and similar general lighting purposes
LVD031	EN 60446 2000	Basic and safety principles for man-machine interface, marking and identification - Identification of conductors by colours or numerals
LVD032	EN 60519-1 1993	Safety in electroheat installations - Part 1: General requirements
LVD033	EN 60570 1997	Electrical supply track systems for luminaires
LVD034	EN 60825-2 2000	Safety of laser products - Part 2: Safety of optical fibre communication systems (OFCS)
LVD035	EN 60947-2 2003	Low-voltage switchgear and controlgear - Part 2: Circuit-breakers
LVD036	EN 60947-3 1999	Low-voltage switchgear and controlgear - Part 3: Switches, disconnectors, switch-disconnectors and fuse-combination units
LVD037	EN 60947-4-1 2001	Low-voltage switchgear and controlgear - Part 4-1: Contactors and motor-starters - Electromechanical contactors and motor-starters
LVD038	EN 60947-4-3 2000	Low-voltage switchgear and controlgear - Part 4-3: Contactors and motor-starters - AC semiconductor controllers and contactors for non-motor loads
LVD039	EN 60947-5-4 2003	Low-voltage switchgear and controlgear - Part 5-4: Control circuit devices and switching elements - Method of assessing the performance of low-energy contacts - Special tests
LVD040	EN 60947-5-5 1998	Low-voltage switchgear and controlgear - Part 5-5: Control circuit devices and switching elements - Electrical emergency stop device with mechanical latching function
LVD041	EN 60947-5-7 2003	Low-voltage switchgear and controlgear - Part 5-7: Control circuit devices and switching elements - Requirements for proximity devices with analogue output
LVD042	EN 60947-6-1 2005	Low-voltage switchgear and controlgear - Part 6-1: Multiple function equipment - Automatic transfer switching equipment
LVD043	EN 60947-6-2 2003	Low-voltage switchgear and controlgear - Part 6-2: Multiple function equipment - Control and protective switching devices (or equipment) (CPS)
LVD044	EN 60947-8 2003	Low-voltage switchgear and controlgear - Part 8: Control units for built-in thermal protection (PTC) for rotating electrical machines
LVD045	EN 60974-1 2005	Arc welding equipment - Part 1: Welding power sources
LVD046	EN 61010-1 2001	Safety requirements for electrical equipment for measurement, control, and laboratory use - Part 1: General requirements
LVD047	EN 61010-2-010 1995	Safety requirements for electrical equipment for measurement, control, and laboratory use - Part 2-010: Particular requirements for laboratory equipment for the heating of material
LVD048	EN 61058-1 2002	Switches for appliances - Part 1: General requirements
LVD049	EN 61558-1 2005	Safety of power transformers, power supplies, reactors and similar products - Part 1: General requirements and tests
LVD050	EN 61558-2-1 1998	Safety of power transformers, power supply units and similar - Part 2-1: Particular requirements for separating transformers for general use
LVD051	EN 61558-2-6 1998	Safety of power transformers, power supply units and similar - Part 2-6: Particular requirements for safety isolating transformers for general use
LVD052	EN 61558-2-7 1998	Safety of power transformers, power supply units and similar - Part 2-7: Particular requirements for transformers for toys
LVD053	EN 61558-2-17 1998	Safety of power transformers, power supply units and similar - Part 2-17: Particular requirements for transformers for switch mode power supplies
LVD054	EN 61558-2-19 2001	Safety of power transformers, power supply units and similar devices - Part 2-19: Particular requirements for perturbation attenuation transformers
LVD055	IEC 60228 2004	Conductors of insulated cables
LVD056	IEC 60335-1 2001	Safety of household and similar electrical appliances - Part 1: General requirements
LVD057	IEC 60335-1 2004	Safety of household and similar electrical appliances - Part 1: General requirements
LVD058	IEC 60598-2-3 2002	Luminaires - Part 2-3: Particular requirements - Luminaires for road and street lighting
LVD059	IEC 60598-2-4 1997	Luminaires - Part 2: Particular requirements - Section 4: Portable general purpose luminaires
LVD060	IEC 60598-2-8 2001	Luminaires - Part 2-8: Particular requirements - Handlamps
LVD061	IEC 60598-2-11 2005	Luminaires - Part 2-11: Particular requirements - Aquarium luminaires
LVD062	IEC 60598-2-12 2006	Luminaires - Part 2-12: Particular requirements - Mains socketoutlet mounted nightlights
LVD063	IEC 60598-2-20 2003	Luminaires - Part 2-20: Particular requirements - Lighting chains
LVD064	IEC 60670-21 2004	Boxes and enclosures for electrical accessories for household and similar fixed electrical installations - Part 21: Particular requirements for boxes and enclosures with provision for suspension means
LVD065	IEC 60825-1 2001	Safety of laser products - Part 1: Equipment classification, requirements and user's guide
LVD066	IEC 60825-1 2007	Safety of laser products - Part 1: Equipment classification, requirements and user's guide
LVD067	IEC 60825-2 2007	Safety of laser products - Part 2: Safety of optical fibre communication systems (OFCS)
LVD068	IEC 61347-2-13 2006	Lamp controlgear - Part 2-13: Particular requirements for d.c. or a.c. supplied electronic controlgear for LED modules
LVD069	IEC 61558-1 2005	Safety of power transformers, power supplies, reactors and similar products - Part 1: General requirements and tests

電磁相容性標準

編號	歐市標準	名稱 ( 英文 )
EMC0001	CISPR 11 2004	Industrial, scientific and medical (ISM) radio-frequency equipment — Electromagnetic disturbance characteristics — Limits and methods of measurement
EMC002	CISPR 22 2006	Information technology equipment — Radio disturbance characteristics — Limits and methods of measurement
EMC003	EN 50083-2 2001	Cable networks for television signals, sound signals and interactive services — Part 2: Electromagnetic compatibility for equipment
EMC004	EN 50121-1 2006	Railway applications — Electromagnetic compatibility — Part 1: General
EMC005	EN 50121-2 2006	Railway applications — Electromagnetic compatibility — Part 2: Emission of the whole railway system to the outside world
EMC006	EN 50121-3-1 2006	Railway applications — Electromagnetic compatibility — Part 3-1: Rolling stock — Train and complete vehicle
EMC007	EN 50121-3-2 2006	Railway applications — Electromagnetic compatibility — Part 3-2: Rolling stock — Apparatus
EMC008	EN 50121-4 2006	Railway applications — Electromagnetic compatibility — Part 4: Emission and immunity of the signalling and telecommunications apparatus
EMC009	EN 50121-5 2000	Railway applications — Electromagnetic compatibility — Part 5: Emission and immunity of fixed power supply installations and apparatus
EMC010	EN 50121-5 2006	Railway applications — Electromagnetic compatibility — Part 5: Emission and immunity of fixed power supply installations and apparatus
EMC011	EN 55011 1998	Industrial, scientific and medical (ISM) radio-frequency equipment — Radio disturbance characteristics — Limits and methods of measurement
EMC012	EN 55011 2007	Industrial, scientific and medical (ISM) radio-frequency equipment — Radio disturbance characteristics — Limits and methods of measurement
EMC013	EN 55014-1 2006	Electromagnetic compatibility — Requirements for household appliances, electric tools and similar apparatus — Part 1: Emission
EMC014	EN 55015 2001	Limits and methods of measurement of radio disturbance characteristics of electrical lighting and similar equipment
EMC015	EN 55022 2006	Information technology equipment — Radio disturbance characteristics — Limits and methods of measurement
EMC016	EN 60947-2 2003	Low-voltage switchgear and control gear — Part 2: Circuit-breakers
EMC017	EN 60947-3 1999	Low-voltage switchgear and control gear — Part 3: Switches, disconnectors, switchdisconnectors and fuse-combination units
EMC018	EN 60947-4-1 2001	Low-voltage switchgear and control gear — Part 4-1: Contactors and motor-starters — Electromechanical contactors and motor-starters
EMC019	EN 60947-4-3 2000	Low-voltage switchgear and control gear — Part 4-3: Contactors and motor-starters — AC semiconductor controllers and contactors for non-motor loads
EMC020	EN 60947-5-7 2003	Low-voltage switchgear and control gear — Part 5-7: Control circuit devices and switching elements — Requirements for proximity devices with analogue output
EMC021	EN 60947-6-1 2005	Low-voltage switchgear and control gear — Part 6-1: Multiple function equipment — Transfer switching equipment
EMC022	EN 60947-6-2 2003	Low-voltage switchgear and control gear — Part 6-2: Multiple function equipment — Control and protective switching devices (or equipment) (CPS)
EMC023	EN 60947-8 2003	Low-voltage switchgear and control gear — Part 8: Control units for built-in thermal protection (PTC) for rotating electrical machines
EMC024	EN 61000-3-2 2001	Electromagnetic compatibility (EMC) — Part 3-2: Limits — Limits for harmonic current emissions (equipment input current up to and including 16 A per phase)
EMC025	EN 61000-3-3 1996 +A1 2001 +A2 2006	Electromagnetic compatibility (EMC) — Part 3-3: Limits — Limitation of voltage changes, voltage fluctuations and flicker in public low-voltage supply systems, for equipment with rated current ? 16 A per phase and not subject to conditional connection
EMC026	EN 61000-6-1 2001	Electromagnetic compatibility (EMC) — Part 6-1: Generic standards — Immunity for residential, commercial and light-industrial environments
EMC027	EN 61000-6-1 2007	Electromagnetic compatibility (EMC) — Part 6-1: Generic standards — Immunity for residential, commercial and light-industrial environments
EMC028	EN 61000-6-2 2005	Electromagnetic compatibility (EMC) — Part 6-2: Generic standards — Immunity for industrial environments
EMC029	EN 61000-6-3 2001	Electromagnetic compatibility (EMC) — Part 6-3: Generic standards — Emission standard for residential, commercial and light-industrial environments
EMC030	EN 61000-6-3 2007	Electromagnetic compatibility (EMC) — Part 6-3: Generic standards — Emission standard for residential, commercial and light-industrial environments
EMC031	EN 61000-6-4 2007	Electromagnetic compatibility (EMC) — Part 6-4: Generic standards — Emission standard for industrial environments
EMC032	IEC 61000-3-2 2000	Electromagnetic compatibility (EMC) — Part 3-2: Limits — Limits for harmonic current emissions (equipment input current up to and including 16 A per phase)
EMC033	IEC 61000-3-2 2005	Electromagnetic compatibility (EMC) — Part 3-2: Limits — Limits for harmonic current emissions (equipment input current ? 16 A per phase)
EMC034	IEC 61000-3-3 1994	Electromagnetic compatibility (EMC) — Part 3-3: Limits — Limitation of voltage changes, voltage fluctuations and flicker in public low-voltage supply systems, for equipment with rated current ? 16 A per phase and not subject to conditional connection
EMC035	IEC 61000-3-3 2005	Electromagnetic compatibility (EMC) — Part 3-3: Limits — Limitation of voltage changes, voltage fluctuations and flicker in public low-voltage supply systems, for equipment with rated current ? 16 A per phase and not subject to conditional connection
EMC036	IEC 61000-3-12 2004	Electromagnetic compatibility (EMC) — Part 3-12: Limits — Limits for harmonic currents produced by equipment connected to public low-voltage systems with input current > 16 A and ? 75 A per phase
EMC037	IEC 61000-6-1 1997	Electromagnetic compatibility (EMC) — Part 6-1: Generic standards — Immunity for residential, commercial and light-industrial environments
EMC038	IEC 61000-6-1 2005	Electromagnetic compatibility (EMC) — Part 6-1: Generic standards — Immunity for residential, commercial and light-industrial environments
EMC039	IEC 61000-6-2 2005	Electromagnetic compatibility (EMC) — Part 6-2: Generic standards — Immunity for industrial environments
EMC040	IEC 61000-6-4 2006	Electromagnetic compatibility (EMC) — Part 6-4: Generic standards — Emission standard for industrial environments
EMC041	ETSI EN 300 386 2008	Electromagnetic compatibility and radio spectrum matters (ERM); Telecommunication network equipment; Electromagnetic compatibility (EMC) requirements

◎ 營建產品

編號	歐市標準	名稱 ( 英文 )
CPD0001	DIN EN10312 1999	Welded stainless steel tubes for the conveyance of aqueous liquids including water for human consumption Technical delivery conditions
CPD0002	EN 54-2 1998	Fire detection and fire alarm systems — Part 2. Control and indicating equipment
CPD003	EN 54-4 1998	Fire detection and fire alarm systems — Power supply equipment
CPD004	EN 523 1997	Steel strip sheaths for prestressing tendons — Terminology, requirements, quality control
CPD005	EN 681-1 1996	Elastomeric seals — Material requirements for pipe joint seals used in water and drainage applications — Part 1. Vulcanized rubber
CPD006	EN 717-1 2004	Wood-based panels — Determination of formaldehyde release — Part 1: Formaldehyde emission by the chamber method
CPD007	EN 717-2 1995	Wood-based panels — Determination of formaldehyde release — Part 2: Formaldehyde release by the gas analysis method
CPD008	EN 717-3 1996	Wood-based panels — Determination of formaldehyde release — Part 3: Formaldehyde release by the flask method
CPD009	EN 845-3 2003	Specification for ancillary components for masonry — Part 3: Bed joint reinforcement of steel meshwork
CPD010	EN 877 1999	Cast iron pipes and fittings, their joints and accessories for the evacuation of water from buildings — Requirements, test methods and quality assurance
CPD011	EN 1154 2002	Building hardware — Controlled door closing devices — Requirements and test methods
CPD012	EN 1279-5 2005	Glass in building — Insulating glass units Part 5: Evaluation of conformity
CPD013	EN 10025-1 2004	Hot rolled products of structural steels — Part 1: General technical delivery conditions
CPD014	EN 10210-1 1994	Hot finished structural hollow sections of non-alloy and fine grain structural steels — Part 1: Technical delivery requirements
CPD015	EN 10210-1 2006	Hot finished structural hollow sections of non-alloy and fine grain structural steels — Part 1: Technical delivery requirements
CPD016	EN 10219-1 1997	Cold formed welded structural hollow sections of non-alloy and fine grain steels — Part 1. Technical delivery requirements
CPD017	EN 10219-1 2006	Cold formed welded structural hollow sections of non-alloy and fine grain steels — Part 1: Technical delivery conditions
CPD018	EN 10224 2003	Non-alloy steel tubes and fittings for the conveyance of water and other aqueous liquids — Technical delivery conditions
CPD019	EN 12094-8 1998	Fixed firefighting systems — Components for gas extinguishing systems — Part 8: Requirements and test methods for flexible connectors for CO2 systems
CPD020	EN 12352 2000	Traffic control equipment — Warning and safety light devices
CPD021	EN 14411 2003	Ceramic tiles — Definitions, classification, characteristics and marking
CPD022	EN 14528 2005	Bidets — Functional requirements and test methods
CPD023	EN ISO 6946 1997	Building components and building elements — Thermal resistance and thermal transmittance — Calculation method
CPD024	prEN 13964 2003	Suspended ceilings — Requirements and test methods

壓力設備

編號	歐市標準	名稱 ( 英文 )
PED0001	DIN EN 1092-1 2005	Flanges and their joints － Circular flanges for pipes, valves, fittings and accessories, PN-designated － Part 1: Steel flanges
PED002	DIN EN 1563 2005	Founding － Spheroidal graphite cast irons
PED003	DIN EN 10028-1 2003	Flat products made of steels for pressure purposes — Part 1: General requirements
PED004	DIN EN 10216-1 2004	Seamless steel tubes for pressure purposes – Technical delivery conditions Part 1: Non-alloy steel tubes with specified room temperature properties
PED005	DIN EN 10216-2 2004	Seamless steel tubes for pressure purposes – Technical delivery conditions Part 2: Non-alloy and alloy steel tubes with specified elevated temperature properties
PED006	DIN EN 10216-3 2004	Seamless steel tubes for pressure purposes – Technical delivery conditions Part 3: Alloy fine grain steel tubes
PED007	DIN EN 10216-4 2004	Seamless steel tubes for pressure purposes – Technical delivery conditions Part 4: Non-alloy and alloy steel tubes with specified low temperature properties
PED008	DIN EN 10253-2 1999	Butt-welding pipe fittings - Part 2: Non alloy and ferritic alloy steels with specific inspection requirements
PED009	DIN EN 10253-4 2003	Butt welding pipe fittings - Part 4. Wrought austenitic & austenitic-ferritic (duplex) stainless steels with specific inspection requirements
PED010	DIN EN 10305-4 2003	Steel tubes for precision applications – Technical delivery conditions Part 4: Seamless cold drawn tubes for hydraulic and pneumatic power systems
PED011	DIN EN 13789 2003	Industrial valves – Cast iron globe valves
PED012	EN 287-1 1992	Qualification test of welders – Fusion welding – Part 1: Steels
PED013	EN 287-1 2004	Qualification test of welders – Fusion welding – Part 1: Steels
PED014	EN 334 1999	Gas pressure regulators for inlet pressures up to 100 bar
PED015	EN 1057 1996	Copper and copper alloys — Seamless, round copper tubes for water and gas in sanitary and heating applications
PED016	EN 1092-1 2002	Flanges and their joints — Circular flanges for pipes, valves, fittings and accessories, PN designated — Steel flanges
PED017	EN 1092-3 2003	Flanges and their joints — Circular flanges for pipes, valves, fittings and accessories, PN designated — Part 3: Copper alloy flanges
PED018	EN 1092-4 2002	Flanges and their joints — Circular flanges for pipes, valves, fittings and accessories, PN designated — Part 4: Aluminium alloy flanges
PED019	EN 1171 2002	Industrial valves — Cast iron gate valves
PED020	EN 1252-1 1998	Cryogenic vessels — Materials — Part 1: Toughness requirements for temperatures below — 80 °C
PED021	EN 1759-3 2003	Flanges and their joints — Circular flanges for pipes, valves, fittings and accessories, Class designated — Part 3: Copper alloy flanges
PED022	EN 1759-4 2003	Flanges and their joint — Circular flanges for pipes, valves, fittings and accessories, class designated — Part 4: Aluminium alloy flanges
PED023	EN 1983 2006	Industrial valves — Steel ball valves
PED024	EN 10028-1 2000	Flat products made of steels for pressure purposes — Part 1: General requirements
PED025	EN 10028-2 2003	Flat products made of steels for pressure purposes — Part 2: Non-alloy and alloy steels with specified elevated temperature properties
PED026	EN 10028-3 2003	Flat products made of steels for pressure purposes — Part 3: Weldable fine grain steels, normalized
PED027	EN 10028-4 2003	Flat products made of steels for pressure purposes — Part 4: Nickel alloy steels with specified low temperature properties
PED028	EN 10028-5 2003	Flat products made of steels for pressure purposes — Part 5 Weldable fine grain steels, thermomechanically rolled
PED029	EN 10028-6 2003	Flat products made of steels for pressure purposes — Part 6: Weldable fine grain steels, quenched and tempered
PED030	EN 10204 1991	Metallic products — Types of inspection documents
PED031	EN 10204 2004	Metallic products — Types of inspection documents
PED032	EN 10213-1 1996	Technical delivery conditions for steel castings for pressure purposes Part 1.General
PED033	EN 10213-2 1996	Technical Delivery Conditions for Steel Castings for Pressure Purposes Part 2: Steel Grades for Use at Room Temperature and at Elevated Temperature (V)
PED034	EN 10213-3 1996	Technical Delivery Conditions for Steel Castings for Pressure Purposes Part 3: Steels for Use at Low Temperatures
PED035	EN 10213-4 1996	Technical Delivery Conditions for Steel Castings for Pressure Purposes Part 4: Austenitic and Austenitic-Ferritic Steel Grades (Q)
PED036	EN 10216-1 2002	Seamless steel tubes for pressure purposes — Technical delivery conditions — Part 1: Non-alloy steel tubes with specified room temperature properties
PED037	EN 10216-2 2002	Seamless steel tubes for pressure purposes — Technical delivery conditions — Part 2: Non-alloy and alloy steel tubes with specified elevated temperature properties
PED038	EN 10216-5 2004	Seamless steel tubes for pressure purposes — Technical delivery conditions — Part 5: Stainless steel tubes
PED039	EN 10217-1 2002	Welded steel tubes for pressure purposes — Technical delivery conditions — Part 1: Non-alloy steel tubes with specified room temperature properties
PED040	EN 10222-3 1999	Steel forgings for pressure purposes — Part 3: Nickel steels with specified low-temperature properties
PED041	EN 10222-4 1999	Steel forgings for pressure purposes — Part 4: Weldable fine-grain steels with high proof strength
PED042	EN 10222-5 1999	Steel forgings for pressure purposes — Part 5: Martensitic, austenitic and austenitic-ferritic stainless steels
PED043	EN 12266-1 2003	Industrial valves — Testing of valves — Part 1: Pressure tests, test procedures and acceptance criteria Mandatory requirements
PED044	EN 12516-1 2005	Industrial valves — Shell design strength — Part 1: Tabulation method for steel valve shells
PED045	EN 12516-3 2002	Valves — Shell design strength — Part 3: Experimental method
PED046	EN 12735-2 2001	Copper and copper alloys — Seamless, round copper tubes for air conditioning and refrigeration — Part 2: Tubes for equipment
PED047	EN 12952-1 2002	Water-tube boilers and auxiliary installations — Part 1: General
PED048	EN 12952-2 2001	Water-tube boilers and auxiliary installations — Part 2: Materials for pressure parts of boilers and accessories
PED049	EN 12952-3 2001	Water-tube boilers and auxiliary installations — Part 3: Design and calculation of pressure parts
PED050	EN 12952-5 2001	Water-tube boilers and auxiliary installations — Part 5: Workmanship and construction of pressure parts of the boiler
PED051	EN 12952-6 2002	Water-tube boilers and auxiliary installations - Part 6: Inspection during construction; documentation and marking of pressure parts of the boiler
PED052	EN 12952-7 2002	Water-tube boilers and auxiliary installations -
PED052	EN 12952-7 2002	Part 7: Requirements for equipment for the boiler
PED053	EN 12952-8 2002	Water-tube boilers and auxiliary installations -
PED053	EN 12952-8 2002	Part 8: Requirements for firing systems for liquid and gaseous fuels for the boiler
PED054	EN 12952-9 2003	Water-tube boilers and auxiliary installations -
PED054	EN 12952-9 2003	Part 9: Requirements for firing systems for pulverized solid fuels for the boiler
PED055	EN 12952-10 2002	Water-tube boilers and auxiliary installations -
PED055	EN 12952-10 2002	Part 10: Requirements for safeguards against excessive pressure
PED056	EN 12952-11 2007	Water-tube boilers and auxiliary installations -
PED056	EN 12952-11 2007	Part 11: Requirements for limiting devices of the boiler and accessories
PED057	EN 12952-14 2004	Water-tube boilers and auxiliary installations -
PED057	EN 12952-14 2004	Part 14: Requirements for flue gas DENOX-systems using liquefied pressurized ammonia and ammonia water solution
PED058	EN 12952-16 2003	Water-tube boilers and auxiliary installations -
PED058	EN 12952-16 2003	Part 16: Requirements for grate and fluidized-bed firing systems for solid fuels for the boiler
PED059	EN 12953-1 2002	Shell boilers — Part 1: General
PED060	EN 12953-2 2002	Shell boilers — Part 2: Materials for pressure parts of boilers and accessories
PED061	EN 12953-3 2002	Shell boilers — Part 3: Design and calculation for pressure parts
PED062	EN 12953-4 2002	Shell boilers — Part 4: Workmanship and construction of pressure parts of the boiler
PED063	EN 12953-5 2002	Shell boilers — Part 5: Inspection during construction, documentation and marking of pressure parts of the boiler
PED064	EN 12953-6 2002	Shell boilers — Part 6: Requirements for equipment for the boiler
PED065	EN 12953-7 2002	Shell boilers — Part 7: Requirements for firing systems for liquid and gaseous fuels for the boilers
PED066	EN 12953-8 2001	Shell boilers — Part 8: Requirements for safeguards against excessive pressure
PED067	EN 12953-9 2007	Shell boilers — Part 9: Requirements for limiting devices of the boiler and accessories
PED068	EN 13121-1 2003	GRP tanks and vessels for use above ground — Part 1: Raw materials — Specification conditions and acceptance conditions
PED069	EN 13121-2 2003	GRP tanks and vessels for use above ground — Part 2: Composite materials — Chemical resistance
PED070	EN 13133 2000	Brazing — Brazer approval
PED071	EN 13134 2000	Brazing — Procedure approval
PED072	EN 13136 2001 +A1 2005	Refrigerating systems and heat pumps — Pressure relief devices and their associated piping — Methods for calculation
PED073	EN 13445-2 2002	Unfired pressure vessels — Part 2: Materials
PED074	EN 13445-3 2002	Unfired pressue vessels — Part 3: Design
PED075	EN 13445-4 2002	Unfired pressure vessels — Part 4: Fabrication
PED076	EN 13445-5 2002	Unfired pressure vessels — Part 5: Inspection and testing
PED077	EN 13445-6 2002 +A1 2004	Unfired pressure vessels — Part 6: Requirements for the design and fabrication of pressure vessels and pressure parts constructed from spheroidal graphite cast iron
PED078	EN 13480-1 2002	Metallic industrial piping — Part 1: General
PED079	EN 13480-2 2002	Metallic industrial piping — Part 2: Materials
PED080	EN 13480-4 2002	Metallic industrial piping — Part 4: Fabrication and installation
PED081	EN 13480-5 2002	Metallic industrial piping — Part 5: Inspection and testing
PED082	EN 13648-3 2002	Cryogenic vessels – Safety devices for protection against excessive pressure Part 3: Determination of required discharge – Capacity and sizing
PED083	EN 13835 2002	Founding — Austenitic cast irons
PED084	EN 14129 2004	Pressure relief valves for LPG tanks
PED085	EN 14197-1 2003	Cryogenic vessels — Static non-vacuum insulated vessels — Part 1: Fundamental requirements
PED086	EN 14276-1 2006	Pressure equipment for refrigerating systems and heat pumps — Part 1: Vessels — General requirements
PED087	EN 14276-2 2003	Pressure equipment for refrigerating systems and heat pumps — Part 2. Piping — General Requirements
PED088	EN 14341 2006	Industrial valves — Steel check valves
PED089	EN 14359 2006	Gas-loaded accumulators for fluid power applications
PED090	EN ISO 4126-1 2004	Safety devices for protection against excessive pressure — Part 1: Safety valves
PED091	EN ISO 4126-4 2004	Safety devices for protection against excessive pressure — Part 4: Pilot-operated safety valves
PED092	EN ISO 4126-5 2004	Safety devices for protection against excessive pressure — Part 5: Controlled safety pressure-relief systems (CSPRS)
PED093	EN ISO 9606-2 2004	Qualification test of welders — Fusion welding — Part 2: Aluminium and aluminium alloys
PED094	EN ISO 15614-1 2004	Specification and qualification of welding procedures for metallic materials — Welding procedure test — Part 1: Arc and gas welding of steels and arc welding of nickel and nickel alloys
PED095	EN ISO 15614-5 2004	Specification and qualification of welding procedures for metallic materials — Welding procedure test — Part 5: Arc welding of titanium, zirconium and their alloys
PED096	EN ISO 15614-8 2002	Specification and qualification of welding procedures for metallic materials — Welding procedure test — Part 8: Welding of tubes to tube-plate joints
PED097	EN ISO 15614-11 2002	Specification and qualification of welding procedures for metallic materials — Welding procedure test — Part 11: Electron and laser beam welding
PED098	ISO 9606-3 1999	Approval testing of welders — Fusion welding — Part 3: Copper and copper alloys
PED099	ISO 15614-4 2005	Specification and qualification of welding procedures for metallic materials — Welding procedure test — Part 4: Finishing welding of aluminium castings
PED100	ISO 15614-6 2006	Specification and qualification of welding procedures for metallic materials — Welding procedure test — Part 6: Arc and gas welding of copper and its alloys
PED101	ISO 15614-7 2007	Specification and qualification of welding procedures for metallic materials — Welding procedure test — Part 7: Overlay welding
PED102	NF EN 10216-3 2002	Seamless steel tubes for pressure purposes Technical delivery conditions Part 3: Alloy fine grain steel tubes
PED103	NF EN 10216-5 2005	Seamless steel tubes for pressure purposes Technical delivery conditions Part 5: Stainless steel tubes
PED104	prEN 14276-2 2003	Pressure equipment for refrigerating systems and heat pumps Part 2. Piping - General Requirements

醫療標準

編號	歐市標準	名稱 ( 英文 )
MDD0001	EN 1985 1999	Walking aids- General requirements and test methods
MDD0002	ISO 11199-1 2000	Walking aids manipulated by both arms- Requirements and test methods- Part1: Walking frames
MDD0003	ISO 11199-2 2005	Walking aids manipulated by both arms- Requirements and test methods- Part 2: Rollators
MDD0004	ISO 11334-1 1994	Walking aids manipulated by one arm Requirements and test methods — Part 1:Elbow crutches
MDD0005	ISO 11334-4 1999	Walking sticks with three or more legs
MDD0006	EN 12182 1999	Technical aids for disabled persons- General requirements and test methods
MDD0007	prEN 12182	Technical aids for disabled persons- General requirements and test methods
MDD008	EN 285 2006	Sterilization — Steam sterilizers — Large sterilizers
MDD009	EN 455-1 2001	Medical gloves for single use — Part 1: Requirements and testing for freedom from holes
MDD010	EN 552 1994	Sterilization of health care products — Radiation — Part 1: Requirements for development, validation and routine control of a sterilization process for medical devices
MDD011	EN 556 1995	Sterilization of medical devices — Requirements for medical devices to be designated ‘ STERILE' — Part 1: Requirements for terminally sterilized medical devices
MDD012	EN 556-1 2001	Sterilization of medical devices — Requirements for medical devices to be designated ‘ STERILE' — Part 1: Requirements for terminally sterilized medical devices
MDD013	EN 556-2 2003	Sterilization of medical devices — Requirements for medical devices to be designated ‘ STERILE' — Part 2: Requirements for aseptically processed medical devices
MDD014	EN 868-1 1997	Packaging for terminally sterilized medical devices — Part 1: Requirements for materials, sterile barrier systems and packaging systems (ISO 11607-1:2006)
MDD015	EN 980 2003	Graphical symbols for use in the labelling of medical devices
MDD016	EN 980 2008	Graphical symbols for use in the labelling of medical devices
MDD017	EN 1041 1998	Information supplied by the manufacturer with medical devices
MDD018	EN 1174-1 1996	Sterilization of medical devices — Microbiological methods — Part 1: Determination of a population of microorganisms on products (ISO 11737-1:2006)
MDD019	EN 1174-2 1997	Sterilization of medical devices — Microbiological methods — Part 1: Determination of a population of microorganisms on products (ISO 11737-1:2006)
MDD020	EN 12006-2 1998	Non active surgical implants — Particular requirements for cardiac and vascular implants — Part 2: Vascular prostheses including cardiac valve conduits
MDD021	EN 12006-3 1999	Non active surgical implants — Particular requirements for cardiac and vascular implants — Part 3: Endovascular devices
MDD022	EN 13060 2004	Small steam sterilizers
MDD023	EN ISO 4074 2002	Natural latex rubber condoms — Requirements and test methods
MDD024	EN ISO 11607-1 2006	Packaging for terminally sterilized medical devices — Part 1: Requirements for materials, sterile barrier systems and packaging systems (ISO 11607-1:2006)
MDD025	EN ISO 11607-2 2006	Packaging for terminally sterilized medical devices — Part 2: Validation requirements for forming, sealing and assembly processes (ISO 11607-2:2006)
MDD026	EN ISO 14971 2007	Medical devices — Application of risk management to medical devices
MDD027	ISO 10993-4 AMD1 2006	Biological evaluation of medical devices — Part 4: Selection of tests for interactions with blood
MDD028	ISO 10993-11 2006	Biological evaluation of medical devices — Part 11: Tests for systemic toxicity
MDD029	ISO 11135-1 2007	Sterilization of health care products — Ethylene oxide — Part 1: Requirements for development, validation and routine control of a sterilization process for medical devices
MDD030	ISO 11137-1 2006	Sterilization of health care products — Radiation — Part 1: Requirements for development, validation and routine control of a sterilization process for medical devices
MDD031	ISO 11137-2 2006	Sterilization of health care products — Radiation — Part 2: Establishing the sterilization dose
MDD032	ISO 13485 2003	Medical devices — Quality management systems — Requirements for regulatory purposes
MDD033	ISO 14155-1 2003	Clinical investigation of medical devices for human subjects — Part 1: General requirements
MDD034	ISO 14155-2 2003	Clinical investigation of medical devices for human subjects — Part 2: Clinical investigation plans
MDD035	ISO 14630 2008	Non-active surgical implants — General requirements
MDD036	ISO 14971 2000	Medical devices — Application of risk management to medical devices
MDD037	ISO 14971 2007	Medical devices — Application of risk management to medical devices

個人保護設備

編號	歐市標準	名稱 ( 英文 )
PPE001	EN 133 1991	Respiratory protective devices — Classification
PPE002	EN 133 2001	Respiratory protective devices — Classification
PPE003	EN 138 1994	Respiratory protective devices — Specification for fresh air hose breathing apparatus for use with full face mask, half mask or mouthpiece assembly
PPE004	EN 165 1996	Personal eye-protection — Vocabulary
PPE005	EN 165 2005	Personal eye-protection — Vocabulary
PPE006	EN 167 2002	Personal eye protection — Optical test methods
PPE007	EN 168 2002	Personal eye-protection — Non-optical test methods
PPE007	EN 250 1993	Respiratory equipment — Open-circuit self-contained compressed air diving apparatus — Requirements, testing, marking
PPE008	EN 353-2 1993	Personal protective equipment against falls from a height: guided type fall arresters — Part 2: Specification for guided type fall arresters on a flexible anchorage line
PPE009	EN 354 1993	Personal protective equipment against falls from a height — Lanyards
PPE010	EN 407 1994	Protective gloves against thermal risks (heat and/or fire)
PPE011	EN 458 1994	Hearing protectors — Recommendations for selection, use, care and maintenance — Guidance document
PPE012	EN 471 1994	Specification for High-visibility warning clothing
PPE013	EN 1149-1 2006	Protective clothing — Electrostatic properties — Part 1: Test method for measurement of surface resistivity
PPE014	EN 1149-2 1997	Protective clothing — Electrostatic properties — Part 2. Test method for measurement of the electrical resistance through a material (vertical resistance)
PPE015	EN 1149-3 2004	Protective clothing — Electrostatic properties — Part 3: Test methods for measurement of charge decay
PPE016	EN 1836 1997	Personal eye protection — Sunglasses, sunglare filters for general use and filters for direct observation of the sun
PPE017	EN 1938 1999	Personal eye protection — Goggles for motorcycle and moped users
PPE018	EN 13087-6 2000	Protective helmets — Test methods — Part 6: Field of vision
PPE019	EN 13287 2004	Personal protective equipment — Footwear — Test method for slip resistance
PPE020	EN 14120 2003	Protective clothing — Wrist, palm, knee and elbow protectors for users of roller sports equipment — Requirements and test methods

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