CE簡介

CE低電壓
CE 壓力設備指令
中聯CE標準資料庫
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我們的服務性與專業度
◎ 與多家工業局財團法人合作，如：金屬中心、PMC、鞋技中心
◎ 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： TUV(LGA), DNV, IG, SGS等
◎ 擁有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 )
2006/42/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 (2006/42/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

　 　 　

 

 

CE機械
　
何謂機械 ?
　

機械指令 (MD 2006/42/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
　 　 　

1.2006/42/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。

 

 

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
　 　 　

 

 

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
　 　 　

 

 

 

CE 建築
標誌營建產品 指令 CPD (89/106/EEC)
壹：
　

本指令係為各會員國為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。

營建產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。舉凡建築用螺栓配件、瓷磚、牆磚、地磚、天花板、輕鋼架、木材結構、木製嵌板、鑲板、壁板、火災偵測及警報系統、火災服務設備、建築玻璃、門、窗、建築五金、工程用結構鋼和熱軋鋼、熱交換器等產品皆屬該指令範圍。

指令中制定各產品銷售於歐盟會員國前，應遵守的要項及檢測需求，同時指令亦將產品區分為各種等級，每一種產品需依照其等級之規定，並藉由歐盟認可單位進行測試、工廠檢查等相關認證工作執行，以取得 CE 證書及在產品上黏貼 CE 標誌，才能銷售至歐盟各國。
　　
　

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

※ ITT&文件審查：
就ITT的資料與過程來加以比對、確認，並同時審閱工廠作業管制的相關文件與紀錄。
※ FPC&現場評審：
根據相關規範來確認生產線實地作業情形，藉以達到有效的工廠作業管制。
※ ITT (initial type testing) 的實驗室測試資格部分，需滿足以下兩項其中之一：
1. 實驗室需通過ISO17025認證
2. 歐盟所認可之實驗室
　 合作的國外認可驗證機構：
　

1. 德國LGA
• 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
��
2. 丹麥DANISH
• 執行防火測試
��
3. 英國勞氏 (Lloyd's Register Verification Limited)
• 核發合格證書
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。
　

 

 

 

 

 

CE壓力設備指令
　
CE 壓力設備指令 97/23/EEC
　

指令概要：

針對壓力設備或容器，歐盟制定了壓力設備指令，一般簡稱為 PED 。其定義包含容器、管路、安全及壓力附件，只要是設計壓力值超過 0.5bar 的設備，不管壓力、容積大小為何，都必須符合 PED 規範。所以產品涵蓋了：

•  壓力容器
•  熱交換器
•  氣體壓力鋼瓶
•  蒸氣鍋爐
•  管路設備
•  儲存槽
•  釋放壓力設備
•  閥、 調節閥
•  其他

同時也包含了所有壓力零件及產品，例如法蘭、噴嘴、吊車零件、快速接頭等。

規範依據壓力設備之危險等級，將其區分為四大類（ Category I, II, III, IV ），故危險性越高，則分類等級越高，規定也就越趨嚴格。除了此分類之外，也必須依照產品選擇適當的模式，而模式與產品單產或量產、製造商品質系統有關。

　 符合 PED 需求：
　


壓力設備製造廠在準備 CE 認證前，應先了解 PED 指令的要求及驗證流程，一般所牽涉到的程序有：

•  設備認證
•  設計分析及認可
•  焊接程序認可：須 視產品形式及分類而定
•  焊接人員認證：須 視產品形式及分類而定
•  材料測試及認證
•  最終設備檢驗及認證

另外，製造廠商於驗證過程中，需準備技術文件，如產品設計圖、產品規格及依據標準、強度計算書、材料材質證明、水壓或氣壓測試程序、 ESR 基本安全要求、風險評估等等，如此，才能證明該壓力設備符合 PED 指令的要求是安全無慮的。
　 　 　

 

 

 

 

 

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

2006/42/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
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
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
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 —
N 809:1998/AC:2001
MD0028 EN 811 1997 Safety of machinery — Safety distances to prevent danger zones being reached by the lower limbs
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
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
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
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 –
Part 1: Safety requirements for blade granulators
MD0049 EN ISO 12100-1 2003 Safety of machinery Basic concepts, general principles for design
Part 1: Basic terminology, methodology
MD0050 EN ISO 12100-2 2003 Safety of machinery Basic concepts, general principles for design
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 —
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-
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
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
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-
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 —
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
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

MD0162

EN 115

Safety of escalators and moving walks — Part 1: Construction and installation

MD0163

EN 1612-2:2000

Plastics and rubber machines — Reaction moulding machines — Part 2: Safety requirements for reaction moulding plant

MD0164

EN 13001-1:2004

Cranes — General design — Part 1: General principles and requirements

MD0165

EN 13001-2:2004

Cranes — General design — Part 2: Load actions

MD0166

EN 13218:2002

Machine tools — Safety — Stationary grinding machines

MD0167

EN 13732:2002

Food processing machinery — Bulk milk coolers on farms — Requirements for construction, performance, suitability for use, safety and hygiene

 

◎ 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

LVD070

EN 60127-1:2006

Miniature fuses — Part 1: Definitions for miniature fuses and general requirements for miniature fuse-links

LVD071

EN 60127-2:2003

Miniature fuses — Part 2: Cartridge fuse-links

LVD072

EN 60127-3:1996

Miniature fuses — Part 3: Sub-miniature fuse-links

LVD073

EN 60127-4:2005

Miniature fuses — Part 4: Universal modular fuse-links (UMF) — Through-hole

and surface mount types

LVD074

EN 61347-1:2001

Lamp control gear — Part 1: General and safety requirements

 

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

CPD025

EN 14399-1:2005

High-strength structural bolting assemblies for preloading — Part 1: General requirements

 

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 -

Part 7: Requirements for equipment for the boiler

PED053

EN 12952-8 2002

Water-tube boilers and auxiliary installations -

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 -

Part 9: Requirements for firing systems for pulverized solid fuels for the boiler

PED055

EN 12952-10 2002

Water-tube boilers and auxiliary installations -

Part 10: Requirements for safeguards against excessive pressure

PED056

EN 12952-11 2007

Water-tube boilers and auxiliary installations -

Part 11: Requirements for limiting devices of the boiler and accessories

PED057

EN 12952-14 2004

Water-tube boilers and auxiliary installations -

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 -

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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