IVDD协调标准清单（医疗器械CE认证资料） _ 工业工程网

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EN 375: 2001 Information supplied by the manufacturer with in vitro diagnostic reagents for professional use
智能拖地机器人，云鲸 NARWAL
EN 376: 2002 Information supplied by the manufacturer with in vitro diagnostic reagents for self-testing
智能拖地机器人，云鲸 NARWAL 智能拖地机器人，云鲸 NARWAL
EN 591: 2001 Instructions for use in vitro diagnostic instruments for professional use
智能拖地机器人，云鲸 NARWAL
EN 592: 2002 Instructions for use for in vitro diagnostic instruments for self-testing
智能拖地机器人，云鲸 NARWAL
EN 928: 1995 In vitro diagnostic systems – Guidance on the application of EN 29001 and EN 46001 and of EN 29002 and EN 46002 for in vitro diagnostic medical devices
智能拖地机器人，云鲸 NARWAL 智能拖地机器人，云鲸 NARWAL
EN 980: 1996/ A2:2001 Graphical symbols for use in the labelling of medical devices
EN 1658: 1996 Requirements for marking of in vitro diagnostic instruments
智能拖地机器人，云鲸 NARWAL 智能拖地机器人，云鲸 NARWAL
EN 12286: 1998/ A1:2000 In vitro diagnostic medical devices – Measurement of quantities in samples of biological origin – Presentation of reference measurement procedures
智能拖地机器人，云鲸 NARWAL 智能拖地机器人，云鲸 NARWAL
EN 12287: 1999 In vitro diagnostic medical devices – Measurement of quantities in samples of biological origin – Description of reference materials
EN 12322: 1999/ A1:2001 In vitro diagnostic medical devices – Culture media for microbiology – Performance criteria for culture media
智能拖地机器人，云鲸 NARWAL 智能拖地机器人，云鲸 NARWAL
EN 13532: 2002 General requirements for in vitro diagnostic medical devices for self-testing
智能拖地机器人，云鲸 NARWAL
EN 13612: 2002 Performance evaluation of in vitro diagnostic medical devices
EN 13640: 2002 Stability testing of in vitro diagnostic medical devices
EN 13641: 2002 Elimination or reduction of risk of infection related to in vitro diagnostic reagents
EN 13975:2003 Sampling procedures used for acceptance testing of in vitro diagnostic medical devices - Statistical aspects
智能拖地机器人，云鲸 NARWAL 智能拖地机器人，云鲸 NARWAL
EN ISO 14971: Medical devices – Application of risk management to medical devices (ISO 14971:2000)
智能拖地机器人，云鲸 NARWAL
2000
智能拖地机器人，云鲸 NARWAL 智能拖地机器人，云鲸 NARWAL
EN ISO 18153:2003 In vitro diagnostic medical devices - Measurement of quantities in biological samples - Metrological traceability of values for catalytic concentration of enzymes assigned to calibrators and control materials (ISO 18153:2003)
智能拖地机器人，云鲸 NARWAL
EN 61010-2-101: 2002 Safety requirements for electrical equipment for measurement, control, and laboratory use - Part 2-101: Particular requirements for in vitro diagnostic (IVD) medical equipment
智能拖地机器人，云鲸 NARWAL
Reference document: IEC 61010-2-101:2002 (Modified)</ul>
智能拖地机器人，云鲸 NARWAL

pmp148 (2006-8-03 02:05:58)哈哈学习
多谢分享pmp148 (2006-8-29 00:22:56)出口认证--开拓国际市场的通行证！
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希望可以为您的产品出口提供“通行证”！hua0530 (2007-4-18 11:46:38)tttttttttttttttttttttttttttttttt

[ 本帖最后由 hua0530 于 2007-7-13 17:42 编辑 ]sc623 (2007-6-08 15:40:45):) 出口认证--开拓国际市场的通行证！
xo p%P*J,zsrL您好
%o}4[)u3jd x~5Y.`我专门负责医疗器械出口认证
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"O-c3K3Y#O3{.F希望可以为您的产品出口提供“通行证”！bztest (2007-8-29 09:22:09)争创认证领域的第一品牌
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专注CE 服务中国 || 权威认证值得信赖mantail (2007-8-29 14:53:26)做医疗器械的多交流

顶上去智能拖地机器人，云鲸 NARWAL

linynan · 发表于 2020-10-9 19:12:40

楼上你为何这么吊

aaaaaa · 发表于 2020-10-9 19:32:03

谢谢楼主，共同发展

jiao99 · 发表于 2020-10-9 21:03:15

我在论坛打滚这么多年，所谓阅人无数，就算没有见过猪走路，也总明白猪肉是啥味道的。

狼道 · 发表于 2020-10-9 21:24:18

支持下很好的资料

yangchang123 · 发表于 2020-10-9 21:29:20

学习了，谢谢分享

hijk712 · 发表于 2020-10-9 21:44:06

我想加入 QQ群

woooons · 发表于 2020-10-9 21:50:54

我是来刷分的，嘿嘿

zlimlx · 发表于 2020-10-10 08:07:24

大爱工业工程

tengle56 · 发表于 2020-10-10 08:13:50

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IVDD协调标准清单（医疗器械CE认证资料） _ 工业工程网

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