有人看過 BS EN ISO 14971:2009 医疗器械风险管理標準嗎?
在其他网上看到,权限不够,无法下载,不知这标准是真或假BS EN ISO 14971:2009
Medical Devices - Application of Risk Management to Medical Devices
希望有人能上传来确认一下, 应该和ISO 14971:2007没什么两样吧！
难道欧洲人又加入了新要求？？？ the original standard is dated : 2007
probably british standard institute made a mistake so they published the new version in 2009.
you cant use the BS EN ISO 14971:2007
but you can use EN ISO 14971:2007
important is using the true dated version of EN standard
if you want i can upload the version of 2007 今天好信儿了一下，查了一圈，确认下这个2009是怎么来的。以下是查询结果：
Reference number: EN ISO 14971:2009
Title: Medical devices - Application of risk management to medical devices (ISO 14971:2007, Corrected version 2007-10-01)
楼上说的带BS的就是英国由BSI等同这个标准转化的英标了，看意思09版是对07版的一个勘误版本，或许吧。 故事是这样的：
ISO 组织发布了一个14971：2007的标准，欧盟一看，不错，我也用吧，就在前面加了一个EN， 叫EN ISO 14971，由于也是在2007年发布的，所以叫 EN ISO 14971:2007. 一般来说，不会有差别，就是多了一个EN ，有可能在附录中加了本标准和MDD 附录一的对照。英国人一看，想，我们也用吧，作为英国本国的标准，但是英国人办事比较慢，想了两年才想通，在2009年才发布，所以叫 BS EN ISO 14971：2009了。 引用第4楼stingray于2009-11-25 16:29发表的:
故事是这样的：
ISO 组织发布了一个14971：2007的标准，欧盟一看，不错，我也用吧，就在前面加了一个EN， 叫EN ISO 14971，由于也是在2007年发布的，所以叫 EN ISO 14971:2007. 一般来说，不会有差别，就是多了一个EN ，有可能在附录中加了本标准和MDD 附录一的对照。英国人一看，想，我们也用吧，作为英国本国的标准，但是英国人办事比较慢，想了两年才想通，在2009年才发布，所以叫 BS EN ISO 14971：2009了。
这个真不是，EN确实有个2009的版本，BS也是把2007的升版到2009了，可不是两年后才发布。 医疗器械法规,实事求是,眼见为凭,大家继续关注,
BS EN ISO 14971:2007
http://www.angui.org/read.php?tid-16344-keyword-14971.html
ISO14971-2007 中文.pdf
ISO14971－2007英文.pdf
http://www.angui.org/read.php?tid-38219-keyword-14971.html BS EN ISO 14971:2009
*New* Medical Devices. Medical devices. Application of risk management to medical devices
This standard specifies a procedure by which a manufacturer can identify the hazards associated with medical devices and their accessories, including in vitro diagnostic medical devices. It also specifies a procedure to estimate and evaluate the identified risks, control these risks and monitor the effectiveness of the control.
The requirements of BS EN ISO 14971:2009 are applicable to all stages of the lifecycle of a medical device, but do not apply to clinical judgements relating to the use of a medical device and it does not specify acceptable risk levels.
£ 180.00 ---- from BSI "BS EN ISO 14971 Medical devices. Application of risk management to medical devices has been revised and now contains three additional informative annexes, to ensure conformity with a means of conforming to the Essential Requirements of the EU Directives 93/42/EEC (medical devices), 90/385/EEC (active implantable medical devices) and 98/79/EC (in vitro diagnostic devices)."
and
"BS EN ISO 14971:2009 replaces BS EN ISO 14971:2007, which has been withdrawn" There is some text changes in Annex ZA - relationship between the standard and medical device directives - but not anything significant. There is an addition of Annex ZB - links to 90/385/EEC (Active Implantable Medical Devices) and Annex ZC with links to 98/79/EC (IVD devices). The text of each annex is essentially the same - just referrencing the specific directives. The Annex ZA now just covers 93/42/EEC i.e. 3 seperate pages when 1 was OK before!
