BS EN ISO 14971:2012 PDF
Medical devices. Application of risk management to medical devices
Medical devices. Application of risk management to medical devices
- Статус документа:
- Отменён
- Формат:
- Электронный (PDF)
- Дата публикации:
- 31 июля 2012 г.
- ICS:
- 11.040.01
- Технический комитет:
- CEN
- SKU:
- BS EN ISO 14971:2012
Abstract
BS EN ISO 14971:2012 Medical devices. Application of risk management to medical devices
In 2011 the European Commission raised a concern around the legal text supporting presumption of conformity to the Medical Device Directives (Annexes ZA, ZB, ZC) in EN ISO 14971:2009 . The outcome was that CEN decided to publish a new edition of the standard ( EN ISO 14971:2012 ).
This standard has a revised Foreword and Annexes ZA, ZB and ZC, but the core text remains unchanged. What is BS EN :2012?
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