BS EN ISO 13485:2012


Medical devices. Quality management systems. Requirements for regulatory purposes British Standard / European Standard / International Organization for Standardization / 31-Mar-2012 / 86 pages ISBN: 9780580778605

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 13485:2003. The outcome was that CEN decided to publish a new edition of the standard (EN ISO 13485:2012). This standard has a revised Foreword and Annexes ZA, ZB and ZC, but the core text remains unchanged.

Cross References:
ISO 9000:2000
ISO 9001:2000
ISO 10012
ISO 11134:1994
ISO 11135:1994
ISO 11137:1995
ISO 13683:1997
ISO 14155-1:2003
ISO 14155-2:2003
ISO 14160:1998
ISO 14937:2000
ISO/TR 14969
ISO 14971:2000
ISO 19011:2002

Replaces BS EN ISO 13485:2003 which remains current
All current amendments available at time of purchase are included with the purchase of this document.

Keywords: Medical equipment; Medical instruments; Medical technology; Quality management; Quality assurance systems; Acceptance (approval); Management
Product Code(s): 30258513,30258513

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