BS EN ISO 13485:2012

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:
90/385/EEC
93/42/EEC
98/79/EC
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): 30268037,30268037

This product references:ISO 11134:1994 - Sterilization of health care products -- Requirements for validation and routine control -- Industrial moist heat sterilization
ISO 11135:1994 - Medical devices -- Validation and routine control of ethylene oxide sterilization
ISO 13683:1997 - Sterilization of health care products -- Requirements for validation and routine control of moist heat sterilization in health care facilities
ISO 14155-1:2003 - Clinical investigation of medical devices for human subjects - Part 1: General requirements
ISO 14155-2:2003 - Clinical investigation of medical devices for human subjects - Part 2: Clinical investigation plans
ISO 14160:1998 - Sterilization of single-use medical devices incorporating materials of animal origin -- Validation and routine control of sterilization by liquid chemical sterilants
ISO 14937:2000 - Sterilization of health care products -- General requirements for characterization of a sterilizing agent and the development, validation and routine control of a sterilization process for medical devices
ISO 11137:1995 - Sterilization of health care products -- Requirements for validation and routine control -- Radiation sterilization
ISO 14971:2000 - Medical devices -- Application of risk management to medical devices
ISO 9001:2000 - Quality management systems -- Requirements
ISO 19011:2002 - Guidelines for quality and/or environmental management systems auditing
This product replaces:BS EN ISO 13485:2003 - Medical devices. Quality management systems. Requirements for regulatory purposes
This product same asISO 13485:2003 - Medical devices. Quality management systems. Requirements for regulatory purposes

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BS EN ISO 13485:2012
BS EN ISO 13485:2003
BS EN ISO 13485:2001
BS EN ISO 13488:2001
BS EN 46003:1999
BS EN 46001:1997
BS EN 46002:1997