BS EN ISO 13485:2012 Medical devices. Quality management systems. Requirements for regulatory purposes

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BS EN ISO 13485:2012

Medical devices. Quality management systems. Requirements for regulatory purposes

Status : Revised, Withdrawn   Published : March 2012 Replaced By : BS EN ISO 13485:2016

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ISO 13485

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.


What is BS EN ISO 13485:2012?

BS EN ISO 13485 is a key standard to measure the quality of medical equipment, medical instruments and medical technology. This standard sets out the requirements for a quality management system and quality assurance systems relating to the design, development, production, installation and servicing of medical devices. BS EN ISO 13485 can also be used by internal and external parties, including certification bodies to test an organization’s ability to meet both customer and regulatory requirements.

How does it work?

Specifying the requirements for a quality management system, BS EN ISO 13485 helps organizations to provide medical devices and related services that live up to the expectations of customers and regulatory bodies. Its main objective is to deliver harmonised medical device regulatory requirements, and provide quality management system specifications that complement the technical aspects of related products and services.

Who should buy it?

Organizations dealing with the design, development, production, installation or servicing of medical equipment, devices and technology.

Why BSI?

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Standard NumberBS EN ISO 13485:2012
TitleMedical devices. Quality management systems. Requirements for regulatory purposes
StatusRevised, Withdrawn
Publication Date31 March 2012
Withdrawn Date29 February 2016
Cross References90/385/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
Replaced ByBS EN ISO 13485:2016
ReplacesBS EN ISO 13485:2003
International RelationshipsEN ISO 13485:2012,ISO 13485:2003
Amended ByCorrigendum, September 2012.
DescriptorsMedical equipment, Medical instruments, Medical technology, Quality management, Quality assurance systems, Acceptance (approval), Management
ICS03.100.70
03.120.10
11.040.01
Title in FrenchDispositifs médicaux. Systèmes de manegement de la qualité. Exigences à des fins réglementaires
Title in GermanMedizinprodukte. Qualitätsmanagementsysteme. Anforderungen für regulatorische Zwecke
CommitteeCH/210/1
ISBN978 0 580 79953 2
PublisherBSI
FormatA4
DeliveryNo
Pages86
File Size1.687 MB
Price£244.00


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