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

BS-EN-ISO-13485 - 2016/A11 EDITION - CURRENT
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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.


Acceptance (approval);Quality assurance systems;Medical instruments;Medical technology;Medical equipment;Quality management;Management

To find similar documents by classification:

03.120.10 (Quality management and quality assurance)

11.040.01 (Medical equipment in general)

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Document Number

BS EN ISO 13485:2016+A11:2021

Revision Level

2016/A11 EDITION



Publication Date

Sept. 8, 2021


BS EN ISO 13485:2012

Page Count



Claudia's Notes:
BS EN ISO 13485 is the Official English Language Edition of the EN ISO 13485.  The 2012 Edition is now 86 pages in length, compared to the 72 pages of the 2003 Edition republished in 2010 with the 3 corrigenda interfiled.  Changes have been made to the foreword and especially to the annexes, which accounts for the additional material.  If you use the EN edition of the ISO 13485, you'll want to be sure you're using the latest edition.  The changes to the Annexes will impact your business.



International Equivalent

EN ISO 13485:2016/A11:2021

Committee Number