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Standard
Designated
Withdrawn

BS EN ISO 13485:2016

Medical devices. Quality management systems. Requirements for regulatory purposes

Published:

29 Feb 2016

•

Withdrawn:

8 Sep 2021

Overview
Preview
References
History
Product Details
Descriptors
Acceptance (approval)
Quality assurance systems
Medical instruments
Medical technology
Medical equipment
Quality management
Management
ICS Codes
03.120.10 Quality management and quality assurance
11.040.01 Medical equipment in general
Committee
CH/210/1
International relationships
Identical to:

EN ISO 13485:2016/AC:2016

ISBN
978 0 580 96770 2
Publisher
BSI