Standard

BS EN ISO 13485:2016+A11:2021

Medical devices. Quality management systems. Requirements for regulatory purposes

Current

•

Published:

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

EN ISO 13485:2016/A11:2021

Modified from:

ISO 13485:2016

ISBN
978 0 539 06073 7
Publisher
BSI