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BS EN ISO 13485:2016+A11:2021 | British Standards

Standards Shop | ICS 03 | ICS 03.120 |  ICS 03.120.10

03.120.10 Quality management and quality assurance

Medical devices. Quality management systems. Requirements for regulatory purposes

Medical devices. Quality management systems. Requirements for regulatory purposes

BS EN ISO 13485:2016+A11:2021

Medical devices. Quality management systems. Requirements for regulatory purposes


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ISBN: 9780539060737

Keywords:
Acceptance (approval), Quality assurance systems, Medical instruments, Medical technology, Medical equipment, Quality management, Management, PDF
Publication Date08 Sep 2021
Product SKU30401043
ISBN9780539060737
BSI CodeBS EN ISO 13485:2016+A11:2021
No. of pages90
ReplacesBS EN ISO 13485:2012
AmendsBS EN ISO 13485:2016
PublisherBritish Standards Institution
Identical National Standard to:
  • EN ISO 13485:2016/A11:2021
  • EN ISO 13485:2016/A11:2021
Modified National Standard of:
  • ISO 13485:2016




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