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PN EN ISO 13485 : 2016

Current
Current

The latest, up-to-date edition.

MEDICAL DEVICES - QUALITY MANAGEMENT SYSTEMS - REQUIREMENTS FOR REGULATORY PURPOSES (ISO 13485:2016)
Published date

01-12-2013

Committee
TC 247
DevelopmentNote
Supersedes PN EN 46003. (09/2007) Polish translation issued on 02/10/2017. (10/2017) NEW CHILD AMD 11 2022 IS NOW ADDED.
DocumentType
Standard
ProductNote
NEW CHILD AMD 11 2022 IS NOW ADDED. New child AC 2018 is now added
PublisherName
Polish Committee for Standardization
Status
Current
Supersedes

Standards Relationship
EN ISO 13485:2016 Identical
ISO 13485:2016 Identical
EN ISO 13485:2016/AC:2018 Identical

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