NA 145
DIN Standards Committee Technology of Materials
Standards
[CURRENT]
DIN EN ISO 13485
DIN EN ISO 13485
Medical devices - Quality management systems - Requirements for regulatory purposes (ISO 13485:2016); German version EN ISO 13485:2016 + AC:2018 + A11:2021
Title (German)
Medizinprodukte - Qualitätsmanagementsysteme - Anforderungen für regulatorische Zwecke (ISO 13485:2016); Deutsche Fassung EN ISO 13485:2016 + AC:2018 + A11:2021
Document: references other documents
Document: referenced in other documents
Responsible national committee
NA 176-01-02 AA - Quality management and corresponding general aspects for medical devices
Responsible european committee
CEN/CLC/JTC 3 - Quality management and corresponding general aspects for medical devices
