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OENORM EN ISO 10993-9
Biological evaluation of medical devices - Part 9: Framework for identification and quantification of potential degradation products (ISO 10993-9:2019)
Edition
2022-02-15
SN EN ISO 13485/A11
Medical devices - Quality management systems - Requirements for regulatory purposes (ISO 13485:2016); Amendment A11
Edition
2021-11
SN EN ISO 13485
Medical devices - Quality management systems - Requirements for regulatory purposes (ISO 13485:2016)
Edition
2016-03
SN EN ISO 13485/AC
Medical devices - Quality management systems - Requirements for regulatory purposes (ISO 13485:2016); Corrigendum AC
Edition
2020-04
OEVE/OENORM EN ISO 13485
Medical devices - Quality management systems - Requirements for regulatory purposes (ISO 13485:2016)
Edition
2022-02-01
OENORM EN ISO 7405
Dentistry - Evaluation of biocompatibility of medical devices used in dentistry (ISO/DIS 7405:2024)
Edition
2024-04-15
OENORM EN ISO 10993-5
Biological evaluation of medical devices - Part 5: Tests for in vitro cytotoxicity (ISO 10993-5:2009)
Edition
2009-12-01
SN EN ISO 10993-5
Biological evaluation of medical devices - Part 5: Tests for in vitro cytotoxicity (ISO 10993-5:2009)
Edition
2009-11
OENORM EN ISO 10993-1
Biological evaluation of medical devices - Part 1: Requirements and general principles for the evaluation of biological safety within a risk management process (ISO/DIS 10993-1:2024)
Edition
2024-07-15