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ISO 13408-7
Aseptic processing of health care products - Part 7: Alternative processes for medical devices and combination products
Edition
2012-08
IEC/TR 80002-1
Medical device software - Part 1: Guidance on the application of ISO 14971 to medical device software
Edition
2009-09
ISO/TS 37137-1
Biological evaluation of absorbable medical devices - Part 1: General requirements
Edition
2021-03
ISO/TS 10993-20
Biological evaluation of medical devices - Part 20: Principles and methods for immunotoxicology testing of medical devices
Edition
2006-08
ISO/TS 21726
Biological evaluation of medical devices - Application of the threshold of toxicological concern (TTC) for assessing biocompatibility of medical device constituents
Edition
2019-02
ISO/TR 24971
Medical devices - Guidance on the application of ISO 14971 (ISO/TR 24971:2020)
Edition
2020-06
ISO/TR 10993-33
Biological evaluation of medical devices - Part 33: Guidance on tests to evaluate genotoxicity - Supplement to ISO 10993-3
Edition
2015-03
ISO/TR 21582
Pyrogenicity - Principles and methods for pyrogen testing of medical devices
Edition
2021-07
ISO/TR 19727
Medical devices - Pump tube spallation test - General procedure
Edition
2017-08
ISO/TR 10993-22
Biological evaluation of medical devices - Part 22: Guidance on nanomaterials
Edition
2017-07
