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EUV 2022/2346
Commission Implementing Regulation (EU) 2022/2346 of 1 December 2022 laying down common specifications for the groups of products without an intended medical purpose listed in Annex XVI to Regulation (EU) 2017/745 of the European Parliament and of the Council on medical devices
Edition
2022-12-01
NF S99-501-23 ; NF EN ISO 10993-23:2021-03-31
Biological evaluation of medical devices - Part 23: tests for irritation
Edition
2021-03-31
BS EN ISO 20857
Sterilization of health care products. Dry heat. Requirements for the development, validation and routine control of a sterilization process for medical devices
Edition
2013-04-30
PD IEC/TR 80002-1
Medical device software. Guidance on the application of ISO 14971 to medical device software
Edition
2010-05-31
BS EN 15986
Symbol for use in the labelling of medical devices. Requirements for labelling of medical devices containing phthalates
Edition
2011-03-31
23/30457243 DC
BS EN 556-1. Sterilization of medical devices. Requirements for medical devices to be designated "STERILE". Part 1. Requirements for terminally sterilized medical devices
Edition
2023-01-24
FD S99-125 ; FD CEN ISO/TR 20416:2020-09-23
Medical devices - Post-market surveillance for manufacturers
Edition
2020-09-23
NF C74-054-1 ; NF EN 62366-1:2015-12-18
Medical devices - Part 1: application of usability engineering to medical devices
Edition
2015-12-18
NF C74-054-1/A1 ; NF EN 62366-1/A1:2020-08-07
Medical devices - Part 1: application of usability engineering to medical devices
Edition
2020-08-07
OENORM EN ISO 10993-23
Biological evaluation of medical devices - Part 23: Tests for irritation (ISO 10993-23:2021)
Edition
2021-09-15
