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SN EN 15986
Symbol for use in the labelling of medical devices - Requirements for labelling of medical devices containing phthalates
Edition
2011-07
NF C74-801-1 ; NF EN IEC 80001-1:2021-10-29
Application of risk management for IT-networks incorporating medical devices - Part 1: safety, effectiveness and security in the implementation and use of connected medical devices or connected health software
Edition
2021-10-29
PR NF S91-224 ; PR NF EN ISO 7405
Dentistry - Preclinical evaluation of biocompatibility of medical devices used in dentistry - Test methods for dental materials.
PR NF S97-414
Restoration to suitable condition for use of medical devices for individual use - General requirements and safety
PR NF S98-107-1 ; PR NF EN 556-1
Sterilization of medical devices - Requirements for medical devices to be designated "STERILE" - Part 1: Requirements for terminally sterilized medical devices
PR NF S98-107-2 ; PR NF EN 556-2
Sterilization of medical devices - Requirements for medical devices to be designated ''STERILE'' - Part 2: requirements for aseptically processed medical devices
PR NF S99-014-1/A1 ; PR NF EN ISO 15223-1/A1
Medical devices - Symbols to be used with medical device labels, labelling and information to be supplied - Part 1: general requirements
PR NF S99-501-4/A1 ; PR NF EN ISO 10993-4/A1
Biological evaluation of medical devices - Part 4 : selection of tests for interaction with blood.
PR NF S99-501-6 ; PR NF EN ISO 10993-6
Biological evaluation of medical devices - Part 6 : tests for local effects after implantation.
PR NF S99-501-7 ; PR NF EN ISO 10993-7
Biological evaluation of medical devices - Part 7 : ethylene oxide sterilization residuals.
