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Packaging for terminally sterilized medical devices - Part 2: sterilization wrap - Requirements and test methods
Edition 2017-04-08

Standards [CURRENT]

PD IEC/TR 80001-2-1

Application of risk management for IT-networks incorporating medical devices. Step-by-step risk management of medical IT-networks. Practical applications and examples
Edition 2012-10-31

Systems for evacuation of plume generated by medical devices
Edition 2024-04-17

Standards [CURRENT]

ISO 14155

Clinical investigation of medical devices for human subjects - Good clinical practice
Edition 2020-07

Draft standard

24/30479646 DC

BS EN 868-3 Packaging for terminally sterilized medical devices. Part 3: Paper for use in the manufacture of paper bags (specified in EN 868-4) and in the manufacture of pouches and reels (specified in EN 868-5) - Requirements and test methods
Edition 2024-04-11

Standards [CURRENT]

SNG CEN ISO/TR 24971

Medical devices - Guidance on the application of ISO 14971 (ISO/TR 24971:2020)
Edition 2020-08

Biological evaluation of medical devices - Part 10: tests for skin sensitization
Edition 2023-02-08

Standards [CURRENT]

ISO 28620

Medical devices - Non-electrically driven portable infusion devices
Edition 2020-01

Standards [CURRENT]

BS EN 868-5

Packaging for terminally sterilized medical devices. Sealable pouches and reels of porous materials and plastic film construction. Requirements and test methods
Edition 2019-01-07

Standards [CURRENT]

ISO 10993-4

Biological evaluation of medical devices - Part 4: Selection of tests for interactions with blood
Edition 2017-04

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