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Biological evaluation of medical devices - Part 22: guidance on nanomaterials
Edition 2017-08-23

Biological evaluation of medical devices - Part 23: tests for irritation
Edition 2021-03-31

Biological evaluation of medical devices - Part 2: Animal welfare requirements
Edition 2022-11-23

Pyrogenicity - Principles and methods for pyrogen testing of medical devices
Edition 2021-12-01

Cardiovascular biological evaluation of medical devices - Guidance for absorbable implants
Edition 2014-09-17

Standards [CURRENT]

FD X50-795

Availability of medical devices at home - Preliminary assessment of the residences
Edition 2005-08-01

Draft standard

23/30457240 DC

BS EN 556-2. Sterilization of medical devices. Requirements for medical devices to be designated "STERIL". Part 2. requirements for aseptically processed medical devices
Edition 2023-01-24

Draft standard

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

Standards [New]

BS EN 556-1

Sterilization of medical devices. Requirements for medical devices to be designated "STERILE". Requirements for terminally sterilized medical devices
Edition 2024-07-03

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