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Draft standard

ISO/DIS 10993-6

Biological evaluation of medical devices - Part 6: Tests for local effects after implantation
Edition 2024-05

Sterilization of health-care products . Ethylene oxide . Requirements for the development, validation and routine control of a sterilization process for medical devices

Draft standard

ISO/DIS 15883-7

Washer-disinfectors - Part 7: Requirements and tests for washer-disinfectors employing chemical disinfection for non-critical thermolabile medical devices and health care equipment
Edition 2024-02

Standards [CURRENT]

ISO 10993-6

Biological evaluation of medical devices - Part 6: Tests for local effects after implantation
Edition 2016-12

Standards [CURRENT]

BS EN ISO 14160

Sterilization of health care products. Liquid chemical sterilizing agents for single-use medical devices utilizing animal tissues and their derivatives. Requirements for characterization, development, validation and routine control of a sterilization process for medical devices
Edition 2021-07-05

Draft standard

24/30479643 DC

BS EN 868-4 Packaging for terminally sterilized medical devices. Part 4: Paper bags - Requirements and test methods
Edition 2024-04-11

Standards [CURRENT]

ISO 10993-1

Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process
Edition 2018-08

Standards [CURRENT]

BS EN ISO 10993-15

Biological evaluation of medical devices. Identification and quantification of degradation products from metals and alloys
Edition 2023-05-24

Standards [CURRENT]

BS EN IEC 80001-1

Application of risk management for IT-networks incorporating medical devices. Safety, effectiveness and security in the implementation and use of connected medical devices or connected health software
Edition 2021-11-01

Standards [CURRENT]

BS EN ISO 11607-1+A1

Packaging for terminally sterilized medical devices. Requirements for materials, sterile barrier systems and packaging systems
Edition 2020-01-20

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