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Standards [CURRENT]

BS ISO 15223-2

Medical devices. Symbols to be used with medical device labels, labelling, and information to be supplied. Symbol development, selection and validation
Edition 2010-06-30

Standards [CURRENT]

BS EN 868-2

Packaging for terminally sterilized medical devices. Sterilization wrap. Requirements and test methods
Edition 2017-02-28

Standards [CURRENT]

BS EN 868-4

Packaging for terminally sterilized medical devices. Paper bags. Requirements and test methods
Edition 2017-02-28

Standards [CURRENT]

PD IEC/TR 80001-2-2

Application of risk management for IT-networks incorporating medical devices. Guidance for the disclosure and communication of medical device security needs, risks and controls
Edition 2012-10-31

Draft standard [New]

OENORM EN ISO 10993-7

Biological evaluation of medical devices - Part 7: Ethylene oxide sterilization residuals (ISO/DIS 10993-7:2024)
Edition 2024-07-01

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

Dentistry - Medical devices for dentistry - Dental implants
Edition 2013-06-22

Clinical investigation of medical devices for human subjects - Good clinical practice
Edition 2020-08-19

Standards [CURRENT]

BS EN ISO 14937

Sterilization of health care products - General requirements for characterization of a sterilizing agent and the development, validation and routine control of a sterilization process for medical devices
Edition 2010-03-31

Standards [CURRENT]

ISO 10993-13

Biological evaluation of medical devices - Part 13: Identification and quantification of degradation products from polymeric medical devices
Edition 2010-06

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