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Standards [CURRENT]

BS EN ISO 11607-2+A1

Packaging for terminally sterilized medical devices. Validation requirements for forming, sealing and assembly processes
Edition 2020-01-20

Standards [CURRENT]

PD ISO/TR 21730

Health informatics. Use of mobile wireless communication and computing technology in healthcare facilities. Recommendations for electromagnetic compatibility (management of unintentional electromagnetic interference) with medical devices
Edition 2007-03-30

Standards [CURRENT]

PD CEN ISO/TS 16775

Packaging for terminally sterilized medical devices. Guidance on the application of ISO 11607-1 and ISO 11607-2
Edition 2021-11-26

Standards [CURRENT]

BS EN ISO 17665

Sterilization of health care products. Moist heat. Requirements for the development, validation and routine control of a sterilization process for medical devices. Titre manque
Edition 2024-03-22

Standards [CURRENT]

ISO 11135

Sterilization of health-care products - Ethylene oxide - Requirements for the development, validation and routine control of a sterilization process for medical devices
Edition 2014-07

Technical rule [CURRENT]

ISO/TR 10993-55

Biological evaluation of medical devices - Part 55: Interlaboratory study on cytotoxicity
Edition 2023-02

Standards [CURRENT]

ISO 11135 AMD 1

Revision of Annex E, Single batch release
Edition 2018-10

Technical rule [CURRENT]

ISO/TR 11633-2

Health informatics - Information security management for remote maintenance of medical devices and medical information systems - Part 2: Implementation of an information security management system (ISMS)
Edition 2021-02

Technical rule [CURRENT]

ISO/TR 22442-4

Medical devices utilizing animal tissues and their derivatives - Part 4: Principles for elimination and/or inactivation of transmissible spongiform encephalopathy (TSE) agents and validation assays for those processes
Edition 2010-12

Technical rule [CURRENT]

IEC/TR 80001-2-8

Application of risk management for IT-networks incorporating medical devices - Part 2-8: Application guidance - Guidance on standards for establishing the security capabilities identified in IEC 80001-2-2
Edition 2016-05

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