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BS EN ISO 11607-2+A1
Packaging for terminally sterilized medical devices. Validation requirements for forming, sealing and assembly processes
Edition
2020-01-20
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
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
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
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
ISO/TR 10993-55
Biological evaluation of medical devices - Part 55: Interlaboratory study on cytotoxicity
Edition
2023-02
ISO 11135 AMD 1
Revision of Annex E, Single batch release
Edition
2018-10
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
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
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