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BSI BS EN ISO 17664:2017

Sterilization of medical devices. Information to be provided by the manufacturer for the processing of resterilizable medical devices

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BSI BS EN ISO 17664:2017

Sterilization of medical devices. Information to be provided by the manufacturer for the processing of resterilizable medical devices

PUBLISH DATE 2018

PAGES 32

Document Information

Processing of health care products. Information to be provided by the medical device manufacturer for the processing of medical devices. Part 1: Devices that require cleaning followed by disinfection and/or sterilization


SDO	BSI: British Standards Institution
Document Number	BS EN ISO 17664
Publication Date	Jan. 8, 2018
Language	en - English
Page Count	32
Revision Level
Supercedes
Committee

Publish Date	Document Id	Type	View
Jan. 8, 2018	BS EN ISO 17664:2017	Revision
March 12, 2004	BS EN ISO 17664:2004	Revision

SDO	Document	Title
BSI	BS ISO 17664-2	Processing of health care products. Information to be provided by the medical device manufacturer for the processing of medical devices. Non-critical medical devices.
CSA	CSA ISO 17664-2:23	Processing of health care products — Information to be provided by the medical device manufacturer for the processing of medical devices — Part 2: Non-critical medical devices (Adopted ISO 17664-2:2021, first edition, 2021-02)
BSI	BS EN ISO 17664-1	Processing of health care products. Information to be provided by the medical device manufacturer for the processing of medical devices. Critical and semi-critical medical devices.
ISO	ISO 17664-2	Processing of health care products - Information to be provided by the medical device manufacturer for the processing of medical devices - Part 2: Non-critical medical devices
ISO	ISO 17664-1	Processing of health care products - Information to be provided by the medical device manufacturer for the processing of medical devices - Part 1: Critical and semi-critical medical devices
CSA	CSA ISO 17664-1:23	Processing of health care products — Information to be provided by the medical device manufacturer for the processing of medical devices — Part 1: Critical and semi-critical medical devices (Adopted ISO 17664-1:2021, first edition, 2021-07)
BSI	BS EN 556-2	Sterilization of medical devices. Requirements for medical devices to be designated STERILE. Requirements for aseptically processed medical devices
BSI	BS EN 556-1	Sterilization of medical devices. Requirements for medical devices to be designated STERILE. Requirements for terminally sterilized medical devices
BSI	BS EN 13824	Sterilization of medical devices. Aseptic processing of liquid medical devices. Requirements - Replaced by BS-EN-ISO-13408-1
BSI	PD IEC/TR 80002-3	Medical device software. Process reference model of medical device software life cycle processes (IEC 62304)
BSI	BS EN 15424	Sterilization of medical devices. Low temperature steam and formaldehyde. Requirements for development, validation and routine control of a sterilization process for medical devices
BSI	BS EN ISO 25424	Sterilization of medical devices. Low temperature steam and formaldehyde. Requirements for development, validation and routine control of a sterilization process for medical devices
ISO	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
BSI	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
BSI	PD ISO/TR 11633-2	Health informatics. Information security management for remote maintenance of medical devices and medical information systems. Implementation of an information security management system (ISMS)
BSI	BS EN 556	Sterilization of medical devices. Requirements for terminally-sterilized devices to be labelled 'Sterile'
BSI	BS EN 868-6	Packaging for terminally sterilized medical devices. Paper for low temperature sterilization processes. Requirements and test methods
ISO	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)
ASTM	E3418	Standard Practice for Calculating Scientifically Justifiable Limits of Residues for Cleaning of Pharmaceutical and Medical Device Manufacturing Equipment and for Medical Devices
BSI	BS EN 868-4	Packaging for terminally sterilized medical devices. Paper bags. Requirements and test methods. Packaging for terminally sterilized medical devices. Paper bags. Requirements and test methods
BSI	BS EN 868-7	Packaging for terminally sterilized medical devices. Adhesive coated paper for low temperature sterilization processes. Requirements and test methods
BSI	PD ISO/TS 11633-1	Health informatics. Information security management for remote maintenance of medical devices and medical information systems. Requirements and risk analysis
ISO	ISO/TS 11633-1	Health informatics - Information security management for remote maintenance of medical devices and medical information systems - Part 1: Requirements and risk analysis
CSA	CSA ISO 14937:F11 (C2021)	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 (Adopted ISO 14937:2009, second edition, 2009-10-15)
ISO	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