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BSI TH 42076:1999

Ce Marking of Medical Devices, a Guide To the European Directive

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BSI TH 42076:1999

Ce Marking of Medical Devices, a Guide To the European Directive

PUBLISH DATE 1999

PAGES 105

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CE MARKING OF MEDICAL DEVICES


SDO	BSI: British Standards Institution
Document Number	TH 42076
Publication Date	Feb. 1, 1999
Language	en - English
Page Count	105
Revision Level
Supercedes
Committee

Publish Date	Document Id	Type	View
Feb. 1, 1999	TH 42076:1999	Revision

SDO	Document	Title
BSI	PD CEN/TR 17223	Guidance on the relationship between EN ISO 13485:2016 (Medical devices. Quality management systems. Requirements for regulatory purposes) and European Medical Devices Regulation and In Vitro Diagnostic Medical Devices Regulation
BSI	TH 42097	Construction Products. A Guide to the Requirements of the European Directive and to CE Marking
BSI	TH 42072	Personal Protective Equipment. A Guide to the Requirements of the European Directive and to CE Marking
BSI	TH 42056	Electromagnetic Compatibility (EMC). A Guide to the Requirements of the European Directive and to CE Marking
BSI	TH 42073	Machinery. A Guide to the Requirements of the European Directive and to CE Marking
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.
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
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.
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	BIP 0113	Guide to European medical device trials and BS EN ISO 14155
BSI	TH 42075	The Low Voltage Directive. A guide to CE marking
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
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)
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
BSI	BS EN ISO 11073-20701	Health informatics. Device interoperability. Point-of-care medical device communication. Service oriented medical device exchange architecture and protocol binding.
IEEE	IEEE/ISO/IEC 11073-20701	ISO/IEC/IEEE International Standard for Health informatics--Device interoperability--Part 20701:Point-of-care medical device communication--Service oriented medical device exchange architecture and protocol binding
ISO	ISO/IEEE 11073-20701	Health informatics - Device interoperability - Part 20701: Point-of-care medical device communication - Service oriented medical device exchange architecture and protocol binding
BSI	BS ISO 16142-2	Medical devices. Recognized essential principles of safety and performance of medical devices. General essential principles and additional specific essential principles for all IVD medical devices and guidance on the selection of standards
BSI	BS EN ISO 15225	Medical devices. Quality management. Medical device nomenclature data structure
BSI	BS ISO 16142-1	Medical devices. Recognized essential principles of safety and performance of medical devices. General essential principles and additional specific essential principles for all non-IVD medical devices and guidance on the selection of standards
ISO	ISO/IEEE 11073-20702	Health informatics - Point-of-care medical device communication - Part 20702: Medical devices communication profile for web services
IEEE	IEEE 11073-20702	IEEE Standard for Health informatics--Point-of-care medical device communication Part 20702: Medical Devices Communication Profile for Web Services
IEEE	IEEE/ISO 11073-20702	ISO/IEEE International Standard for Health informatics -- Point-of-care medical device communication -- Part 20702: Medical devices communication profile for web services
BSI	BS EN 13824	Sterilization of medical devices. Aseptic processing of liquid medical devices. Requirements - Replaced by BS-EN-ISO-13408-1

BSI TH 42076:1999

Ce Marking of Medical Devices, a Guide To the European Directive

BSI TH 42076:1999

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