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BSI - BS EN 45502-1

Active Implantable Medical Devices Part 1: General Requirements for Safety, Marking and Information to be Provided by the Manufacturer

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Organization: BSI
Publication Date: 15 February 1998
Status: inactive
Page Count: 30
ICS Code (Implants for surgery, prosthetics and orthotics): 11.040.40

Document History

BS EN 45502-1
June 30, 2015
Implants for surgery — Active implantable medical devices Part 1: General requirements for safety, marking and for information to be provided by the manufacturer
A description is not available for this item.
BS EN 45502-1
February 15, 1998
Active Implantable Medical Devices Part 1: General Requirements for Safety, Marking and Information to be Provided by the Manufacturer
A description is not available for this item.

References

This document references:
BS EN ISO 10993-1 - Biological evaluation of medical devices Part 1: Evaluation and testing within a risk management process
Published by BSI on December 31, 2020
A description is not available for this item.
This document references:
EN 1041 - Information supplied by the manufacturer of medical devices
Published by CEN on August 1, 2008
This European Standard specifies requirements for information to be supplied by a manufacturer for medical devices regulated by Council Directive 90/385/EEC relating to active implantable medical...
This document references:
EN 550 - Sterilization of Medical Devices - Validation and Routine Control of Ethylene Oxide Sterilization
Published by CEN on January 1, 1994
A description is not available for this item.
This document is referenced by:
BS EN 50527-1 - Procedure for the assessment of the exposure to electromagnetic fields of workers bearing active implantable medical devices Part 1: General
Published by BSI on January 31, 2017
A description is not available for this item.
This document is referenced by:
BS 7273-2 - Code of practice for The operation of fire protection measures - Part 2: Mechanical actuation of gaseous total flooding and local application extinguishing systems
Published by BSI on May 1, 1992
Recommendations for the planning, installation and servicing of mechanical equipment for the actuation of gaseous fire extinguishing systems.
This document is referenced by:
BS EN 45502-2-2 - Active implantable medical devices - Part 2-2: Particular requirements for active implantable medical devices intended to treat tachyarrhythmia (includes implantable defibrillators)
Published by BSI on October 31, 2008
A description is not available for this item.
This document is referenced by:
BS EN 45502-2-1 - Active implantable medical devices Part 2-1: Particular requirements for active implantable medical devices intended to treat bradyarrhythmia (cardiac pacemakers)
Published by BSI on January 20, 2004
A description is not available for this item.
This document is referenced by:
BS EN 45502-2-3 - Active implantable medical devices Part 2-3: Particular requirements for cochlear and auditory brainstem implant systems
Published by BSI on March 31, 2010
A description is not available for this item.
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