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BSI - BS EN 45502-1

Implants for surgery — Active implantable medical devices Part 1: General requirements for safety, marking and for information to be provided by the manufacturer

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Organization: BSI
Publication Date: 30 June 2015
Status: active
Page Count: 64
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 1041 - Information supplied by the manufacturer of medical devices
Published by BSI on August 31, 2008
A description is not available for this item.
This document references:
60068-2-17 - Environmental testing – Part 2-17: Tests – Test Q: Sealing
Published by IEC on June 1, 2023
This part of IEC 60068 deals with seal tests applicable to the external and internal detection in container sealing of gross leaks and fine leaks to determine the effectiveness of seals of specimens....
This document references:
BS EN 1041 - Information supplied by the manufacturer of medical devices
Published by BSI on August 31, 2008
A description is not available for this item.
This document is referenced by:
BS 7373-2 - Product Specifications - Part 2: Guide to Identifying Criteria for a Product Specification and to Declaring Product Conformity
Published by BSI on July 15, 2001
A description is not available for this item.
This document is referenced by:
BS ISO 27185 - Cardiac rhythm management devices - Symbols to be used with cardiac rhythm management device labels, and information to be supplied - General requirements
Published by BSI on March 31, 2012
A description is not available for this item.
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 45502-2-3 - 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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