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BSI - BS EN ISO 20417 - TC

Tracked Changes (Redline) - Medical devices - Information to be supplied by the manufacturer

inactive, Most Current
Organization: BSI
Publication Date: 19 May 2021
Status: inactive
Page Count: 190
ICS Code (Pharmaceutics in general): 11.120.01
ICS Code (Medical equipment in general): 11.040.01
ICS Code (Technical product documentation): 01.110

Document History

BS EN ISO 20417 - TC
May 19, 2021
Tracked Changes (Redline) - Medical devices - Information to be supplied by the manufacturer
A description is not available for this item.

References

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:
IEC 80001-1 - Application of risk management for IT-networks incorporating medical devices – Part 1: Roles, responsibilities and activities
Published by IEC on October 1, 2010
Recognizing that MEDICAL DEVICES are incorporated into IT-NETWORKS to achieve desirable benefits (for example, INTEROPERABILITY), this international standard defines the roles, responsibilities and...
This document references:
ISO 16142-1 - Medical devices - Recognized essential principles of safety and performance of medical devices - Part 1: General essential principles and additional specific essential principles for all non‐IVD medical devices and guidance on the selection of standards
Published by ISO on March 1, 2016
This part of ISO 16142, which includes the essential principles of safety and performance, identifies significant standards and guides that can be used in the assessment of conformity of a medical...
This document references:
ISO 16142-2 - Medical devices - Recognized essential principles of safety and performance of medical devices - Part 2: General essential principles and additional specific essential principles for all IVD medical devices and guidance on the selection of standards
Published by ISO on August 1, 2017
This document, which includes the essential principles of safety and performance, identifies significant standards and guides that can be used in the assessment of conformity of a medical device to...
This document references:
ISO 22742 - Packaging — Linear bar code and twodimensional symbols for product packaging
Published by ISO on December 15, 2010
This International Standard a) specifies the minimum requirements for the design of labels containing a linear bar code and two-dimensional symbols on product packages to convey data between trading...
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