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PD ISO/TR 16142:2006

Superseded

Superseded

A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.

View Superseded by

Medical devices. Guidance on the selection of standards in support of recognized essential principles of safety and performance of medical devices

Available format(s)

Hardcopy , PDF

Superseded date

31-03-2016

Superseded by

BS ISO 16142-1:2016

Language(s)

English

Published date

03-02-2006

€217.36
Excluding VAT

Foreword
Introduction
1 Scope
2 Terms and definitions
3 Essential principles of safety and performance of medical
  devices
4 Use of standards and guides in support of regulatory
  requirements
5 Essential principles and references to relevant standards
  or guides
6 How to find relevant standards
Annex A (informative) Table relating essential principles
        to standards
Annex B (informative) Examples of reference to basic
        standards
Annex C (informative) Website listings of other standards
        suitable for the medical device sector and for
        assessment purposes
Annex D (informative) Information on the Global
        Harmonization Task Force
Bibliography

Considers and identifies certain significant standards and guides that can be useful in the assessment of conformity of medical devices with recognized essential principles of safety and performance.

Committee
CH/210
DevelopmentNote
Supersedes 05/30080067 DC. (03/2006)
DocumentType
Standard
Pages
26
PublisherName
British Standards Institution
Status
Superseded
SupersededBy
Supersedes

Standards Relationship
ISO/TR 16142:2006 Identical

ISO 14160:2011 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
IEC 60601-1-6:2010+AMD1:2013 CSV Medical electrical equipment - Part 1-6: General requirements for basic safety and essential performance - Collateral standard: Usability
ISO 13485:2016 Medical devices Quality management systems Requirements for regulatory purposes
ISO 14937:2009 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
ISO/TR 14969:2004 Medical devices Quality management systems Guidance on the application of ISO 13485: 2003
IEC TR 60513:1994 Fundamental aspects of safety standards for medical electrical equipment
ISO/IEC Guide 63:2012 Guide to the development and inclusion of safety aspects in International Standards for medical devices
ISO/IEC Guide 51:2014 Safety aspects — Guidelines for their inclusion in standards
IEC TR 60878:2015 Graphical symbols for electrical equipment in medical practice
ISO 14971:2007 Medical devices Application of risk management to medical devices
ISO 7000:2014 Graphical symbols for use on equipment Registered symbols
IEC 60601-1-4:1996+AMD1:1999 CSV Medical electrical equipment - Part 1-4: General requirements for safety - Collateral Standard: Programmable electrical medical systems
ISO 15223:2000 Medical devices Symbols to be used with medical device labels, labelling and information to be supplied

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