AAMI ISO TIR 16142 : 2005
Superseded
A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.
View Superseded by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
Hardcopy , PDF
06-05-2016
English
01-01-2005
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Glossary of equivalent standards
Committee representation
Background of AAMI adoption of ISO/TR 16142:2005
Forward
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
4.1 Basic standards
4.2 Recognition of standards
4.3 Conformity assessment
4.4 Reference to basic standards
5 Essential principles and references to relevant standards
or guides
6 How to find relevant standards
Annexes
A - Table relating essential principles to standards
B - Examples of reference to basic standards
C - Website listings of other standards suitable for the
medical device sector and for assessment purposes
D - Information on the Global Harmonization Task Force
Bibliography
Describes certain significant standards that can be useful in the assessment of conformity of medical devices with recognized essential principles of safety and performance.
| Committee |
WG 02
|
| DocumentType |
Standard
|
| Pages |
30
|
| PublisherName |
Association for the Advancement of Medical Instrumentation
|
| Status |
Superseded
|
| SupersededBy |
| 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 |
| 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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