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Superseded
A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.
A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.
Hardcopy , PDF
05-06-2016
English
01-01-2005
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
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