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Superseded
A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.
MEDICAL DEVICES - GUIDANCE ON THE SELECTION OF STANDARDS IN SUPPORT OF RECOGNIZED ESSENTIAL PRINCIPLES OF SAFETY AND PERFORMANCE OF MEDICAL DEVICES
Hardcopy , PDF
05-06-2016
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Superseded
|
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