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Superseded
A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.
A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.
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
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
Access your standards online with a subscription
Features
-
Simple online access to standards, technical information and regulations.
-
Critical updates of standards and customisable alerts and notifications.
-
Multi-user online standards collection: secure, flexible and cost effective.