ANSI/AAMI/ISO 16142-2:2017
Withdrawn
MEDICAL DEVICES - RECOGNIZED ESSENTIAL PRINCIPLES OF SAFETY AND PERFORMANCE OF MEDICAL DEVICES - PART 2: GENERAL ESSENTIAL PRINCIPLES AND ADDITIONAL SPECIFIC ESSENTIAL PRINCIPLES FOR ALL IVD MEDICAL DEVICES AND GUIDANCE ON THE SELECTION OF STANDARDS
English
31-07-2017
18-08-2023
Glossary of equivalent standards
Committee representation
Background of ANSI/AAMI adoption
of ISO 16142-2:2017
Foreword
Introduction
1 Scope
2 Normative references
3 Terms and definitions
4 Essential principles of safety and performance
of IVD medical devices
5 Use of standards and guides in support
of the essential principles
6 Essential principles and references to
relevant standards and guides
Annex A (informative) - Rationale and guidance
Annex B (normative) - Table relating essential
principles to standards
Annex C (informative) - Website listings of other
standards suitable for the medical device
sector and for assessment purposes
Annex D (informative) - Reference to the essential
principles by International Standards
Annex E (informative) - Terminology - Alphabetized
index of defined terms
Bibliography
Covers the essential principles of safety and performance, identifies significant standards and guides that can be used in the assessment of conformity of a medical device to the recognized essential principles that when met, indicate a medical device is safe and performs as intended.
| Committee |
210
|
| DevelopmentNote |
Supersedes AAMI ISO TIR 16142. (08/2017)
|
| DocumentType |
Guide
|
| ISBN |
978-1-57020-671-9
|
| Pages |
56
|
| PublisherName |
Association for the Advancement of Medical Instrumentation
|
| Status |
Withdrawn
|
| Supersedes |
| Standards | Relationship |
| ISO 16142-2:2017 | Identical |
This standard has been withdrawn and is no longer current. No replacement edition is available.
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