15/30328959 DC : 0
Superseded
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BS ISO 16142-2 - 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
Hardcopy , PDF
English
30-09-2017
1 Scope
2 Normative references
3 Terms and definitions
4 Essential principles of safety and performance
of 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 (normative) - 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
BS ISO 16142-2.
| Committee |
CH/210
|
| DocumentType |
Draft
|
| Pages |
48
|
| PublisherName |
British Standards Institution
|
| Status |
Superseded
|
| SupersededBy |
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