14/30257644 DC : 0
Superseded
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BS EN ISO 13485 - MEDICAL DEVICES - QUALITY MANAGEMENT SYSTEMS - REQUIREMENTS FOR REGULATORY PURPOSES
Hardcopy , PDF
English
02-29-2016
Foreword
0 Introduction
1 Scope
2 Normative references
3 Terms and definitions
4 Quality management system
5 Management
6 Resource management
7 Product realization
8 Measurement, analysis and improvement
Annex A (informative) - Explanation of differences
between ISO 13485:201x and
ISO 9001:2008
Annex B (informative) - Explanation of differences
between ISO 13485:201x and
ISO 13485:2003
Annex ZA (informative) - Relationship between this
European Standard and the Conformity
Assessment Requirements of EU Directive
90/385/EEC
Annex ZB (informative) - Relationship between this
European Standard and the Conformity
Assessment Requirements of EU Directive
93/42/EEC
Annex ZC (informative) - Relationship between this
European Standard and the Conformity
Assessment Requirements of EU Directive
98/79/EC
Bibliography
BS EN ISO 13485
| Committee |
CH/210/1
|
| DocumentType |
Draft
|
| Pages |
194
|
| PublisherName |
British Standards Institution
|
| Status |
Superseded
|
| SupersededBy |
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