15/30321131 DC : 0
Superseded
A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.
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BS EN ISO 13485 - MEDICAL DEVICES - QUALITY MANAGEMENT SYSTEMS - REQUIREMENTS FOR REGULATORY PURPOSES
Hardcopy , PDF
02-29-2016
English
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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) - Comparison of content of
ISO 13485:2003 and ISO DIS2 13485:2015
Annex ZA (informative) - Relationship between this
European Standard and the Conformity Assessment
Requirements of EU Directive 90/385/EEC (as amended)
Annex ZB (informative) - Relationship between this
European Standard and the Conformity Assessment
Requirements of EU Directive 93/42/EEC (as amended)
Annex ZC (informative) - Relationship between this
European Standard and the Conformity Assessment
Requirements of EU Directive 98/79/EC (as amended)
Bibliography
BS EN ISO 13485.
| Committee |
CH/210/1
|
| DocumentType |
Draft
|
| Pages |
116
|
| PublisherName |
British Standards Institution
|
| Status |
Superseded
|
| SupersededBy |
| ISO 19011:2011 | Guidelines for auditing management systems |
| ISO 11607-2:2006 | Packaging for terminally sterilized medical devices Part 2: Validation requirements for forming, sealing and assembly processes |
| ISO/TS 16775:2014 | Packaging for terminally sterilized medical devices Guidance on the application of ISO 11607-1 and ISO 11607-2 |
| ISO 10012:2003 | Measurement management systems — Requirements for measurement processes and measuring equipment |
| ISO 9001:2015 | Quality management systems — Requirements |
| ISO 9000:2015 | Quality management systems — Fundamentals and vocabulary |
| ISO 14971:2007 | Medical devices Application of risk management to medical devices |
| ISO 11607-1:2006 | Packaging for terminally sterilized medical devices Part 1: Requirements for materials, sterile barrier systems and packaging systems |
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