14/30257644 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Superseded
A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.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
English
29-02-2016
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Superseded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 |
| ISO 19011:2011 | Guidelines for auditing management systems |
| ISO 14160:2011 | Sterilization of health care products — Liquid chemical sterilizing agents for single-use medical devices utilizing animal tissues and their derivatives — Requirements for characterization, development, validation and routine control of a sterilization process for medical devices |
| ISO 14155-2:2003 | Clinical investigation of medical devices for human subjects — Part 2: Clinical investigation plans |
| ISO 11135:2014 | Sterilization of health-care products — Ethylene oxide — Requirements for the development, validation and routine control of a sterilization process for medical devices |
| ISO 14937:2009 | Sterilization of health care products — General requirements for characterization of a sterilizing agent and the development, validation and routine control of a sterilization process for medical devices |
| ISO 14155-1:2003 | Clinical investigation of medical devices for human subjects — Part 1: General requirements |
| ISO/TR 14969:2004 | Medical devices — Quality management systems — Guidance on the application of ISO 13485: 2003 |
| 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 11134:1994 | Sterilization of health care products — Requirements for validation and routine control — Industrial moist heat sterilization |
| ISO 14971:2007 | Medical devices — Application of risk management to medical devices |
| ISO 11137:1995 | Sterilization of health care products — Requirements for validation and routine control — Radiation sterilization |
| ISO 13683:1997 | Sterilization of health care products — Requirements for validation and routine control of moist heat sterilization in health care facilities |
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