I.S. EN ISO 13485:2016
Superseded
A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.
View Superseded by
MEDICAL DEVICES - QUALITY MANAGEMENT SYSTEMS - REQUIREMENTS FOR REGULATORY PURPOSES (ISO 13485:2016)
Hardcopy , PDF
08-06-2019
English
01-01-2016
For Harmonized Standards, check the EU site to confirm that the Standard is cited in the Official Journal.
Only cited Standards give presumption of conformance to New Approach Directives/Regulations.
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National foreword
European foreword
Foreword
Introduction
1 Scope
2 Normative references
3 Terms and definitions
4 Quality management system
5 Management responsibility
6 Resource management
7 Product realization
8 Measurement, analysis and improvement
Annex A (informative) - Comparison of content between
ISO 13485:2003 and ISO 13485:2016
Annex B (informative) - Correspondence between ISO 13485
:2016 and ISO 9001:2015
Bibliography
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
Provides requirements for a quality management system where an organization needs to demonstrate its ability to provide medical devices and related services that consistently meet customer and applicable regulatory requirements.
| Committee |
TC 210
|
| DevelopmentNote |
Supersedes I.S. EN 46001 (10/2003) Supersedes I.S. EN ISO 13488. (11/2003) Supersedes I.S. EN 46003. (07/2007) 2016 Edition Incorporates Corrigendum. (03/2016) Supersedes I.S. CEN ISO/TR 14969. (02/2017)
|
| DocumentType |
Standard
|
| Pages |
82
|
| PublisherName |
National Standards Authority of Ireland
|
| Status |
Superseded
|
| SupersededBy | |
| Supersedes |
| Standards | Relationship |
| ISO 13485:2016 | Identical |
| NF EN ISO 13485 : 2016 | Identical |
| NBN EN ISO 13485 : 2016 | Identical |
| NEN EN ISO 13485 : 2016 C11 2017 | Identical |
| SN EN ISO 13485:2016 | Identical |
| UNI EN ISO 13485 : 2004 | Identical |
| EN ISO 13485:2016 | Identical |
| BS EN ISO 13485:2016 | Identical |
| UNE-EN ISO 13485:2016 | Identical |
| DIN EN ISO 13485:2016-08 | Identical |
| 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 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 |
| EN ISO 9000:2015 | Quality management systems - Fundamentals and vocabulary (ISO 9000:2015) |
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