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Superseded

Superseded

A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.

View Superseded by
superseded

A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.

BS EN ISO 13485 - MEDICAL DEVICES - QUALITY MANAGEMENT SYSTEMS - REQUIREMENTS FOR REGULATORY PURPOSES

Available format(s)

Hardcopy , PDF

Superseded date

02-29-2016

Language(s)

English

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Superseded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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