14/30257644 DC : 0

Superseded

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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Superseded date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

Publisher

British Standards Institution

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Status	Superseded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	BS EN ISO 13485:2016

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