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17/30359001 DC : 0

NA
NA

Status of Standard is Unknown

BS ISO/IEC GUIDE 63 - GUIDE TO THE DEVELOPMENT AND INCLUSION OF ASPECTS OF SAFETY IN INTERNATIONAL STANDARDS FOR MEDICAL DEVICES
Available format(s)

Hardcopy , PDF

Language(s)

English

Foreword
Introduction
1 Scope and objective
2 Terms and definitions
3 Use of the terms 'safety', 'safe', 'effective',
  and 'effectiveness'
4 Principles for including aspects of safety in
  medical device standards
5 The nature of risk
6 Risk-based process for developing a medical
  device standard that include aspects of safety
7 Overview of the application of medical device
  standards including aspects of safety in a
  risk management framework
Annex A (informative) - Product and process
        safety standards
Annex B (informative) - Risk information
Bibliography

BS ISO/IEC Guide 63.

Committee
CH/210/4
DocumentType
Draft
Pages
35
PublisherName
British Standards Institution
Status
NA

IEC GUIDE 109:2012 Environmental aspects - Inclusion in electrotechnical product standards
IEC 80001-1:2010 Application of risk management for IT-networks incorporating medical devices - Part 1: Roles, responsibilities and activities
ISO 11137-1:2006 Sterilization of health care products Radiation Part 1: Requirements for development, validation and routine control of a sterilization process for medical devices
ISO 7010:2011 Graphical symbols Safety colours and safety signs Registered safety signs
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/IEC Guide 14:2003 Purchase information on goods and services intended for consumers
ISO 13485:2016 Medical devices Quality management systems Requirements for regulatory purposes
ISO/IEC Guide 41:2003 Packaging Recommendations for addressing consumer needs
ISO/IEC Guide 51:2014 Safety aspects Guidelines for their inclusion in standards
ISO/IEC Guide 37:2012 Instructions for use of products by consumers
ISO 7001:2007 Graphical symbols — Public information symbols
ISO 10377:2013 Consumer product safety — Guidelines for suppliers
ISO/IEC Guide 2:2004 Standardization and related activities General vocabulary
ISO 14971:2007 Medical devices Application of risk management to medical devices
ISO 7000:2014 Graphical symbols for use on equipment Registered symbols
IEC 82079-1:2012 Preparation of instructions for use - Structuring, content and presentation - Part 1: General principles and detailed requirements
ISO 15223-1:2016 Medical devices Symbols to be used with medical device labels, labelling and information to be supplied Part 1: General requirements

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