17/30359001 DC : 0
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
Hardcopy , PDF
English
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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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