AAMI/ISO/ IEC Guide 63:2019
Current
The latest, up-to-date edition.
Guide to the development and inclusion of aspects of safety in International Standards for medical devices
English
22-12-2019
This document provides requirements and recommendations to writers of medical device standards on the inclusion of aspects related to safety in International Standards, based on well-established risk management concepts and methodology.
| Committee |
ISO/TC 210
|
| DocumentType |
Guide
|
| ISBN |
978-1-57020-729-7
|
| Pages |
38
|
| PublisherName |
Association for the Advancement of Medical Instrumentation
|
| Status |
Current
|
| IEC GUIDE 109:2012 | Environmental aspects - Inclusion in electrotechnical product standards |
| 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 14971:2019 | Medical devices — Application of risk management to medical devices |
| ISO 11135:1994 | Medical devices — Validation and routine control of ethylene oxide sterilization |
| ISO 15223-1:2021 | Medical devices — Symbols to be used with information to be supplied by the manufacturer — Part 1: General requirements |
| IEC 80001-1:2021 | Application of risk management for IT-networks incorporating medical devices - Part 1: Safety, effectiveness and security in the implementation and use of connected medical devices or connected health software |
| ISO 13485:2016 | Medical devices — Quality management systems — Requirements for regulatory purposes |
| ISO 7010:2003 | Graphical symbols — Safety colours and safety signs — Safety signs used in workplaces and public areas |
| ISO 10993-1:1997 | Biological evaluation of medical devices — Part 1: Evaluation and testing |
| IEC 60417:2024 DB | Graphical symbols for use on equipment - 12-month subscription to regularly updated online database comprising all graphical symbols published in IEC 60417 |
| IEC 62366-1:2015 | Medical devices - Part 1: Application of usability engineering to medical devices |
| ISO/IEC Guide 14:2018 | Products and related services — Information for consumers |
| ISO/IEC Guide 51:2014 | Safety aspects — Guidelines for their inclusion in standards |
| IEC 62304:2006+AMD1:2015 CSV | Medical device software - Software life cycle processes |
| ISO/IEC Guide 37:2012 | Instructions for use of products by consumers |
| ISO 7001:2007 | Graphical symbols — Public information symbols |
| ISO 7000:2019 | Graphical symbols for use on equipment — Registered symbols |
| ISO 9000:2015 | Quality management systems — Fundamentals and vocabulary |
| ISO/IEC Guide 2:2004 | Standardization and related activities — General vocabulary |
| ISO/TR 24971:2020 | Medical devices — Guidance on the application of ISO 14971 |
| IEC 82079-1:2012 | Preparation of instructions for use - Structuring, content and presentation - Part 1: General principles and detailed requirements |
| ISO/IEC Guide 41:2018 | Packaging — Recommendations for addressing consumer needs |
| ISO 3864:1984 | Safety colours and safety signs |
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