GUIDE 63 Third edition 2019-08 Guide to the development and inclusion of aspects of safety in International Standards for medical devices Guide pour I'elaboration des aspects de sécurité et leur incorporation dans des Normes internationales relatives aux dispositifs médicaux Reference number IS0/IEC GUIDE 63:2019(E) IEC ISO IS0/IEC 2019 ISO/IEC GUIDE 63:2019(E) COPYRIGHTPROTECTEDDOCUMENT IS0/IEC2019 be reproduced or utilized otherwise in any form or by any means, electronic or mechanical, including photocopying, or posting on the internet or an intranet, without prior written permission. Permission can be requested from either ISO at the address beloworIso'smemberbodyinthecountryoftherequester. ISO copyright office CP 401 : Ch. de Blandonnet 8 CH-1214 Vernier, Geneva Phone:+41227490111 Fax: +4122 749 09 47 Email: [email protected] Website: www.iso.org Published in Switzerland ii IS0/IEC2019-Allrightsreserved IS0/IEC GUIDE 63:2019(E) Contents Page Foreword V Introduction .vii 1 Scope .1 2 Normative references .1 3 Terms and definitions .1 4 Use of the terms"safety", "safe", "effective", and "effectiveness" .4 4.1 Safety.. 4 4.2 Safe.. 5 4.3 Effective 5 5 4.4 Effectiveness 5 Principles for including aspects of safety in medical device standards 5 5.1 Scope of medical device standards that include aspects of safety 5 5.2 Objective of medical device standards that include aspects of safety 6 5.3 Types of standards. 6 5.3.1 Product standards 6 5.3.2 Process standards 6 5.3.3 Installation and environmental standards 7 5.3.4 In-service standards 7 5.4 Taking a practical view of safety. 7 5.5 Coordination of medical device standards 7 5.6 Implications of the regulatory or legal use of standards .8 6 The nature of risk. .8 6.1 The elements of risk .8 6.2 Systematic or random nature of risks .9 6.2.1 Types of causes of risks 9 6.2.2 Risks arising from systematic causes 10 6.2.3 Risks arising from random causes. 10 7 Risk-based process for developing a medical device standard that includes aspects ofsafety 10 .10 7.1 General 7.2 Preparatory work 11 7.2.1 Identifying the need for a new or revised standard including aspects of safety... 11 7.2.2 Establishing the risk management framework under which the standard will be developed. 11 12 7.2.3 Risk acceptability criteria Drafting. 7.3 14 7.3.1 General. 14 7.3.2 Iterative process of managing risk 14 7.3.3 Intended use and characteristics that can influence safety 16 .17 7.3.4 Identification of hazards and hazardous situations.. 7.3.5 Risk estimation. 18 7.3.6 Risk evaluation 19 7.3.7 Identification of risk controls 19 22 7.3.8 Verification of effectiveness. 7.3.9 .22 Assessment of residual risks 22 7.3.10 Impactofintroducedriskcontrolmeasure 7.3.11 All identified hazards and hazardous situations considered 22 7.4 Validation of the standard. 22 7.5 Conclusion. 8 Overview of the application of medical device standards including aspects of safety 22 in a risk management framework @ IS0/IEC 2019 - All rights reserved iii