1、 GUIDE 63 Guide to the development and inclusion of safety aspects in International Standards for medical devices Second edition 2012 ISO/IEC 2012 ISO/IEC GUIDE 63:2012(E) COPYRIGHT PROTECTED DOCUMENT ISO/IEC 2012 All rights reserved. Unless otherwise specified, no part of this publication may be re
2、produced or utilized in any form or by any means, electronic or mechanical, including photocopying and microfilm, without permission in writing from either ISO at the address below or ISOs member body in the country of the requester. ISO copyright office Case postale 56 CH-1211 Geneva 20 Tel. + 41 2
3、2 749 01 11 Fax + 41 22 749 09 47 E-mail copyrightiso.org Web www.iso.org Published in Switzerland ii ISO/IEC 2012 All rights reservedISO/IEC GUIDE 63:2012(E) ISO/IEC 2012 All rights reserved iiiContents Page Foreword iv Introduction . v 1 Scope 1 2 Terms and definitions . 1 3 Principles for prepari
4、ng medical device safety standards . 4 3.1 General considerations . 4 3.2 Scope of safety standards 5 3.3 Types of standards 5 3.4 Taking a practical view of safety . 6 3.5 Managing risks 6 3.6 Risk acceptability criteria . 7 3.7 Risk control methods/methodology 7 3.8 Coordination of medical device
5、safety standards . 7 3.9 Regulatory implications 7 4 Risk-based framework for developing a medical device safety standard . 8 4.1 General . 8 4.2 Management of the risk-based framework . 8 4.3 Application and characteristics . 8 4.4 Identification of hazards and hazardous situations 9 4.5 Types of h
6、azards and hazardous situations. 10 4.6 Systematic or random nature of risks . 12 4.7 Risk estimation 13 4.8 Risk acceptability criteria . 14 4.9 Risk evaluation 15 4.10 Risks to be controlled by the standard . 15 4.11 Conclusion . 16 5 Facilitating the implementation of ISO 14971 though product or
7、process standards . 16 5.1 Product standards . 16 5.2 Process standards 17 5.3 Overview of the application of medical device safety standards in an ISO 14971 framework 17 Annex A (informative) Product and process safety standards 19 Annex B (informative) Risk information . 20 Bibliography 21 ISO/IEC
8、 GUIDE 63:2012(E) iv ISO/IEC 2012 All rights reservedForeword ISO (the International Organization for Standardization) is a worldwide federation of national standards bodies (ISO member bodies). The work of preparing International Standards is normally carried out through ISO technical committees. E
9、ach member body interested in a subject for which a technical committee has been established has the right to be represented on that committee. International organizations, governmental and non-governmental, in liaison with ISO, also take part in the work. ISO collaborates closely with the Internati
10、onal Electrotechnical Commission (IEC) on all matters of electrotechnical standardization. International Standards are drafted in accordance with the rules given in the ISO/IEC Directives, Part 2. Draft Guides adopted by the responsible Committee or Group are circulated to the member bodies for voti
11、ng. Publication as a Guide requires approval by at least 75 % of the member bodies casting a vote. Attention is drawn to the possibility that some of the elements of this document may be the subject of patent rights. ISO shall not be held responsible for identifying any or all such patent rights. IS
12、O/IEC Guide 63 was prepared jointly by ISO/TC 210, Quality management and corresponding general aspects for medical devices, and IEC/SC 62A, Common aspects of electrical equipment used in medical practice, in a Joint Working Group, Application of risk management to medical devices. This second editi
13、on cancels and replaces the first edition (ISO/IEC Guide 63:1999), which has been technically revised. ISO/IEC GUIDE 63:2012(E) ISO/IEC 2012 All rights reserved vIntroduction ISO/IEC Guide 51 was the first of a series of guides intended to provide a harmonized approach to the concept of safety when
14、preparing International Standards. ISO/IEC Guide 51 anticipated the need for sectoral guides such as this Guide. Consistent with ISO/IEC Guide 51, additional guidance might be needed for sectors within the broad category of medical devices. The concept of safety, including safety-related performance
15、 and usability, is closely related to safeguarding the integrity of the patients who are the subjects of medical care, as well as that of those persons who are giving the care and any other persons. As medical devices and medical systems have become more complex, the diligence required to ensure the
16、ir safety has similarly increased. As different circumstances warrant different approaches to ensuring safety, it is impossible to provide precise requirements and recommendations that apply to every case. However, these guidelines, when followed on a judicious “use when applicable” basis, will help
17、 in developing reasonably consistent standards. ISO/IEC GUIDE 63:2012(E) ISO/IEC 2012 All rights reserved 1Guide to the development and inclusion of safety aspects in International Standards for medical devices 1 Scope This Guide provides guidance to standards writers on how to include safety aspect
18、s in the development of medical device safety standards intended to be used within the risk management framework established in ISO 14971. It expands on the concepts developed in ISO/IEC Guide 51 to include safety-related performance and usability. This Guide is intended to be read in conjunction wi
19、th ISO/IEC Guide 51 and ISO 14971. 2 Terms and definitions For the purposes of this document, the following terms and definitions apply. 2.1 accompanying document document accompanying a medical device and containing information for those accountable for the installation, use and maintenance of the
20、medical device, the operator or the user, particularly regarding safety ISO 14971:2007, definition 2.1 2.2 harm physical injury or damage to the health of people, or damage to property or the environment ISO/IEC Guide 51:1999, definition 3.3 2.3 hazard potential source of harm NOTE The term hazard c
21、an be qualified in order to define its origin or the nature of the expected harm (e.g. electric shock hazard, crushing hazard, cutting hazard, toxic hazard, fire hazard, drowning hazard). ISO/IEC Guide 51:1999, definition 3.5 2.4 hazardous situation circumstance in which people, property or the envi
22、ronment are exposed to one or more hazards ISO/IEC Guide 51:1999, definition 3.6 2.5 intended use intended purpose use for which a product, process, or service is intended according to the specifications, instructions and information provided by the manufacturer ISO 14971:2007, definition 2.5 ISO/IE
23、C GUIDE 63:2012(E) 2 ISO/IEC 2012 All rights reserved2.6 life cycle all phases in the life of a medical device, from the initial conception to final decommissioning and disposal ISO 14971:2007, definition 2.7 2.7 manufacturer natural or legal person with responsibility for the design, manufacture, p
24、ackaging, or labelling of a medical device, assembling a system, or adapting a medical device before it is placed on the market or put into service, regardless of whether these operations are carried out by that person or on that persons behalf by a third party NOTE 1 Attention is drawn to the fact
25、that the provisions of national or regional regulations can apply to the definition of manufacturer. NOTE 2 For a definition of labelling, see ISO 13485:2003, definition 3.6. ISO 14971:2007, definition 2.8 2.8 medical device any instrument, apparatus, implement, machine, appliance, implant, in vitro
26、 reagent or calibrator, software, material or other similar or related article, intended by the manufacturer to be used, alone or in combination, for human beings for one or more of the specific purpose(s) of diagnosis, prevention, monitoring, treatment or alleviation of disease, diagnosis, monitori
27、ng, treatment, alleviation of, or compensation for, an injury, investigation, replacement, modification, or support of the anatomy or of a physiological process, supporting or sustaining life, control of conception, disinfection of medical devices, providing information for medical purposes by means
28、 of in vitro examination of specimens derived from the human body, and which does not achieve its primary intended action in or on the human body by pharmacological, immunological or metabolic means, but which may be assisted in its function by such means NOTE 1 This definition has been developed by
29、 the Global Harmonization Task Force (GHTF). NOTE 2 Products, which could be considered to be medical devices in some jurisdictions, but for which there is not yet a harmonized approach, are aids for disabled/handicapped people, devices for the treatment/diagnosis of diseases and injuries in animals
30、, accessories for medical devices, disinfection substances, devices incorporating animal and human tissues which can meet the requirements of the above definition but are subject to different controls. NOTE 3 Adapted from ISO 13485:2003, definition 3.7, and ISO 14971:2007, definition 2.9. 2.9 residu
31、al risk risk remaining after risk control measures have been taken ISO/IEC GUIDE 63:2012(E) ISO/IEC 2012 All rights reserved 3NOTE 1 ISO/IEC Guide 51:1999, definition 3.9, uses the term “protective measures” rather than “risk control measures”. NOTE 2 Adapted from ISO 14971:2007, definition 2.15. 2.
32、10 risk combination of the probability of occurrence of harm and the severity of that harm ISO/IEC Guide 51:1999, definition 3.2 2.11 risk analysis systematic use of available information to identify hazards and to estimate the risk ISO/IEC Guide 51:1999, definition 3.10 NOTE Risk analysis includes
33、the examination of different sequences of events that can produce hazardous situations and harm. 2.12 risk control process in which decisions are made and measures implemented by which risks are reduced to, or maintained within, specified levels ISO 14971:2007, definition 2.19 2.13 risk estimation p
34、rocess used to assign values to the probability of occurrence of harm and the severity of that harm ISO 14971:2007, definition 2.20 2.14 risk evaluation process of comparing the estimated risk against given risk criteria to determine the acceptability of the risk ISO 14971:2007, definition 2.21 2.15
35、 risk management systematic application of management policies, procedures and practices to the tasks of analysing, evaluating, controlling and monitoring risk ISO 14971:2007, definition 2.22 2.16 safety freedom from unacceptable risk ISO/IEC Guide 51:1999, definition 3.1 2.17 severity measure of th
36、e possible consequences of a hazard ISO 14971:2007, definition 2.25 ISO/IEC GUIDE 63:2012(E) 4 ISO/IEC 2012 All rights reserved2.18 usability characteristic of the user interface that establishes effectiveness, efficiency, ease of user learning and user satisfaction IEC 62366:2007, definition 3.17 2
37、.19 use error act or omission of an act that results in a different medical device response than intended by the manufacturer or expected by the user NOTE 1 Use error includes slips, lapses, and mistakes. NOTE 2 See also IEC 62366:2007, Annex B and D.1.3. NOTE 3 An unexpected physiological response
38、of the patient is not in itself considered use error. IEC 62366:2007, definition 3.21 2.20 verification confirmation, through the provision of objective evidence, that specified requirements have been fulfilled NOTE 1 The term “verified” is used to designate the corresponding status. NOTE 2 Confirma
39、tion can comprise activities such as performing alternative calculations, comparing a new design specification with a similar proven design specification, undertaking tests and demonstrations, and reviewing documents prior to issue. ISO 9000:2005, definition 3.8.4 3 Principles for preparing medical
40、device safety standards 3.1 General considerations The goal of medical device safety standards is to support the development and production of medical devices with a predictable, consistent level of safety. To achieve this goal, medical device safety standards should a) assist manufacturers in the d
41、esign and production of safe and effective medical devices, b) assist manufacturers, certification bodies, testing laboratories or test houses, and regulatory authorities in assessing compliance with legal and market requirements, and c) assist health care providers in managing risks associated with
42、 the use of medical devices. To produce medical device safety standards that are well suited to assisting the stakeholders listed above, the standards writers are encouraged to employ a risk-based framework (see Clause 4). ISO/IEC GUIDE 63:2012(E) ISO/IEC 2012 All rights reserved 53.2 Scope of safet
43、y standards The planning and development of medical device safety standards require a global approach that includes manufacturers, users, regulatory authorities and other stakeholders. Close coordination within and among committees responsible for different medical devices is necessary to create a c
44、oherent approach to the treatment of safety in the preparation of standards. Defining the scope of safety standards will ensure that each standard is restricted to specific aspects and makes reference to standards of wider application for all other relevant aspects. Such a hierarchy is built on: bas
45、ic safety standards, including fundamental concepts, principles and requirements with regard to general safety aspects applicable to all kinds or a wide range of products, processes and services (basic safety standards are sometimes referred to as horizontal standards); group safety standards, inclu
46、ding safety aspects applicable to several, or a family of, similar products, processes or services dealt with by two or more technical committees or subcommittees, making reference, as far as possible, to basic safety standards; product safety standards, including all necessary safety aspects of a s
47、pecific, or a family of, product(s), process(es), or service(s) within the scope of a single technical committee or subcommittee, making reference, as far as possible, to basic safety standards and group safety standards (product safety standards are sometimes referred to as vertical standards). Thi
48、s hierarchy is set out in ISO/IEC Guide 51:1999, 7.1. Safety requirements for medical devices may be incorporated in different types of standards (see 3.3) that may be found at any appropriate level in the hierarchy described above. 3.3 Types of standards 3.3.1 Product standards These can be standar
49、ds that state safety or performance parameters and include reference test methods that can be used to demonstrate conformance to those parameters, or disclosure and test method standards where adherence to declared pass/fail criteria are necessary for safety and performance. See Clause A.1 for a discussion of how product standards can contribute to the safety and the effectiveness of medical devices. 3.3.2 Process standards These can be a) quality system standards that esta
