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1、JIS JAPANESE I NDUSTRIAL STANDARD Translated and Published by Japanese Standards Association JIS T 14971 :2003 (IS0 14971 2000) (JFMDA) Medical devices - Application of risk management to medical devices ICs 11.040.01 Reference number : JIS T 14971 : 2003 (E PROTECTED BY COPYRIGHT 2 1 s Copyright Ja
2、panese Standards Association Provided by IHS under license with JSALicensee=IHS Employees/1111111001, User=Wing, Bernie Not for Resale, 03/13/2007 00:42:57 MDTNo reproduction or networking permitted without license from IHS -,-,- Foreword This translation has been made based on the original Japanese
3、 Indus- trial Standard established by the Minister of Economy, Trade and Industry, and Minister of Health, Labour and Welfare through de- liberations at the Japanese Industrial Standards Committee according to the proposal of establishing a Japanese Industrial Standard from Japan Federation of Medic
4、al Devices Associations(JFMDA)/the Japanese Standards Assosiation(JSA), with a draft of Industrial Standard based on the provision of Article 12 Clause 1 of the Industrial Standardization Law. This Standard has been made based on IS0 14971 : 2000 Medical de- vices - Application of risk management to
5、 medical devices for the pur- poses of making it easier to compare this Standard with International Standard; to prepare Japanese Industrial Standard conforming with International Standard; and to propose a draft of an International Standard which is based on Japanese Industrial Standard. Date of Es
6、tablishment: 2003-08-25 Date of Public Notice in Official Gazette: 2003-08-25 Investigated by: Japanese Industrial Standards Committee Standards Board Technical Committee on Medical Equipment JIS T 14971 : 2003, First English edition published in 2004-02 Translated and pubIished by: Japanese Standar
7、ds Association 4-1-24, Akasaka, Minato-ku, Tokyo, 107-8440 JAPAN In the event of any doubts arising as to the contents, the original JIS is to be the final authority. O JSA 2004 All rights reserved. Unless otherwise specified, no part of this publication may be reproduced or utilized in any form or
8、by any means, electronic or mechanical, including photocopying and microfilm, without permission in writing from the publisher. Printed in Japan PROTECTED BY COPYRIGHT Copyright Japanese Standards Association Provided by IHS under license with JSALicensee=IHS Employees/1111111001, User=Wing, Bernie
9、Not for Resale, 03/13/2007 00:42:57 MDTNo reproduction or networking permitted without license from IHS -,-,- T 14971 : 2003(ISO 14971 : 2000) Contents Page . Introduction 1 1 Scope 1 2 2.1 2.2 2.3 2.4 2.5 2.6 2.7 2.8 2.9 2.10 2.11 2.12 2.13 2.14 2.15 2.16 2.17 2.18 2.19 2.20 2.21 2.22 Terms and def
10、initions 1 accompanying document 1 harm 1 hazard 1 hazardous situati on 1 intended use / intended 2 manufacturer 2 me. Namely., .measure- .of*harm 2.22 verification confirmation by examination and provision of objective evidence that specified requirements have been fulfilled NOTE : In design and de
11、velopment, verification concerns the process of examin- ing the result of a given activity to determine conformity with the stated requirement for that activity. IS0 8402 : 1994, definition 2.171 3 3.1 National or regional regulatory requirements Because of the wide variety of medical devices covere
12、d by this Standard and the different national or regional regu- latory requirements covering those devices, the requirements given in 3.3 and 3.4 ap- ply as appropriate. 3.2 Risk management process The manufacturer shall establish and maintain a process for ident - risk evaluation; - risk control; a
13、nd - post-production information. Where a documented product desigddevelopment process exists, it shall incorporate NOTES 1 A documented product desigddevelopment process can be used to deal with safety in a systematic manner, in particular to enable the early identification of hazards in complex sy
14、stems and environments. the appropriate parts of the risk management process. 2 A schematic representation of the risk management process is shown in Figure 1. 3 See the bibliography. Compliance is checked by inspection of the risk management file. 3.3 Management responsibilities The manufacturer sh
15、all a) define the policy for determining acceptable risk, taking into account relevant standards, and national or regional regulations, b) ensure the provision of adequate resources, c) ensure the assignment of trained personnel (see 3.4) for management, performance of work and assessment activities
16、, and d) review the results of risk management activities at defined intervals to ensure con- tinuing suitability and the effectiveness of the risk management process. The above shall be documented in the risk management me. Compliance is checked by inspection of the risk management file. PROTECTED
17、BY COPYRIGHT Copyright Japanese Standards Association Provided by IHS under license with JSALicensee=IHS Employees/1111111001, User=Wing, Bernie Not for Resale, 03/13/2007 00:42:57 MDTNo reproduction or networking permitted without license from IHS -,-,- 5 T 14971 : 2003(ISO 14971 : 2000) _I Risk an
18、alysis I e Intended usefintended 0 Review of risk management Figure 1 Schematic representation of the risk management process 3.4 Qualification of personnel The manufacturer shall ensure that those performing risk management tasks include persons with knowledge and experience appropriate to the task
19、s assigned to them. This shall include, where appropriate, knowledge and ex- perience of the medical device and its use and risk management techniques. Records of the appropriate qualifications shall be maintained. Compliance is checked by inspection of the appropriate records. 3 . 5 Risk management
20、 plan For the particular medical device or accessory being con- sidered, the manufacturer shall prepare a risk management plan in accordance with the risk management process. The risk management plan shall be part of the risk management file. This plan shall include the following: a) the scope of th
21、e plan, identimng and describing the medical device and the life cy- cle phases for which the plan is applicable; b) a verification plan; c) allocation of responsibilities; d) requirements for review of risk management activities; and e) criteria for risk acceptability. PROTECTED BY COPYRIGHT Copyri
22、ght Japanese Standards Association Provided by IHS under license with JSALicensee=IHS Employees/1111111001, User=Wing, Bernie Not for Resale, 03/13/2007 00:42:57 MDTNo reproduction or networking permitted without license from IHS -,-,- 6 T 14971 : 2003(ISO 14971 : 2000) NOTE : The criteria for risk
23、acceptability will do much to determine the ultimate effectiveness of the risk management process. Refer to Annex E for guidance on establishing such criteria. If the plan changes during the life cycle of the medical device, a record of the changes shall be maintained in the risk management file. Co
24、mpliance is checked by inspection of the risk management file. 3.6 For the particular medical device or accessory being considered, the results of all risk management activities shall be recorded and maintained in the risk management 2e. NOTES 1 The records and other documents that make up the risk
25、management $.le can form part of other documents and files required, for example, by a manufacturers quality management system. 2 The risk management file need not physically contain all the documents relating to this Standard. However, it should contain at least references or pointers to all requir
26、ed documentation. The manufacturer should be able to assemble the information referenced in the risk management file in a timely fashion. Risk management file 4 Risk analysis (Steps 1,2 and 3 of Figure 2) 4.1 Risk analysis procedure Risk analysis, as described in 4.2 to 4.4, shall be per- formed and
27、 the conduct and results of the risk analysis shall be recorded in the risk management file. NOTE : If a risk analysis is available for a similar medical device, it may be used as a reference provided it can be demonstrated that the processes are similar or that the changes that have been made will
28、not introduce sig- nificant differences in results. This should be based on a systematic evaluation of the changes and the ways they can influence the various hazards present. In addition to the records required in 4.2 to 4.4, the documentation of the conduct and results of the risk analysis shall i
29、nclude at least the following: a) a description and identification of the medical device or accessory that was ana- lysed; b) identification of the person(s) and organization which carried out the risk analysis; c) date of the analysis. Compliance is checked by inspection of the risk management file
30、. 4.2 Intended use/intended purpose and identication of characteristics related to the safety of the medical device (Step 1 ) For the particular medical device or accessory being considered, the manufacturer shall describe the intended usehtended purpose and any reasonably foreseeable misuse. The ma
31、nufacturer shall list all those qualita- tive and quantitative characteristics that could affect the safety of the medical device and, where appropriate, their defined limits (see NOTES i). These records shall be PROTECTED BY COPYRIGHT Copyright Japanese Standards Association Provided by IHS under l
32、icense with JSALicensee=IHS Employees/1111111001, User=Wing, Bernie Not for Resale, 03/13/2007 00:42:57 MDTNo reproduction or networking permitted without license from IHS -,-,- 7 T 14971 : 2003(ISO 14971 : 2000) maintained in the risk management file. NOTES 1 Annex A contains questions that can ser
33、ve as a useful guide in drawing 2 Additional guidance on risk analysis techniques for ir1 vitro diagnostic 3 Additional guidance on risk analysis techniques for toxicological haz- up such a list. medical devices is given in Annex B. ards is given in Annex C. Compliance is checked by inspection of th
34、e risk management file. 4.3 Identification of known or foreseeable hazards (Step 2) The manufacturer shall compile a list of known or foreseeable hazards associated with the medical device in both normal and fault conditions. Previously recognized hazards shall be identified. This list shall be main
35、tained in the risk management file. Foreseeable sequences of events that may result in a hazardous situation shall be NOTES 1 The examples of possible hazards listed in Annex D, and in Annex B.2 for in vitro diagnostic medical devices, can be used as an aide-memoire. 2 To identify hazards not previo
36、usly recognized, systematic methods cov- ering the specific situation can be used (see Annex F). considered and recorded. Compliance is checked by inspection of the risk management file. 4.4 Estimation of the risk(s) for each hazard (Step 3) For each identified hazard, the risk(s) in both normal and
37、 fault conditions shall be estimated using available informa- tion or data. For hazards for which the probability of the occurrence of harm cannot be estimated, a listing of the possible consequences of the hazard shall be prepared. The estimate of the risk(s) shall be recorded in the risk managemen
38、t le. Any system used for qualitative or quantitative categorization of probability esti- mates or severity levels shall be recorded in the risk management file. NOTES 1 2 3 4 Risk estimation incorporates an analysis of the probability of occurrence and the consequences. Depending on the area of app
39、lication, only Cer- tain elements of the risk estimation process may need to be considered. For example, in some instances it will not be necessary to go beyond an initial hazard and consequence analysis. Risk estimation can be quantitative or qualitative. Methods of risk es- timation including thos
40、e resulting from systematic faults, are described in Annex E. Clause B.3 gives information useful for estimating risks for in vitro diagnostic medical devices. Some techniques that can be used for analysis of risks are described in Annex F. Information or data for estimating risks can be obtained, f
41、or example, from - published standards, - scientific technical data, PROTECTED BY COPYRIGHT Copyright Japanese Standards Association Provided by IHS under license with JSALicensee=IHS Employees/1111111001, User=Wing, Bernie Not for Resale, 03/13/2007 00:42:57 MDTNo reproduction or networking permitt
42、ed without license from IHS -,-,- 8 T 14971 : 2003(ISO 14971 : 2000) - field data from similar medical devices already in use including pub- lished reported incidents, - usability tests employing typical users, - clinical evidence, - results of appropriate investigations, - expert opinion, - externa
43、l quality assessment schemes. Compliance is checked by inspection of the risk management file. PROTECTED BY COPYRIGHT Copyright Japanese Standards Association Provided by IHS under license with JSALicensee=IHS Employees/1111111001, User=Wing, Bernie Not for Resale, 03/13/2007 00:42:57 MDTNo reproduc
44、tion or networking permitted without license from IHS -,-,- 9 T 14971 : 2003(ISO 14971 : 000) Risk analysis Risk evaluation Risk mntrol Overall residual risk evaluation POSI- production information I I C _L - - Start I Intended userintended purpose I i I Identify charactefiscs (4.2) 1 I Idenilfyknow
45、norforeseeable i t I hazards (4.3) t r f Estimate risk) for each hazard I (4.4) I i rneauire(s), rewrd rfsk control b) protective measures in the medical device itself or in the manufacturing process; c) information for safety. NOTES 1 Measures of risk control can reduce the severity of the potentia
46、l harm or reduce the probability of occurrence of the harm, or both. 2 Technical standards address inherent, protective and descriptive safe for many medical devices. These should be consulted as part of the risk management process. See also Annex G. The risk control measures selected shall be recor
47、ded in the risk management file. If, during option analysis, the manufacturer determines that further risk reduction is impractical, the manufacturer shall conduct a rismenefit analysis of the residual risk (see 6.5); otherwise, the manufacturer shall proceed to implement the selected risk control m
48、easures. Compliance is checked by inspection of the risk management fite. 6.3 Implementation of risk control measure(s) (Step 6) The manufacturer shall im- plement the risk control measureh) selected in 6.2. The measure(s) used to control the risks shall be recorded in the risk management le. The effectiveness of the risk control measures shall be verified and the results of the verification shall be recorded in the risk management Eie. PROTECTED BY COPYRIGHT Copyright Japanese Standards Association Provided by IHS under license with JSALicensee=IHS Employees/1111111001, User=Wing, Be