ANSI TIR24971-2013 Medical devices - Guidance on the application of ISO 14971.pdf

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1、ANSI/AAMI/ISO TIR24971: 2013/(R)2016Technical Information ReportMedical devices Guidance on the application of ISO 14971An ANSI Technical Report Prepared by AAMI ANSI/AAMI/ISO TIR24971:2013/(R)2016 Medical devices Guidance on the application of ISO 14971 Approved 27 June 2013 by AAMI Registered 26 A

2、ugust 2013 and reaffirmed 30 December 2016 by American National Standards Institute, Inc. Abstract: Provides guidance that addresses specific areas that are problematic for those implementing a risk management system. Keywords: risk managementPublished by AAMI4301 N. Fairfax Dr., Suite 301 Arlington

3、, VA 22203-1633 www.aami.org 2013 by the Association for the Advancement of Medical Instrumentation All Rights Reserved Publication, reproduction, photocopying, storage, or transmission, electronically or otherwise, of all or any part of this document without the prior written permission of the Asso

4、ciation for the Advancement of Medical Instrumentation is strictly prohibited by law. It is illegal under federal law (17 U.S.C. 101, et seq.) to make copies of all or any part of this document (whether internally or externally) without the prior written permission of the Association for the Advance

5、ment of Medical Instrumentation. Violators risk legal action, including civil and criminal penalties, and damages of $100,000 per offense. For permission regarding the use of all or any part of this document, complete the reprint request form at www.aami.org or contact AAMI, 4301 N. Fairfax Drive Su

6、ite 301, Arlington, VA 22203-1633. Phone: +1-703- 525-4890; Fax: +1-703-276-0793. Printed in the United States of America ISBN 978-1-57020-501-9AAMI Technical Information Report A technical information report (TIR) is a publication of the Association for the Advancement of Medical Instrumentation (A

7、AMI) Standards Board that addresses a particular aspect of medical technology. Although the material presented in a TIR may need further evaluation by experts, releasing the information is valuable because the industry and the professions have an immediate need for it. A TIR differs markedly from a

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12、ng safety or performance issues than a standard or recommended practice, or because achieving consensus is extremely difficult or unlikely. Unlike a standard, a TIR permits the inclusion of differing viewpoints on technical issues. CAUTION NOTICE: This AAMI TIR may be revised or withdrawn at any tim

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15、for enforcement of its rules and regulations. Comments on this technical information report are invited and should be sent to AAMI, Attn: Standards Department, 4301 N. Fairfax Drive, Suite 301, Arlington, VA 22203-1633. ANSI Technical Report This AAMI TIR has been registered by the American National

16、 Standards Institute as an ANSI Technical Report. Publication of this ANSI Technical Report has been approved by the accredited standards developer (AAMI). This document is registered as a Technical Report series of publications according to the Procedures for the Registration of Technical Reports w

17、ith ANSI. This document is not an American National Standard and the material contained herein is not normative in nature. Comments on the content of this document should be sent to AAMI, Attn: Standards Department, 4301 N. Fairfax Drive, Suite 301, Arlington, VA 22203-1633. Contents Page Glossary o

18、f equivalent standards . v Committee representation. vi Background of US adoption of ISO/TS 24971:2013 viii Foreword . ix Introduction . x 1 Scope 1 2 The role of international product safety and process standards in risk management . 1 2.1 Overview 1 2.2 Use of international product safety standard

19、s in risk management . 2 2.3 International process standards and ISO 14971 5 3 Developing the policy for determining the criteria for risk acceptability 7 4 Production and post-production feedback loop 8 4.1 Overview 8 4.2 Observation and transmission 8 4.3 Assessment . 11 4.4 Action . 11 5 Differen

20、tiation of information for safety and disclosure of residual risk 12 5.1 Difference between “information for safety” and “disclosure of residual risk” 12 5.2 Information for safety . 12 5.3 Disclosure of residual risk . 13 6 Evaluation of overall residual risk . 13 6.1 Overview 13 6.2 Inputs and oth

21、er considerations for overall residual risk evaluation 14 Figures Figure 1 Use of international product safety standards and example of such standard that specifies requirements and provides specific test acceptance criteria 4 Figure 2 Production and Post-Production Feedback Loop . 10 2013 Associati

22、on for the Advancement of Medical Instrumentation ANSI/AAMI/ISO TIR24971:2013 v Glossary of equivalent standards International Standards adopted in the United States may include normative references to other International Standards. AAMI maintains a current list of each International Standard that h

23、as been adopted by AAMI (and ANSI). Available on the AAMI website at the address below, this list gives the corresponding U.S. designation and level of equivalency to the International Standard. www.aami.org/standards/glossary.pdf vi 2013 Association for the Advancement of Medical Instrumentation AN

24、SI/AAMI/ISO TIR24971:2013 Committee representation Association for the Advancement of Medical Instrumentation Quality Management and Corresponding General Aspects for Medical Devices Committee The adoption of ISO Technical Specification (TS) 24971:2013 as a new AAMI Technical Information Report was

25、initiated by the AAMI Quality Management and Corresponding General Aspects for Medical Devices Committee, which also functions as a U.S. Technical Advisory Group to the relevant work in the International Organization for Standardization (ISO). U.S. representatives from the AAMI Application of Risk M

26、anagement to Medical Devices Working Group (U.S. Sub-TAG for ISO/IEC JWG 1), chaired by Charles B. Sidebottom, PE of Medtronic, Inc. and Harvey Rudolph of Underwriters Laboratories, Inc., played an active part in developing the ISO Technical Specification. At the time this document was published, th

27、e AAMI Quality Management and Corresponding General Aspects for Medical Devices Committee had the following members: Cochairs Scott Colburn, MS, BSN, RN, FDA/CDRH Charles B. Sidebottom, PE, Medtronic Inc. WHQ Campus Members Scott Colburn, MS, BSN, RN, FDA/CDR Ed R. Kimmelman, BME, JD, (Independent E

28、xpert) Sherry M. Leichtweis, Abbott Laboratories Emmanuel Nyakako, Zimmer Inc. David G. Osborn, Philips Electronics North America Harvey Rudolph, PhD, Underwriters Laboratories Inc. Charles B. Sidebottom, PE, Medtronic Inc. WHQ Campus Al Van Houdt, Spacelabs Medical Inc. Alternates David J. Geraghty

29、, Spacelabs Medical Inc. Mike Hudon, Philips Electronics North America Luann M. Pendy, Medtronic Inc. WHQ Campus Kimberly A. Trautman, FDA/CDRH NOTE-Participation by federal agency representatives in the development of this document does not constitute endorsement by the federal government or any of

30、 its agencies. At the time this document was published, the Application of Risk Management to Medical Devices Working Group had the following members: Cochairs Charles B. Sidebottom, PE, Medtronic Inc. Harvey Rudolph, UL LLC Members Arayan Amsalu, PhD, Hill-Rom Holdings Pat Baird, Baxter Healthcare

31、Corporation Edwin L. Bills, RAC, CQE, CQA, Hill-Rom Company Sherman Eagles, SoftwareCPR Rich Eaton, MITA David Geraghty, Spacelabs Medical Inc. Gottlieb Glauninger, Eli Lilly develop the policy for determining the criteria for risk acceptability; incorporate production and post-production feedback l

32、oop into risk management; differentiate between “information for safety” and “disclosure of residual risk”; and evaluate overall residual risk. 2 The role of international product safety and process standards in risk management 2.1 Overview International product safety and process standards play a s

33、ignificant role in risk management as described by ISO 14971. In principle, these standards are developed using a type of risk management that can include identifying hazards and hazardous situations, estimating risks, evaluating risks, and specifying risk control measures. More information on a pro

34、cess for developing medical device standards using a type of risk management can be found in documents such as ISO/IEC Guide 51 and ISO/IEC Guide 63. International product safety and process standards are developed by experts in the field and represent the generally accepted state of the art (see D.

35、4 of ISO 14971:2007). These standards can have an important role in risk management. When performing risk management, the manufacturer first needs to consider the medical device being designed, its intended use and the hazards/hazardous situations related to it. Manufacturers can, if they choose, id

36、entify standard(s) that contain specific requirements that help manage the risks related to those hazards/hazardous situations. For medical devices that satisfy the requirements and compliance criteria of these standards, the residual risks related to those hazards/hazardous situations can be consid

37、ered acceptable unless there is objective evidence to the contrary. Some potential sources of objective evidence to the contrary can include reports of adverse events, product recalls and complaints. The requirements of International Standards, such as engineering or analytical processes, specific o

38、utput limits, warning statements, or design specifications, can be considered risk control measures established by the standards writers that 2 2013 Association for the Advancement of Medical Instrumentation ANSI/AAMI/ISO TIR24971:2013 are intended to address the risks of specific hazardous situatio

39、ns that have been identified and evaluated as needing risk control. In many cases, the standards writers have taken on and completed elements of risk management and provided manufacturers with answers in the form of design requirements and test methods for establishing conformity. When performing ri

40、sk management activities, manufacturers can take advantage of the work of the standards writers and need not repeat the analyses leading to the requirements of the standard. International standards, therefore, provide valuable information on risk acceptability that has been validated during a worldw

41、ide evaluation process, including multiple rounds of review, comment, and voting. 2.2 Use of international product safety standards in risk management An international product safety standard can establish requirements that, when implemented, result in acceptable risk for specific hazardous situatio

42、ns (e.g. safety limits). The manufacturer can apply these requirements in the following way when managing risk. a) Where an international product safety standard specifies technical requirements addressing particular hazards or hazardous situations, together with specific acceptance criteria, compli

43、ance with those requirements is presumed to establish that the residual risks have been reduced to acceptable levels unless there is objective evidence to the contrary. For example, in IEC 60601-1, Medical electrical equipment Part 1: General requirements for basic safety and essential performance,

44、leakage current must be controlled to achieve an acceptable level of risk. IEC 60601-1 provides leakage current limits that are considered to result in an acceptable level of risk when measured under the conditions stated in 8.7 of IEC 60601-1:2005. For this example, further risk management would no

45、t be necessary. The following steps need to be taken in this case. 1) Implement 4.2 and 4.3 of ISO 14971:2007 to identify characteristics related to safety and identify hazards and hazardous situations associated with the device as completely as possible. 2) Identify those hazards and hazardous situ

46、ations relevant to the particular medical device that are exactly covered by the international product safety standard. 3) For those identified hazards and hazardous situations exactly covered by the international product safety standard, the manufacturer may choose not to estimate (4.4 of ISO 14971

47、:2007) or evaluate (Clause 5 of ISO 14971:2007) the risks so identified but rather rely on the requirements contained in the international standard to demonstrate the completion of risk estimation and risk evaluation. 4) To the extent possible, the manufacturer should identify the design specificati

48、ons that satisfy the requirements in the standard and serve as risk control measures (6.2 of ISO 14971:2007). NOTE For some international product safety standards, the possibility of identifying all the specific risk control measures is limited. One example is electromagnetic compatibility testing i

49、n IEC 606011-2, Medical electrical equipment Part 1-2: General requirements for basic safety and essential performance Collateral standard: Electromagnetic compatibility Requirements and tests, for complex medical devices. 5) Verification of the implementation of the risk control measures for these hazardous situations is obtained from the design documents. Verification of the effectiveness of the risk control measures is obtained from the tests and test results demonstrating that the device meets the relevant requirements of the international prod