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1 DOCUMENT: Future AAMI/IEC :2015/Amendment 1, Medical devices Application of usability Engineering to medical devices Amendment 1 Public Review Draft Designation: AAMI/CDV :2015/DAmd 1 AAMI has circulated this draft to committee members for comment and vote. Consensus on this draft will be developed by the AAMI Human Factors Engineering Committee. Interested parties may submit public review comments, in writing, to: AAMI 4301 N Fairfax Dr Ste 301 Arlington, VA ATTN: Jennifer Moyer jmoyer@aami.org COMMENT DEADLINE: 1 November 2018 INSTRUCTIONS FOR COMMENTING: Comments should be received by AAMI by the above deadline (earlier if possible) to ensure their consideration by the Committee. Comments should be set forth as follows: a. Section number, section heading, and page number of document; b. Comments/objection; c. Rationale for comment/objection; and, d. Suggested alternative text to resolve comment/objection. NOTE The above format is not required for comments concerning typographical errors; simply identify the nature and location of the error (e.g, by page, paragraph, and line number). Failure to comply fully with these instructions may cause comments to be considered nonpersuasive. An electronic Public Reviewer form is available from the AAMI website: WORD Please be sure to identify the document by designation: 'AAMI/IEC :2015/DAmd 1' and include your name, address, phone number, fax number and address in the event we need to contact you about your comments rights reserved.

2 AAMI/IEC CDV (Amendment to ANSI/AAMI/IEC :2015) Committee Draft for Vote AAMI Amendment to a Standard NOTE - This document is still under study and subject to change. It should not be used for reference purposes. Medical devices Application of usability Engineering to medical devices Amendment 1 Abstract: This amendment corrects identified inaccuracies in ANSI/AAMI/IEC :2015 while making no fundamental changes to the usability engineering process as originally conceived in that document. Keywords: human factors engineering, ergonomics, human factors, usability Association for the Advancement of Medical Instrumentation 4301 N Fairfax Drive, Suite 301, Arlington VA Phone 703/ Fax 703/ Internet

3 Published by Association for the Advancement of Medical Instrumentation 4301 N Fairfax Drive, Suite 301 Arlington, VA by the Association for the Advancement of Medical Instrumentation Rights Reserved This publication is subject to copyright claims of AAMI. Publication, reproduction, photocopying, storage, or transmission, electronically or otherwise, of all or any part of this document without the prior written permission of the Association 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 Advancement 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 or contact AAMI at 4301 N Fairfax Drive, Suite 301, Arlington, VA Phone: (703) ; Fax: (703) Printed in the United States of America

4 3 30 INTRODUCTION TO AMENDMENT The first edition of IEC was published in Since its publication, experts working in the field have identified several inaccuracies that warrant correction. In total, 22 issues were identified and presented to the National Committee members of IEC/SC 62A and to the Member Bodies of ISO/TC 210. A majority of the members of both committees that stated a position supported developing this amendment to address the identified issues while making no fundamental changes to the USABILITY ENGINEERING PROCESS as originally conceived in IEC : FOREWORD In the existing paragraph beginning "This first edition of ", replace "IEC " with "IEC TR " In the next paragraph, replace ISO 14971:2007 with ISO 14971:, set MEDICAL DEVICE USER INTERFACES in small caps and correct the spelling of MANUFACTURERS and set in small caps. 44 In the print types paragraph, replace "International Standard" with "document". 45 Replace the verbal forms paragraph and its list with the following: The verbal forms used in this standard conform to usage described in ISO/IEC Directives, Part 2. For the purposes of this standard, the auxiliary verb: shall means that compliance with a requirement or a test is mandatory for compliance with this standard; should means that compliance with a requirement or a test is recommended but is not mandatory for compliance with this standard; may is used to describe a permission (e.g. a permissible way to achieve compliance with a requirement or test); 54 "can" is used to describe a possibility or capability; 55 "must" is used express an external constraint. 56 INTRODUCTION 57 In the third paragraph, replace "International Standard" with "document" In the fourth paragraph, replace "International Standard" with "document", and replace "IEC " with "IEC TR ". 60 In the note, replace functionality" with "performance". 61 In the last paragraph, replace benefits with advantages. 62 Replace footnote 1 with the following ) IEC TR , Medical devices Part 2: Guidance on the application of usability engineering to medical devices. ISO/IEC 2018 rights reserved

5 Scope 66 In NOTE 1, replace "functionality" with "performance". 67 In NOTE 2, replace "IEC " with "IEC TR ". 68 In the second paragraph, replace "International Standard" with "document". 69 Replace footnote 2 with the following ) In the first paragraph, replace the first sentence with: The following documents are referred to in the text in such a way that some or all of their content constitutes requirements of this document Box Note 1: IEC has one normative reference and that is to ISO 14971:2007. A third edition of ISO is currently under development and is planned to be completed in The IEC/SC 62A secretariat is considering synchronizing the work on this amendment so its publication would not occur until the new edition of ISO is approved for publication. The references in this draft amendment have been har monized with ISO/DIS 14971: In the first paragraph replace ISO 14971:2007 with ISO 14971:. 84 In definition 3.1 and its example, replace intentional with deliberate in 3 places. 85 Replace definition 3.2 with the following: Note 1 to entry: The ACCOMPANYING DOCUMEN TATION can consist of the instructions for use, technical description, installation manual, quick reference guide, etc Note 2 to entry: A CCOMPANYING DOCUMENTATION is not necessarily a written or printed document but could involve auditory, visual, or tactile materials and multiple media types Note 3 to entry: M EDICAL DEVICES that can be used safely without instructions for use are exempted from having instructions for use by some authorities with jurisdiction [SOURCE: ISO 14971:, 3.1, modified OPERATOR has been deleted and note 3 to entry has been added.] 99 In Note 2 to entry of definition 3.11, delete the extra full stop at the end of the note. IEC TR , Medical devices Part 2: Guidance on the application of usability engineering to medical devices. Normative references Terms and definitions ACCOMPANYING DOCUMENTATION materials accompanying a MEDICAL DEVICE and containing information for the USER or those accountable for the installation, use, maintenance, decommissioning and disposal of the MEDICAL DEVICE, particularly regarding safe use ISO/IEC 2018 rights reserved

6 5 100 In Note 1 to entry of definition 3.20, add to the end of the sentence the following: 101 as well as social attributes such as team versus individual, chaotic versus calm, stre ss level, length of shift 102 In Note 3 to entry of definition 3.23, replace ISO 14971:2007 with ISO 14971:. 103 Replace definition 3.29 with the following: summary of the mental, physical and demographic traits of an intended USER GROUP, as well as characteristics, such as knowledge, skills and abilities, which can have a bearing on design decisions In the third paragraph, replace ISO 13485:2003 with ISO 13485: In NOTE 1, replace ISO 13485:2003 with ISO 13485: In the fourth paragraph, replace ISO 14971:2007 with ISO 14971:. 113 In the fifth paragraph, replace carried out with carried out iteratively or. 114 In the compliance check, replace "International Standard" with "document" Replace the first paragraph and list items a) to c) with the following: To reduce use-related RISK, the MANUFACTURER shall use one or more of the following options, in the priority listed (as required by ISO 14971:, 7.1): 119 a) inherently safe design and manufacture; 120 b) protective measures in the MEDICAL DEVICE itself or in the manufacturing PROCESS ; and 121 c) information for SAFETY, and, where appropriate, training In NOTE 2, replace "IEC " with "IEC TR ". 124 In the third paragraph, replace intentional with deliberate in 2 places Delete the compliance check. Principles General requirements U SABILITY ENGINEERING PROCESS R ISK CONTROL as it relates to USER INTERFACE design Information for SAFETY as it relates to USABILITY Tailoring of the USABILITY ENGINEERING effort ISO/IEC 2018 rights reserved

7 Replace the fifth dash with: * USABILITY ENGINEERING PROCESS * Prepare USE SPECIFICATION * intended USE ENVIRONMENT ; and Identify USER INTERFACE characteristics related to SAFETY and potential USE ERRORS In the first paragraph, replace ISO 14971:2007, 4.2 with ISO 14971:, Replace the last sentence of the first paragraph with the following This identification shall include consideration of the PRIMARY OPERATING FUNCTIONS if they are provided in applicable product-specific MEDICAL DEVICE SAFETY standards In NOTE 1, replace ISO 14971:2007, C.2.29 to C.2.34 with ISO TR 24971:, A.2.29 to A In NOTE 2, replace "IEC " with "IEC TR " Replace the last sentence of the first paragraph with the following This identification shall be conducted as part of a RISK ANALYSIS performed according to ISO 14971:, Replace the text of the subclause with the following: The MANUFACTURER shall select the HAZARD - RELATED USE SCENARIOS to be included in the SUMMATIVE EVALUATION. 148 The MANUFACTURER shall select: 149 all HAZARD - RELATED USE SCENARIOS ; or a subset of the HAZARD - RELATED USE SCENARIOS based on the SEVERITY of the potential HARM that could be caused by USE ERROR (e.g. for which medical intervention would be needed); or * Select the HAZARD - RELATED USE SCENARIOS for SUMMATIVE EVALUATION NOTE Identify known or foreseeable HAZARDS and HAZARDOUS SITUATIONS The severity of harm is determined in ISO 14971:, 5.5. a subset of HAZARD - RELATED USE SCENARIOS based on SEVERITY of the potential HARM and on other circumstances specific to the MEDICAL DEVICE and the MANUFACTURER. NOTE 2 Examples of selection schemes are given in Annex A, 5.5, and IEC TR A summary of any selection scheme, the rationale for its use and the results of applying it shall be stored in the USABILITY ENGINEERING FILE. 159 Compliance is checked by inspection of the USABILITY ENGINEERING FILE. ISO/IEC 2018 rights reserved

8 In NOTE 1, replace "IEC " with "IEC TR ". 163 Replace the first dash under list item b) with the following: * Establish USER INTERFACE EVALUATION plan 164 General document which USER GROUPS are intended to be included in the test; EXAMPLE 1 In a FORMATIVE EVALUATION, clinical personnel who are employees of the MANUFACTURER are used to represent a nurse- USER GROUP EXAMPLE 2 In a SUMMATIVE EVALUATION, a panel of practicing intensive care nurses is used to represent a critical care nursing USER GROUP Multiple USER PROFILES may be combined into a USER GROUP for the purposes of a USABILITY TEST ; 171 In the penultimate dash under list item b) add and after the semicolon. 172 In NOTE 3, replace scaling with tailoring Replace list item e) with the following: 175 e) * for a USABILITY TEST, * SUMMATIVE EVALUATION planning 176 how the test participants are representative of the intended USER PROFILES ; justifying how the test participants are grouped into USER GROUPS for the purpose of determining the number of test participants; the test environment and conditions of use and a rationale for how they are adequately representative of the actual conditions of use; 181 the definition of CORRECT USE for the HAZARD - RELATED USE SCENARIO ; and the method of collecting data during the USABILITY TEST for the subsequent analysis of observed USE ERRORS. 184 Delete NOTE In NOTE 1, replace ISO 14971:2007, Subclause 6.6 with ISO 14971:, Replace the second paragraph with the following The MANUFACTURER shall analyse the data of the SUMMATIVE EVALUATION and shall identify all USE ERRORS and use difficulties that occurred. If a USE ERROR or use difficulty can lead to a HAZARDOUS SITUATION, the root cause any such USE ERROR or use difficulty shall be determined. The root causes should be determined based on observations of USER performance and subjective comments from the USER related to that performance. 194 Replace item i) with the following. 195 Perform USER INTERFACE design, implementation and FORMATIVE EVALUATION * Perform SUMMATIVE EVALUATION of the USABILITY of the USER INTERFACE i) document why improvement is not necessary or not practicable; ISO/IEC 2018 rights reserved

9 8 196 In NOTE 2, replace ISO 14971:2007, 6.2 with ISO TR 24971:, Clauses C.2 and C Replace item iii) with the following. iii) evaluate the RESIDUAL RISK according to ISO 14971:, 7.3; In NOTE 3, replace ISO 14971:2007, Subclause 6.6 with ISO 14971:, In NOTE 4, replace ISO 14971:2007, Clause 7 with ISO 14971:, Clause In the fourth paragraph, replace "International Standard" with "document". 202 In the compliance check, replace "ISO 14971:2007, 6.4 with ISO 14971:, Annex A General guidance and rationale 204 A Clause 1 Scope In the first, second, fourth and fifth paragraphs, replace "International Standard" with "document" In the sixth paragraph, replace "International Standard" with "document", and set BENEFITS in small caps in 2 places. 210 In the seventh paragraph, replace "IEC " with "IEC TR ". 211 In the last paragraph, replace benefits with advantages. 212 Definition 3.1 ABNORMAL USE 213 In the third dash, replace RISK benefit with BENEFIT RISK. 214 In EXAMPLE 2, replace RISK /benefit with BENEFIT / RISK. 215 In the first sentence of the last paragraph, replace inaction with lack of USER action. 216 Definition 3.11 PRIMARY OPERATING FUNCTION 217 Replace the rationale with the following: For the purposes of this document, a PRIMARY OPERATING FUNCTION is a function that is directly related to the SAFETY of the MEDICAL DEVICE. P RIMARY OPERATING FUNCTIONS are provided in some product-specific safety standards to serve as mandatory input for the USABILITY ENGINEERING PROCESS. This document does not require any further identification of PRIMARY OPERATING FUNCTIONS because this document requires the identification, description and evaluation of HAZARD - RELATED USE SCENARIOS. 224 Definition 3.17 U SABILITY ENGINEERING or HUMAN FACTORS ENGINEERING Delete the second sentence of the first paragraph and combine the first and second paragraphs. Rationale for particular clauses and subclauses ISO/IEC 2018 rights reserved

10 9 227 Definition 3.18 U SABILITY ENGINEERING FILE 228 Insert a paragraph break between the second and third sentences. 229 Definition 3.21 USE ERROR 230 Replace the first and second sentences of the first paragraph with: U SE ERRORS often can be an indication of USER INTERFACE design flaws that affect the interaction of a USER with a MEDICAL DEVICE. 233 Definition 3.22 USE SCENARIO 234 Add the following sentence to the end of the second paragraph A TASK in a HAZARD - RELATED USE SCENARIO, in which a USE ERROR can lead to serious HARM, can be thought of as a 'critical task'. 237 Definition 3.24 U SER 238 In the second paragraph, replace "International Standard" with "document". 239 Clause 5 U SABILITY ENGINEERING PROCESS 240 Replace the entire rationale for Clause 5 including Figure A.4 with the following: The purpose of the USABILITY ENGINEERING PROCESS, as described in this standard, is to provide use-related SAFETY of the MEDICAL DEVICE for the PATIENT, USER and others. To achieve this purpose, the USABILITY ENGINEERING PROCESS mitigates RISK caused by USER interaction problems associated with NORMAL USE, such as USE ERROR To establish criteria for the acceptability of RESIDUAL RISKS related to USABILITY, the MANUFACTURER considers relevant available data (e.g., the state of technology, experience with similar MEDICAL DEVICES, POST - PRODUCTION surveillance reports). The MANUFACTURER can apply these criteria according to ISO 14971, which additionally considers RESIDUAL RISK relative to the BENEFIT of the MEDICAL DEVICE O BJECTIVE EVIDENCE to support the determination that use-related RESIDUAL RISK has been reduced to acceptable levels is generated by conducting SUMMATIVE EVALUATION of the USABILITY of the USER INTERFACE A comprehensive RISK MANAGEMENT PROCESS, such as that defined in ISO 14971, requires a MANUFACTURER establish, document and maintain a PROCESS for identifying HAZARDS HAZARDOUS SITUATIONS associated with a MEDICAL DEVICE, estimating and evaluating associated RISKS, controlling those RISKS, and monitoring how effective those controls throughout the LIFE - CYCLE. Such a PROCESS includes the following elements: 258 RISK ANALYSIS ; 259 RISK EVALUATION ; 260 RISK CONTROL ; 261 production and POST - PRODUCTION information When applying a comprehensive RISK MANAGEMENT PROCESS to the USER INTERFACE, estimating the RISK associated with each USE ERROR can be problematic, particularly because no validated techniques are known to exist to predict, in advance, the likelihood of a person committing a USE ERROR. However, this document provides a PROCESS that a MANUFACTURER that and the are and ISO/IEC 2018 rights reserved

11 can use to analyse, specify, design and evaluate the USABILITY of a MEDICAL DEVICE. Implementing this PROCESS permits the MANUFACTURER to address the unpredictability of a USER and minimize USE ERROR. This PROCESS helps the MANUFACTURER accomplish these objectives by: 270 a) discovering HAZARDS and HAZARDOUS SITUATIONS related to the USER INTERFACE ; b) designing and implementing measures to control the RISKS related to the USER INTERFACE ; and 273 c) evaluating the RISK CONTROL measures Other advantages of the USABILITY ENGINEERING PROCESS can include improved customer satisfaction, but these aspects are beyond the scope of this standard Figure A.4 provides an overview of relationship and interactions between the RISK MANAGEMENT PROCESS in ISO and the USABILITY ENGINEERING PROCESS of this standard. R ISK MANAGEMENT is a decision-making PROCESS for determining acceptable RISK whereas USABILITY ENGINEERING is a design and development PROCESS for the USER INTERFACE to reduce the possibility of USE ERRORS that could result in use-related RISKS When the MANUFACTURER is identifying the characteristics related to SAFETY of the MEDICAL DEVICE in accordance with the requirements of ISO 14971:, 5.3, the USABILITY ENGINEERING PROCESS can provide the detail necessary (see 5.2) to accomplish this step for the USER INTERFACE of the MEDICAL DEVICE Further, when the MANUFACTURER is compiling a list of known or foreseeable HAZARDS and HAZARDOUS SITUATIONS associated with the MEDICAL DEVICE in accordance with the requirements of ISO 14971:, 5.4, the USABILITY ENGINEERING PROCESS provides a list of items that are required to be considered (see 5.3) in order to accomplish this step for the USER INTERFACE of the MEDICAL DEVICE ISO requires that RISKS associated with each of the identified HAZARDOUS SITUATIONS be estimated (ISO 14971:, 5.5), and evaluated (ISO 14971:, Clause 6). If a RISK is not acceptable according to the MANUFACTURER ' S RISK acceptability criteria, the MANUFACTURER is required to identify RISK CONTROL measure(s) that are appropriate for reducing the RISK ( S ) to an acceptable level (ISO 14971:, 7.1). The MANUFACTURER is then required to implement the identified RISK CONTROL measures and verify that they are effective in reducing the RISK to an acceptable level (ISO 14971:, 7.2) The USABILITY ENGINEERING PROCESS requires that all known or foreseeable HAZARD - RELATED USE SCENARIOS (see 5.4) are identified and described prior to selecting the HAZARD - RELATED USE SCENARIOS (see 5.5) that are used in preparing the USER INTERFACE EVALUATION plan. In this standard, RISK CONTROL options related to use are identified during the development of the USER INTERFACE SPECIFICATION with testable requirements (see 5.6). The HAZARD - RELATED USE SCENARIOS, the RISK CONTROL measures and the USER INTERFACE EVALUATION plan are iteratively updated based on the results from FORMATIVE EVALUATIONS and from the other parts of product realization PROCESS, as appropriate. ISO/IEC 2018 rights reserved

12 11 ISO (decision making process) RISK MANAGEMENT IEC (design and development process) USABILITY ENGINEERING A, B, C, D, E and F represent information flow between the two PROCESSES. The heavy solid lines (B, D and F) represent information flow required by this standard. New problems identified should be interpreted to mean new HAZARDS, HAZARDOUS SITUATIONS or HAZARD - RELATED USE SCENARIOS discovered or implemented RISK CONTROL is ineffective a 312 Key 313 A U SE SPECIFICATION is an input to ISO 14971:, B Identified USER INTERFACE characteristics related to SAFETY (see 5.2) 315 C Identified foreseeable HAZARD and HAZARDOUS SITUATIONS (see 5.3) D Identified sequences of events leading to HAZARDOUS SITUATIONS from ISO 14971:, 5.4 are an input to determining HAZARD - RELATED USE SCENARIOS (see 5.4) E The SEVERITY of HARM is determined in ISO 14971:, 5.5 is an input to selecting the HAZARD - RELATED USE SCENARIOS to be included in the SUMMATIVE EVALUATION. 320 F Evaluate RESIDUAL RISK New problems identified should be interpreted to mean new USE ERRORS, HAZARDS, HAZARDOUS SITUATIONS, or HAZARD - RELATED USE SCENARIOS have been identified. Figure A.4 The relationship between the RISK MANAGEMENT PROCESS (ISO 14971: ) and the USABILITY ENGINEERING PROCESS (IEC ) ISO/IEC 2018 rights reserved

13 Both the FORMATIVE EVALUATION and the SUMMATIVE EVALUATION of the implemented USER INTERFACE are planned in the USER INTERFACE EVALUATION plan (see 5.7). F ORMATIVE EVALUATION is carried out during USER INTERFACE design and implementation (see 5.8) to explore the USER INTERFACE, identify the need for improvement or to confirm adequacy of the USER INTERFACE. For each selected HAZARD - RELATED USE SCENARIO, the implemented USER INTERFACE is subject to SUMMATIVE EVALUATION (see 5.9) to produce OBJECTIVE EVIDENCE that use-related RESIDUAL RISK has been reduced to acceptable levels. These steps achieve the same objective as 5.5 through 7.2 of ISO 14971: Subclause 5.2 Identify USER INTERFACE characteristics related to SAFETY and potential 333 In the first paragraph, replace ISO 14971:2007, C.2.1 with ISO TR 24971:, A In list item a), replace ISO 14971:2007, C.2.9 with ISO TR 24971:, A In list item b), replace ISO 14971:2007, C.2.12 with ISO TR 24971:, A In list item c), replace ISO 14971:2007, C.2.26 with ISO TR 24971:, A.2.26 and ISO 14971:2007, C.2.27 with ISO TR 24971:, A In list item d), replace ISO 14971:2007, C.2.29 with ISO TR 24971:, A Subclause 5.3 Identify known or foreseeable HAZARDS and HAZARDOUS SITUATIONS In the third sentence of the first paragraph, replace Figure E.1 from ISO 14971:2007 with Figure C.1 from ISO 14971:. 342 Subclause 5.6 Establish USER INTERFACE SPECIFICATION 343 Replace the entire rationale for subclause 5.6 with the following: The detailed and testable design requirements for the USER INTERFACE contained in the USER INTERFACE SPECIFICATION are generated based on the information collected in the preceding PROCESS steps. This information includes the USE SPECIFICATION as well as the identified USE ERRORS and the HAZARD - RELATED USE SCENARIOS. As the USER INTERFACE is evaluated, the USER INTERFACE SPECIFICATION is updated, as needed. 349 Subclause F ORMATIVE EVALUATION planning 350 Replace the entire rationale for subclause with: The purpose of FORMATIVE EVALUATION of the USER INTERFACE, which could include USABILITY TESTS, is to iterate the design of the USER INTERFACE to achieve a specified quality level and to increase the likelihood that the final SUMMATIVE EVALUATION of the USABILITY of the USER INTERFACE can be conducted successfully. The decision to stop iterating the USER INTERFACE design is based on the quality level being measured during the later stages of FORMATIVE EVALUATIONS. No further iterations are required when the quality level has been achie ved that gives the MANUFACTURER the confidence that the SUMMATIVE EVALUATION conducted at the end of the iterative design cycle can generate sufficient OBJECTIVE EVIDENCE that use-related RESIDUAL RISK is acceptable. USE ERRORS ISO/IEC 2018 rights reserved

14 Subclause S UMMATIVE EVALUATION planning 361 d) (availability of the ACCOMPANYING DOCUMENTATION and provision of training) 362 In the NOTE, replace ISO 14971:2007, 6.3 with ISO 14971:, e) ( USABILITY TEST ) 364 Replace the first paragraph with the following The standard requires assessment of whether USE ERRORS occurred, the USERS had use difficulties or the USERS successfully completed the TASKS associated with the HAZARD RELATED USE SCENARIOS (i.e. CORRECT USE ) that the MANUFACTURER selected for inclusion in the SUMMATIVE EVALUATION. A use difficulty where a USER almost commits a USE ERROR while performing a TASK, but recovers in time to avoid making the USE ERROR is sometimes called a close call. 371 Subclause 5.9 Perform SUMMATIVE EVALUATION of the USABILITY of the USER INTERFACE In the fourth paragraph, replace USE ERRORS with USE ERRORS and use difficulties and add the following as the last sentence of the paragraph: 374 See rationale to e) for additional information regardi ng use difficulties. 375 Annex B Examples of possible HAZARDOUS SITUATIONS related to USABILITY 376 In the heading of Table B.1, replace ISO 14971:2007 with ISO 14971:. 377 In the meaning of HARM, delete physical. 378 Replace the meaning of HAZARDOUS SITUATION with the following: circumstance in which people, property, or the environment is/are exposed to one or more HAZARDS 381 Annex C Evaluation of a USER INTERFACE OF UNKNOWN PROVENANCE ( UOUP ) 382 C In the first paragraph, replace scaled with tailored. 384 In the third paragraph, replace IEC : ' with IEC In EXAMPLE 1, replace IEC : with IEC : In EXAMPLE 2, replace IEC : with IEC : In EXAMPLE 3, replace IEC : with IEC : In EXAMPLE 4, replace IEC : with IEC :2015. General ISO/IEC 2018 rights reserved

15 C.2.5 R ESIDUAL RISK evaluation 390 In the first paragraph, replace ISO 14971:2007, 6.4 with ISO 14971:, Clause Annex D Types of MEDICAL DEVICE use, with examples) In the first paragraph, replace inactions with lack of USER actions in two places, and replace "International Standard" with "document". 394 In the third paragraph, replace the second sentence with the following: Alternately, the use could result from a USE ERROR or could result from deliberate conduct that is beyond any additional means of USER INTERFACE -related RISK CONTROL by the MANUFACTURER, i.e., ABNORMAL USE. This does not necessarily mean that ABNORMAL USE results in a poor outcome for the PATIENT. 399 Replace Figure D.1 with the following: ISO/IEC 2018 rights reserved

16 Figure D.1 Interrelationships between the different types of MEDICAL DEVICE use, with examples ISO/IEC 2018 rights reserved

17 Annex E Reference to the essential principles 405 Replace the entire annex with the following: 406 E This document has been prepared to support the essential principles of safety and performance of non-ivd MEDICAL DEVICES as MEDICAL DEVICES according to ISO :2016 [12]. This document is intended to be acceptable for conformity assessment purposes Compliance with this document provides one means of demonstrating conformance with the specific essential principles of ISO :2016 [12]. Other means are possible. Table E.1 maps the clauses and subclauses of this document with the essential principles o f ISO : Table E.1 Correspondence between this document and the essential principles Non-IVD MEDICAL DEVICES Essential principle of ISO :2016, Annex B Corresponding clause(s)/ sub-clause(s) of this document [12] 1 Qualifying remarks /notes a) b) The part related to known or foreseeable risks as they relate to use is addressed. a) b) The part related to understood by the users is addressed Addressed as it relates to safe use. The part relating to manufacturing is not addressed 19.1 Addressed as it relates to safe use E.2 IVD MEDICAL DEVICES This document has been prepared to support the essential principles of safety and performance of IVD MEDICAL DEVICES as MEDICAL DEVICES according to ISO : This document is intended to be acceptable for conformity assessment purposes Compliance with this document provides one means of demonstrating conformance with the specific essential principles of ISO : Other means are possible. Table E.2 ISO/IEC 2018 rights reserved

18 maps the clauses and subclauses of this document with the essential principles of ISO : Table E.2 Correspondence between this document and the essential principles Essential principle of ISO :2017, Annex B 1 Corresponding clause(s)/ sub-clause(s) of this document 18 Qualifying remarks /notes a) b) 6 The part related to known or foreseeable risks as they relate to use is addressed. 9.1 not addressed a) b) c) 11.2 a) b) c) h) The part related to understood by the users is addressed Addressed as it relates to safe use. The part relating to manufacturing is not addressed Addressed as it relates to safe use. The part relating to manufacturing is not addressed Addressed as it relates to safe use. The part relating to manufacturing is not addressed Addressed as it relates to safe use. a) Addressed as it relates to safe use b) 425 Bibliography 426 Add to [1], IEC :2005/AMD2: 427 Add to [2], IEC :2010/AMD2: ISO/IEC 2018 rights reserved

19 Add to [3], IEC :2006/AMD2: 429 Replace [4] with the following: [4] 435 In [6], replace 2012 with. 436 In [8], replace 2005 with In [9], replace 2008 with In [11], replace 2003 with Replace [12] with the following: [12] ISO :2016, Medical devices Recognized essential principles of safety and performance of medical devices Part 1: General essential principles and additional specific essential principles for all non-ivd medical devices and guidance on the selection of standards 444 Add a new item [47] as follows: 445 [47] ISO :2017, Medical devices Recognized essential principles of safety and performance of medical devices Part 2: General essential principles and additional specific essential principles for all IVD medical devices and guidance on the selection of standards 449 Index of defined terms 450 Update the following terms: 451 HARM 452 HAZARD 453 HAZARDOUS SITUATION 454 INTENDED USE 455 LIFE - CYCLE 456 MANUFACTURER... ISO 14971:, MEDICAL DEVICE... ISO 14971:, OBJECTIVE EVIDENCE 459 POST - PRODUCTION PROCEDURE 461 PROCESS 462 RECORD IEC :2015, Medical electrical equipment Part 1-11: General requirements for basic safety and essential performance Collateral standard: Requirements for medical electrical equipment and medical electrical systems used in the home healthcare environment IEC :2015/AMD1:... ISO 14971:, ISO 14971:, ISO 14971:, ISO 14971:, ISO 14971:, ISO 14971:, 3.11 ISO 14971:, ISO 14971:, ISO 14971:, ISO 14971:, 3.16 ISO/IEC 2018 rights reserved

20 19... ISO 14971:, RESIDUAL RISK 464 RISK 465 RISK ANALYSIS 466 RISK ASSESSMENT 467 RISK CONTROL 468 RISK EVALUATION 469 RISK MANAGEMENT 470 RISK MANAGEMENT FILE 471 SAFETY 472 SEVERITY 473 Add the following term: 474 BENEFIT... ISO 14971:, ISO 14971:, ISO 14971:, ISO 14971:, ISO 14971:, ISO 14971:, ISO 14971:, ISO 14971:, ISO 14971:, ISO 14971:, ISO/IEC 2018 rights reserved