Medicintekniska produkter - Tillämpning av metoder för att. säkerställa medicintekniska produkters användarvänlighet - Bilaga 1

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1 Medicintekniska produkter - Tillämpning av metoder för att säkerställa medicintekniska produkters användarvänlighet - Bilaga 1 SIS-remiss Remisstiden utgår: Remissen omfattar: IEC/DIS 62366:2007//DAmd1 Medical devices - Application of usability engineering to medical devices - Amendment 1 Medicintekniska produkter - Tillämpning av metoder för att säkerställa medicintekniska produkters användarvänlighet - Bilaga 1 dokument/05. Remisshantering/5.1 Remisser under beredning/2012/ SIS 10416/Remiss10416.doc SIS, Swedish Standards Institute Postadress: STOCKHOLM Telefon: Telefax: Postal address: STOCKHOLM, Sweden Phone: Telefax: SIS is the Swedish member of ISO and CEN Besöksadress: Sankt Paulsgatan 6, Stockholm Organisationsnr: E-post: info@sis.se Office address: Sankt Paulsgatan 6, Stockholm V.A.T. No. SE info@sis.se

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3 Medicintekniska produkter - Tillämpning av metoder för att säkerställa medicintekniska produkters användarvänlighet - Bilaga Ditt svar är viktigt Orientering Det är viktigt att svenska företag, myndigheter och andra organisationer får möjlighet att påverka hur standarderna är utformade. Dina synpunkter på standardförslaget bidrar till att testa riktigheten i den kommande standarden och genom ditt svar ökar också möjligheten att standarden kommer att bli använd och accepterad. SIS eftersträvar att miljöhänsyn tas i standardiseringsarbetet. Vi tar därför gärna emot dina synpunkter även när det gäller dessa frågor. Om du vill påverka innehållet i den kommande standarden ska du använda svarsblanketten som är bifogad. Den internationella kommittén ISO/TC 210, i vilken Sverige aktivt deltar har utarbetat det förslag till ISO/IEC-standard som presenteras i denna remiss. Avsikten är att förslaget skall fastställas och ges ut som svensk standard utan förnyad remiss när det fastställts som internationell standard. Den slutgiltiga standarden kan i vissa delar komma att avvika från förslaget beroende på resultatet av den internationella remissbehandlingen. För att kunna fastställas som svensk standard måste ISO/IEC-standarden vara förenlig med svensk lagstiftning. Det är viktigt att berörda svenska myndigheter klarlägger om förslaget till ISO/IEC-standard är förenligt med svensk lagstiftning. Svaren på denna remiss kommer att utgöra underlag för det svenska yttrandet. Kommentarerna ska vara på engelska. Något om förslaget Översättning Svensk kommitté Frågor Beställning The first edition of IEC was published in This amendment is intended to add urgently needed requirements to deal with legacy devices where the user interface design is of unknown provenance. Work is continuing in parallel to develop the 2nd edition of IEC Den engelska texten föreslås ges ut som svensk standard utan översättning. Om ni anser att texten bör översättas ber vi er ange detta i ert svar. Samtidigt ber vi er då meddela om ni är beredda att bidra till de extra arbetsinsatser som en översättning skulle kräva. Synpunkter på föreslagen svensk titel tas tacksamt emot. Svaren på denna remiss kommer att behandlas av Medicintekniska kvalitetssystem, SIS/TK 355, som är svensk referensgrupp för ISO/TC 210 Frågor kring remissen besvaras av Git Eliasson, SIS, telefon: , epost: git.eliasson@sis.se Förslaget kan beställas från Josefine Kayalioglu, SIS, telefon: , epost: josefine.kayalioglu@sis.se dokument/05. Remisshantering/5.1 Remisser under beredning/2012/ SIS 10416/Remiss10416.doc SIS, Swedish Standards Institute Postadress: STOCKHOLM Telefon: Telefax: Postal address: STOCKHOLM, Sweden Phone: Telefax: SIS is the Swedish member of ISO and CEN Besöksadress: Sankt Paulsgatan 6, Stockholm Organisationsnr: E-post: info@sis.se Office address: Sankt Paulsgatan 6, Stockholm V.A.T. No. SE info@sis.se

4 Pris Vilka får remissen? Svar på remissen Anvisningar för remissvar Pris för standardförslaget är 400 kronor exkl. moms Remissen har sänts ut till följande: SIS/TK 355, RG 355 Besvara remissen genom att returnera bifogade svarsblankett, till Se anvisningar. Ett remissvar består av två delar: Svarsblankett (där du röstar ja eller nej till förslaget, eller avstår); Kommentarer. Om remissen innehåller flera standardförslag skall ett svar avges för varje ingående standardförslag. I svarsblanketten finns förberedda svarsalternativ för samtliga standardförslag. OBS! Försök inte skilja svarsblankett och kommentarsdelen, eftersom de länkade uppgifterna då försvinner. Så här fyller du i svarsblanketten "Avstår" om du inte är insatt i förslaget och dess konsekvenser eller om du inte har tid eller möjlighet att sätta dig in i förslaget. "Tillstyrker utan kommentarer" om du anser att förslaget kan godtas som standard utan förändringar. "Tillstyrker med kommentarer" om du anser att förslaget kan godtas som standard, fast med de förändringar du angivit i dina kommentarer. "Avstyrker med motivering" om du anser att förslaget innehåller felaktigheter eller är olämpligt att godta som standard. Du måste ange en motivering till avstyrkandet och skälen skall vara av allvarligare karaktär. Ange om du/ni har erfarenhet inom den föreslagna standardens tillämpningsområde och om du/ni haft möjlighet att pröva förslagets tillämpning i er verksamhet. Kom gärna med synpunkter på den föreslagna svenska titeln Om du vill lämna kommentarer Så här fyller du i blanketten för kommentarer Fyll i medföljande blankett för kommentarer enligt anvisningarna nedan, Om standardförslaget är på engelska ska kommentarerna vara på engelska. Detta för att säkerställa en korrekt användning av fackuttryck. För att skapa en ny tabellrad ställer du markören i sista tabellcellen och trycker tab. ID Lämna blankt eller ange en kortform av er identitet som svarslämnare (t.ex. initialer, eller förkortning av företags-/organisationsnamn) Clause No./Subclause No./Annex (e.g. 3.1)

5 För varje kommentar ges en referens till relevant avsnitt i standardförslaget. Paragraph/Figure/Table/Note (e.g. Table 1) Om möjligt preciseras relevant stycke, figurnr, tabellnr, not, eller dylikt i standardförslaget. Type of comment Varje kommentar kategoriseras med någon av förkortningarna te, ed, ge med följande innebörd: te: teknisk kommentar ed: redaktionell kommentar (editorial) ge: generell kommentar Comment (justification for change) Föreslagna ändringar motiveras/förklaras kortfattat. Proposed change För te- och ed-kommentarer ges entydiga förslag till ersättningstext, tillägg eller strykning, gärna enligt följande exempel: Change shall to should. Add the text see enclosure. Remove the text see enclosure.

6 SVARSBLANKETT SIS-remiss (2) e-post: SIS Remissvar Git Eliasson STOCKHOLM SIS/TK 355, Medicintekniska kvalitetssystem Svar på SIS-remiss avseende IEC/DIS 62366:2007//DAmd1 Senaste svarsdatum Uppgifter om svarslämnaren Företag/Organisation/Myndighet Enskild person Företag/Organisation/Myndighet Handläggare (namn, telefon) Datum Remissvar Avstår Tillstyrker utan kommentarer Tillstyrker med kommentarer Avstyrker med motivering Har erfarenhet inom det område förslaget täcker Har tillämpat förslaget Ej berörd Kommentarer till föreslagen svensk titel SIS, Swedish Standards Institute SIS is the Swedish member of ISO and CEN Postadress: STOCKHOLM Besöksadress: Sankt Paulsgatan 6, Stockholm Organisationsnr: Telefon: Telefax: E-post: Postal address: STOCKHOLM, Sweden Office address: Sankt Paulsgatan 6, Stockholm V.A.T. No. SE Phone: Telefax: info@sis.se

7 Datum Svarslämnare: Kommentarer på: SIS-remiss Förslag: IEC/DIS 62366:2007//DAmd1 1 2 (3) 4 5 (6) (7) ID Clause No./ Subclause No./ Annex (e.g. 3.1) Paragraph/ Figure/Table/N ote (e.g. Table 1) Type of comm ent 1 Comment (justfication for changes) Proposed change Fylls i av SIS 1 Type of comment: ge = general te = technical ed = editorial

8 DRAFT AMENDMENT IEC/DIS 62366:2007/DAM 1 ISO/TC 210 Secretariat: ANSI Voting begins on Voting terminates on INTERNATIONAL ORGANIZATION FOR STANDARDIZATION МЕЖДУНАРОДНАЯ ОРГАНИЗАЦИЯ ПО СТАНДАРТИЗАЦИИ ORGANISATION INTERNATIONALE DE NORMALISATION INTERNATIONAL ELECTROTECHNICAL COMMISSION МЕЖДУНАРОДНАЯ ЭЛЕКТРОТЕХНИЧЕСКАЯ КОММИСИЯ COMMISSION ÉLECTROTECHNIQUE INTERNATIONALE Medical devices Application of usability engineering to medical devices AMENDMENT 1 Dispositifs médicaux Application de l'ingénierie de l'aptitude à l'utilisation aux dispositifs médicaux AMENDEMENT 1 ICS This draft is submitted to a parallel enquiry in ISO and a CDV vote in the IEC. THIS DOCUMENT IS A DRAFT CIRCULATED FOR COMMENT AND APPROVAL. IT IS THEREFORE SUBJECT TO CHANGE AND MAY NOT BE REFERRED TO AS AN INTERNATIONAL STANDARD UNTIL PUBLISHED AS SUCH. IN ADDITION TO THEIR EVALUATION AS BEING ACCEPTABLE FOR INDUSTRIAL, TECHNOLOGICAL, COMMERCIAL AND USER PURPOSES, DRAFT INTERNATIONAL STANDARDS MAY ON OCCASION HAVE TO BE CONSIDERED IN THE LIGHT OF THEIR POTENTIAL TO BECOME STANDARDS TO WHICH REFERENCE MAY BE MADE IN NATIONAL REGULATIONS. RECIPIENTS OF THIS DRAFT ARE INVITED TO SUBMIT, WITH THEIR COMMENTS, NOTIFICATION OF ANY RELEVANT PATENT RIGHTS OF WHICH THEY ARE AWARE AND TO PROVIDE SUPPORTING DOCUMENTATION. International Electrotechnical Commission, 2012

9 IEC/DIS 62366:2007/DAM 1 International Electrotechnical Commission, 2012 ii

10 62366/Ed1/A1/CDV IEC(E) -2-62A/826/CDV FOREWORD This amendment has been prepared by subcommittee 62A: Common aspects of electrical equipment used in medical practice, of IEC technical committee 62: Electrical equipment in medical practice. The text of this amendment is based on the following documents: 6) FDIS 7) Report on voting 8) XX/XX/FDIS 9) XX/XX/RVD Full information on the voting for the approval of this amendment can be found in the report on voting indicated in the above table. The committee has decided that the contents of this amendment and the base publication will remain unchanged until the maintenance result date 1) indicated on the IEC web site under " in the data related to the specific publication. At this date, the publication will be reconfirmed, withdrawn, replaced by a revised edition, or amended. 1) The National Committees are requested to note that for this publication the stability date will remain Registered trademark of the International Electrotechnical Commission

11 62366/Ed1/A1/CDV IEC(E) 3 62A/826/CDV INTRODUCTION The first edition of IEC was published in This amendment is intended to add urgently needed requirements to deal with legacy devices where the user interface design is of unknown provenance. Work is continuing in parallel to develop the 2 nd edition of IEC

12 62A/826/CDV /Ed1/A1/CDV IEC(E) FOREWORD Add the following note at the end of the Foreword: NOTE The attention of National Committees is drawn to the fact that equipment manufacturers and testing organizations may need a transitional period following publication of a new, amended or revised IEC or ISO publication in which to make products in accordance with the new requirements and to equip themselves for conducting new or revised tests. It is the recommendation of the committee that the content of this publication be adopted for mandatory implementation nationally not earlier than 3 years from the date of publication. INTRODUCTION Add after the last paragraph of the introduction the following paragraph: Amendment 1 updates the standard to add urgently needed requirements to deal with legacy devices where the USER INTERFACE design is of unknown provenance. 32

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14 62366/Ed1/A1/CDV IEC(E) 5 62A/826/CDV MEDICAL DEVICES APPLICATION OF USABILITY ENGINEERING TO MEDICAL DEVICES 2 Normative references In the existing introductory paragraph, replace the first sentence with: The following documents, in whole or in part, are normatively referenced in this document and are indispensable for its application Terminology and definitions Add the following new definition: 3.27 USER INTERFACE OF UNKNOWN PROVENANCE UOUP USER INTERFACE or part of a USER INTERFACE of a MEDICAL DEVICE previously developed for which RECORDS of the USABILITY ENGINEERING PROCESS of this standard are not available Add the following new subclause: * USER INTERFACE OF UNKNOWN PROVENANCE (UOUP) Instead of the requirements of 5.1 through 5.9, UOUP may be evaluated according to Annex K. 54 NOTE This subclause does not apply to the changed or newly developed portions of the MEDICAL DEVICE. 55 Compliance is checked by application of Annex K. 56 Annex A General guidance and rationale A.2 Rationale for requirements in particular clauses and subclauses Clause 1 Scope Following the existing last paragraph, add the following note NOTE Compliance with IEC :2010+A1: 2 is considered to be evidence of compliance with this standard. Clause 7 Training and materials for training Following the existing paragraph of the rationale for Clause 7, add the following new rationale. 2) To be published.

15 62A/826/CDV /Ed3/A1/CDV IEC(E) Subclause K.1 General Figure A.2 provides a decision tree to aid in applying Annex K to UOUP. Start Is the project an entirely new development with no UOUP? Yes IEC Subclauses applies No Is this a legacy device with no IEC documentation? Yes IEC Subclause 5.10 applies No Is this a change to a legacy device with no IEC documentation? Yes IEC Subclause 5.10 applies No Is this a project with a UOUP component? Yes IEC Subclause 5.10 applies for the UOUP component IEC Subclauses applies for the remainder of the equipment Figure A.2 Decision tree for UOUP PROCESS End Annex J (informative) Reference to the essential principles Immediately following the existing Table J.1, add the following new annex.

16 62366/Ed1/A1/CDV IEC(E) 7 62A/826/CDV Annex K (normative) Evaluation of a USER INTERFACE OF UNKNOWN PROVENANCE (UOUP) K.1 * General In recognition of the fact that many MANUFACTURERS will be interested in applying the tools defined in this standard to MEDICAL DEVICES that have already been commercialized combined with the fact that this standard focuses on USABILITY ENGINEERING as part of the product development PROCESS, it was determined that an appropriately scaled (as described in subclause 4.3 of this standard) and refocused PROCESS should be developed. The following represents such a process that relies wherever possible on existing documentation that should have been created during the development of legacy MEDICAL DEVICES. It also attempts to allow the PROCESS to be applied utilizing organizational resources as efficiently as possible. When completed, it will result in the creation of a USABILITY ENGINEERING FILE and assure that the MEDICAL DEVICE S RISK MANAGEMENT FILE Identifies RISKS caused by USABILITY problems of the MEDICAL DEVICE. In doing so it identifies RISKS (if any) that were caused by USABILITY problems and not adequately addressed in the original design process. This process can be applied to UOUP for three scenarios: MEDICAL DEVICES on the market that were not developed using the USABILITY ENGINEERING PROCESS of IEC 62366:2007 (so called legacy MEDICAL DEVICES); MEDICAL DEVICES that have changes to the USER INTERFACE and that were not originally developed using IEC 62366:2007; and NOTE Only the unchanged portions of the USER INTERFACE are considered UOUP. MEDICAL DEVICES that incorporate an off-the-shelf component that itself was not developed using the USABILITY ENGINEERING PROCESS of IEC 62366: K.2 Usability engineering process for user interface of unknown provenance K.2.1 Application specification The MANUFACTURER shall review the ACCOMPANYING DOCUMENT of the MEDICAL DEVICE with UOUP and identify the elements of the application specification as identified in 5.1 (see also Note 1 of Clause 6). If elements of the summary of the application specification are missing, those elements shall be established. The MANUFACTURER shall record this application specification in the USABILITY ENGINEERING FILE. Compliance is checked by inspection of the USABILITY ENGINEERING FILE. K.2.2 Frequently used functions The MANUFACTURER shall identify FREQUENTLY USED FUNCTIONS of the MEDICAL DEVICE with UOUP as required by 5.2. The MANUFACTURER shall record the FREQUENTLY USED FUNCTIONS in the USABILITY ENGINEERING FILE. Compliance is checked by inspection of the USABILITY ENGINEERING FILE. K.2.3 PRIMARY OPERATING FUNCTIONS The MANUFACTURER shall identify the PRIMARY OPERATING FUNCTIONS of the MEDICAL DEVICE with UOUP as required by 5.4. The MANUFACTURER shall record the PRIMARY OPERATING FUNCTIONS in the USABILITY ENGINEERING FILE.

17 62A/826/CDV /Ed3/A1/CDV IEC(E) Compliance is checked by inspection of the USABILITY ENGINEERING FILE. K.2.4 Review of post-market information The MANUFACTURER of the MEDICAL DEVICE with UOUP shall review available post-market data including complaint/field reports for incidents/near incidents or complaints associated with the use of the PRIMARY OPERATING FUNCTIONS. NOTE This review should not consider frequency of occurrence in determining whether a given USE ERROR is considered because USE ERRORS are significantly underreported. All identified cases of USE ERROR that could result in a HAZARDOUS SITUATION or those cases where field information suggests an issue (potentially resulting in HARM) that could have been caused by poor USABILITY shall be recorded in the USABILITY ENGINEERING FILE and addressed in K.2.5 and K.2.6. Compliance is checked by inspection of the USABILITY ENGINEERING FILE. K.2.5 HAZARDS and HAZARDOUS SITUATIONS caused by USABILITY problems The MANUFACTURER shall review the RISK ANALYSIS of the MEDICAL DEVICE with UOUP and ensure that the HAZARDS and HAZARDOUS SITUATIONS caused by USABILITY problems and associated with PRIMARY OPERATING FUNCTIONS that would lead to HAZARDOUS SITUATIONS have been identified. The MANUFACTURER shall update the RISK MANAGEMENT FILE as appropriate. Compliance is checked by inspection of the RISK MANAGEMENT FILE. K.2.6 RISK CONTROL The MANUFACTURER shall verify that all identified HAZARDS AND HAZARDOUS SITUATIONS identified in K.2.5 have adequate RISK CONTROL measures and result in acceptable RISK as indicated by the RISK ASSESSMENT. If the MANUFACTURER determines in K.2.1 that the ACCOMPANYING DOCUMENT of the MEDICAL DEVICE with UOUP does not contain an adequate summary of the application specification, the ACCOMPANYING DOCUMENT shall be updated to include that information. If the MANUFACTURER determines that changes to any part of the USER INTERFACE are required, those changes shall not be considered UOUP and shall be subject to the requirements of 5.1 through 5.9. The MANUFACTURER shall re-evaluate the overall RESIDUAL RISK and document it as well as any new information identified in performing steps K.2.5 and K.2.6 in the RISK MANAGEMENT FILE according to ISO 14971:2007. Compliance is checked by inspection of the RISK MANAGEMENT FILE and where appropriate, the ACCOMPANYING DOCUMENT Index of defined terms Insert following USER INTERFACE, the following defined term. USER INTERFACE OF UNKNOWN PROVENANCE (UOUP)