AAMI/IEC62366 1 2015 AMD1 2020
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ANSI/AAMI/IEC 62366-1: 2015+AMD1:2020 (Consolidated Text), Medical devices-Part 1: Application of usability engineering to medical devices, including Amendment 1
| Published By | Publication Date | Number of Pages |
| AAMI | 2020 | 54 |
The first edition of IEC 62366-1 was published in 2015. Since its publication, experts working in the field have identified several inaccuracies that warrant correction.
PDF Catalog
| PDF Pages | PDF Title |
|---|---|
| 1 | ANSI/AAMI/IEC 62366-1:2015+AMD1:2020; Medical devices—Part 1: Application of usability engineering to medical devices—Amendment 1 (Consolidated Text) |
| 3 | Title page |
| 4 | AAMI Standard Copyright information |
| 5 | Contents |
| 6 | Committee representation |
| 9 | Background of ANSI/AAMI adoption of IEC 62366-1:2015 and IEC 62366-1:2015/A1:2020 |
| 10 | Foreword |
| 12 | Introduction INTRODUCTION to Amendment 1 |
| 13 | 1 * Scope 2 Normative references 3 Terms and definitions |
| 14 | Figure 1 – Relationship of the types of use |
| 18 | 4 Principles 4.1 General requirements 4.1.1 * Usability engineering process 4.1.2 * Risk control as it relates to user interface design |
| 19 | 4.1.3 Information for safety as it relates to usability 4.2 * Usability engineering file 4.3 Tailoring of the usability engineering effort 5 * Usability engineering process 5.1 * Prepare use specification |
| 20 | 5.2 * Identify user interface characteristics related to safety and potential use errors 5.3 * Identify known or foreseeable hazards and hazardous situations 5.4 * Identify and describe hazard-related use scenarios |
| 21 | 5.5 * Select the hazard-related use scenarios for summative evaluation 5.6 * Establish user interface specification 5.7 * Establish user interface evaluation plan 5.7.1 General |
| 22 | 5.7.2 * Formative evaluation planning 5.7.3 * Summative evaluation planning |
| 23 | 5.8 * Perform user interface design, implementation and formative evaluation 5.9 * Perform summative evaluation of the usability of the user interface |
| 24 | 5.10 User interface of unknown provenance |
| 25 | Annex A (informative) General guidance and rationale A.1 General guidance A.2 Rationale for requirements in particular clauses and subclauses |
| 28 | Figure A.1 – Model of USER-MEDICAL DEVICE interaction |
| 29 | Figure A.2 – Relationship of TASKS and functions within a USE SCENARIO |
| 30 | Figure A.3 – Relationship of TASKS and functions and USE ERROR within a HAZARD-RELATED USE SCENARIO |
| 32 | Figure A.4 – Types of use as described in this document and their relationship to the concept of “reasonably foreseeable misuse” in ISO 14971 |
| 34 | Figure A.5 – The relationship between the RISK MANAGEMENT PROCESS (ISO 14971:2019) and the USABILITY ENGINEERING PROCESS (IEC 62366-1) |
| 41 | Annex B (informative) Examples of possible hazardous situations related to usability Table B.1 – Glossary of relevant RISK MANAGEMENT terms Table B.2 – Examples of HARM caused by USE ERROR(S) or poor USABILITY |
| 44 | Annex C (normative) Evaluation of a user interface of unknown provenance (uoup) C.1 General C.2 Usability engineering process for user interface of unknown provenance C.2.1 * Use specification |
| 45 | C.2.2 * Review of post-production information C.2.3 Hazards and hazardous situations related to usability C.2.4 Risk control C.2.5 Residual risk evaluation |
| 46 | Annex D (informative) Types of medical device use, with examples |
| 47 | Figure D.1 – Interrelationships between the different types of MEDICAL DEVICE use, with examples |
| 48 | Annex E (informative) Reference to the essential principles E.1 Non-IVD medical devices Table E.1 – Correspondence between this document and the essential principles E.2 IVD medical devices |
| 49 | Table E.2 – Correspondence between this document and the essential principles |
| 50 | Bibliography |
| 53 | Index of defined terms |
