AAMI 62366 1 2015 A1 2020
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ANSI/AAMI/IEC 62366-1:2015/A1:2020, Medical devices-Part 1: Application of usability engineering to medical devices-Amendment 1
| Published By | Publication Date | Number of Pages |
| AAMI | 2020 | 28 |
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/A1:2020Medical devices—Part 1: Application of usability engineering to medical devices—Amendment 1 |
| 3 | Title page |
| 4 | AAMI Standard Copyright information |
| 5 | Contents |
| 6 | Committee representation |
| 9 | Background of ANSI/AAMI adoption of IEC 62366-1:2015/Amendment 1:2020 |
| 10 | Foreword |
| 11 | Introduction |
| 13 | INTRODUCTION 1 * Scope 2 Normative references 3 Terms and definitions |
| 14 | 4.1.1 * Usability engineering process 4.1.2 * Risk control as it relates to user interface design 4.1.3 Information for safety as it relates to usability |
| 15 | 4.3 Tailoring of the usability engineering effort 5.1 * Prepare use specification 5.2 * Identify user interface characteristics related to safety and potential use errors 5.3 * Identify known or foreseeable hazards and hazardous situations 5.5 * Select the hazard-related use scenarios for summative evaluation |
| 16 | 5.7.1 General 5.7.3 * Summative evaluation planning 5.8 * Perform user interface design, implementation and formative evaluation 5.9 * Perform summative evaluation of the usability of the user interface |
| 17 | A.2 Rationale for requirements in particular clauses and subclauses Clause 1 – Scope Definition 3.1 – abnormal use Definition 3.11 – primary operating function Definition 3.17 – Usability engineering or human factors engineering Definition 3.21 – use error Definition 3.22 – use scenario Clause 5 – Usability engineering process |
| 18 | Figure A.4 – Types of use as described in this document and their relationship to the concept of “reasonably foreseeable misuse” in ISO 14971 |
| 20 | Figure A.5 – The relationship between the RISK MANAGEMENT PROCESS (ISO 14971:2019) and the USABILITY ENGINEERING PROCESS (IEC 62366-1) |
| 21 | Subclause 5.1 – Prepare use specification Subclause 5.2 – Identify user interface characteristics related to safety and potential use errors Subclause 5.3 – Identify known or foreseeable hazards and hazardous situations |
| 22 | Subclause 5.6 – Establish user interface specification Subclause 5.7.2 – Formative evaluation planning Subclause 5.7.3 – Summative evaluation planning Subclause 5.9 – Perform summative evaluation of the usability of the user interface Table B.1 – Glossary of relevant risk management terms Table B.2 – Examples of harm due to risk caused by use error(s) or poor usability |
| 23 | C.1 General C.2.5 Residual risk evaluation Annex D – Types of medical device use, with examples Figure D.1 – Interrelationships between the different types of medical device use, with examples |
| 25 | Annex E – Reference to the essential principles 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 |
| 26 | E.2 IVD medical devices Table E.2 – Correspondence between this document and the essential principles |
| 27 | Bibliography |
| 28 | Index of defined terms |
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