ANSI/AAMI/ IEC 62366- 1:2015 pdf download – Medical devices – Part 1: Application of usability engineering to medical devices.
1 * Scope This part of IEC 62366 specifies a PROCESS for a MANUFACTURER to analyze, specify, develop and evaluate the USABILITY of a MEDICAL DEVICE as it relates to SAFETY . This USABILITY ENGINEERING ( HUMAN FACTORS ENGINEERING ) PROCESS permits the MANUFACTURER to assess and mitigate RISKS associated with CORRECT USE and USE ERRORS , i.e., NORMAL USE . It can be used to identify but does not assess or mitigate RISKS associated with ABNORMAL USE . NOTE 1 S AFETY is freedom from unacceptable RISK . Unacceptable RISK can arise from USE ERROR , which can lead to exposure to direct physical HAZARDS or loss or degradation of clinical functionality. NOTE 2 Guidance on the application of USABILITY ENGINEERING to MEDICAL DEVICES is available in IEC 62366-2 2 , which addresses not only SAFETY but also aspects of USABILITY not related to SAFETY . If the USABILITY ENGINEERING PROCESS detailed in this International Standard has been complied with, then the USABILITY of a MEDICAL DEVICE as it relates to SAFETY is presumed to be acceptable, unless there is OBJECTIVE EVIDENCE to the contrary. NOTE 3 Such OBJECTIVE EVIDENCE can subsequently originate from POST – PRODUCTION surveillance. 2 Normative references The following documents, in whole or in part, are normatively referenced in this document and are indispensable for its application. For dated references, only the edition cited applies. For undated references, the latest edition of the referenced document (including any amendments) applies. NOTE 1 The way in which these referenced documents are cited in normative requirements determines the extent (in whole or in part) to which they apply. NOTE 2 Informative references are listed in the bibliography beginning on page 37. ISO 1 4971 :2007, Medical devices – Application of risk management to medical devices 3 Terms and definitions For the purpose of this document, the terms and definitions given in ISO 1 4971 :2007 and the following apply.
4 Principles 4.1 General requirements 4.1 .1 * U SABILITY ENGINEERING PROCESS The MANUFACTURER shall establish, document, implement and maintain a USABILITY ENGINEERING PROCESS , as defined in Clause 5, to provide SAFETY for the PATIENT , USER and others. The PROCESS shall address USER interactions with the MEDICAL DEVICE according to the ACCOMPANYING DOCUMENTATION , including, but not limited to: – * transport; – * storage; – installation; – operation; – maintenance and repair; and – disposal. U SABILITY ENGINEERING activities for a MEDICAL DEVICE shall be planned, carried out, and documented by personnel competent on the basis of appropriate education, training, skills or experience. Where a documented product realization PROCESS exists, such as that described in Clause 7 of ISO 1 3485:2003 [1 1 ], it shall incorporate the appropriate parts of or reference the USABILITY ENGINEERING PROCESS . NOTE 1 Subclause 6.2 of ISO 1 3485:2003 contains additional information relating to personnel competence. A depiction of the interrelationship between the RISK MANAGEMENT PROCESS of ISO 1 4971 :2007 and the USABILITY ENGINEERING PROCESS described in this standard is shown in Figure A.4. The activities described in Clause 5, as shown Figure A.4, are described in a logical order, but they may be carried out in a flexible order as appropriate. Consider compliance with this subclause to exist when the requirements of this International Standard have been fulfilled. 4.1 .2 * R ISK CONTROL AS IT RELATES TO USER INTERFACE DESIGN To reduce use-related RISK , the MANUFACTURER shall use one or more of the following options, in the priority listed (as required by ISO 1 4971 :2007, 6.2): a) inherent SAFETY by design; b) protective measures in the MEDICAL DEVICE itself or in the manufacturing PROCESS ; c) information for SAFETY . NOTE Information for SAFETY can also be required by product standards and other sources.