{"id":374188,"date":"2024-10-20T02:37:24","date_gmt":"2024-10-20T02:37:24","guid":{"rendered":"https:\/\/pdfstandards.shop\/product\/uncategorized\/aami-62366-1-2015-a1-2020\/"},"modified":"2024-10-26T04:35:04","modified_gmt":"2024-10-26T04:35:04","slug":"aami-62366-1-2015-a1-2020","status":"publish","type":"product","link":"https:\/\/pdfstandards.shop\/product\/publishers\/aami\/aami-62366-1-2015-a1-2020\/","title":{"rendered":"AAMI 62366 1 2015 A1 2020"},"content":{"rendered":"

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.<\/p>\n

PDF Catalog<\/h4>\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n
PDF Pages<\/th>\nPDF Title<\/th>\n<\/tr>\n
1<\/td>\nANSI\/AAMI\/IEC 62366-1:2015\/A1:2020Medical devices\u2014Part 1: Application of usability engineering to medical devices\u2014Amendment 1 <\/td>\n<\/tr>\n
3<\/td>\nTitle page <\/td>\n<\/tr>\n
4<\/td>\nAAMI Standard
Copyright information <\/td>\n<\/tr>\n
5<\/td>\nContents <\/td>\n<\/tr>\n
6<\/td>\nCommittee representation <\/td>\n<\/tr>\n
9<\/td>\nBackground of ANSI\/AAMI adoption of IEC 62366-1:2015\/Amendment 1:2020 <\/td>\n<\/tr>\n
10<\/td>\nForeword <\/td>\n<\/tr>\n
11<\/td>\nIntroduction <\/td>\n<\/tr>\n
13<\/td>\nINTRODUCTION
1\u2003* Scope
2\u2003Normative references
3\u2003Terms and definitions <\/td>\n<\/tr>\n
14<\/td>\n4.1.1\u2003* Usability engineering process
4.1.2\u2003* Risk control as it relates to user interface design
4.1.3\u2003Information for safety as it relates to usability <\/td>\n<\/tr>\n
15<\/td>\n4.3\u2003Tailoring of the usability engineering effort
5.1\u2003* Prepare use specification
5.2\u2003* Identify user interface characteristics related to safety and potential use errors
5.3\u2003* Identify known or foreseeable hazards and hazardous situations
5.5\u2003* Select the hazard-related use scenarios for summative evaluation <\/td>\n<\/tr>\n
16<\/td>\n5.7.1\u2003General
5.7.3\u2003* Summative evaluation planning
5.8\u2003* Perform user interface design, implementation and formative evaluation
5.9\u2003* Perform summative evaluation of the usability of the user interface <\/td>\n<\/tr>\n
17<\/td>\nA.2\u2003Rationale for requirements in particular clauses and subclauses
Clause 1 \u2013 Scope
Definition 3.1 \u2013 abnormal use
Definition 3.11 \u2013 primary operating function
Definition 3.17 \u2013 Usability engineering or human factors engineering
Definition 3.21 \u2013 use error
Definition 3.22 \u2013 use scenario
Clause 5 \u2013 Usability engineering process <\/td>\n<\/tr>\n
18<\/td>\nFigure A.4 \u2013 Types of use as described in this document and their relationship to the concept of \u201creasonably foreseeable misuse\u201d in ISO 14971 <\/td>\n<\/tr>\n
20<\/td>\nFigure A.5 \u2013 The relationship between the RISK MANAGEMENT PROCESS (ISO 14971:2019) and the USABILITY ENGINEERING PROCESS (IEC 62366-1) <\/td>\n<\/tr>\n
21<\/td>\nSubclause 5.1 \u2013 Prepare use specification
Subclause 5.2 \u2013 Identify user interface characteristics related to safety and potential use errors
Subclause 5.3 \u2013 Identify known or foreseeable hazards and hazardous situations <\/td>\n<\/tr>\n
22<\/td>\nSubclause 5.6 \u2013 Establish user interface specification
Subclause 5.7.2 \u2013 Formative evaluation planning
Subclause 5.7.3 \u2013 Summative evaluation planning
Subclause 5.9 \u2013 Perform summative evaluation of the usability of the user interface
Table B.1 \u2013 Glossary of relevant risk management terms
Table B.2 \u2013 Examples of harm due to risk caused by use error(s) or poor usability <\/td>\n<\/tr>\n
23<\/td>\nC.1\u2003General
C.2.5\u2003Residual risk evaluation
Annex D \u2013 Types of medical device use, with examples
Figure D.1 \u2013 Interrelationships between the different types of medical device use, with examples <\/td>\n<\/tr>\n
25<\/td>\nAnnex E \u2013 Reference to the essential principles
Annex E (informative) Reference to the essential principles
E.1\u2003Non-IVD medical devices
Table E.1 \u2013 Correspondence between this document and the essential principles <\/td>\n<\/tr>\n
26<\/td>\nE.2\u2003IVD medical devices
Table E.2 \u2013 Correspondence between this document and the essential principles <\/td>\n<\/tr>\n
27<\/td>\nBibliography <\/td>\n<\/tr>\n
28<\/td>\nIndex of defined terms <\/td>\n<\/tr>\n<\/table>\n","protected":false},"excerpt":{"rendered":"

ANSI\/AAMI\/IEC 62366-1:2015\/A1:2020, Medical devices-Part 1: Application of usability engineering to medical devices-Amendment 1<\/b><\/p>\n\n\n\n\n
Published By<\/td>\nPublication Date<\/td>\nNumber of Pages<\/td>\n<\/tr>\n
AAMI<\/b><\/a><\/td>\n2020<\/td>\n28<\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n","protected":false},"featured_media":374198,"template":"","meta":{"rank_math_lock_modified_date":false,"ep_exclude_from_search":false},"product_cat":[2654],"product_tag":[],"class_list":{"0":"post-374188","1":"product","2":"type-product","3":"status-publish","4":"has-post-thumbnail","6":"product_cat-aami","8":"first","9":"instock","10":"sold-individually","11":"shipping-taxable","12":"purchasable","13":"product-type-simple"},"_links":{"self":[{"href":"https:\/\/pdfstandards.shop\/wp-json\/wp\/v2\/product\/374188","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/pdfstandards.shop\/wp-json\/wp\/v2\/product"}],"about":[{"href":"https:\/\/pdfstandards.shop\/wp-json\/wp\/v2\/types\/product"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/pdfstandards.shop\/wp-json\/wp\/v2\/media\/374198"}],"wp:attachment":[{"href":"https:\/\/pdfstandards.shop\/wp-json\/wp\/v2\/media?parent=374188"}],"wp:term":[{"taxonomy":"product_cat","embeddable":true,"href":"https:\/\/pdfstandards.shop\/wp-json\/wp\/v2\/product_cat?post=374188"},{"taxonomy":"product_tag","embeddable":true,"href":"https:\/\/pdfstandards.shop\/wp-json\/wp\/v2\/product_tag?post=374188"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}