{"id":577266,"date":"2024-11-05T20:00:32","date_gmt":"2024-11-05T20:00:32","guid":{"rendered":"https:\/\/pdfstandards.shop\/product\/uncategorized\/iec-tr-60601-4-12017\/"},"modified":"2024-11-05T20:00:32","modified_gmt":"2024-11-05T20:00:32","slug":"iec-tr-60601-4-12017","status":"publish","type":"product","link":"https:\/\/pdfstandards.shop\/product\/publishers\/iec\/iec-tr-60601-4-12017\/","title":{"rendered":"IEC TR 60601-4-1:2017"},"content":{"rendered":"

IEC TR 60601-4-1:2017(E) is intended to help a manufacturer through the key decisions and steps to be taken to perform a detailed risk management and usability engineering processes for medical electrical equipment or a medical electrical system, hereafter referred to as MEE or MES, employing a degree of autonomy (DOA).
\nThis document provides a definition of DOA of MEE or MES and a medical robot, and also provides guidance on:
\n– methodologies to perform the risk management process and usability engineering for an MEE or MES with a DOA;
\n– considerations of basic safety and essential performance for an MEE and MES with a DOA; and
\n– identifying the use of DOA, and similar concepts in existing ISO\/IEC standards dealing with MEE or MES with the goal to facilitate alignment of standards by consistent use of the concept of DOA; and
\n– distinguishing between medical robots, and other MEE and MES.
\nUnless specified otherwise, this document considers MEE and MES together.
\nThe manufacturer of an MEE or MES with a DOA is expected to design and manufacture an MEE or MES that fulfils its intended use and does not have unacceptable risk throughout its life-cycle.
\nThis document provides guidance to help the manufacturer in complying with the requirements of IEC 60601-1:2005 and IEC 60601-1:2005\/AMD1:2012 for MEE and MES with DOA. The document is also intended as guidance for future standard writers.
\nThere are no prerequisites to this document.<\/p>\n","protected":false},"excerpt":{"rendered":"

Medical electrical equipment – Part 4-1: Guidance and interpretation – Medical electrical equipment and medical electrical systems employing a degree of autonomy<\/b><\/p>\n\n\n\n\n
Published By<\/td>\nPublication Date<\/td>\nNumber of Pages<\/td>\n<\/tr>\n
IEC<\/b><\/a><\/td>\n2017-05-22<\/td>\n84<\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n","protected":false},"featured_media":577277,"template":"","meta":{"rank_math_lock_modified_date":false,"ep_exclude_from_search":false},"product_cat":[136,2636],"product_tag":[],"class_list":{"0":"post-577266","1":"product","2":"type-product","3":"status-publish","4":"has-post-thumbnail","6":"product_cat-11-040-01","7":"product_cat-iec","9":"first","10":"instock","11":"sold-individually","12":"shipping-taxable","13":"purchasable","14":"product-type-simple"},"_links":{"self":[{"href":"https:\/\/pdfstandards.shop\/wp-json\/wp\/v2\/product\/577266","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\/577277"}],"wp:attachment":[{"href":"https:\/\/pdfstandards.shop\/wp-json\/wp\/v2\/media?parent=577266"}],"wp:term":[{"taxonomy":"product_cat","embeddable":true,"href":"https:\/\/pdfstandards.shop\/wp-json\/wp\/v2\/product_cat?post=577266"},{"taxonomy":"product_tag","embeddable":true,"href":"https:\/\/pdfstandards.shop\/wp-json\/wp\/v2\/product_tag?post=577266"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}