{"id":599559,"date":"2024-11-05T22:01:44","date_gmt":"2024-11-05T22:01:44","guid":{"rendered":"https:\/\/pdfstandards.shop\/product\/uncategorized\/iso-17664-12021\/"},"modified":"2024-11-05T22:01:44","modified_gmt":"2024-11-05T22:01:44","slug":"iso-17664-12021","status":"publish","type":"product","link":"https:\/\/pdfstandards.shop\/product\/publishers\/iso\/iso-17664-12021\/","title":{"rendered":"ISO 17664-1:2021"},"content":{"rendered":"<p>This document specifies requirements for the information to be provided by the medical device manufacturer for the processing of critical or semi-critical medical devices (i.e. a medical device that enters normally sterile parts of the human body or a medical device that comes into contact with mucous membranes or non-intact skin) or medical devices that are intended to be sterilized.<\/p>\n<p>This includes information for processing prior to use or reuse of the medical device.<\/p>\n<p>Processing instructions are not defined in this document. Rather, this document specifies requirements to assist manufacturers of medical devices in providing detailed processing instructions that consist of the following activities, where applicable:<\/p>\n<p>a) initial treatment at the point of use;<\/p>\n<p>b) preparation before cleaning;<\/p>\n<p>c) cleaning;<\/p>\n<p>d) disinfection;<\/p>\n<p>e) drying;<\/p>\n<p>f) inspection and maintenance;<\/p>\n<p>g) packaging;<\/p>\n<p>h) sterilization;<\/p>\n<p>i) storage;<\/p>\n<p>j) transportation.<\/p>\n<p>This document excludes processing of the following:<\/p>\n<p>\u2014\u00a0\u00a0\u00a0 non-critical medical devices unless they are intended to be sterilized;<\/p>\n<p>\u2014\u00a0\u00a0\u00a0 textile devices used in patient draping systems or surgical clothing;<\/p>\n<p>\u2014\u00a0\u00a0\u00a0 medical devices specified by the manufacturer for single use only and supplied ready for use.<\/p>\n<p>NOTE\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0 See ISO 17664-2:2021, Annex\u00a0E, for further guidance on the application of the ISO\u00a017664 series to a medical device.<\/p>\n","protected":false},"excerpt":{"rendered":"<p><b>Processing of health care products \u2014 Information to be provided by the medical device manufacturer for the processing of medical devices \u2014 Part 1: Critical and semi-critical medical devices<\/b><\/p>\n<table style=\"width: 100%\" border=\"0\" cellspacing=\"0\" cellpadding=\"0\">\n<tbody>\n<tr>\n<td>Published By<\/td>\n<td>Publication Date<\/td>\n<td>Number of Pages<\/td>\n<\/tr>\n<tr>\n<td><a href=\"https:\/\/pdfstandards.shop\/product-category\/publishers\/iso\/\"><b>ISO<\/b><\/a><\/td>\n<td>2021-07<\/td>\n<td>30<\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n","protected":false},"featured_media":599567,"template":"","meta":{"rank_math_lock_modified_date":false,"ep_exclude_from_search":false},"product_cat":[154,2634],"product_tag":[],"class_list":{"0":"post-599559","1":"product","2":"type-product","3":"status-publish","4":"has-post-thumbnail","6":"product_cat-11-080-01","7":"product_cat-iso","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\/599559","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\/599567"}],"wp:attachment":[{"href":"https:\/\/pdfstandards.shop\/wp-json\/wp\/v2\/media?parent=599559"}],"wp:term":[{"taxonomy":"product_cat","embeddable":true,"href":"https:\/\/pdfstandards.shop\/wp-json\/wp\/v2\/product_cat?post=599559"},{"taxonomy":"product_tag","embeddable":true,"href":"https:\/\/pdfstandards.shop\/wp-json\/wp\/v2\/product_tag?post=599559"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}