{"id":435966,"date":"2024-10-20T07:52:17","date_gmt":"2024-10-20T07:52:17","guid":{"rendered":"https:\/\/pdfstandards.shop\/product\/uncategorized\/aami-17664-2-2022\/"},"modified":"2024-10-26T14:53:45","modified_gmt":"2024-10-26T14:53:45","slug":"aami-17664-2-2022","status":"publish","type":"product","link":"https:\/\/pdfstandards.shop\/product\/publishers\/aami\/aami-17664-2-2022\/","title":{"rendered":"AAMI 17664 2 2022"},"content":{"rendered":"

Specifies requirements for the information to be provided by the medical device manufacturer for the processing of non-critical medical devices not intended to be sterilized.<\/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\n\n\n\n\n
PDF Pages<\/th>\nPDF Title<\/th>\n<\/tr>\n
1<\/td>\nANSI\/AAMI\/ISO 17664-2:2022; Processing of health care products\u2014Information to be provided by the medical device manufacturer for the processing of medical devices\u2014Part 2: Non-critical medical devices <\/td>\n<\/tr>\n
3<\/td>\nTitle page <\/td>\n<\/tr>\n
4<\/td>\nAAMI Standard <\/td>\n<\/tr>\n
5<\/td>\nCopyright information
Contents <\/td>\n<\/tr>\n
6<\/td>\nCommittee representation <\/td>\n<\/tr>\n
9<\/td>\nBackground of ANSI\/AAMI adoption of ISO 17664-2:2021 <\/td>\n<\/tr>\n
10<\/td>\nForeword <\/td>\n<\/tr>\n
11<\/td>\nIntroduction <\/td>\n<\/tr>\n
13<\/td>\n1 Scope <\/td>\n<\/tr>\n
14<\/td>\n2 Normative references
3 Terms and definitions <\/td>\n<\/tr>\n
17<\/td>\n4 Risk analysis <\/td>\n<\/tr>\n
18<\/td>\n5 Validation of the processes identified in the information provided by the medical device manufacturer
6 Information to be provided by the medical device manufacturer
6.1 General <\/td>\n<\/tr>\n
19<\/td>\n6.2 Processing instructions
6.3 Limitations and restrictions on processing <\/td>\n<\/tr>\n
20<\/td>\n6.4 Preparation before processing
6.5 Cleaning
6.5.1 General
6.5.2 Manual cleaning
6.5.3 Automated cleaning <\/td>\n<\/tr>\n
21<\/td>\n6.6 Disinfection
6.6.1 General
6.6.2 Manual disinfection <\/td>\n<\/tr>\n
22<\/td>\n6.6.3 Automated disinfection
6.7 Drying <\/td>\n<\/tr>\n
23<\/td>\n6.8 Inspection and maintenance
6.9 Packaging
6.10 Storage
6.11 Transportation
7 Presentation of the information <\/td>\n<\/tr>\n
24<\/td>\nAnnex A (informative) Commonly utilized processing methods
Table A.1 \u2014 Processing steps typically performed in a health care facility <\/td>\n<\/tr>\n
29<\/td>\nAnnex B (informative) Example processing instructions for non-critical reusable medical devices <\/td>\n<\/tr>\n
30<\/td>\nTable B.1 \u2014 Processing instructions (non-critical reusable medical devices) <\/td>\n<\/tr>\n
31<\/td>\nAnnex C (informative) Processing classification and grouping of medical devices
C.1 General
C.2 The Spaulding classification
C.2.1 General
C.2.2 Non-critical items
C.2.3 Semi-critical items
C.2.4 Critical items <\/td>\n<\/tr>\n
32<\/td>\nC.3 Medical device design groups for processing
C.3.1 Key principles
C.3.2 Medical device design features <\/td>\n<\/tr>\n
33<\/td>\nAnnex D (informative) Additional guidance on information to be provided by the medical device manufacturer
D.1 \u200bEvaluation of appropriate processing methods (see Clause 6)
D.2 Generic information versus trade names (see 6.1.5) <\/td>\n<\/tr>\n
34<\/td>\nAnnex E (informative) Examples of medical devices and their relationship to this document <\/td>\n<\/tr>\n
35<\/td>\nFigure E.1 \u2014 Flow chart to assist with identifying the applicable part of the ISO 17664 series <\/td>\n<\/tr>\n
36<\/td>\nTable E.1 \u2014 Examples of medical device types and suggested applicable part of the ISO 17664 series <\/td>\n<\/tr>\n
38<\/td>\nBibliography <\/td>\n<\/tr>\n<\/table>\n","protected":false},"excerpt":{"rendered":"

ANSI\/AAMI\/ISO 17664-2:2022 Processing Of Health Care Products – Information To Be Provided By The Medical Device Manufacturer For The Processing Of Medical Devices – Part 2: Non-Critical Medical Devices<\/b><\/p>\n\n\n\n\n
Published By<\/td>\nPublication Date<\/td>\nNumber of Pages<\/td>\n<\/tr>\n
AAMI<\/b><\/a><\/td>\n2022<\/td>\n<\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n","protected":false},"featured_media":435972,"template":"","meta":{"rank_math_lock_modified_date":false,"ep_exclude_from_search":false},"product_cat":[2654],"product_tag":[],"class_list":{"0":"post-435966","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\/435966","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\/435972"}],"wp:attachment":[{"href":"https:\/\/pdfstandards.shop\/wp-json\/wp\/v2\/media?parent=435966"}],"wp:term":[{"taxonomy":"product_cat","embeddable":true,"href":"https:\/\/pdfstandards.shop\/wp-json\/wp\/v2\/product_cat?post=435966"},{"taxonomy":"product_tag","embeddable":true,"href":"https:\/\/pdfstandards.shop\/wp-json\/wp\/v2\/product_tag?post=435966"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}