{"id":198100,"date":"2024-10-19T12:36:42","date_gmt":"2024-10-19T12:36:42","guid":{"rendered":"https:\/\/pdfstandards.shop\/product\/uncategorized\/aami-st77-2013-ra-2018\/"},"modified":"2024-10-25T05:09:53","modified_gmt":"2024-10-25T05:09:53","slug":"aami-st77-2013-ra-2018","status":"publish","type":"product","link":"https:\/\/pdfstandards.shop\/product\/publishers\/aami\/aami-st77-2013-ra-2018\/","title":{"rendered":"AAMI ST77 2013 RA 2018"},"content":{"rendered":"

This standard covers minimum labeling and performance requirements for rigid sterilization container systems and for instrument organizers.<\/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
PDF Pages<\/th>\nPDF Title<\/th>\n<\/tr>\n
1<\/td>\nANSI\/AAMI ST77:2013\/(R)2018, Containment devices for reusable medical device sterilization <\/td>\n<\/tr>\n
2<\/td>\nObjectives and uses of AAMI standards and recommended practices
\n <\/td>\n<\/tr>\n
3<\/td>\nTitle page
\n <\/td>\n<\/tr>\n
4<\/td>\nAAMI standard
\n
Copyright information
\n <\/td>\n<\/tr>\n
5<\/td>\nContents <\/td>\n<\/tr>\n
6<\/td>\nGlossary of equivalent standards <\/td>\n<\/tr>\n
7<\/td>\nCommittee representation <\/td>\n<\/tr>\n
10<\/td>\nForeword <\/td>\n<\/tr>\n
11<\/td>\nIntroduction
\n
1 Scope
1.1 General <\/td>\n<\/tr>\n
12<\/td>\n1.2 Inclusions
1.3 Exclusions <\/td>\n<\/tr>\n
13<\/td>\n2 Normative references <\/td>\n<\/tr>\n
14<\/td>\n3 Definitions and abbreviations <\/td>\n<\/tr>\n
17<\/td>\n4 Requirements
4.1 General
4.2 Materials of construction
4.2.1 Durability
4.2.2 Compatibility with the sterilization process
4.2.3 Corrosion resistance
4.2.4 Biocompatibility
4.3 Design
4.3.1 General <\/td>\n<\/tr>\n
18<\/td>\n4.3.2 Decontamination
4.3.3 Perforations
4.3.4 Stacking
4.3.4.1 Internal stacking
4.3.4.2 External stacking <\/td>\n<\/tr>\n
19<\/td>\n4.3.5 Maximum weight
4.3.6 Additional requirements for reusable rigid sterilization containers
4.3.6.1 Gaskets
4.3.6.2 Filters <\/td>\n<\/tr>\n
20<\/td>\n4.3.6.3 Valves (if applicable)
4.3.6.4 Handles
4.3.6.5 Lid-base compatibility
4.3.6.6 Latching mechanisms
4.3.6.7 Tamper-evident system <\/td>\n<\/tr>\n
21<\/td>\n4.4 Performance
4.4.1 Sterilization
4.4.1.1 General Requirements
4.4.1.2 Reconfiguration and combining of cases and sets
4.4.1.3 Documentation <\/td>\n<\/tr>\n
22<\/td>\n4.4.2 Drying (if applicable)
4.4.2.1 General Requirements
4.4.2.2 Documentation <\/td>\n<\/tr>\n
23<\/td>\n4.4.3 Sterilant residual removal (if applicable)
4.4.3.1 General Requirements
4.4.3.2 Documentation
4.4.4 Sterility maintenance
4.4.4.1 General Requirements <\/td>\n<\/tr>\n
24<\/td>\n4.4.4.2 Documentation
4.5 Labeling requirements
4.5.1 Device markings
4.5.2 Instructions for use (IFU) <\/td>\n<\/tr>\n
26<\/td>\n5 Tests
5.1 General
5.2 Biocompatibility
5.3 Gaskets and filters
5.4 Valves
5.5 Handles
5.6 Sterilization <\/td>\n<\/tr>\n
28<\/td>\n5.7 Drying (if applicable)
5.8 Sterilant residual removal (if applicable)
5.9 Sterility
5.9.1 Sterility maintenance
5.9.1.1 General
5.9.1.2 Whole-package microbial challenge test
5.9.1.3 Physical integrity tests <\/td>\n<\/tr>\n
29<\/td>\nAnnex A (Informative) Medical device integration with rigid sterilization container systems
A.1 Introduction
\n
A.2 Critical assessments
\n <\/td>\n<\/tr>\n
31<\/td>\nA.3 Validation plan
\n
A.4 FDA clearance considerations
\n <\/td>\n<\/tr>\n
32<\/td>\nA.5 Change control
\n <\/td>\n<\/tr>\n
33<\/td>\nBibliography <\/td>\n<\/tr>\n<\/table>\n","protected":false},"excerpt":{"rendered":"

ANSI\/AAMI ST77:2013\/(R)2018 – Containment devices for reusable medical device sterilization<\/b><\/p>\n\n\n\n\n
Published By<\/td>\nPublication Date<\/td>\nNumber of Pages<\/td>\n<\/tr>\n
AAMI<\/b><\/a><\/td>\n2013<\/td>\n34<\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n","protected":false},"featured_media":198102,"template":"","meta":{"rank_math_lock_modified_date":false,"ep_exclude_from_search":false},"product_cat":[2654],"product_tag":[],"class_list":{"0":"post-198100","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\/198100","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\/198102"}],"wp:attachment":[{"href":"https:\/\/pdfstandards.shop\/wp-json\/wp\/v2\/media?parent=198100"}],"wp:term":[{"taxonomy":"product_cat","embeddable":true,"href":"https:\/\/pdfstandards.shop\/wp-json\/wp\/v2\/product_cat?post=198100"},{"taxonomy":"product_tag","embeddable":true,"href":"https:\/\/pdfstandards.shop\/wp-json\/wp\/v2\/product_tag?post=198100"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}