{"id":198286,"date":"2024-10-19T12:37:22","date_gmt":"2024-10-19T12:37:22","guid":{"rendered":"https:\/\/pdfstandards.shop\/product\/uncategorized\/aami-st91-2015\/"},"modified":"2024-10-25T05:10:29","modified_gmt":"2024-10-25T05:10:29","slug":"aami-st91-2015","status":"publish","type":"product","link":"https:\/\/pdfstandards.shop\/product\/publishers\/aami\/aami-st91-2015\/","title":{"rendered":"AAMI ST91 2015"},"content":{"rendered":"

Provides guidelines for precleaning, leak-testing, cleaning, packaging (where indicated), storage, high-level disinfecting, and\/or sterilizing of flexible gastrointestinal (GI) endoscopes, flexible bronchoscopes, surgical flexible endoscopes (e.g., flexible ureteroscopes), and semi-rigid operative endoscopes (e.g., choledochoscopes) in health care facilities. These guidelines are intended to provide comprehensive information and direction for health care personnel in the processing of these devices and accessories.<\/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\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 ST91:2015, Flexible and semi-rigid endoscope processing in health care facilities <\/td>\n<\/tr>\n
2<\/td>\nObjectives and uses of AAMI standards and recommended practices <\/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
8<\/td>\nGlossary of equivalent standards <\/td>\n<\/tr>\n
9<\/td>\nCommittee representation <\/td>\n<\/tr>\n
11<\/td>\nForeword <\/td>\n<\/tr>\n
13<\/td>\nIntroduction <\/td>\n<\/tr>\n
15<\/td>\n1 Scope
1.1 Inclusions
1.2 Exclusions
2 Definitions and abbreviations <\/td>\n<\/tr>\n
20<\/td>\n3 Design of endoscope processing area
3.1 General considerations
3.2 Work flow
3.2.1 General considerations
3.2.2 Physical separation <\/td>\n<\/tr>\n
21<\/td>\n3.2.3 Traffic control
3.3 Physical facilities
3.3.1 Space requirements <\/td>\n<\/tr>\n
22<\/td>\n3.3.2 Sinks and accessories
3.3.3 Electrical systems
3.3.4 Floors and walls <\/td>\n<\/tr>\n
23<\/td>\n3.3.5 Ceilings
3.3.6 Doors
3.3.7 Temperature, relative humidity, and ventilation
3.3.7.1 Temperature and relative humidity
3.3.7.2 Ventilation <\/td>\n<\/tr>\n
24<\/td>\n3.3.8 Lighting <\/td>\n<\/tr>\n
25<\/td>\nTable 1\u2014IES-recommended illuminance levels for work environments
3.3.9 Hand hygiene facilities
3.3.10 Emergency eyewash\/shower equipment <\/td>\n<\/tr>\n
26<\/td>\n3.3.11 Environmental cleaning
4 Personnel
4.1 General considerations
4.2 Policies and procedures <\/td>\n<\/tr>\n
27<\/td>\n4.3 Education, training, and competency verification <\/td>\n<\/tr>\n
28<\/td>\n4.4 Standard precautions <\/td>\n<\/tr>\n
29<\/td>\n4.5 Hand hygiene
4.6 Attire
4.6.1 General considerations
4.6.2 Personal protective equipment <\/td>\n<\/tr>\n
30<\/td>\n4.7 Immunizations <\/td>\n<\/tr>\n
31<\/td>\n5 Cleaning and high-level disinfection
5.1 General considerations
5.2 Precleaning at the point of use
5.3 Transporting used endoscopes <\/td>\n<\/tr>\n
32<\/td>\n5.4 Leak testing
5.4.1 General considerations
5.4.2 Manual (dry) leak testing
5.4.3 Mechanical (wet) leak testing <\/td>\n<\/tr>\n
33<\/td>\n5.4.4 Mechanical (dry) leak testing
5.4.5 Mechanical leak testing using an AER <\/td>\n<\/tr>\n
34<\/td>\n5.4.6 Leak test failures
5.5 Manual cleaning <\/td>\n<\/tr>\n
35<\/td>\n5.6 Manual rinsing
5.7 High-level disinfection and liquid chemical sterilization
5.7.1 General considerations
5.7.2 High-level disinfection <\/td>\n<\/tr>\n
36<\/td>\n5.7.3 Liquid chemical sterilants\/liquid chemical sterilization <\/td>\n<\/tr>\n
37<\/td>\n5.7.4 Manual liquid chemical sterilization\/high-level disinfection
5.7.4.1 Disinfection
5.7.4.2 Manual rinsing
5.7.4.3 Manual drying <\/td>\n<\/tr>\n
38<\/td>\n6 Automated endoscope reprocessors <\/td>\n<\/tr>\n
40<\/td>\n7 Sterile endoscope sheaths used as protective microbial barriers
8 Terminal sterilization by gaseous chemical sterilization processes
8.1 General considerations <\/td>\n<\/tr>\n
41<\/td>\n8.2 Packaging for terminal sterilization
8.2.1 General considerations
8.2.2 Sterilization pouches
8.2.3 Sterilization wraps
8.2.4 Rigid sterilization containment systems
8.3 Ethylene oxide gas (EO) sterilization <\/td>\n<\/tr>\n
42<\/td>\n8.4 Hydrogen peroxide gas sterilization <\/td>\n<\/tr>\n
43<\/td>\n8.5 Ozone sterilization
9 Processing of endoscope accessories <\/td>\n<\/tr>\n
44<\/td>\n10 Storage of reprocessed endoscopes
10.1 General Considerations <\/td>\n<\/tr>\n
45<\/td>\n10.2 Storage of high-level disinfected endoscopes
10.3 Storage of sterilized endoscopes
10.4 Hang time for high-level disinfected endoscopes
10.4.1 General considerations
10.4.2 Existing guidelines <\/td>\n<\/tr>\n
46<\/td>\n10.4.3 Risk assessment <\/td>\n<\/tr>\n
47<\/td>\nTable 2\u2014Endoscope storage risk assessment checklist
11 Transport of high-level disinfected endoscopes
12 Quality Control
12.1 General considerations <\/td>\n<\/tr>\n
49<\/td>\n12.2 Product identification and traceability
12.3 Documentation and record-keeping
12.3.1 Documentation <\/td>\n<\/tr>\n
50<\/td>\n12.3.2 Expiration dating
12.4 Verification and monitoring of the cleaning process
12.4.1 General Considerations <\/td>\n<\/tr>\n
51<\/td>\n12.4.2 Cleaning verification
12.4.3 Cleaning verification tests for users <\/td>\n<\/tr>\n
52<\/td>\n12.4.4 Testing cleaning efficacy
12.5 Monitoring processes that use liquid chemical sterilization\/high-level disinfection
12.5.1 Manual processes
12.5.1.1 Use of physical monitors
12.5.1.2 Solution test strips or chemical monitoring devices
12.5.1.2.1 General considerations
12.5.1.2.2 Using solution test strips or chemical monitoring devices
12.5.1.2.3 Frequency of use <\/td>\n<\/tr>\n
53<\/td>\n12.5.1.2.4 Interpretation
12.5.1.2.5 Inadequate processing <\/td>\n<\/tr>\n
54<\/td>\n12.5.2 Automated processes
12.5.2.1 General considerations
12.5.2.2 Use of physical monitors and process monitoring devices
12.5.2.3 Automated processing equipment malfunction <\/td>\n<\/tr>\n
55<\/td>\n12.5.2.4 Inadequate processing
12.5.3 Routine testing of stored endoscopes <\/td>\n<\/tr>\n
56<\/td>\n12.6 Monitoring gaseous chemical sterilization processes
12.6.1 Use of physical monitors
12.6.2 Gaseous chemical sterilizer malfunction <\/td>\n<\/tr>\n
57<\/td>\n12.7 Chemical indicators
12.7.1 General considerations
12.7.2 Using chemical indicators
12.7.3 Nonresponsive or inconclusive chemical indicators <\/td>\n<\/tr>\n
58<\/td>\n12.8 Biological indicators
12.8.1 General considerations
12.8.2 Using biological indicators and process challenge devices
12.8.3 Frequency of use of BIs and PCDs
12.9 Sterilizer testing
12.9.1 General considerations <\/td>\n<\/tr>\n
59<\/td>\n12.9.2 Qualification test procedure with BIs
12.9.3 Qualification testing acceptance criteria
12.9.4 Routine test procedure with BIs
12.9.5 Routine testing acceptance criteria
12.9.6 Positive BI results <\/td>\n<\/tr>\n
60<\/td>\n12.9.7 Microbiological testing
12.9.8 Product release
12.10 Product recalls
12.10.1 General considerations <\/td>\n<\/tr>\n
61<\/td>\n12.10.2 Recall procedure
12.10.3 Recall order
12.10.4 Recall summary report
12.10.5 Outbreak report
12.11 Quality process improvement
12.11.1 General considerations <\/td>\n<\/tr>\n
62<\/td>\n12.11.2 Risk analysis <\/td>\n<\/tr>\n
63<\/td>\n12.11.3 Decontamination
12.11.4 Liquid chemical sterilization, high-level disinfection, and gaseous chemical sterilization <\/td>\n<\/tr>\n
64<\/td>\n12.11.5 Functional areas for product and process improvement
12.11.5.1 Workplace design
12.11.5.2 Processing policies and procedures
12.11.5.3 Product use
12.11.5.5 Implementation of product and process improvements <\/td>\n<\/tr>\n
66<\/td>\nAnnex A: Bibliography <\/td>\n<\/tr>\n<\/table>\n","protected":false},"excerpt":{"rendered":"

ANSI\/AAMI ST91:2015 – Flexible and semi-rigid endoscope processing in healthcare facilities<\/b><\/p>\n\n\n\n\n
Published By<\/td>\nPublication Date<\/td>\nNumber of Pages<\/td>\n<\/tr>\n
AAMI<\/b><\/a><\/td>\n2015<\/td>\n70<\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n","protected":false},"featured_media":198291,"template":"","meta":{"rank_math_lock_modified_date":false,"ep_exclude_from_search":false},"product_cat":[2654],"product_tag":[],"class_list":{"0":"post-198286","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\/198286","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\/198291"}],"wp:attachment":[{"href":"https:\/\/pdfstandards.shop\/wp-json\/wp\/v2\/media?parent=198286"}],"wp:term":[{"taxonomy":"product_cat","embeddable":true,"href":"https:\/\/pdfstandards.shop\/wp-json\/wp\/v2\/product_cat?post=198286"},{"taxonomy":"product_tag","embeddable":true,"href":"https:\/\/pdfstandards.shop\/wp-json\/wp\/v2\/product_tag?post=198286"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}