{"id":198392,"date":"2024-10-19T12:37:46","date_gmt":"2024-10-19T12:37:46","guid":{"rendered":"https:\/\/pdfstandards.shop\/product\/uncategorized\/aami-tir17665-2-2009-ra-2016\/"},"modified":"2024-10-25T05:10:49","modified_gmt":"2024-10-25T05:10:49","slug":"aami-tir17665-2-2009-ra-2016","status":"publish","type":"product","link":"https:\/\/pdfstandards.shop\/product\/publishers\/aami\/aami-tir17665-2-2009-ra-2016\/","title":{"rendered":"AAMI TIR17665 2 2009 RA 2016"},"content":{"rendered":"

AAMI\/ISO TIR17665-2 provides guidance for validation and routine control of moist heat sterilization processes for medical devices.<\/p>\n

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PDF Pages<\/th>\nPDF Title<\/th>\n<\/tr>\n
1<\/td>\nANSI\/AAMI\/ISO TIR17665-2:2009\/(R)2016, Sterilization of health care products \u2014 Moist heat \u2014 Part 2: Guidance on the application of ANSI\/AAMI\/ISO 17665-1 <\/td>\n<\/tr>\n
2<\/td>\nTitle page <\/td>\n<\/tr>\n
3<\/td>\nCopyright information <\/td>\n<\/tr>\n
4<\/td>\nAAMI Technical Information Report
ANSI Technical Report <\/td>\n<\/tr>\n
5<\/td>\nContents <\/td>\n<\/tr>\n
7<\/td>\nGlossary of equivalent standards <\/td>\n<\/tr>\n
9<\/td>\nCommittee representation <\/td>\n<\/tr>\n
11<\/td>\nBackground of AAMI adoption of ISO\/TS 17665-2:2009 <\/td>\n<\/tr>\n
12<\/td>\nAAMI inclusion to ISO\/TS 17665-2:2009 <\/td>\n<\/tr>\n
13<\/td>\nForeword <\/td>\n<\/tr>\n
14<\/td>\nIntroduction <\/td>\n<\/tr>\n
16<\/td>\n1 Scope
2 Normative references <\/td>\n<\/tr>\n
17<\/td>\n3 Terms and definitions
4 Quality management system elements
5 Sterilizing agent characterization
5.1 Sterilizing agent
5.2 Microbicidal effectiveness <\/td>\n<\/tr>\n
18<\/td>\n5.3 Material effects
5.4 Environmental considerations
6 Process and equipment characterization
6.1 Process
6.1.1 General <\/td>\n<\/tr>\n
19<\/td>\n6.1.2 Saturated steam processes <\/td>\n<\/tr>\n
21<\/td>\n6.1.3 Contained product processes
6.2 Equipment <\/td>\n<\/tr>\n
23<\/td>\n7 Product definition <\/td>\n<\/tr>\n
24<\/td>\n8 Process definition <\/td>\n<\/tr>\n
26<\/td>\n9 Validation
9.1 General <\/td>\n<\/tr>\n
27<\/td>\n9.2 Installation qualification (IQ)
9.2.1 Equipment
9.2.2 Installation
9.2.3 Function <\/td>\n<\/tr>\n
28<\/td>\n9.3 Operational qualification (OQ) <\/td>\n<\/tr>\n
29<\/td>\n9.4 Performance qualification (PQ) <\/td>\n<\/tr>\n
31<\/td>\n9.5 Review and approval of the validation <\/td>\n<\/tr>\n
32<\/td>\n10 Routine monitoring and control <\/td>\n<\/tr>\n
33<\/td>\n11 Product release from sterilization <\/td>\n<\/tr>\n
34<\/td>\n12 Maintaining process effectiveness
12.1 Demonstration of continued effectiveness
12.2 Recalibration
12.3 Maintenance of equipment
12.4 Requalification <\/td>\n<\/tr>\n
35<\/td>\n12.5 Assessment of change <\/td>\n<\/tr>\n
36<\/td>\nAnnex A Evaluation of a sterilization process primarily based on the measurement of physical parameters
A.1 Introduction
A.2 Hollow load test
A.3 Standard test pack <\/td>\n<\/tr>\n
38<\/td>\nA.4 Thermometric tests
A.4.1 Small load thermometric test <\/td>\n<\/tr>\n
39<\/td>\nA.4.2 Full load thermometric test
A.5 Bowie and Dick test
A.6 Air leakage flow rate test
A.7 Air detector tests (if fitted), small load, full load and function <\/td>\n<\/tr>\n
40<\/td>\nA.8 Load dryness \u2014 Small and full load with textiles, full load with metal
A.9 Sound power test
A.10 Dynamic pressure test
A.11 Steam quality tests <\/td>\n<\/tr>\n
42<\/td>\nA.12 Water
A.13 Compressed air
A.14 Test programs <\/td>\n<\/tr>\n
44<\/td>\nAnnex B Evaluation of a sterilization process primarily based on biological inactivation and an accompanying mechanical air removal procedure
B.1 Introduction <\/td>\n<\/tr>\n
45<\/td>\nB.2 Biological qualification of a sterilization process
B.3 Biological challenge
B.4 Mechanical air removal <\/td>\n<\/tr>\n
47<\/td>\nAnnex C Temperature and pressure of saturated steam for use in moist heat sterilization <\/td>\n<\/tr>\n
50<\/td>\nAnnex D Special considerations for health care settings
D.1 Introduction
D.2 Quality management system elements (additional guidance for ISO 17665-1:2006, 4.1) <\/td>\n<\/tr>\n
52<\/td>\nD.3 Process and equipment characterization (additional guidance for ISO 17665-1:2006, Clause 6)
D.3.1 Process (additional guidance for ISO 17665-1:2006, 6.1) <\/td>\n<\/tr>\n
53<\/td>\nD.3.2 Equipment (additional guidance for ISO 17665-1:2006, 6.2.)
D.4 Product definition in health care facilities (additional guidance for ISO 17665-1:2006, Clause 7)
D.4.1 Additional guidance on ISO 17665-1:2006, 7.1
D.4.2 Additional guidance on ISO 17665-1:2006, 7.3
D.4.3 Additional guidance on ISO 17665-1:2006, 7.10
D.5 Process definition (additional guidance for ISO 17665-1:2006, Clause 8) <\/td>\n<\/tr>\n
54<\/td>\nD.5.2 Additional guidance on ISO 17665-1:2006, 8.3
D.5.3 Additional guidance on ISO 17665-1:2006, 8.4
D.5.4 Additional guidance on ISO 17665-1:2006, 8.12
D.6 Validation (additional guidance for ISO 17665-1:2006, Clause 9)
D.6.1 Operational qualification (additional guidance for ISO 17665-1:2006, 9.3.1) <\/td>\n<\/tr>\n
55<\/td>\nD.6.2 Performance qualification (additional guidance on ISO 17665-1:2006, 9.4)
D.6.2.1 Additional guidance for ISO 17665-1:2006, 9.4.1
D.6.2.2 Additional guidance for ISO 17665-1:2006, 9.4.2
D.6.2.3 Additional guidance for ISO 17665-1:2006, 9.4.4 <\/td>\n<\/tr>\n
56<\/td>\nD.6.3 Review and approval of the validation (additional guidance for ISO 17665-1:2006, 9.5.2)
D.7 Routine monitoring and control (additional guidance for ISO 17665-1:2006, Clause 10)
D.7.1 Additional guidance for ISO 17665-1:2006, 10.1 <\/td>\n<\/tr>\n
57<\/td>\nD.7.2 Additional guidance for ISO 17665-1:2006, 10.3
D.8 Product release from sterilization (additional guidance for ISO 17665-1:2006, 11.1) <\/td>\n<\/tr>\n
58<\/td>\nD.9 Maintaining process effectiveness (additional guidance for ISO 17665-1:2006, Clause 12)
D.9.1 Recalibration (additional guidance for ISO 17665-1:2006, 12.2)
D.9.2 Maintenance of equipment (additional guidance for ISO 17665-1:2006, 12.3.1)
D.9.3 Requalification (additional guidance for ISO 17665-1:2006, 12.4.1) <\/td>\n<\/tr>\n
59<\/td>\nAnnex E Index of normative clauses\/subclauses of ISO 17665-1 and cited references or related guidance given in ISO 17665-1 and ISO\/TS 17665-2 <\/td>\n<\/tr>\n
62<\/td>\nBibliography <\/td>\n<\/tr>\n<\/table>\n","protected":false},"excerpt":{"rendered":"

ANSI\/AAMI\/ISO TIR17665-2:2009\/(R)2016 – Technical Information Report Sterilization of health care products \u2013 Moist Heat \u2013 Part 2: Guidance on the application of ANSI\/AAMI\/ISO 17665-1<\/b><\/p>\n\n\n\n\n
Published By<\/td>\nPublication Date<\/td>\nNumber of Pages<\/td>\n<\/tr>\n
AAMI<\/b><\/a><\/td>\n2009<\/td>\n65<\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n","protected":false},"featured_media":198398,"template":"","meta":{"rank_math_lock_modified_date":false,"ep_exclude_from_search":false},"product_cat":[2654],"product_tag":[],"class_list":{"0":"post-198392","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\/198392","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\/198398"}],"wp:attachment":[{"href":"https:\/\/pdfstandards.shop\/wp-json\/wp\/v2\/media?parent=198392"}],"wp:term":[{"taxonomy":"product_cat","embeddable":true,"href":"https:\/\/pdfstandards.shop\/wp-json\/wp\/v2\/product_cat?post=198392"},{"taxonomy":"product_tag","embeddable":true,"href":"https:\/\/pdfstandards.shop\/wp-json\/wp\/v2\/product_tag?post=198392"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}