{"id":198207,"date":"2024-10-19T12:37:03","date_gmt":"2024-10-19T12:37:03","guid":{"rendered":"https:\/\/pdfstandards.shop\/product\/uncategorized\/aami-17665-1-2006-ra-2013\/"},"modified":"2024-10-25T05:10:13","modified_gmt":"2024-10-25T05:10:13","slug":"aami-17665-1-2006-ra-2013","status":"publish","type":"product","link":"https:\/\/pdfstandards.shop\/product\/publishers\/aami\/aami-17665-1-2006-ra-2013\/","title":{"rendered":"AAMI 17665 1 2006 RA 2013"},"content":{"rendered":"

Specifies requirements for the development, validation, and routine control of a moist heat sterilization process for medical devices used in any facility that manufacturers or reprocesses medical devices.<\/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
PDF Pages<\/th>\nPDF Title<\/th>\n<\/tr>\n
1<\/td>\nANSI\/AAMI\/ISO 17665-1:2006\/(R)2013, Sterilization of health care products – Moist heat – Part 1 Requirements for the development, validation, and routine control of a sterilization process for medical devices <\/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
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 17665-1:2006 <\/td>\n<\/tr>\n
12<\/td>\nForeword <\/td>\n<\/tr>\n
13<\/td>\nIntroduction <\/td>\n<\/tr>\n
15<\/td>\n1 Scope
1.1 Inclusions
1.2 Exclusions <\/td>\n<\/tr>\n
16<\/td>\n2 Normative references <\/td>\n<\/tr>\n
17<\/td>\n3 Terms and definitions <\/td>\n<\/tr>\n
25<\/td>\n4 Quality management system elements
4.1 Documentation
4.2 Management responsibility
4.3 Product realization <\/td>\n<\/tr>\n
26<\/td>\n5 Sterilizing agent characterization
5.1 Sterilizing agent
5.2 Microbicidal effectiveness
5.3 Materials effects
5.4 Environmental consideration
6 Process and equipment characterization
6.1 Process
6.1.1 General <\/td>\n<\/tr>\n
27<\/td>\n6.1.2 Saturated steam processes <\/td>\n<\/tr>\n
28<\/td>\n6.1.3 Contained product processes
6.2 Equipment <\/td>\n<\/tr>\n
30<\/td>\n7 Product definition <\/td>\n<\/tr>\n
31<\/td>\n8 Process definition <\/td>\n<\/tr>\n
32<\/td>\n9 Validation
9.1 General <\/td>\n<\/tr>\n
33<\/td>\n9.2 Installation qualification (IQ)
9.2.1 Equipment
9.2.2 Installation
9.2.3 Function
9.3 Operational qualification (OQ)
9.4 Performance qualification (PQ) <\/td>\n<\/tr>\n
35<\/td>\n9.5 Review and approval of validation <\/td>\n<\/tr>\n
36<\/td>\n10 Routine monitoring and control <\/td>\n<\/tr>\n
37<\/td>\n11 Product release from sterilization
12 Maintaining process effectiveness
12.1 Demonstration of continued effectiveness
12.2 Recalibration <\/td>\n<\/tr>\n
38<\/td>\n12.3 Maintenance of equipment
12.4 Requalification
12.5 Assessment of change <\/td>\n<\/tr>\n
39<\/td>\nAnnex A Guidance
A.1 Scope
A.1.1 Inclusions
A.1.2 Exclusions
A.2 Normative references <\/td>\n<\/tr>\n
40<\/td>\nA.3 Terms and definitions
A.4 Quality management system elements
A.4.1 Documentation
A.4.2 Management responsibility
A.4.3 Product realization
A.4.4 Measurement, analysis and improvement \u2014 Control of nonconforming product <\/td>\n<\/tr>\n
41<\/td>\nA.5 Sterilizing agent characterization
A.6 Process and equipment characterization
A.7 Product definition
A.8 Process definition <\/td>\n<\/tr>\n
42<\/td>\nA.9 Validation
A.10 Routine monitoring and control
A.11 Product release from sterilization
A.12 Maintaining process effectiveness <\/td>\n<\/tr>\n
44<\/td>\nAnnex B Process definition based on inactivation of the microbial population in its natural state (bioburden-based method)
B.1 General
B.2 Sampling
B.3 Procedure
B.4 Follow up <\/td>\n<\/tr>\n
45<\/td>\nAnnex C Process definition based on the inactivation of a reference microorganism and a knowledge of bioburden on product items to be sterilized (combined bioburden\/biological indicator based method)
C.1 General
C.2 Procedure <\/td>\n<\/tr>\n
46<\/td>\nAnnex D Conservative process definition based on inactivation of reference microorganisms (overkill method)
D.1 General
D.2 Procedure
D.3 Partial cycle approach <\/td>\n<\/tr>\n
47<\/td>\nD.4 Full cycle approach <\/td>\n<\/tr>\n
48<\/td>\nAnnex E Operating cycles <\/td>\n<\/tr>\n
49<\/td>\nE.3 Air pressurization operating cycles
E.3.1 General
E.3.2 Air steam mixtures
E.3.3 Water spray <\/td>\n<\/tr>\n
50<\/td>\nE.3.4 Water immersion <\/td>\n<\/tr>\n
55<\/td>\nBibliography <\/td>\n<\/tr>\n<\/table>\n","protected":false},"excerpt":{"rendered":"

ANSI\/AAMI\/ISO 17665-1:2006\/(R)2013 – Sterilization of health care products-Moist Heat-Guidance on the designation of a medical product to a product family and processing category for steam 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>\n2006<\/td>\n57<\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n","protected":false},"featured_media":198212,"template":"","meta":{"rank_math_lock_modified_date":false,"ep_exclude_from_search":false},"product_cat":[2654],"product_tag":[],"class_list":{"0":"post-198207","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\/198207","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\/198212"}],"wp:attachment":[{"href":"https:\/\/pdfstandards.shop\/wp-json\/wp\/v2\/media?parent=198207"}],"wp:term":[{"taxonomy":"product_cat","embeddable":true,"href":"https:\/\/pdfstandards.shop\/wp-json\/wp\/v2\/product_cat?post=198207"},{"taxonomy":"product_tag","embeddable":true,"href":"https:\/\/pdfstandards.shop\/wp-json\/wp\/v2\/product_tag?post=198207"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}