{"id":198308,"date":"2024-10-19T12:37:28","date_gmt":"2024-10-19T12:37:28","guid":{"rendered":"https:\/\/pdfstandards.shop\/product\/uncategorized\/aami-14160-2011-ra-2016\/"},"modified":"2024-10-25T05:10:33","modified_gmt":"2024-10-25T05:10:33","slug":"aami-14160-2011-ra-2016","status":"publish","type":"product","link":"https:\/\/pdfstandards.shop\/product\/publishers\/aami\/aami-14160-2011-ra-2016\/","title":{"rendered":"AAMI 14160 2011 RA 2016"},"content":{"rendered":"

Specifies requirements for the development, validation, process control and monitoring of the sterilization, by the use of liquid chemical sterilants, of single-use medical devices comprising, in whole or in part, materials of animal origin.<\/p>\n

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PDF Pages<\/th>\nPDF Title<\/th>\n<\/tr>\n
1<\/td>\nANSI\/AAMI\/ISO 14160:2011\/(R)2016, Sterilization of health care products \u2014 Liquid chemical sterilizing agents for single-use medical devices utilizing animal tissues and their derivatives \u2014 Requirements for characterization, 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
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4<\/td>\nAAMI Standard
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Copyright information
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5<\/td>\nContents
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7<\/td>\nGlossary of equivalent standards
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9<\/td>\nCommittee representation
\n <\/td>\n<\/tr>\n
11<\/td>\nBackground of ANSI\/AAMI adoption of ISO 14160:2011
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12<\/td>\nForeword
\n <\/td>\n<\/tr>\n
13<\/td>\nIntroduction
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15<\/td>\n1 Scope <\/td>\n<\/tr>\n
16<\/td>\n2 Normative references
3 Terms and definitions <\/td>\n<\/tr>\n
20<\/td>\n4 Quality management system elements
4.1 Documentation
4.2 Management responsibility
4.3 Product realization <\/td>\n<\/tr>\n
21<\/td>\n4.4 Measurement, analysis and improvement \u2014 Control of non-conforming products
5 Sterilizing agent characterization
5.1 General
5.2 Sterilizing agent
5.3 Microbicidal effectiveness <\/td>\n<\/tr>\n
22<\/td>\n5.4 Effects on materials
5.5 Safety and the environment
6 Process and equipment characterization
6.1 General
6.2 Process characterization <\/td>\n<\/tr>\n
23<\/td>\n6.3 Equipment characterization
7 Product definition <\/td>\n<\/tr>\n
24<\/td>\n8 Process definition
8.1 Purpose
8.2 Determination of the inactivation kinetics <\/td>\n<\/tr>\n
25<\/td>\n8.3 Method for neutralization
8.4 Safety quality and performance
9 Validation
9.1 General <\/td>\n<\/tr>\n
26<\/td>\n9.2 Installation qualification
9.2.1 Equipment
9.2.2 Installation
9.3 Operational qualification <\/td>\n<\/tr>\n
27<\/td>\n9.4 Performance qualification
9.4.1 General
9.4.2 Microbiological performance qualification
9.4.2.1 Combined reference organism\/bioburden approach <\/td>\n<\/tr>\n
28<\/td>\n9.4.2.2 Overkill approach
9.4.3 Physical performance qualification <\/td>\n<\/tr>\n
29<\/td>\n9.4.4 Aseptic processing qualification
9.5 Review and approval of validation <\/td>\n<\/tr>\n
30<\/td>\n10 Routine monitoring and control <\/td>\n<\/tr>\n
31<\/td>\n11 Product release from sterilization <\/td>\n<\/tr>\n
32<\/td>\n12 Maintaining process effectiveness
12.1 General
12.2 Maintenance of equipment
12.3 Requalification
12.4 Assessment of change <\/td>\n<\/tr>\n
33<\/td>\nAnnex A Guidance for the application of this International Standard
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A.1 General considerations
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A.2 Normative references
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A.3 Quality management system elements
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A.3.1 Documentation
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A.3.2 Management responsibility
\n <\/td>\n<\/tr>\n
34<\/td>\nA.4 Sterilizing agent characterization
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A.5 Product definition
\n <\/td>\n<\/tr>\n
37<\/td>\nA.6 Process definition
\n <\/td>\n<\/tr>\n
42<\/td>\nA.7 Validation
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A.8 Routine monitoring and control
\n <\/td>\n<\/tr>\n
43<\/td>\nA.9 Product release from sterilization
\n <\/td>\n<\/tr>\n
44<\/td>\nA.10 Maintaining process effectiveness
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45<\/td>\nAnnex B Determination of lethal rate of the sterilization process
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B.1 Combined reference organism\/bioburden approach
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B.1.1 General
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B.1.2 Procedure
\n <\/td>\n<\/tr>\n
46<\/td>\nB.1.3 Process lethality determination
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B.1.3.1 Direct enumeration (survivor curve)
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B.1.3.2 Fraction negative method using the Holcomb-Spearman-Karber procedure (HSKP)
\n <\/td>\n<\/tr>\n
47<\/td>\nB.1.3.3 Fraction negative method using the Stumbo-Murphy-Cochran procedure (SMCP)
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B.2 Overkill approach
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B.2.1 General
\n <\/td>\n<\/tr>\n
48<\/td>\nB.2.2 Procedure
\n <\/td>\n<\/tr>\n
49<\/td>\nAnnex C Flowchart for microbicidal effectiveness (see 5.3), process definition (see Clause 8), and microbiological performance qualification (see 9.4.2)
\n <\/td>\n<\/tr>\n
50<\/td>\nBibliography
\n <\/td>\n<\/tr>\n<\/table>\n","protected":false},"excerpt":{"rendered":"

ANSI\/AAMI\/ISO 14160:2011\/(R)2016 – Sterilization of health care products-Liquid chemical sterilizing agents for single-use medical devices utilizing animal tissues and their derivatives-Requirements for characterization, development, validation and routine control of a sterilization process for 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>\n2011<\/td>\n50<\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n","protected":false},"featured_media":198314,"template":"","meta":{"rank_math_lock_modified_date":false,"ep_exclude_from_search":false},"product_cat":[2654],"product_tag":[],"class_list":{"0":"post-198308","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\/198308","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\/198314"}],"wp:attachment":[{"href":"https:\/\/pdfstandards.shop\/wp-json\/wp\/v2\/media?parent=198308"}],"wp:term":[{"taxonomy":"product_cat","embeddable":true,"href":"https:\/\/pdfstandards.shop\/wp-json\/wp\/v2\/product_cat?post=198308"},{"taxonomy":"product_tag","embeddable":true,"href":"https:\/\/pdfstandards.shop\/wp-json\/wp\/v2\/product_tag?post=198308"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}