{"id":457349,"date":"2024-10-20T09:50:43","date_gmt":"2024-10-20T09:50:43","guid":{"rendered":"https:\/\/pdfstandards.shop\/product\/uncategorized\/aami-11138-1-2017-r2024\/"},"modified":"2024-10-26T18:17:44","modified_gmt":"2024-10-26T18:17:44","slug":"aami-11138-1-2017-r2024","status":"publish","type":"product","link":"https:\/\/pdfstandards.shop\/product\/publishers\/aami\/aami-11138-1-2017-r2024\/","title":{"rendered":"AAMI 11138 1 2017 R2024"},"content":{"rendered":"

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PDF Pages<\/th>\nPDF Title<\/th>\n<\/tr>\n
1<\/td>\nANSI\/AAMI\/ISO 11138-1:2017\/(R)2024; Sterilization of health care products\u2014Biological indicators\u2014Part 1: General requirements <\/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
6<\/td>\nGlossary of equivalent standards <\/td>\n<\/tr>\n
7<\/td>\nCommittee representation <\/td>\n<\/tr>\n
9<\/td>\nBackground of AAMI adoption of ISO 11138-1:2017 <\/td>\n<\/tr>\n
10<\/td>\nForeword <\/td>\n<\/tr>\n
11<\/td>\nIntroduction <\/td>\n<\/tr>\n
13<\/td>\n1 Scope
2 Normative references
3 Terms and definitions <\/td>\n<\/tr>\n
16<\/td>\n4 General manufacturing requirements
4.1 Manufacturing controls
4.1.1 Quality management systems
4.1.2 Traceability
4.1.3 Finished product requirements
4.1.4 Personnel <\/td>\n<\/tr>\n
17<\/td>\n4.2 Test organism
4.2.1 Strain
4.2.2 Originating inoculum for suspension
4.2.3 Test organism count
4.3 Information to be provided by the manufacturer (labelling) <\/td>\n<\/tr>\n
18<\/td>\nTable 1\u2014Information to be provided by the manufacturer
4.4 Storage and transport <\/td>\n<\/tr>\n
19<\/td>\n5 Specific manufacturing requirements
5.1 Suspensions
5.2 Carrier, primary and secondary packaging
5.3 Inoculated carrier <\/td>\n<\/tr>\n
20<\/td>\n5.4 Biological indicators
5.5 Self-contained biological indicators
6 Determination of population and resistance
6.1 General resistance requirements
6.2 Test organism
6.3 Population of test organisms
6.4 Resistance characteristics <\/td>\n<\/tr>\n
21<\/td>\n6.5 Test conditions
Table 2\u2014Minimum test samples according to method <\/td>\n<\/tr>\n
22<\/td>\n7 Culture conditions
7.1 Incubator
7.2 Growth medium
7.3 Incubation
7.4 Software validation
7.5 Incubation time using detection system <\/td>\n<\/tr>\n
23<\/td>\nAnnex A (normative) Determination of viable count
A.1 General
A.2 Minimum number of test samples
A.3 Sample preparation and culture methods
A.4 Incubation and enumeration <\/td>\n<\/tr>\n
25<\/td>\nAnnex B (normative) Determination of growth inhibition by carriers and primary packaging materials exposed to sterilization processes
B.1 Principle
B.2 Materials
B.3 Procedure <\/td>\n<\/tr>\n
26<\/td>\nB.4 Interpretation of results
B.5 Determination of growth inhibition by primary packaging materials <\/td>\n<\/tr>\n
27<\/td>\nAnnex C (normative) D value determination by survivor curve method
C.1 Principle
C.2 Materials
C.3 Procedure <\/td>\n<\/tr>\n
28<\/td>\nTable C.1\u2014Examples of regression analysis <\/td>\n<\/tr>\n
29<\/td>\nTable C.2\u2014Examples of calculations for slope <\/td>\n<\/tr>\n
31<\/td>\nAnnex D (normative) D value determination by fraction negative method
D.1 Principle
D.2 Materials
D.3 Procedure
D.3.1 Holcomb-Spearman-Karber procedure (HSKP) <\/td>\n<\/tr>\n
32<\/td>\nD.3.1.1 Procedure
D.3.1.2 Calculations using the HSKP <\/td>\n<\/tr>\n
33<\/td>\nTable D.1\u2014Examples of data collected for HSKP <\/td>\n<\/tr>\n
35<\/td>\nD.3.1.3 Example calculation of the Holcomb-Spearman-Karber procedure (HSKP)
Table D.2\u2014Examples of data with non-constant time intervals and non-constant number of samples <\/td>\n<\/tr>\n
39<\/td>\nD.3.2 Limited Holcomb-Spearman-Karber procedure (LHSKP)
D.3.2.1 Calculations using LHSKP
Table D.3\u2014Examples of data collected for LHSKP with constant time intervals and constant number of samples <\/td>\n<\/tr>\n
41<\/td>\nD.3.2.2 Example calculations of the Limited Holcomb-Spearman-Karber procedure (LHSKP)
Table D.4\u2014Examples of data with constant time intervals and constant number of samples <\/td>\n<\/tr>\n
42<\/td>\nD.3.3 The Stumbo-Murphy-Cochran-Procedure (SMCP)
D.3.3.1 Procedure <\/td>\n<\/tr>\n
43<\/td>\nD.3.3.2 Calculations using the Stumbo-Murphy-Cochran-Procedure <\/td>\n<\/tr>\n
44<\/td>\nD.3.3.3 Example calculations of SMCP
Table D.5\u2014Calculations of D value using only one data set in the fraction negative range <\/td>\n<\/tr>\n
48<\/td>\nAnnex E (normative) Survival-kill response characteristics
E.1 Principle
E.2 Materials
E.3 Procedure <\/td>\n<\/tr>\n
50<\/td>\nAnnex F (informative) Relationship between components of biological indicators
Table F.1\u2014Relationship between components of biological indicators <\/td>\n<\/tr>\n
52<\/td>\nBibliography <\/td>\n<\/tr>\n<\/table>\n","protected":false},"excerpt":{"rendered":"

ANSI\/AAMI\/ISO 11138-1:2017\/(R)2024 – Sterilization of health care products\u2014Biological indicators\u2014Part 1: General requirements<\/b><\/p>\n\n\n\n\n
Published By<\/td>\nPublication Date<\/td>\nNumber of Pages<\/td>\n<\/tr>\n
AAMI<\/b><\/a><\/td>\n2017<\/td>\n53<\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n","protected":false},"featured_media":457356,"template":"","meta":{"rank_math_lock_modified_date":false,"ep_exclude_from_search":false},"product_cat":[2654],"product_tag":[],"class_list":{"0":"post-457349","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\/457349","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\/457356"}],"wp:attachment":[{"href":"https:\/\/pdfstandards.shop\/wp-json\/wp\/v2\/media?parent=457349"}],"wp:term":[{"taxonomy":"product_cat","embeddable":true,"href":"https:\/\/pdfstandards.shop\/wp-json\/wp\/v2\/product_cat?post=457349"},{"taxonomy":"product_tag","embeddable":true,"href":"https:\/\/pdfstandards.shop\/wp-json\/wp\/v2\/product_tag?post=457349"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}