{"id":198290,"date":"2024-10-19T12:37:23","date_gmt":"2024-10-19T12:37:23","guid":{"rendered":"https:\/\/pdfstandards.shop\/product\/uncategorized\/aami-11138-1-2017\/"},"modified":"2024-10-25T05:10:31","modified_gmt":"2024-10-25T05:10:31","slug":"aami-11138-1-2017","status":"publish","type":"product","link":"https:\/\/pdfstandards.shop\/product\/publishers\/aami\/aami-11138-1-2017\/","title":{"rendered":"AAMI 11138 1 2017"},"content":{"rendered":"

Specifies general requirements for production, labelling, test methods and performance characteristics of biological indicators, including inoculated carriers and suspensions, and their components, to be used in the validation and routine monitoring of sterilization processes<\/p>\n

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1<\/td>\nANSI\/AAMI\/ISO 11138-1:2017; Sterilization of health care products\u2014Biological indicators\u2014Part 1: General requirements <\/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
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 – Sterilization of health care products-Biological indicators-Part 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":198298,"template":"","meta":{"rank_math_lock_modified_date":false,"ep_exclude_from_search":false},"product_cat":[2654],"product_tag":[],"class_list":{"0":"post-198290","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\/198290","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\/198298"}],"wp:attachment":[{"href":"https:\/\/pdfstandards.shop\/wp-json\/wp\/v2\/media?parent=198290"}],"wp:term":[{"taxonomy":"product_cat","embeddable":true,"href":"https:\/\/pdfstandards.shop\/wp-json\/wp\/v2\/product_cat?post=198290"},{"taxonomy":"product_tag","embeddable":true,"href":"https:\/\/pdfstandards.shop\/wp-json\/wp\/v2\/product_tag?post=198290"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}