{"id":198294,"date":"2024-10-19T12:37:23","date_gmt":"2024-10-19T12:37:23","guid":{"rendered":"https:\/\/pdfstandards.shop\/product\/uncategorized\/aami-11138-7-2019\/"},"modified":"2024-10-25T05:10:31","modified_gmt":"2024-10-25T05:10:31","slug":"aami-11138-7-2019","status":"publish","type":"product","link":"https:\/\/pdfstandards.shop\/product\/publishers\/aami\/aami-11138-7-2019\/","title":{"rendered":"AAMI 11138 7 2019"},"content":{"rendered":"

Provides guidance for the selection, use and interpretation of results from application of biological indicators when used in the development, validation and routine monitoring of sterilization processes.<\/p>\n

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1<\/td>\nANSI\/AAMI\/ISO 11138-7:2019; Sterilization of health care products\u2014Biological indicators\u2014Part 7: Guidance for the selection, use and interpretation of results <\/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>\nCommittee representation <\/td>\n<\/tr>\n
8<\/td>\nBackground of AAMI adoption of ISO 11138-7:2019 <\/td>\n<\/tr>\n
9<\/td>\nForeword <\/td>\n<\/tr>\n
10<\/td>\nIntroduction <\/td>\n<\/tr>\n
11<\/td>\n1 Scope
2 Normative references
3 Terms and definitions <\/td>\n<\/tr>\n
14<\/td>\n4 General <\/td>\n<\/tr>\n
16<\/td>\n5 Characteristics of biological indicators
5.1 General <\/td>\n<\/tr>\n
17<\/td>\n5.2 Test organism suspension for direct inoculation of products <\/td>\n<\/tr>\n
18<\/td>\n5.3 Inoculated carriers
5.4 Self-contained biological indicators <\/td>\n<\/tr>\n
19<\/td>\n6 Selection of supplier
6.1 General <\/td>\n<\/tr>\n
20<\/td>\n6.2 Documentation
6.2.1 General
6.2.2 Manufacturer audit <\/td>\n<\/tr>\n
21<\/td>\n7 Biological indicators in process development
7.1 General <\/td>\n<\/tr>\n
22<\/td>\n7.2 Overkill approach <\/td>\n<\/tr>\n
23<\/td>\n7.3 Combined biological indicator and bioburden method
7.4 Bioburden method <\/td>\n<\/tr>\n
24<\/td>\n8 Biological indicators in sterilization validation
8.1 General
8.2 Placement and handling of biological indicators
8.3 Sterilizer qualification <\/td>\n<\/tr>\n
25<\/td>\n8.4 Performance qualification
8.5 Review and approval of validation
8.6 Requalification
9 Biological indicators in routine monitoring
9.1 General <\/td>\n<\/tr>\n
26<\/td>\n9.2 Placement and handling of biological indicators
9.3 Process challenge device <\/td>\n<\/tr>\n
27<\/td>\n10 Interpretation and acceptance criteria
10.1 General
10.2 Interpretation of results
11 Application of biological indicator standards
11.1 General assessment of biological indicator performance by the user <\/td>\n<\/tr>\n
28<\/td>\n11.2 Nominal population of test organism <\/td>\n<\/tr>\n
29<\/td>\n11.3 Resistance determination
11.3.1 General
11.3.2 Survivor curve method
11.3.3 Fraction-negative method <\/td>\n<\/tr>\n
30<\/td>\n11.3.4 Survival-kill response characteristics
11.4 z value determination
11.4.1 General
11.4.2 Graphically plotting the z value <\/td>\n<\/tr>\n
31<\/td>\nFigure 1\u2014Graphically plotting the z value
11.4.3 Mathematically calculating the z value <\/td>\n<\/tr>\n
32<\/td>\n11.4.4 Correlation coefficient, r, for the z value
11.5 F(T, z) equivalent sterilization value determination
11.6 Establishing spore-log-reduction <\/td>\n<\/tr>\n
33<\/td>\n11.7 Sterility assurance level calculation
11.8 Test equipment <\/td>\n<\/tr>\n
34<\/td>\n12 Culture conditions
12.1 General
12.2 Incubation temperature
12.3 Incubation period <\/td>\n<\/tr>\n
35<\/td>\n12.4 Choice of growth medium
13 Third-party considerations
13.1 General <\/td>\n<\/tr>\n
36<\/td>\n13.2 Minimum requirements from ISO 11138-1 for replicates and total number of biological indicators
Table 1\u2014Minimum samples according to method
13.3 Test equipment
14 Personnel training <\/td>\n<\/tr>\n
37<\/td>\n15 Storage and handling
16 Disposal of biological indicators <\/td>\n<\/tr>\n
38<\/td>\nAnnex A (informative) Microbiological inactivation kinetics and enumeration techniques
Figure A.1\u2014Examples of relationship between the biological indicator and the product bioburden in a reference microorganism method <\/td>\n<\/tr>\n
39<\/td>\nFigure A.2\u2014Examples of equivalent biological challenges with preparations of different resistance <\/td>\n<\/tr>\n
40<\/td>\nFigure A.3\u2014Example of a z value determination (see 11.4) <\/td>\n<\/tr>\n
41<\/td>\nFigure A.4\u2014Areas for D value determination methods under uniform conditions <\/td>\n<\/tr>\n
42<\/td>\nAnnex B (informative) Process challenge devices
B.1 General
B.2 Helices
B.3 Standard test packs
B.4 User’s process challenge devices
B.5 Biological test packs <\/td>\n<\/tr>\n
43<\/td>\nAnnex C (informative) Formulae for D value determination by fraction-negative method
C.1 Principles
C.2 Materials <\/td>\n<\/tr>\n
44<\/td>\nC.3 Procedure
C.3.1 Holcomb-Spearman-Karber Procedure (HSKP)
C.3.1.1 Procedure
C.3.1.2 Calculations using the HSKP <\/td>\n<\/tr>\n
45<\/td>\nTable C.1\u2014Examples of data collected for HSKP <\/td>\n<\/tr>\n
47<\/td>\nC.3.1.3 Example calculations using the HSKP
Table C.2\u2014Examples of data with non-constant time intervals and non-constant number of samples <\/td>\n<\/tr>\n
51<\/td>\nC.3.2 Limited Holcomb-Spearman-Karber Procedure (LHSKP)
C.3.2.1 Calculations using the LHSKP
Table C.3\u2014Examples of data collected for LHSKP with constant time intervals and constant number of samples <\/td>\n<\/tr>\n
52<\/td>\nC.3.2.2 Example calculations using the LHSKP
Table C.4\u2014Examples of data with constant time intervals and constant number of samples <\/td>\n<\/tr>\n
54<\/td>\nC.3.3 Stumbo-Murphy-Cochran Procedure (SMCP)
C.3.3.1 Procedure <\/td>\n<\/tr>\n
55<\/td>\nC.3.3.2 Calculations using the SMCP
C.3.3.3 Example calculations using the SMCP <\/td>\n<\/tr>\n
56<\/td>\nTable C.5\u2014Calculations of D value using only one data set in the fraction-negative range <\/td>\n<\/tr>\n
59<\/td>\nAnnex D (informative) Examples of documentation for biological indicators prepared by the user
D.1 General
D.1.1 Sources of microorganisms
Figure D.1\u2014Sources of microorganisms
D.1.2 Documentation <\/td>\n<\/tr>\n
60<\/td>\nD.2 Commercially available suspension
D.3 Suspension from a commercially available strain <\/td>\n<\/tr>\n
61<\/td>\nD.4 Suspension from in-house isolates
D.5 Inoculated carriers
D.5.1 General
D.5.2 Documentation of fluid carrier materials <\/td>\n<\/tr>\n
62<\/td>\nD.5.3 Documentation of solid carrier materials
D.5.4 Documentation of inoculated carriers used for D value determinations <\/td>\n<\/tr>\n
64<\/td>\nAnnex E (informative) Calculation of z value <\/td>\n<\/tr>\n
65<\/td>\nTable E.1\u2014Examples of data collected for regression analysis
Table E.2\u2014Examples of calculations for slope <\/td>\n<\/tr>\n
67<\/td>\nAnnex F (informative) D value determination by survivor curve method
F.1 Principle
F.2 Materials
F.3 Procedure <\/td>\n<\/tr>\n
68<\/td>\nTable F.1\u2014Examples of regression analysis <\/td>\n<\/tr>\n
69<\/td>\nTable F.2\u2014Examples of calculations for slope <\/td>\n<\/tr>\n
71<\/td>\nAnnex G (informative) Survival-kill response characteristics
G.1 Principle
G.2 Materials
G.3 Procedure <\/td>\n<\/tr>\n
73<\/td>\nBibliography <\/td>\n<\/tr>\n<\/table>\n","protected":false},"excerpt":{"rendered":"

ANSI\/AAMI\/ISO 11138-7:2019 – Sterilization of health care products-Biological indicators-Part 7: Guidance for the selection, use and interpretation of results<\/b><\/p>\n\n\n\n\n
Published By<\/td>\nPublication Date<\/td>\nNumber of Pages<\/td>\n<\/tr>\n
AAMI<\/b><\/a><\/td>\n2019<\/td>\n74<\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n","protected":false},"featured_media":198299,"template":"","meta":{"rank_math_lock_modified_date":false,"ep_exclude_from_search":false},"product_cat":[2654],"product_tag":[],"class_list":{"0":"post-198294","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\/198294","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\/198299"}],"wp:attachment":[{"href":"https:\/\/pdfstandards.shop\/wp-json\/wp\/v2\/media?parent=198294"}],"wp:term":[{"taxonomy":"product_cat","embeddable":true,"href":"https:\/\/pdfstandards.shop\/wp-json\/wp\/v2\/product_cat?post=198294"},{"taxonomy":"product_tag","embeddable":true,"href":"https:\/\/pdfstandards.shop\/wp-json\/wp\/v2\/product_tag?post=198294"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}