{"id":198418,"date":"2024-10-19T12:37:51","date_gmt":"2024-10-19T12:37:51","guid":{"rendered":"https:\/\/pdfstandards.shop\/product\/uncategorized\/aami-14161-2009-ra-2014\/"},"modified":"2024-10-25T05:10:54","modified_gmt":"2024-10-25T05:10:54","slug":"aami-14161-2009-ra-2014","status":"publish","type":"product","link":"https:\/\/pdfstandards.shop\/product\/publishers\/aami\/aami-14161-2009-ra-2014\/","title":{"rendered":"AAMI 14161 2009 RA 2014"},"content":{"rendered":"

Provides guidance for the selection, use, and interpretation of results from the application of biological indicators in the development, validation, and routine monitoring of sterilization processes.<\/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\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 14161:2009\/(R)2014, Sterilization of health care products \u2014 Biological indicators \u2014Guidance for the selection, use and interpretation of results <\/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
12<\/td>\nBackground of ANSI\/AAMI adoption of ISO 14161:2009 <\/td>\n<\/tr>\n
13<\/td>\nForeword <\/td>\n<\/tr>\n
14<\/td>\nIntroduction <\/td>\n<\/tr>\n
15<\/td>\n1 Scope
2 Normative references <\/td>\n<\/tr>\n
16<\/td>\n3 Terms and definitions <\/td>\n<\/tr>\n
20<\/td>\n4 General <\/td>\n<\/tr>\n
21<\/td>\n5 Characteristics of biological indicators
5.1 General <\/td>\n<\/tr>\n
22<\/td>\n5.2 Test organism suspension for direct inoculation of products <\/td>\n<\/tr>\n
23<\/td>\n5.3 Inoculated carriers
5.4 Self-contained biological indicators <\/td>\n<\/tr>\n
24<\/td>\n5.5 Other biological indicators
6 Selection of supplier
6.1 General <\/td>\n<\/tr>\n
25<\/td>\n6.2 Documentation
6.2.1 General
6.2.2 Manufacturer audit <\/td>\n<\/tr>\n
26<\/td>\n7 Biological indicators in process development
7.1 General <\/td>\n<\/tr>\n
27<\/td>\n7.2 Overkill approach <\/td>\n<\/tr>\n
28<\/td>\n7.3 Combined biological indicator and bioburden method <\/td>\n<\/tr>\n
29<\/td>\n7.4 Bioburden method
8 Biological indicators in sterilization validation
8.1 General
8.2 Placement and handling of biological indicators <\/td>\n<\/tr>\n
30<\/td>\n8.3 Sterilizer qualification
8.4 Performance qualification
8.5 Review and approval of validation
8.6 Requalification <\/td>\n<\/tr>\n
31<\/td>\n9 Biological indicators in routine monitoring
9.1 General
9.2 Placement and handling of biological indicators <\/td>\n<\/tr>\n
32<\/td>\n9.3 Process challenge device (PCD)
10 Results
10.1 General
10.2 Interpretation of results <\/td>\n<\/tr>\n
33<\/td>\n11 Application of biological indicator standards
11.1 General assessment of biological indicator performance by the user
11.2 Nominal population of test organism <\/td>\n<\/tr>\n
34<\/td>\n11.3 Resistance determination
11.3.1 General <\/td>\n<\/tr>\n
35<\/td>\n11.3.2 Survivor curve method
11.3.3 Fraction-negative method <\/td>\n<\/tr>\n
36<\/td>\n11.3.4 Survival-kill response characteristics
11.4 z value determination
11.4.1 General <\/td>\n<\/tr>\n
37<\/td>\n11.4.2 Graphically plotting the z value
11.4.3 Mathematically calculating the z value <\/td>\n<\/tr>\n
38<\/td>\n11.4.4 Correlation coefficient, r, for the z value <\/td>\n<\/tr>\n
39<\/td>\n11.5 F(T,\u00a0z) equivalent sterilization value determination
11.6 Establishing spore-log-reduction (SLR) <\/td>\n<\/tr>\n
40<\/td>\n11.7 Sterility assurance level (SAL) calculation
11.8 Test equipment
12 Culture conditions
12.1 General <\/td>\n<\/tr>\n
41<\/td>\n12.2 Incubation temperature
12.3 Incubation period
12.4 Choice of growth medium <\/td>\n<\/tr>\n
42<\/td>\n13 Third-party requirements
13.1 General <\/td>\n<\/tr>\n
43<\/td>\n13.2 Minimum requirements for replicates and total number of biological indicators
13.3 Test equipment <\/td>\n<\/tr>\n
44<\/td>\n14 Personnel training
15 Storage and handling
16 Disposal of biological indicators <\/td>\n<\/tr>\n
46<\/td>\nAnnex A Microbiological inactivation kinetics and enumeration techniques <\/td>\n<\/tr>\n
52<\/td>\nAnnex B Process challenge devices
B.1 General
B.2 Helices
B.3 Standard test packs
B.4 User’s process challenge devices <\/td>\n<\/tr>\n
53<\/td>\nB.5 Biological test packs <\/td>\n<\/tr>\n
54<\/td>\nAnnex C Formulae for fraction negative methods for D value calculations (adapted from ISO 11138-1:2006, Annex D)
C.1 General
C.2 Materials <\/td>\n<\/tr>\n
55<\/td>\nC.3 Methods
C.3.1 Holcomb-Spearman-Karber Procedure (HSKP)
C.3.1.1 Introduction
C.3.1.2 Calculations using the HSKP <\/td>\n<\/tr>\n
58<\/td>\nC.3.1.3 Example calculation of the Holcomb-Spearman-Karber Procedure (HSKP) <\/td>\n<\/tr>\n
61<\/td>\nC.3.2 Limited Holcomb-Spearman-Karber Procedure (LHSKP)
C.3.2.1 Calculations using the LHSKP <\/td>\n<\/tr>\n
63<\/td>\nC.3.2.2 Example calculations of the Limited Holcomb-Spearman-Karber Procedure (LHSKP) <\/td>\n<\/tr>\n
65<\/td>\nC.3.3 Stumbo-Murphy-Cochran Procedure (SMCP)
C.3.3.1 Introduction
C.3.3.2 Calculations using the SMCP <\/td>\n<\/tr>\n
66<\/td>\nC.3.3.3 Example calculations of the Stumbo-Murphy-Cochran Procedure (SMCP) <\/td>\n<\/tr>\n
70<\/td>\nAnnex D Examples of documentation for biological indicators prepared by the user
D.1 General
D.1.1 Sources of microorganisms
D.1.2 Documentation <\/td>\n<\/tr>\n
71<\/td>\nD.2 Commercially available suspension
D.3 Suspension from a commercially available strain <\/td>\n<\/tr>\n
72<\/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
73<\/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
75<\/td>\nAnnex E Calculation of z value (adapted from ISO 11138-3:2006, Annex B) <\/td>\n<\/tr>\n
78<\/td>\nAnnex F D value determination by survivor curve method (adapted from ISO 11138-1:2006, Annex C)
F.1 General
F.2 Materials
F.3 Procedure <\/td>\n<\/tr>\n
82<\/td>\nAnnex G Survival-kill response characteristics (adapted from ISO 11138-1:2006, Annex E)
G.1 General
G.2 Materials
G.3 Method <\/td>\n<\/tr>\n
83<\/td>\nBibliography <\/td>\n<\/tr>\n<\/table>\n","protected":false},"excerpt":{"rendered":"

ANSI\/AAMI\/ISO 14161-2009\/(R)2014 – Sterilization of health care products – Biological indicators – 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>\n2009<\/td>\n84<\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n","protected":false},"featured_media":198421,"template":"","meta":{"rank_math_lock_modified_date":false,"ep_exclude_from_search":false},"product_cat":[2654],"product_tag":[],"class_list":{"0":"post-198418","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\/198418","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\/198421"}],"wp:attachment":[{"href":"https:\/\/pdfstandards.shop\/wp-json\/wp\/v2\/media?parent=198418"}],"wp:term":[{"taxonomy":"product_cat","embeddable":true,"href":"https:\/\/pdfstandards.shop\/wp-json\/wp\/v2\/product_cat?post=198418"},{"taxonomy":"product_tag","embeddable":true,"href":"https:\/\/pdfstandards.shop\/wp-json\/wp\/v2\/product_tag?post=198418"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}