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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

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PDF Pages	PDF Title
1	ANSI/AAMI/ISO 11138-1:2017; Sterilization of health care products—Biological indicators—Part 1: General requirements
2	Objectives and uses of AAMI standards and recommended practices
3	Title page
4	AAMI Standard Copyright information
5	Contents
6	Glossary of equivalent standards
7	Committee representation
9	Background of AAMI adoption of ISO 11138-1:2017
10	Foreword
11	Introduction
13	1 Scope 2 Normative references 3 Terms and definitions
16	4 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
17	4.2 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)
18	Table 1—Information to be provided by the manufacturer 4.4 Storage and transport
19	5 Specific manufacturing requirements 5.1 Suspensions 5.2 Carrier, primary and secondary packaging 5.3 Inoculated carrier
20	5.4 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
21	6.5 Test conditions Table 2—Minimum test samples according to method
22	7 Culture conditions 7.1 Incubator 7.2 Growth medium 7.3 Incubation 7.4 Software validation 7.5 Incubation time using detection system
23	Annex 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
25	Annex 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
26	B.4 Interpretation of results B.5 Determination of growth inhibition by primary packaging materials
27	Annex C (normative) D value determination by survivor curve method C.1 Principle C.2 Materials C.3 Procedure
28	Table C.1—Examples of regression analysis
29	Table C.2—Examples of calculations for slope
31	Annex 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)
32	D.3.1.1 Procedure D.3.1.2 Calculations using the HSKP
33	Table D.1—Examples of data collected for HSKP
35	D.3.1.3 Example calculation of the Holcomb-Spearman-Karber procedure (HSKP) Table D.2—Examples of data with non-constant time intervals and non-constant number of samples
39	D.3.2 Limited Holcomb-Spearman-Karber procedure (LHSKP) D.3.2.1 Calculations using LHSKP Table D.3—Examples of data collected for LHSKP with constant time intervals and constant number of samples
41	D.3.2.2 Example calculations of the Limited Holcomb-Spearman-Karber procedure (LHSKP) Table D.4—Examples of data with constant time intervals and constant number of samples
42	D.3.3 The Stumbo-Murphy-Cochran-Procedure (SMCP) D.3.3.1 Procedure
43	D.3.3.2 Calculations using the Stumbo-Murphy-Cochran-Procedure
44	D.3.3.3 Example calculations of SMCP Table D.5—Calculations of D value using only one data set in the fraction negative range
48	Annex E (normative) Survival-kill response characteristics E.1 Principle E.2 Materials E.3 Procedure
50	Annex F (informative) Relationship between components of biological indicators Table F.1—Relationship between components of biological indicators
52	Bibliography

Published By	Publication Date	Number of Pages
AAMI	2017	53


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Standard Title	ANSI/AAMI/ISO 11138-1:2017 – Sterilization of health care products-Biological indicators-Part 1: General requirements
Published Code	AAMI
Publication Date	2017
Pages Count	53

AAMI 11138 1 2017

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