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AAMI 11138 1 2017 R2024

$40.63

ANSI/AAMI/ISO 11138-1:2017/(R)2024 – Sterilization of health care products—Biological indicators—Part 1: General requirements

Published By Publication Date Number of Pages
AAMI 2017 53
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PDF Pages PDF Title
1 ANSI/AAMI/ISO 11138-1:2017/(R)2024; Sterilization of health care products—Biological indicators—Part 1: General requirements
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
AAMI 11138 1 2017 R2024
$40.63