AAMI 11138 1 2017 R2024
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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 |
PDF Catalog
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 |