AAMI 11737 1 2018
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ANSI/AAMI/ISO 11737-1:2018 – Sterilization of health care products-Microbiological methods-Part 1: Determination of a population of microorganisms on products
| Published By | Publication Date | Number of Pages |
| AAMI | 2018 | 62 |
Specifies general criteria to be applied in the estimation of the population of viable microorganisms on a medical device or component, raw material or device packaging.
PDF Catalog
| PDF Pages | PDF Title |
|---|---|
| 1 | ANSI/AAMI/ISO 11737-1:2018; Sterilization of health care products—Microbiological methods—Part 1: Determination of a population of microorganisms on products |
| 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 on the adoption of ISO 11737-1:2018 |
| 11 | Foreword |
| 13 | Introduction |
| 15 | 1 Scope 2 Normative references 3 Terms and definitions |
| 19 | 4 General requirements 4.1 Documentation 4.2 Management responsibility 4.3 Product realization 4.4 Measurement, analysis and improvement |
| 20 | 5 Selection of products 5.1 General 5.2 Sample item portion (SIP) 6 Methods of determination and microbial characterization of bioburden 6.1 Determination of bioburden 6.1.1 Selection of an appropriate method |
| 21 | 6.1.2 Neutralization of inhibitory substances 6.1.3 Removal of microorganisms 6.1.4 Culturing of microorganisms 6.1.5 Enumeration of microorganisms 6.2 Microbial characterization of bioburden |
| 22 | 7 Validation of the method for determining bioburden 7.1 General 7.2 Validation 8 Routine determination of bioburden and interpretation of data 8.1 General 8.2 Limits of detection and plate counting |
| 23 | 8.3 Microbial characterization 8.4 Bioburden data for extent of treatment 8.5 Bioburden spikes 8.6 Bioburden levels 8.7 Data analysis 8.8 Statistical methods 9 Maintenance of the method for determining bioburden 9.1 Changes to the product and/or manufacturing process 9.2 Changes to the method for determining bioburden 9.3 Requalification of the method for determining bioburden |
| 24 | Annex A (informative) Guidance on the determination of a population of microorganisms on products A.1 Related to the Scope A.2 Related to the Normative references A.3 Related to the Terms and definitions A.4 Quality management system elements A.4.1 Documentation |
| 25 | A.4.2 Management responsibility A.4.3 Product realization |
| 26 | A.4.4 Measurement, analysis and improvement |
| 27 | A.5 Selection of products A.5.1 General |
| 28 | A.5.2 Sample item portion (SIP) |
| 29 | Table A.1—Examples of SIP calculation A.6 Methods of determination and microbial characterization of bioburden A.6.1 Determination of bioburden A.6.1.1 Selection of an appropriate method |
| 30 | Figure A.1—Decision tree for selection of a method of bioburden determination |
| 31 | A.6.1.2 Neutralization of inhibitory substances A.6.1.3 Removal of microorganisms A.6.1.4 Culturing of microorganisms |
| 32 | Table A.2—Examples of culture media and incubation conditionsa A.6.1.5 Enumeration of microorganisms |
| 33 | A.6.2 Microbial characterization of bioburden Table A.3—Attributes of common bioburden characterization methods |
| 34 | A.7 Validation of the method for determining bioburden A.7.1 General A.7.2 Validation A.7.2.1 Bioburden method suitability A.7.2.2 Bioburden recovery efficiency |
| 35 | A.7.2.3 Enumeration and culture conditions A.8 Routine determination of bioburden and interpretation of data A.8.1 General |
| 36 | A.8.2 Limits of detection and plate counting A.8.2.1 Limits of detection A.8.2.2 Plate counting |
| 37 | A.8.3 Microbial characterization A.8.4 Bioburden data for extent of treatment A.8.5 Bioburden spikes |
| 38 | Table A.4—Example of bioburden data containing bioburden spikes A.8.6 Bioburden levels |
| 39 | A.8.7 Data analysis A.8.8 Statistical methods A.9 Maintenance of the method for determining bioburden A.9.1 Changes to the product and/or manufacturing process A.9.2 Changes to the method for determining bioburden A.9.3 Requalification of the method for determining bioburden |
| 40 | Annex B (informative) Guidance on methods to determine bioburden B.1 General Figure B.1—Sequence of key steps of the process for determining bioburden B.2 Methods where removal of microorganisms by elution is used B.2.1 General |
| 41 | B.2.2 Removal techniques B.2.2.1 Processing in a stomacher B.2.2.2 Ultrasonication |
| 42 | B.2.2.3 Shaking (mechanical or manual) B.2.2.4 Vortex mixing B.2.2.5 Flushing |
| 43 | B.2.2.6 Blending (disintegration) B.2.2.7 Swabbing B.2.3 Eluents, diluents and transport media |
| 44 | Table B.1—Examples of eluents and diluents B.3 Methods where removal of microorganisms by elution is not used B.3.1 Contact plating B.3.2 Agar overlaying |
| 45 | B.3.3 Most probable number (MPN) approach B.4 Transfer to culture medium B.4.1 General B.4.2 Membrane filtration |
| 46 | B.4.3 Pour plating B.4.4 Spread plating |
| 47 | B.4.5 Spiral plating B.5 Incubation (culture media and incubation conditions) B.6 Enumeration (counting colonies) |
| 48 | B.7 Other techniques for detecting microorganisms B.8 Screening for the release of substances affecting bioburden determinations |
| 49 | B.9 Screening for the adverse effects of physical stress |
| 50 | Annex C (informative) Validation of bioburden recovery efficiency C.1 General C.1.1 Before validation C.1.2 Grouping of products for purposes of bioburden recovery efficiency C.1.3 Sample size C.1.4 Guidance on selection of bioburden recovery efficiency approach |
| 51 | Table C.1—General considerations for selecting a bioburden recovery efficiency approach |
| 52 | C.2 Validation using repetitive recovery C.2.1 General C.2.2 Examples to illustrate calculation of a bioburden correction factor |
| 53 | Table C.2—Example of repetitive recovery data Table C.3—Example of repetitive recovery data |
| 54 | C.3 Product inoculation method C.3.1 Validation using inoculated products C.3.2 Example to illustrate calculation of a bioburden correction factor using product inoculation |
| 55 | Table C.4—Sample data for validation by inoculated recovery C.3.3 Example to illustrate comparisons of two bioburden recovery efficiency methods Table C.5—Comparison of bioburden recovery efficiency percentage for two recovery methods |
| 56 | C.4 Bioburden recovery efficiency for complex product testing Table C.6—Complex product bioburden estimate determined by utilizing two bioburden correction factors and MPN result C.5 Data analysis and application of bioburden correction factor |
| 58 | Annex D (informative) Typical assignment of responsibilities Table D.1—Typical assignment of responsibilities |
| 60 | Bibliography |
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