AAMI 11137 2 2013 RA 2019:2017 Edition
$140.32
ANSI/AAMI/ ISO 11137-2: 2013/(R)2019 – Sterilization of health care products-Radiation-Part 2: Establishing the sterilization dose
| Published By | Publication Date | Number of Pages |
| AAMI | 2017 | 92 |
Describes methods that can be used to determine the minimum dose necessary to achieve the specified requirement for sterility, including methods to substantiate 25 kGy as the sterilization dose.
PDF Catalog
| PDF Pages | PDF Title |
|---|---|
| 1 | ANSI/AAMI/ISO 11137-2:2013/(R)2019, Sterilization of health care products — Radiation —Part 2: Establishing the sterilization dose |
| 3 | Title page |
| 4 | AAMI Standard Copyright information |
| 5 | Contents |
| 7 | Glossary of equivalent standards |
| 8 | Committee representation |
| 11 | Background of ANSI/AAMI adoption of ISO 11137-2:2013 |
| 12 | Foreword |
| 13 | Introduction |
| 15 | 1 Scope 2 Normative references 3 Terms, definitions and abbreviated terms 3.1 Terms and definitions |
| 17 | 3.2 Abbreviated terms |
| 18 | 4 Definition and maintenance of product families for dose setting, dose substantiation and sterilization dose auditing 4.1 General |
| 19 | 4.2 Defining product families |
| 20 | 4.3 Designation of product to represent a product family for performance of a verification dose experiment or sterilization dose audit 4.3.1 Product to represent a product family 4.3.2 Master product 4.3.3 Equivalent product |
| 21 | 4.3.4 Simulated product 4.4 Maintaining product families 4.4.1 Periodic review 4.4.2 Modification to product and/or manufacturing process 4.4.3 Records 4.5 Effect of failure of establishment of sterilization dose or of a sterilization dose audit on a product family |
| 22 | 5 Selection and testing of product for establishing the sterilization dose 5.1 Nature of product |
| 23 | 5.2 Sample item portion (SIP) |
| 24 | 5.3 Manner of sampling 5.4 Microbiological testing 5.5 Irradiation |
| 25 | 6 Methods of dose establishment 7 Method 1: dose setting using bioburden information 7.1 Rationale |
| 26 | 7.2 Procedure for Method 1 for product with an average bioburden greater than or equal to 1.0 for multiple production batches 7.2.1 General |
| 27 | 7.2.2 Stage 1: Select SAL and obtain samples of product 7.2.3 Stage 2: Determine average bioburden 7.2.4 Stage 3: Obtain verification dose |
| 28 | 7.2.5 Stage 4: Perform verification dose experiment 7.2.6 Stage 5: Interpretation of results 7.2.7 Stage 6: Establish sterilization dose |
| 32 | 7.3 Procedure for Method 1 for product with an average bioburden greater than or equal to 1.0 for a single production batch 7.3.1 Rationale 7.3.2 General 7.3.3 Stage 1: Select SAL and obtain samples of product |
| 33 | 7.3.4 Stage 2: Determine average bioburden 7.3.5 Stage 3: Obtain verification dose 7.3.6 Stage 4: Perform verification dose experiment |
| 34 | 7.3.7 Stage 5: Interpretation of results 7.3.8 Stage 6: Establish sterilization dose 7.4 Procedure for Method 1 for product with an average bioburden in the range 0.1 to 0.9 for multiple or single production batches |
| 35 | 8 Method 2: Dose setting using fraction positive information from incremental dosing to determine an extrapolation factor 8.1 Rationale |
| 36 | 8.2 Procedure for Method 2A 8.2.1 General 8.2.2 Stage 1: Select SAL and obtain samples of product 8.2.3 Stage 2: Perform incremental dose experiment 8.2.3.1 General |
| 37 | 8.2.3.2 A and FFP 8.2.3.3 D* |
| 38 | 8.2.3.4 CD* batch 8.2.4 Stage 3: Perform verification dose experiment |
| 39 | 8.2.5 Stage 4: Interpretation of results 8.2.6 Stage 5: Establish sterilization dose |
| 40 | 8.3 Procedure for Method 2B 8.3.1 General 8.3.2 Stage 1: Select SAL and obtain samples of product 8.3.3 Stage 2: Perform incremental dose experiment 8.3.3.1 General |
| 41 | 8.3.3.2 A and FFP 8.3.3.3 D* |
| 42 | 8.3.3.4 CD* batch 8.3.4 Stage 3: Perform verification dose experiment |
| 43 | 8.3.5 Stage 4: Interpretation of results 8.3.6 Stage 5: Establish sterilization dose 9 Method VDmax — Substantiation of 25 kGy or 15 kGy as the sterilization dose 9.1 Rationale |
| 44 | 9.2 Procedure for Method VDmax25 for multiple production batches 9.2.1 General |
| 45 | 9.2.2 Stage 1: Obtain samples of product 9.2.3 Stage 2: Determine average bioburden 9.2.4 Stage 3: Obtain VDmax25 |
| 47 | 9.2.5 Stage 4: Perform verification dose experiment 9.2.6 Stage 5: Interpretation of results |
| 48 | 9.2.7 Confirmatory verification dose experiment 9.2.7.1 General 9.2.7.2 Stage 1: Obtain samples of product 9.2.7.3 Stage 2: Perform confirmatory verification dose experiment 9.2.7.4 Stage 3: Interpretation of results |
| 49 | 9.3 Procedure for Method VDmax25 for a single production batch 9.3.1 Rationale 9.3.2 General 9.3.3 Stage 1: Obtain samples of product 9.3.4 Stage 2: Determine average bioburden 9.3.5 Stage 3: Obtain VDmax25 |
| 50 | 9.3.6 Stage 4: Perform verification dose experiment 9.3.7 Stage 5: Interpretation of results |
| 51 | 9.3.8 Confirmatory verification dose experiment 9.3.8.1 General 9.3.8.2 Stage 1: Obtain samples of product 9.3.8.3 Stage 2: Perform confirmatory verification dose experiment 9.3.8.4 Stage 3: Interpretation of results |
| 52 | 9.4 Procedure for Method VDmax15 for multiple production batches 9.4.1 General 9.4.2 Stage 1: Obtain samples of product 9.4.3 Stage 2: Determine average bioburden 9.4.4 Stage 3: Obtain VDmax15 |
| 53 | 9.4.5 Stage 4: Perform verification dose experiment |
| 54 | 9.4.6 Stage 5: Interpretation of results 9.4.7 Confirmatory verification dose experiment 9.4.7.1 General 9.4.7.2 Stage 1: Obtain samples of product 9.4.7.3 Stage 2: Perform confirmatory verification dose experiment |
| 55 | 9.4.7.4 Stage 3: Interpretation of results 9.5 Procedure for Method VDmax15 for a single production batch 9.5.1 Rationale 9.5.2 General 9.5.3 Stage 1: Obtain samples of product 9.5.4 Stage 2: Determine average bioburden |
| 56 | 9.5.5 Stage 3: Obtain VDmax15 9.5.6 Stage 4: Perform verification dose experiment 9.5.7 Stage 5: Interpretation of results |
| 57 | 9.5.8 Confirmatory verification dose experiment 9.5.8.1 General 9.5.8.2 Stage 1: Obtain samples of product 9.5.8.3 Stage 2: Perform confirmatory verification dose experiment 9.5.8.4 Stage 3: Interpretation of results |
| 58 | 10 Sterilization dose audit 10.1 Purpose and frequency 10.2 Procedure for auditing a sterilization dose established using Method 1, Method 2A or Method 2B 10.2.1 General 10.2.2 Stage 1: Obtain samples of product 10.2.3 Stage 2: Determine average bioburden |
| 59 | 10.2.4 Stage 3: Perform verification dose experiment 10.2.5 Stage 4: Interpretation of results |
| 60 | 10.2.6 Augmentation of a sterilization dose established using Method 1, Method 2A or Method 2B 10.2.6.1 General 10.2.6.2 Stage 1: Analyse data from the failed sterilization dose audit |
| 61 | 10.2.6.3 Stage 2: Determine extrapolation factor, E 10.2.6.4 Stage 3: Calculate adjusted dose (the dose to achieve an SAL value of 10–2) 10.2.6.5 Stage 4: Calculate augmented sterilization dose 10.3 Procedure for auditing a sterilization dose substantiated using Method VDmax25 or Method VDmax15 10.3.1 General |
| 62 | 10.3.2 Stage 1: Obtain samples of product 10.3.3 Stage 2: Determine average bioburden 10.3.4 Stage 3: Perform verification dose experiment 10.3.5 Stage 4: Interpretation of results |
| 63 | 10.3.6 Confirmatory sterilization dose audit 10.3.6.1 General 10.3.6.2 Stage 1: Obtain samples of product 10.3.6.3 Stage 2: Perform confirmatory verification dose experiment |
| 64 | 10.3.6.4 Stage 3: Interpretation of results 10.3.7 Augmentation of a sterilization dose substantiated using Method VDmax25 or Method VDmax15 10.3.7.1 Method VDmax25 |
| 65 | 10.3.7.2 Method VDmax15 |
| 66 | 10.4 Failure of a sterilization dose audit 11 Worked examples 11.1 Worked examples for Method 1 |
| 69 | 11.2 Worked examples for Method 2 11.2.1 General |
| 70 | 11.2.2 Worked example for Method 2A (SIP equal to 1.0) 11.2.2.1 Stage 1: Select SAL and obtain samples of product 11.2.2.2 Stage 2: Perform incremental dose experiment |
| 72 | Stage 3: Perform verification dose experiment |
| 73 | 11.2.2.3 Stages 4 and 5: Interpretation of results and establishment of sterilization dose 11.2.3 Worked example for Method 2A (SIP less than 1.0) 11.2.3.1 Stage 1: Select SAL and obtain samples of product |
| 74 | 11.2.3.2 Stage 2: Perform incremental dose experiment |
| 76 | 11.2.3.3 Stage 3: Perform verification dose experiment |
| 77 | 11.2.3.4 Stages 4 and 5: Interpretation of results and establishment of sterilization dose |
| 78 | 11.2.4 Worked example for Method 2B 11.2.4.1 Stage 1: Select SAL and obtain samples of product 11.2.4.2 Stage 2: Perform incremental dose experiment |
| 80 | 11.2.4.3 Stage 3: Perform verification dose experiment |
| 81 | 11.2.4.4 Stages 4 and 5: Interpretation of results and establishment of sterilization dose 11.3 Worked examples for Method VDmax |
| 83 | 11.4 Worked example of a sterilization dose audit for a dose established using Method 1, the findings from which necessitated augmentation of the sterilization dose |
| 84 | 11.5 Worked example of a sterilization dose audit for a dose established using Method 2A, the findings from which necessitated augmentation of the sterilization dose |
| 85 | 11.6 Worked example of a sterilization dose audit for a sterilization dose substantiated using Method VDmax25 |
| 87 | Bibliography |
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