AAMI TIR13004 2013 RA 2016
$140.32
AAMI/ISO TIR13004:2013/(R)2016 – Sterilization of health care products-Radiation-Substantiation of a selected sterilization dose: Method VDmaxSD
| Published By | Publication Date | Number of Pages |
| AAMI | 2013 | 85 |
This Technical Specification describes a method for substantiating a selected sterilization dose of 17.5, 20, 22.5, 27.5, 30, 32.5 or 35 kGy that achieves a sterility assurance level (SAL) of 10?6 or less for radiation sterilization of health care products. This Technical Specification also specifies a method of sterilization dose audit used to demonstrate the continued effectiveness of the substantiated sterilization dose.
PDF Catalog
| PDF Pages | PDF Title |
|---|---|
| 3 | Title page |
| 4 | Copyright information |
| 5 | AAMI Technical Information Report ANSI Technical Report |
| 6 | Contents |
| 9 | Glossary of equivalent standards |
| 10 | Committee representation |
| 13 | Background of ANSI/AAMI adoption of ISO/TS 13004:2013 |
| 14 | Foreword |
| 15 | Introduction |
| 17 | 1 Scope 1.1 Inclusions 1.2 Exclusions 1.3 Application 2 Normative references |
| 18 | 3 Terms and definitions |
| 22 | 4 Definition and maintenance of product families for sterilization dose substantiation and sterilization dose auditing 4.1 General 4.2 Defining product families |
| 23 | 4.3 Designation of product to represent a product family 4.3.1 Product to represent a product family |
| 24 | 4.3.2 Master product 4.3.3 Equivalent product 4.3.4 Simulated product |
| 25 | 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 Consequence of failure of sterilization dose substantiation or sterilization dose audit |
| 26 | 5 Selection and testing of product for substantiating and auditing a selected sterilization dose 5.1 Nature of product |
| 27 | 5.2 Sample item portion (SIP) |
| 28 | 5.3 Manner of sampling 5.4 Microbiological testing |
| 29 | 5.5 Irradiation 6 Method VDmaxSD — Substantiation of a selected sterilization dose of 17.5, 20, 22.5, 27.5, 30, 32.5, or 35 kGy 6.1 Rationale |
| 30 | 6.2 Procedure for Method VDmaxSD for multiple production batches 6.2.1 General 6.2.2 Stage 1: Obtain samples of product 6.2.3 Stage 2: Determine average bioburden |
| 31 | 6.2.4 Stage 3: Obtain the selected sterilization dose |
| 32 | 6.2.5 Stage 4: Obtain VDmaxSD |
| 33 | 6.2.6 Stage 5: Perform verification dose experiment |
| 34 | 6.2.7 Stage 6: Interpretation of results 6.2.8 Confirmatory verification dose experiment 6.2.8.1 General 6.2.8.2 Stage 1: Obtain samples of product |
| 35 | 6.2.8.3 Stage 2: Perform confirmatory verification dose experiment 6.2.8.4 Stage 3: Interpretation of results |
| 36 | 6.3 Procedure for Method VDmaxSD for a single production batch 6.3.1 Rationale 6.3.2 General 6.3.3 Stage 1: Obtain samples of product 6.3.4 Stage 2: Determine average bioburden |
| 37 | 6.3.5 Stage 3: Obtain the selected sterilization dose 6.3.6 Stage 4: Obtain VDmaxSD |
| 38 | 6.3.7 Stage 5: Perform verification dose experiment 6.3.8 Stage 6: Interpretation of results |
| 39 | 6.3.9 Confirmatory verification dose experiment 6.3.9.1 General 6.3.9.2 Stage 1: Obtain samples of product 6.3.9.3 Stage 2: Perform confirmatory verification dose experiment |
| 40 | 6.3.9.4 Stage 3: Interpretation of results 7 Maintaining process effectiveness 7.1 General |
| 41 | 7.2 Determination of bioburden 7.2.1 Background to frequency of determination 7.2.2 Frequency of determination specific to Method VDmaxSD 7.3 Sterilization dose audit 7.3.1 Frequency 7.3.2 Outcome |
| 42 | 7.3.3 Procedure for auditing a sterilization dose substantiated using Method VDmaxSD 7.3.3.1 General 7.3.3.2 Stage 1: Obtain samples of product 7.3.3.3 Stage 2: Determine average bioburden 7.3.3.4 Stage 3: Perform verification dose experiment |
| 43 | 7.3.3.5 Stage 4: Interpretation of results |
| 44 | 7.3.3.6 Confirmatory sterilization dose audit 7.3.3.6.1 General 7.3.3.6.2 Stage 1: Obtain samples of product 7.3.3.6.3 Stage 2: Perform confirmatory verification dose experiment |
| 45 | 7.3.3.6.4 Stage 3: Interpretation of results |
| 46 | 7.3.3.7 Augmentation of a sterilization dose substantiated using Method VDmaxSD 7.3.4 Failure of a sterilization dose audit 8 Tables of values for SIP equal to 1.0 VDmaxSD, SIP dose reduction factor and augmentation dose corresponding to applicable values of average bioburden for selected sterilization doses of 17.5, 20, 22.5, 27.5, 30, 32.5 and 35 kGy |
| 80 | 9 Worked examples 9.1 Substantiation of a selected sterilization dose of 17.5 kGy (SIP less than 1.0) |
| 82 | 9.2 Substantiation of a selected sterilization dose of 30 kGy (SIP equal to 1.0) |
| 83 | 9.3 Sterilization dose audit for a sterilization dose substantiated using Method VDmax22.5, the findings from which necessitated augmentation of the sterilization dose |
| 85 | Bibliography |
