AAMI TIR35R2021 2022
$149.56
AAMI TIR35:2016 (R2021) Sterilization of health care products – Radiation sterilization – Product adoption and alternative sampling plans for verification dose experiments and sterilization dose audits
| Published By | Publication Date | Number of Pages |
| AAMI | 2022 |
Describes approaches to the selection and auditing of a sterilization dose that may reduce the number of product items required while maintaining assurance of attaining the desired sterility assurance level (SAL). This approach addresses sampling plans for verification dose experiments and sterilization dose audits. In addition the approaches to adopting a product into an established product family are defined.
PDF Catalog
| PDF Pages | PDF Title |
|---|---|
| 1 | AAMI TIR35:2016/(R)2021; Sterilization of health care products— Radiation sterilization— Product adoption and alternative sampling plans for verification dose experiments and sterilization dose audits |
| 3 | Title page |
| 4 | AAMI Technical Information Report Copyright information |
| 5 | Contents |
| 6 | Glossary of equivalent standards |
| 7 | Committee representation |
| 10 | Introduction |
| 11 | 1 Scope 2 Normative references 3 Terms and definitions |
| 12 | 4 Sample sizes for the verification dose experiment and dose establishment or dose audit 4.1 General |
| 13 | 4.2 Selection and testing of product 4.3 Procedures for verification dose experiments and sterilization dose audits 4.3.1 General 4.3.2 Method 1: Alternative sampling plan for the verification dose experiment |
| 15 | Table 1—Method 1: Alternative sampling plan for the verification dose experiment |
| 16 | 4.3.3 Method 1 or 2: Sterilization dose audits 4.3.3.1 General 4.3.3.2 Alternative sampling plan 1 for the sterilization dose audit (Method 1 or Method 2) |
| 18 | Table 2—Alternative sampling plan 1 for the sterilization dose audit (Method 1 or 2) |
| 19 | 4.3.3.3 Alternative sampling plan 2 for the sterilization dose audit (Methods 1 or 2) |
| 21 | Table 3—Alternative sampling plan 2 for the sterilization dose audit (Methods 1 or 2) |
| 22 | 4.3.3.4 Alternative Sampling Plan 3 for the sterilization dose audit (Methods 1 or 2) |
| 23 | Table 4—Alternative sampling plan 3 for the sterilization dose audit (Methods 1 or 2) |
| 24 | 4.3.4 Method 1: Alternative sampling scheme for the verification dose experiment and dose establishment or dose audit 4.3.4.1 General 4.3.4.2 Alternative sampling scheme for Method 1: Sampling plan for the verification dose experiment (tightened inspection level) |
| 26 | Table 5—Alternative sampling scheme for Method 1: Sampling plan for the verification dose experiment (tightened inspection level) |
| 27 | 4.3.4.3 Alternative sampling scheme for Method 1: Sampling plan for the sterilization dose audit (reduced inspection level) |
| 29 | Table 6—Alternative sampling scheme for Method 1: Sampling plan for the sterilization dose audit (reduced inspection level) 5 Evaluation and Methods for Product Adoption 5.1 Evaluation of Candidate Product for Product Adoption |
| 30 | 5.2 Methods of Product Adoption |
| 31 | 5.3 Designation of the Candidate Product as the Product Family Representative 6 Maintenance of Product Families |
| 33 | Annex A Sample sizes for implementation of sampling plans and sampling scheme |
| 34 | Annex B Radiation product adoption assessment flowchart |
| 36 | Bibliography |
