ANSI/AAMI/ISO 13004:2022
Current
The latest, up-to-date edition.
Sterilization of health care products—Radiation—Substantiation of selected sterilization dose: Method VDmaxSD
English
18-12-2023
This document describes a method for substantiating a selected sterilization dose of 17,5 kGy, 20 kGy, 22,5 kGy, 27,5 kGy, 30 kGy, 32,5 kGy or 35 kGy that achieves a sterility assurance level (SAL) of 10−6 or less for radiation sterilization of health care products.
| Committee |
ISO/TC 198
|
| DocumentType |
Standard
|
| ISBN |
978-1-57020-888-1
|
| Pages |
75
|
| PublisherName |
Association for the Advancement of Medical Instrumentation
|
| Status |
Current
|
| Supersedes |
| ISO 11137-2:2013 | Sterilization of health care products — Radiation — Part 2: Establishing the sterilization dose |
| ISO 11139:2018 | Sterilization of health care products — Vocabulary of terms used in sterilization and related equipment and process standards |
| ISO 11137-3:2006 | Sterilization of health care products — Radiation — Part 3: Guidance on dosimetric aspects |
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