STN EN ISO 13004
| Name: | STN EN ISO 13004 |
| Validity: | Valid |
| Number of pages: | 68 |
| Language: |
EN
|
| Paper: | 24,40€ |
| Electronic version |
a) Only read (without ability to print and copy)
21,96€ b) Without ability to print, with ability to copy (printscreen) 24,40€ c) With ability to print and copy (printscreen) 31,72€ |
| Slovak title | Sterilizácia výrobkov zdravotnej starostlivosti žiarením. Zdôvodnenie zvolenej sterilizačnej dávky: Metóda VDmaxSD (ISO 13004: 2022) |
| English title | Sterilization of health care products - Radiation - Substantiation of selected sterilization dose: Method VDmaxSD (ISO 13004:2022) |
| Release Date: | 01. 09. 2023 |
| Date of withdrawal: | |
| ICS: | 11.080.01 |
| Sorting character/National clasification code | 85 6545 |
| Level of incorporation: | idt ISO 13004:2022, idt EN ISO 13004:2023 |
| Official Journal | 08/23 |
| Amendments | |
| Replaced by: | |
| Repleces: | STN P CEN ISO/TS 13004:2014-09 (85 6545) |
| Note in Official Journal: | |
| Subject of the standard: | Adoption of ISO 13004:2022 – This is currently in FDIS and will be publishing in October 2022. This document 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. NOTE Selection and substantiation of the sterilization dose is used to meet the requirements for establishing the sterilization dose within process definition in ISO 11137-1. |
| Preview: | Náhľad normy (PDF) |