STN EN ISO 25424/Zmena A1
| Name: | STN EN ISO 25424/Zmena A1 |
| Validity: | Valid |
| Number of pages: | 20 |
| Language: |
EN
|
| Paper: | 14,10€ |
| Electronic version |
a) Only read (without ability to print and copy)
12,69€ b) Without ability to print, with ability to copy (printscreen) 14,10€ c) With ability to print and copy (printscreen) 18,33€ |
| Slovak title | Sterilizácia zdravotníckych pomôcok nízkoteplotnou parou a formaldehydom. Požiadavky na vývoj, validáciu a rutinnú kontrolu sterilizačného procesu zdravotníckych pomôcok (ISO 25424: 2018) |
| English title | Sterilization of health care products - Low temperature steam and formaldehyde - Requirements for development, validation and routine control of a sterilization process for medical devices (ISO 25424:2018) |
| Release Date: | 01. 08. 2022 |
| Date of withdrawal: | |
| ICS: | 11.080.01 |
| Sorting character/National clasification code | 85 5016 |
| Level of incorporation: | idt ISO 25424:2018/Amd 1:2022, idt EN ISO 25424:2019/A1:2022 |
| Official Journal | 07/22 |
| Amendments | |
| Replaced by: | |
| Repleces: | |
| Note in Official Journal: | |
| Subject of the standard: | 1.1 Inclusions 1.1.1 This document specifies requirements for the development, validation and routine control of a low temperature steam and formaldehyde (LTSF) sterilization process for medical devices using a mixture of low temperature steam and formaldehyde as sterilizing agent and which operates below ambient pressure. NOTE Although the scope of this document is limited to medical devices, it specifies requirements and provides guidance that can be applicable to other products and equipment. |
| Preview: | Náhľad normy (PDF) |