STN EN ISO 14160
| Name: | STN EN ISO 14160 |
| Validity: | Valid |
| Number of pages: | 52 |
| Language: |
EN
|
| Paper: | 21,40€ |
| Electronic version |
a) Only read (without ability to print and copy)
19,26€ b) Without ability to print, with ability to copy (printscreen) 21,40€ c) With ability to print and copy (printscreen) 27,82€ |
| Slovak title | Sterilizácia výrobkov na zdravotnú starostlivosť. Kvapalné chemické sterilizačné činidlá na jednorazové zdravotnícke pomôcky využívajúce živočíšne tkanivá a ich deriváty. Požiadavky na charakterizáciu, vývoj, validáciu a rutinnú kontrolu procesu sterilizácie zdravotníckych pomôcok (ISO 14160: 2020) |
| English title | Sterilization of health care products — Liquid chemical sterilizing agents for single-use medical devices utilizing animal tissues and their derivatives — Requirements for characterization, development, validation and routine control of a sterilization process for medical devices |
| Release Date: | 01. 09. 2021 |
| Date of withdrawal: | |
| ICS: | 11.080.01 |
| Sorting character/National clasification code | 85 6542 |
| Level of incorporation: | idt EN ISO 14160:2021, idt ISO 14160:2020 |
| Official Journal | 08/21 |
| Amendments | |
| Replaced by: | |
| Repleces: | STN EN ISO 14160:2011-10 (85 6542) |
| Note in Official Journal: | |
| Subject of the standard: | This document specifies requirements for the characterization of a liquid chemical sterilizing agent and for the development, validation, process control and monitoring of sterilization by liquid chemical sterilizing agents of single-use medical devices comprising, in whole or in part, materials of animal origin. This document covers the control of risks arising from contamination with bacteria and fungi by application of a liquid chemical sterilization process. Risks associated with other microorganisms can be assessed using other methods (see NOTE 1). This document is not applicable to material of human origin. This document does not describe methods for the validation of the inactivation of viruses and transmissible spongiform encephalopathy (TSE) agents (see NOTE 2 and NOTE 3). This document does not describe methods for validation of the inactivation or elimination of protozoa and parasites. |
| Preview: | Náhľad normy (PDF) |