STN EN 556-1
| Name: | STN EN 556-1 |
| Validity: | Withdrawn |
| Number of pages: | 14 |
| Language: |
EN
Pripravuje sa preklad do slovenského jazyka. Pre viac informácií nás kontaktujte na navrhynoriem@normoff.gov.sk
|
| Paper: | 9,70€ |
| Electronic version |
a) Only read (without ability to print and copy)
8,73€ b) Without ability to print, with ability to copy (printscreen) 9,70€ c) With ability to print and copy (printscreen) 12,61€ |
| Slovak title | Sterilizácia zdravotníckych pomôcok. Požiadavky na zdravotnícke pomôcky, ktoré sa majú označiť ako STERILNÉ. Časť 1: Požiadavky na zdravotnícke pomôcky sterilizované v spotrebiteľskom balení |
| English title | Sterilization of medical devices - Requirements for medical devices to be designated "STERILE" - Part 1: Requirements for terminally sterilized medical devices |
| Release Date: | 01. 10. 2024 |
| Date of withdrawal: | 01. 07. 2025 |
| ICS: | 11.080.01 |
| Sorting character/National clasification code | 85 6533 |
| Level of incorporation: | idt EN 556-1:2024 |
| Official Journal | 09/24 |
| Amendments | |
| Replaced by: | STN EN 556-1:2025-07 (85 6533) |
| Repleces: | STN EN 556-1:2003-09 (85 6533) |
| Note in Official Journal: | |
| Subject of the standard: | This document specifies the requirements for a terminally sterilized medical device to be designated ‘STERILE’. Part 2 of this European standard specifies the requirements for an aseptically processed medical device to be designated "STERILE". NOTE For the purpose of the EU Directive(s) for medical devices (see Bibliography), designation of a medical device as ‘STERILE’ is only permissible when a validated sterilization process has been applied. Requirements for validation and routine control of processes for the sterilization of medical devices are specified in EN ISO 11135, EN ISO 11137, EN ISO 14160, EN ISO 14937, EN ISO 17665-1, EN ISO 20857, EN ISO 25424 and ISO 22441. |
| Preview: | Náhľad normy (PDF) |