STN EN ISO 11607-1/Zmena A1
| Name: | STN EN ISO 11607-1/Zmena A1 |
| Validity: | Valid |
| Number of pages: | 36 |
| Language: |
EN
|
| Hard copy: | 17,20€ |
| Electronic version |
a) Only read (without ability to print and copy)
15,48€ b) Without ability to print, with ability to copy (printscreen) 17,20€ c) With ability to print and copy (printscreen) 22,36€ |
| Slovak title | Obaly na sterilizované zdravotnícke pomôcky. Časť 1: Požiadavky na materiály, systémy sterilných bariér a obalové systémy. Zmena A1: Uplatňovanie manažérstva rizika (ISO 11607-1: 2019/Amd 1: 2023) |
| English title | Packaging for terminally sterilized medical devices - Part 1: Requirements for materials, sterile barrier systems and packaging systems (ISO 11607-1:2019) |
| Release Date: | 01. 01. 2024 |
| Date of withdrawal: | |
| ICS: | 11.080.30 |
| Sorting character/National clasification code | 85 6543 |
| Level of incorporation: | idt ISO 11607-1:2019/Amd 1:2023, idt EN ISO 11607-1:2020/A1:2023 |
| Official Journal | 12/23 |
| Amendments | |
| Replaced by: | |
| Repleces: | |
| Note in Official Journal: | |
| Subject of the standard: | This document specifies requirements and test methods for materials, preformed sterile barrier systems, sterile barrier systems and packaging systems that are intended to maintain sterility of terminally sterilized medical devices until the point of use. It is applicable to industry, to health care facilities, and to wherever medical devices are placed in sterile barrier systems and sterilized. It does not cover all requirements for sterile barrier systems and packaging systems for medical devices that are manufactured aseptically. Additional requirements can be necessary for drug/device combinations. It does not describe a quality assurance system for control of all stages of manufacture. It does not apply to packaging materials and/or systems used to contain a contaminated medical device during transportation of the item to the site of reprocessing or disposal. |
| Preview: | Náhľad normy (PDF) |