STN EN ISO 10993-12/Zmena A1
| Name: | STN EN ISO 10993-12/Zmena A1 |
| Validity: | Valid |
| Number of pages: | 16 |
| 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 | Biologické hodnotenie zdravotníckych pomôcok. Časť 12: Príprava vzorky a referenčné materiály (ISO 10993-12: 2021) |
| English title | Biological evaluation of medical devices — Part 12: Sample preparation and reference materials |
| Release Date: | 01. 02. 2026 |
| Date of withdrawal: | |
| ICS: | 11.100.20 |
| Sorting character/National clasification code | 85 6510 |
| Level of incorporation: | idt EN ISO 10993-12:2021/A1:2025, idt ISO 10993-12:2021/Amd 1:2025 |
| Official Journal | 01/26 |
| Amendments | |
| Replaced by: | |
| Repleces: | |
| Note in Official Journal: | |
| Subject of the standard: | This document specifies requirements and gives guidance on the procedures in the preparation of samples and the selection of reference materials for medical device testing primarily in biological test systems primarily in accordance with one or more parts of the ISO 10993 series. Specifically, this document addresses the following: — test sample selection; — selection of representative portions from a medical device; — test sample preparation; — experimental controls; — selection of, and requirements for, reference materials; — preparation of extracts. This document is not applicable to live cells but can be relevant to the material or medical device components of combination products containing live cells. Extractions for chemical characterization are covered in ISO 10993-18. Clause 7, 8, 9, 10 [with the exception of 10.3.5 and 10.3.11 b)], and 11 can apply to extractions for chemical characterization. Information given in C.1 to C.4 can also be relevant. |
| Preview: | Náhľad normy (PDF) |