Tagasi

ISO 10993-12:2021

Biological evaluation of medical devices — Part 12: Sample preparation and reference materials

Üldinfo
Kehtiv alates 20.01.2021
Direktiivid või määrused
puuduvad

Standardi ajalugu

Staatus
Kuupäev
Tüüp
Nimetus
20.01.2021
Põhitekst
29.06.2012
Põhitekst
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.
*
*
*
PDF
169,14 € koos KM-ga
Paber
169,14 € koos KM-ga
Standardi monitooring

Teised on ostnud veel

Põhitekst

EVS-EN 17141:2020

Cleanrooms and associated controlled environments - Biocontamination control
Uusim versioon Kehtiv alates 01.09.2020
Põhitekst

EVS-EN ISO 10993-1:2020

Meditsiiniseadmete bioloogiline hindamine. Osa 1: Hindamine ja katsetamine riskihaldusprotsessis
Uusim versioon Kehtiv alates 31.12.2020
Põhitekst

EVS-EN ISO 10993-18:2020

Meditsiiniseadmete bioloogiline hindamine. Osa 18: Meditsiiniseadme materjalide keemiline iseloomustamine riskihaldusprotsessis
Kehtiv alates 15.06.2020
Põhitekst

EVS-EN ISO 10993-3:2014

Meditsiiniseadmete bioloogiline hindamine. Osa 3: Testid geenitoksiliste, kantserogeensete ja reproduktiivsete toksiinide määramiseks
Uusim versioon Kehtiv alates 07.11.2014