Telefon: (011) 7541-421, 3409-301, 3409-335, 6547-293, 3409-310
E-mail: Prodaja standarda: prodaja@iss.rs Seminari, obuke: iss-edukacija@iss.rs Informacije o standardima: infocentar@iss.rs
Stevana Brakusa 2, 11030 Beograd
Glavni meni

ISO 10993-12:2021

Biological evaluation of medical devices — Part 12: Sample preparation and reference materials
20. 1. 2021.

Опште информације

60.60     20. 1. 2021.

ISO

ISO/TC 194

Međunarodni standard

11.100.20  

engleski   francuski  

Kupovina

Objavljen

Jezik na kome želite da primite dokument.

Apstrakt

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.

Životni ciklus

PRETHODNO

POVUČEN
ISO 10993-12:2012

TRENUTNO

OBJAVLJEN
ISO 10993-12:2021
60.60 Standard objavljen
20. 1. 2021.

ISPRAVKE / IZMENE

OBJAVLJEN
ISO 10993-12:2021/Amd 1:2025

REVIDIRAN OD

NAPUŠTEN
ISO/PWI 10993-12

Nacionalna preuzimanja

Biološko vrednovanje medicinskih sredstava – Deo 12: Pripremanje uzoraka i referentnih materijala

60.60   Standard objavljen