19/30376763 DC - BS EN ISO 10993-12. Biological evaluation of medical devices. Part 12. Sample preparation and reference materials

19/30376763 DC

BS EN ISO 10993-12. Biological evaluation of medical devices. Part 12. Sample preparation and reference materials

Status : Current, Draft for public comment   Published : May 2019

Format
PDF

Format
HARDCOPY



This document specifies requirements and gives guidance on the procedures to be followed in the preparation of samples and the selection of reference materials for medical device testing in biological test systems onlyin accordance with one or more parts of ISO 10993. 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.




Standard Number19/30376763 DC
TitleBS EN ISO 10993-12. Biological evaluation of medical devices. Part 12. Sample preparation and reference materials
StatusCurrent, Draft for public comment
Publication Date13 May 2019
Normative References(Required to achieve compliance to this standard)No other standards are normatively referenced
Informative References(Provided for Information)ISO Guide 31, ISO/TS 37137-1, ISO 10993 (all parts), ISO 14971, ISO 17034, ISO Guide 33, ISO Guide 30:2015, ISO Guide 35, ISO/IEC Guide 99:2007
International RelationshipsISO/DIS 10993-12
Draft Expiry Date01 July 2019
DescriptorsControl samples, Biological analysis and testing, Extraction methods of analysis, Selection, Medical equipment, Extraction, Specimen preparation, Test specimens
ICS11.100.20
Title in FrenchÉvaluation biologique des dispositifs médicaux — Partie 12: Préparation des échantillons et matériaux de référence Partie 12: Préparation des échantillons et matériaux de référence
CommitteeCH/194
PublisherBSI
FormatA4
DeliveryYes
Pages35
File Size526 KB
NotesWarning: this draft is not current beyond its expiry date for comments.
Price£20.00


 Your basket
Your basket is empty

Multi-user access to over 3,500 medical device standards, regulations, expert commentaries and other documents


Worldwide Standards
We can source any standard from anywhere in the world


Tracked Changes

Understand the changes made to a standard with our new Tracked Changes version


BSOL

The faster, easier way to work with standards