EN ISO 10993-5:1999

Biological evaluation of medical devices - Part 5: Tests for in vitro cytotoxicity (ISO 10993-5:1999)

This part of ISO 10993 describes test methods to assess the in vitro cytotoxicity of medical devices.  These methods specify the incubation of cultured cells either directly or trough diffusion  a) with extracts of a device , and/or b) in contact with a device.  These methods are designed to determine the biological response of mammalian cells in vitro using appropriate biological parameters.

Biologische Beurteilung von Medizinprodukten - Teil 5: Prüfungen auf Zytotoxizität: In vitro-Methoden (ISO 10993-5:1999)

Dieser Teil von ISO 10993 beschreibt Prüfmethoden zur Bestimmung der in vitro- Zytotoxizität von Medizinprodukten. Bei den angegebenen Methoden erfolgt die Inkubation von Kulturzellen entweder direkt oder durch Diffusion a) mit Extrakten eines Medizinproduktes und/oder b) in Kontakt mit einem Medizin- produkt. Diese Methoden sind so aufgebaut, daß die biologische Reaktion von Säugetierzellen im in vitro-Verfahren durch Verwendung geeigneter biologischer Parameter bestimmt werden kann.

Evaluation biologique des dispositifs médicaux - Partie 5: Essais concernant la cytotoxicité in vitro (ISO 10993-5:1999)

Biološko ovrednotenje medicinskih pripomočkov - 5. del: Preskusi za ugotavljanje citotoksičnosti in vitro (ISO 10993-5:1999)

General Information

• Status: Withdrawn
• Publication Date: 14-May-1999
• Withdrawal Date: 02-Jun-2009
• ICS: 11.100 - Laboratory medicine
• Technical Committee: CEN/TC 206 - Biocompatibility of medical and dental materials and devices
• Drafting Committee: CEN/TC 206 - Biocompatibility of medical and dental materials and devices
• Current Stage: 9960 - Withdrawal effective - Withdrawal
• Start Date: 03-Jun-2009
• Completion Date: 03-Jun-2009
• Directive: 90/385/EEC - Council Directive 90/385/EEC of 20 June 1990 on the approximation of the laws of the Member States relating to active implantable medical devices
• Directive: 93/42/EEC - Council Directive 93/42/EEC of 14 June 1993 concerning medical devices
• Mandate: M/BC/CEN/89/9 - Joint Standardization request to CEN/CENELEC concerning harmonized standards relating to horizontal aspects in the field of medical devices
• Ref Project: SIST EN ISO 10993-5:2000 - Biological evaluation of medical devices - Part 5: Tests for in vitro cytotoxicity (ISO 10993-5:1999)

Relations

• Replaced By: EN ISO 10993-5:2009 - Biological evaluation of medical devices - Part 5: Tests for in vitro cytotoxicity (ISO 10993-5:2009)
• Effective Date: 06-Jun-2009
• Revised: prEN ISO 10993-5 - Biological evaluation of medical devices - Part 5: Tests for in vitro cytotoxicity (ISO 10993-5:1999)
• Effective Date: 18-Jan-2023

Standards Content (Sample)

SLOVENSKI STANDARD
SIST EN ISO 10993-5:2000
01-januar-2000
%LRORãNRRYUHGQRWHQMHPHGLFLQVNLKSULSRPRþNRYGHO3UHVNXVL]DXJRWDYOMDQMH
FLWRWRNVLþQRVWLLQYLWUR,62
Biological evaluation of medical devices - Part 5: Tests for in vitro cytotoxicity (ISO 10993
-5:1999)
Biologische Beurteilung von Medizinprodukten - Teil 5: Prüfungen auf Zytotoxizität: In
vitro-Methoden (ISO 10993-5:1999)
Evaluation biologique des dispositifs médicaux - Partie 5: Essais concernant la
cytotoxicité in vitro (ISO 10993-5:1999)
Ta slovenski standard je istoveten z: EN ISO 10993-5:1999
ICS:
11.100.20 %LRORãNRRYUHGQRWHQMH Biological evaluation of
PHGLFLQVNLKSULSRPRþNRY medical devices
SIST EN ISO 10993-5:2000 en
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

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INTERNATIONAL ISO
STANDARD 10993-5
Second edition
1999-05-15
Biological evaluation of medical devices —
Part 5:
Tests for in vitro cytotoxicity
Évaluation biologique des dispositifs médicaux —
Partie 5: Essais concernant la cytotoxicité in vitro
A
Reference number
ISO 10993-5:1999(E)

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ISO 10993-5:1999(E)
Contents
1 Scope .1
2 Normative references .1
3 Terms and definitions .1
4 Sample preparation .2
5 Cell lines .4
6 Culture medium.4
7 Preparation of cell stock culture .4
8 Test procedures.5
9 Test report .8
10 Assessment of results.8
©  ISO 1999
All rights reserved. Unless otherwise specified, no part of this publication may be reproduced or utilized in any form or by any means, electronic
or mechanical, including photocopying and microfilm, without permission in writing from the publisher.
International Organization for Standardization
Case postale 56 • CH-1211 Genève 20 • Switzerland
Internet [e-mail]
Printed in Switzerland
ii

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© ISO
ISO 10993-5:1999(E)
Foreword
ISO (the International Organization for Standardization) is a worldwide federation of national standards bodies (ISO
member bodies). The work of preparing International Standards is normally carried out through ISO technical
committees. Each member body interested in a subject for which a technical committee has been established has
the right to be represented on that committee. International organizations, governmental and non-governmental, in
liaison with ISO, also take part in the work. ISO collaborates closely with the International Electrotechnical
Commission (IEC) on all matters of electrotechnical standardization.
International Standards are drafted in accordance with the rules given in the ISO/IEC Directives, Part 3.
Draft International Standards adopted by the technical committees are circulated to the member bodies for voting.
Publication as an International Standard requires approval by at least 75 % of the member bodies casting a vote.
International Standard ISO 10993-5 was prepared by Technical Committee ISO/TC 194, Biological evaluation of
medical devices.
This second edition cancels and replaces the first edition (ISO 10993-5:1992), which has been technically revised.
ISO 10993 consists of the following parts, under the general title Biological evaluation of medical devices:

Part 1: Evaluation and testing
 Part 2: Animal welfare requirements
 Part 3: Tests for genotoxicity, carcinogenicity and reproductive toxicity
 Part 4: Selection of tests for interactions with blood
 Part 5: Tests for
...