EN ISO 10993-17:2002

Biological evaluation of medical devices - Part 17: Establishment of allowable limits for leachable substances (ISO 10993-17:2002)

Migrated from Progress Sheet (TC Comment) (2000-07-10): New Tc forecast BP BLI 99-10-20 ++ Contact Mr Vyze ext 850 when processing this project through each stage

Biologische Beurteilung von Medizinprodukten - Teil 17: Nachweis zulässiger Grenzwerte für herauslösbare Bestandteile (ISO 10993-17:2002)

Dieser Teil der ISO 10993 legt das Verfahren zur Bestimmung zulässiger Grenzwerte für herauslösbare Bestandteile aus Medizinprodukten fest. Er ist für die Anwendung bei der Erstellung von Normen vorgesehen sowie für die Abschätzung geeigneter Grenzwerte in den Fällen, in denen keine Normen vorliegen. Er beschreibt einen systematischen Prozess, mit dem festgestellte Risiken durch toxikologisch gefährliche Substanzen, die in Medizinprodukten enthalten sind, quantitativ bestimmt werden können.
Dieser Teil der ISO 10993 ist nicht anwendbar für Produkte, die nicht mit dem Patienten in Kontakt kommen (z. B. Geräte für die in vitro-Diagnostik).
Die Exposition einer besonderen chemischen Substanz kann aus anderen Ursachen hervorgehen, z. B. Lebensmittel, Wasser und Luft. Dieser Teil der ISO 10993 behandelt nicht die mögliche Exposition durch diese Quellen.

Evaluation biologique des dispositifs médicaux - Partie 17: Etablissement des limites admissibles des substances relargables (ISO 10993-17:2002)

Biološko ovrednotenje medicinskih pripomočkov - 17. del: Postavitev dopustnih mej za izlužene snovi (ISO 10993-17:2002)

General Information

• Status: Withdrawn
• Publication Date: 30-Nov-2002
• Withdrawal Date: 28-Apr-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: 29-Apr-2009
• Completion Date: 29-Apr-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 10993-17:2003 - Biological evaluation of medical devices - Part 17: Establishment of allowable limits for leachable substances (ISO 10993-17:2002)

Relations

• Replaced By: EN ISO 10993-17:2009 - Biological evaluation of medical devices - Part 17: Establishment of allowable limits for leachable substances (ISO 10993-17:2002)
• Effective Date: 22-Dec-2008

Standards Content (Sample)

SLOVENSKI STANDARD
SIST EN ISO 10993-17:2003
01-marec-2003
%LRORãNRRYUHGQRWHQMHPHGLFLQVNLKSULSRPRþNRYGHO3RVWDYLWHYGRSXVWQLK
PHM]DL]OXåHQHVQRYL,62
Biological evaluation of medical devices - Part 17: Establishment of allowable limits for
leachable substances (ISO 10993-17:2002)
Biologische Beurteilung von Medizinprodukten - Teil 17: Nachweis zulässiger
Grenzwerte für herauslösbare Bestandteile (ISO 10993-17:2002)
Evaluation biologique des dispositifs médicaux - Partie 17: Etablissement des limites
admissibles des substances relargables (ISO 10993-17:2002)
Ta slovenski standard je istoveten z: EN ISO 10993-17:2002
ICS:
11.100.20 %LRORãNRRYUHGQRWHQMH Biological evaluation of
PHGLFLQVNLKSULSRPRþNRY medical devices
SIST EN ISO 10993-17:2003 en
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

---------------------- Page: 1 ----------------------

EUROPEAN STANDARD
EN ISO 10993-17
NORME EUROPÉENNE
EUROPÄISCHE NORM
December 2002
ICS 11.100
English version
Biological evaluation of medical devices - Part 17: Establishment
of allowable limits for leachable substances (ISO 10993-
17:2002)
Evaluation biologique des dispositifs médicaux - Partie 17: Biologische Beurteilung von Medizinprodukten - Teil 17:
Etablissement des limites admissibles des substances Nachweis zulässiger Grenzwerte für herauslösbare
relargables (ISO 10993-17:2002) Bestandteile (ISO 10993-17:2002)
This European Standard was approved by CEN on 9 October 2002.
CEN members are bound to comply with the CEN/CENELEC Internal Regulations which stipulate the conditions for giving this European
Standard the status of a national standard without any alteration. Up-to-date lists and bibliographical references concerning such national
standards may be obtained on application to the Management Centre or to any CEN member.
This European Standard exists in three official versions (English, French, German). A version in any other language made by translation
under the responsibility of a CEN member into its own language and notified to the Management Centre has the same status as the official
versions.
CEN members are the national standards bodies of Austria, Belgium, Czech Republic, Denmark, Finland, France, Germany, Greece,
Iceland, Ireland, Italy, Luxembourg, Malta, Netherlands, Norway, Portugal, Spain, Sweden, Switzerland and United Kingdom.
EUROPEAN COMMITTEE FOR STANDARDIZATION
COMITÉ EUROPÉEN DE NORMALISATION
EUROPÄISCHES KOMITEE FÜR NORMUNG
Management Centre: rue de Stassart, 36  B-1050 Brussels
© 2002 CEN All rights of exploitation in any form and by any means reserved Ref. No. EN ISO 10993-17:2002 E
worldwide for CEN national Members.

---------------------- Page: 2 ----------------------

EN ISO 10993-17:2002 (E)
CORRECTED  2003-03-26
Foreword
This document (EN ISO 10993-17:2002) has been prepared by Technical Committee ISO/TC
194 "Biological evaluation of medical devices" in collaboration with Technical Committee
CEN/TC 206 "Biocompatibility of medical and dental materials and devices", the secretariat of
which is held by NEN.
This European Standard shall be given the status of a national standard, either by publication of
an identical text or by endorsement, at the latest by June 2003, and conflicting national
standards shall be withdrawn at the latest by June 2003.
This document has been prepared under a mandate given to CEN by the European Commission
and the European Free Trade Association, and supports essential requirements of EU
Directive(s).
For relationship with EU Directive(s), see informative Annex ZB, which is an integral part of this
document.
According to the CEN/CENELEC Internal Regulations, the national standards organizations of
the following countries are bound to implement this European Standard: Austria, Belgium, Czech
Republic, Denmark, Finland, France, Germany, Greece, Iceland, Ireland, Italy, Luxembourg,
Malta, Netherlands, Norway, Portugal, Spain, Sweden, Switzerland and the United Kingdom.
Endorsement notice
The text of ISO 10993-17:2002 has been approved by CEN as EN ISO 10993-17:2002 without
any modifications.
NOTE Normative references to International Standards are listed in annex ZA (normative).
2

---------------------- Page: 3 ----------------------

EN ISO 10993-17:2002 (E)
Annex ZA
(normative)
Normative references to international publications
with their relevant European publications
This European Standard incorporates by dated or undated reference, provisions from other
publications. These normative references are cited at the appropriate places in the text and the
publications are listed hereafter. For dated references, subsequent amendments to or revisions of
any of these publications apply to this European Standard only when incorporated in it by
amendment or revision. For undated references the latest edition of the publication referred to
applies (including amendments).
NOTE Where an International Publi
...