EN ISO 10993-1:2003

Biological evaluation of medical devices - Part 1: Evaluation and testing (ISO 10993-1:2003)

Parallel procedure on a minor revision - UAP of 4 months (NT/021021).

Biologische Beurteilung von Medizinprodukten Teil 1: Beurteilung und Prüfungen (ISO 10993-1:2003)

Dieser Teil von ISO 10993 beschreibt
a)   die allgemeinen Grundsätze, die für die biologische Beurteilung von Medizinprodukten    gelten;
b)   die Einteilung von Medizinprodukten basierend auf Applikationsort und Kontaktdauer mit dem menschlichen Körper;
c)   die Auswahl geeigneter Prüfverfahren.
Dieser Teil von ISO 10993 gilt nicht für Prüfungen von Materialien und Produkten, die weder direkt oder indirekt mit dem Körper des Patienten in Kontakt kommen. Diese Norm beschreibt auch nicht biologische Gefährdungen, die durch mechanisches Versagen hervorgerufen werden.
ANMERKUNG   Andere Teile der ISO 10993 decken spezifische Prüfungen ab (siehe auch die Begründung in A.2).

Evaluation biologique des dispositifs médicaux - Partie 1: Evaluation et essais (ISO 10993-1:2003)

Biološko ovrednotenje medicinskih pripomočkov - 1. del: Ocena in preskusi (ISO 10993-1:2003)

General Information

• Status: Withdrawn
• Publication Date: 31-Jul-2003
• Withdrawal Date: 09-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: 10-Jun-2009
• Completion Date: 10-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 10993-1:2003 - Biological evaluation of medical devices - Part 1: Evaluation and testing (ISO 10993-1:2003)

Relations

• Replaces: EN ISO 10993-1:1997 - Biological evaluation of medical devices - Part 1: Evaluation and testing (ISO 10993-1:1997)
• Effective Date: 22-Dec-2008
• Replaced By: EN ISO 10993-1:2009 - Biological evaluation of medical devices - Part 1: Evaluation and testing (ISO 10993-1:2003)
• Effective Date: 08-Jun-2022

Standards Content (Sample)

SLOVENSKI STANDARD
SIST EN ISO 10993-1:2003
01-november-2003
1DGRPHãþD
SIST EN ISO 10993-1:2000
%LRORãNRRYUHGQRWHQMHPHGLFLQVNLKSULSRPRþNRYGHO2FHQDLQSUHVNXVL,62

Biological evaluation of medical devices - Part 1: Evaluation and testing (ISO 10993-
1:2003)
Biologische Beurteilung von Medizinprodukten Teil 1: Beurteilung und Prüfungen (ISO
10993-1:2003)
Evaluation biologique des dispositifs médicaux - Partie 1: Evaluation et essais (ISO
10993-1:2003)
Ta slovenski standard je istoveten z: EN ISO 10993-1:2003
ICS:
11.100.20 %LRORãNRRYUHGQRWHQMH Biological evaluation of
PHGLFLQVNLKSULSRPRþNRY medical devices
SIST EN ISO 10993-1:2003 en
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

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EUROPEAN STANDARD
EN ISO 10993-1
NORME EUROPÉENNE
EUROPÄISCHE NORM
August 2003
ICS 11.100 Supersedes EN ISO 10993-1:1997
English version
Biological evaluation of medical devices - Part 1: Evaluation and
testing (ISO 10993-1:2003)
Evaluation biologique des dispositifs médicaux - Partie 1: Biologische Beurteilung von Medizinprodukten Teil 1:
Evaluation et essais (ISO 10993-1:2003) Beurteilung und Prüfungen (ISO 10993-1:2003)
This European Standard was approved by CEN on 28 July 2003.
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,
Hungary, Iceland, Ireland, Italy, Luxembourg, Malta, Netherlands, Norway, Portugal, Slovakia, 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
© 2003 CEN All rights of exploitation in any form and by any means reserved Ref. No. EN ISO 10993-1:2003 E
worldwide for CEN national Members.

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EN ISO 10993-1:2003 (E)
CORRECTED  2003-09-24
Foreword
This document (EN ISO 10993-1:2003) 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 February 2004, and conflicting national
standards shall be withdrawn at the latest by February 2004.
This document supersedes EN ISO 10993-1:1997.
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 ZA, 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, Hungary, Iceland, Ireland, Italy,
Luxembourg, Malta, Netherlands, Norway, Portugal, Slovakia, Spain, Sweden, Switzerland and
the United Kingdom.
Endorsement notice
The text of ISO 10993-1:2003 has been approved by CEN as EN ISO 10993-1:2003 without any
modifications.
2

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EN ISO 10993-1:2003 (E)
Annex ZA
(informative)
Clauses of this European Standard addressing essential requirements or
other provisions of EU Directives
This European Standard 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 93/42/EEC.
WARNING Other requirements and other EU Directives may be applicable to the
product(s) falling within the scope of this standard.
Compliance with these clauses of this standard provides one means of conforming with the
specific essential requirements of the Directive concerned and associated EFTA regulations.
3

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INTERNATIONAL ISO
STANDARD 10993-1
Third edition
2003-08-01


Biological evaluation of medical
devices —
Part 1:
Evaluation and testing
Évaluation biologique d
...