SIST 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• Status: Withdrawn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-Oct-2003
• Withdrawal Date: 06-Jul-2009
• ICS: 11.100.20 - Biological evaluation of medical devices
• Technical Committee: VAZ - Healthcare
• Current Stage: 9900 - Withdrawal (Adopted Project)
• Start Date: 07-Jul-2009
• Due Date: 30-Jul-2009
• Completion Date: 07-Jul-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: EN ISO 10993-1:2003 - Biological evaluation of medical devices - Part 1: Evaluation and testing (ISO 10993-1:2003)

Relations

• Replaces: SIST EN ISO 10993-1:2000 - Biological evaluation of medical devices - Part 1: Evaluation and testing (ISO 10993-1:1997)
• Effective Date: 01-Nov-2003
• Replaced By: SIST EN ISO 10993-1:2009 - Biological evaluation of medical devices - Part 1: Evaluation and testing (ISO 10993-1:2003)
• Effective Date: 01-Sep-2009

Standards Content (Sample)

SLOVENSKI STANDARD
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
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

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.

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.
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.
INTERNATIONAL ISO
STANDARD 10993-1
Third edition
2003-08-01
Biological evaluation of medical
devices —
Part 1:
Evaluation and testing
Évaluation biologique des dispositifs médicaux —
Partie 1: Évaluation et essais

Reference number
ISO 10993-1:2003(E)
©
ISO 2003
ISO 10993-1:2003(E)
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ii © ISO 2003 — All rights reserved

ISO 10993-1:2003(E)
Contents Page
Foreword. iv
Introduction . vi
1 Scope. 1
2 Terms and definitions. 1
3 General principles applying to biological evaluation of medical devices . 2
4 Categorization of medical devices . 3
5 Testing. 4
6 Selection of biological evaluation tests. 7
7 Assurance of test methods. 8
Annex A (informative) Rationale .11
Annex B (informative) Flow chart to aid in ensuring a systematic approach to biological
evaluation of medical devices . 13
Bibliography . 14

ISO 10993-1:2003(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 2.
The main task of technical committees is to prepare International Standards. 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.
Attention is drawn to the possibility that some of the elements of this document may be the subject of patent
rights. ISO shall not be held responsible for identifying any or all such patent rights.
ISO 10993-1 was prepared by Technical Committee ISO/TC 194, Biological evaluation of medical devices.
This third edition cancels and replaces the second edition (ISO 10993-1:1997), of which it constitutes a minor
revision.
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 in vitro cytotoxicity
— Part 6: Tests for local effects after implantation
— Part 7: Ethylene oxide sterilization residuals
— Part 8: Selection and qualification of reference materials for biological tests
— Part 9: Framework for identification and quantification of potential degradation products
— Part 10: Tests for irritation and delayed-type hypersensitivity
— Part 11: Tests for systemic toxicity
— Part 12: Sample preparation and reference materials
— Part 13: Identification and quantification of degradation products from polymeric medical devices
— Part 14: Identification and quantification of degradation products from ceramics
— Part 15: Identification and quantification of degradation products from metals and alloys
— Part 16: Toxicokinetic study design for degradation products and leachables
iv © ISO 2003 — All rights reserved

ISO 10993-1:2003(E)
— Part 17: Establishment of allowable limits for leachable substances
— Part 18: Chemical characterization of materials
Future parts will deal with other relevant aspects of biological testing.
ISO 10993-1:2003(E)
Introduction
This part of ISO 10993 is a combination/harmonization of numerous international and national standards and
guidelines concerning the biological evaluation of medical devices. It is intended to be the overall guidance
document for the selection of tests enabling evaluation of biological responses relevant to the safety of
medical devices and materials.
The role of this part of ISO 10993 is to serve as a framework in which to plan such a biological evaluation
which minimizes the number and exposure of test animals.
The protection of humans is the primary goal of ISO 10993.
The appropriate selection and interpretation of biological evaluation tests requires an understanding of the
rationale behind such testing. An informative rationale for the use of this part of ISO 10993 is provided in
Annex A. Annex B contains a flow chart to aid in the systematic approach to the biological evaluation of
medical devices. A bibliography is given at the end of the text.

vi © ISO 2003 — All rights reserved

INTERNATIONAL STANDARD ISO 10993-1:2003(E)

Biological evaluation of medical devices —
Part 1:
Evaluation and testing
1 Scope
This part of ISO 10993 describes
a) the general principles governing the biological evaluation of medical devices;
b) the categorization of devices based on the nature and duration of their contact with the body;
c) the selection of appropriate tests.
This part of ISO 10993 does not cover testing of materials and devices that do not come into direct or indirect
contact with the patient's body, nor does it cover biological hazards arising from any mechanical failure.
NOTE Other parts of ISO 10993 cover specific tests (see also the rationale in A.2).
2 Terms and definitions
For the purposes of this document, the following terms and definitions apply.
2.1
medical device
any instrument, apparatus, appliance, material or other article, including software, whether used alone or in
combination, intended by the manufacturer to be used for human beings solely or principally for the purpose
of:
 diagnosis, prevention, monitoring, treatment or alleviation of disease;
 diagnosis, monitoring, treatment, alleviation of or compensation for an injury or handicap;
 investigation, replacement or modification of the anatomy or of a physiological process;
 control of conception;
and which does not achieve its principal intended action in or on the human body by pharmacological,
immunological or metabolic means, but which may be assisted in its function by such means
NOTE 1 Devices are different from drugs, and their biological evaluation requires a different approach.
NOTE 2 Use of the term “medical device” includes dental devices.
2.2
material
any synthetic or natural polymer, metal, alloy, ceramic or other nonviable substance, including tissue rendered
nonviable, used as a medical device or any part thereof
ISO 10993-1:2003(E)
2.3
final product
medical device in its “as-used” s
...