EN ISO 10993-14:2001

Biological evaluation of medical devices - Part 14: Identification and quantification of degradation products from ceramics (ISO 10993-14:2001)

Migrated from Progress Sheet (TC Comment) (2000-07-10): SPP update 1997-09-30. Waiting for ISO TD. ++ New TC forecast BP BLI 99/10/25 ++ Contact Mr Vyze ext 850 when processing this project through each stage

Biologische Beurteilung von Medizinprodukten - Teil 14: Qualitativer und quantitativer Nachweis von keramischen Abbauprodukten (ISO 10993-14:2001)

Dieser Teil von ISO 10993 legt zwei Verfahren zur Gewinnung von Lösungen von Abbauprodukten aus Keramiken (einschließlich Glas) zum Zweck der quantitativen Bestimmung fest. Er gibt auch eine Anleitung zur analytischen Untersuchung dieser Lösungen zur qualitativen Bestimmung der Abbauprodukte. Wegen der Allgemeingültigkeit dieses Teils der Normenserie ISO 10993 sollte die Anwendung vorhandener produktspezifischer Normen, die die Bildung von Abbauprodukten unter mehr anwendungsbezogenen Bedingungen behandeln, bevorzugt in Erwägung gezogen werden.
Dieser Teil der ISO 10993 berücksichtigt nur die Abbauprodukte, die durch einen chemischen Zerfall der keramischen Werkstoffe während einer Prüfung in vitro entstehen. Ein Abbau durch mechanische Belastung oder äußere Energie wird in diesem Teil von ISO 10993 nicht behandelt. Es wird darauf hingewiesen, dass ISO 6872 und ISO 9693 zwar Prüfungen des chemischen Abbaus enthalten, sie jedoch nicht die Analyse der Abbauprodukte behandeln.
Wegen der Verschiedenartigkeit der in Medizinprodukten verwendeten keramischen Werkstoffe und der unterschiedlichen Anforderungen an die Genauigkeit und Präzision der Ergebnisse werden keine spezifischen analytischen Techniken festgelegt. Weiterhin gibt dieser Teil von ISO 10993 keine spezifischen Anforderungen für vertretbare Konzentrationen von Abbauprodukten an.
Obgleich diese Werkstoffe für die biomedizinische Anwendung vorgesehen sind, wird die biologische Aktivität von deren Abbauprodukten in diesem Teil der ISO 10993 nicht behandelt.

Evaluation biologique des dispositifs médicaux - Partie 14: Identification et quantification des produits de dégradation des céramiques (ISO 10993-14:2001)

L’IEC 62645:2019 établit des exigences et fournit des recommandations pour le développement et la gestion des programmes de sécurité informatique des systèmes numériques programmables d’I&C. Le critère de conformité du programme de sécurité des systèmes numériques programmables d’I&C de la centrale nucléaire aux exigences nationales applicables est inhérent aux exigences et recommandations du présent document.
Le présent document définit les mesures adéquates pour ce qui concerne la prévention, la détection et la réaction à des actes malveillants, réalisés en utilisant des moyens informatiques (cyberattaques), portant atteinte aux systèmes numériques programmables d’I&C. Ceci comprend les situations non sûres, les endommagements d’équipements ou la dégradation des performances.
Cette deuxième édition annule et remplace la première édition parue en 2014. Cette édition inclut les modifications techniques majeures suivantes par rapport à l'édition précédente:
a) aligner la norme sur les nouvelles révisions de l’ISO/IEC 27001;
b) passer en revue les exigences existantes et mettre à jour la terminologie et les définitions;
c) prendre en compte, autant que possible, les exigences associées aux normes publiées depuis la parution de la première édition;
d) prendre en compte le fait que les techniques de cybersécurité, mais aussi les pratiques nationales évoluent.

Biološko ovrednotenje medicinskih pripomočkov – 14. del: Prepoznavanje in ugotavljanje količine razgradnih produktov iz keramike (ISO 10993-14:2001)

General Information

• Status: Withdrawn
• Publication Date: 14-Nov-2001
• 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: 93/42/EEC - Council Directive 93/42/EEC of 14 June 1993 concerning medical devices
• Directive: 98/79/EC - Directive 98/79/EC of the European Parliament and of the Council of 27 October 1998 on in vitro diagnostic 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 10993-14:2002 - Biological evaluation of medical devices - Part 14: Identification and quantification of degradation products from ceramics (ISO 10993-14:2001)

Relations

• Replaced By: EN ISO 10993-14:2009 - Biological evaluation of medical devices - Part 14: Identification and quantification of degradation products from ceramics (ISO 10993-14:2001)
• Effective Date: 06-May-2009

Standards Content (Sample)

SLOVENSKI STANDARD
01-maj-2002
%LRORãNRRYUHGQRWHQMHPHGLFLQVNLKSULSRPRþNRY±GHO3UHSR]QDYDQMHLQ
XJRWDYOMDQMHNROLþLQHUD]JUDGQLKSURGXNWRYL]NHUDPLNH,62
Biological evaluation of medical devices - Part 14: Identification and quantification of
degradation products from ceramics (ISO 10993-14:2001)
Biologische Beurteilung von Medizinprodukten - Teil 14: Qualitativer und quantitativer
Nachweis von keramischen Abbauprodukten (ISO 10993-14:2001)
Evaluation biologique des dispositifs médicaux - Partie 14: Identification et quantification
des produits de dégradation des céramiques (ISO 10993-14:2001)
Ta slovenski standard je istoveten z: EN ISO 10993-14:2001
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 10993-14
NORME EUROPÉENNE
EUROPÄISCHE NORM
November 2001
ICS 11.100
English version
Biological evaluation of medical devices - Part 14: Identification
and quantification of degradation products from ceramics (ISO
10993-14:2001)
Evaluation biologique des dispositifs médicaux - Partie 14: Biologische Beurteilung von Medizinprodukten - Teil 14:
Identification et quantification des produits de dégradation Qualitativer und quantitativer Nachweis von keramischen
des céramiques (ISO 10993-14:2001) Abbauprodukten (ISO 10993-14:2001)
This European Standard was approved by CEN on 14 October 2001.
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, 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
© 2001 CEN All rights of exploitation in any form and by any means reserved Ref. No. EN ISO 10993-14:2001 E
worldwide for CEN national Members.

CORRECTED  2002-02-06
Foreword
This document (ISO 10993-14:2001) 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 May 2002, and conflicting national standards
shall be withdrawn at the latest by May 2002.
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, Iceland, Ireland, Italy, Luxembourg,
Netherlands, Norway, Portugal, Spain, Sweden, Switzerland and the United Kingdom.
Endorsement notice
The text of the International Standard ISO 10993-14:2001 has been approved by CEN as a
European Standard without any modifications.
NOTE Normative references to International Standards are listed in annex ZB (normative).
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.
The following clauses of this standard are likely to support requirements of Directive 93/42/EEC.
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.
Table ZA.1— Correspondence between this European Standard and EU Directives
Comments
Clause/subclause of this Corresponding Essential
European Standard Requirement of Directive
93/42/EEC
4 7.5 - Annex 1
Annex ZB
(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 Publication has been modified by common modifications, indicated
by (mod.), the relevant EN/HD applies.
Publication Year Title EN Year
ISO 3696 1987 Water for analytical laboratory use – EN ISO 3696 1995
Specification and test methods
ISO 6872 1995 Dental ceramic EN ISO 6872 1998
ISO 10993-1 1997 Biological evaluation of medical devices EN ISO 10993-1 1997
– Part 1: Evaluation and testing
ISO 10993-9 1999 Biological evaluation of medical devices EN ISO 10993-9 1999
- Part 9: Framework for identification
and quantification of potential
degradation products
INTERNATIONAL ISO
STANDARD 10993-14
First edition
2001-11-15
Biological evaluation of medical devices —
Part 14:
Identification and quantification of
degradation products from ceramics
Évaluation biologique des dispositifs médicaux —
Partie 14: Identification et quantification des produits de dégradation des
céramiques
Reference number
ISO 10993-14:2001(E)
©
ISO 2001
ISO 10993-14:2001(E)
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ii © ISO 2001 – All rights reserved

ISO 10993-14:2001(E)
Contents Page
Foreword.iv
Introduction.vi
1 Scope .1
2 Normative references .1
3 Terms and definitions .2
4 Test procedures.2
4.1 Principle.2
4.2 Testing of dental devices.2
4.3 General testing techniques.3
4.4 Extreme solution test .4
4.5 Simulation solution test .6
5 Analysis of filtrate.9
5.1 General.9
5.2 Choice of chemicals or elements to be analysed.9
5.3 Sensitivity of the analysis method.9
6 Test report .9
Bibliography.11
ISO 10993-14:2001(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.
Attention is drawn to the possibility that some of the elements of this part of ISO 10993 may be the subject of
patent rights. ISO shall not be held responsible for identifying any or all such patent rights.
International Standard ISO 10993-14 was prepared by Technical Committee ISO/TC 194, Biological evaluation of
medical devices.
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 2001 – All rights reserved

ISO 10993-14:2001(E)
— Part 17: Establishment of allowable limits for leachable substances using health-based risk assessment
— Part 18: Chemical characterization of materials
ISO 10993-14:2001(E)
Introduction
This part of ISO 10993 consists of two tests for the biological evaluation of medical devices: an extreme solution
test and a simulation solution test. The extreme solution test is developed as a worst-case
...