EN ISO 10993-12:2007
(Main)Biological evaluation of medical devices - Part 12: Sample preparation and reference materials (ISO 10993-12:2007)
Biological evaluation of medical devices - Part 12: Sample preparation and reference materials (ISO 10993-12:2007)
2005-08-12 Will be re-submitted to a parallel DIS/CEN enquiry (followed by //FDIS/FV) for publication as complete revision.
2005-02-03 40.20 different than ISO, de-synchronization due to misleading notification from ISO/CS.
2004-11-08 Creation by NT further to ISO/CS request as docs ready to be processed to // Enq ISO lead (NT/041108).
Biologische Beurteilung von Medizinprodukten - Teil 12: Proben-vorbereitung und Referenzmaterialien (ISO 10993-12:2007)
Der vorliegende Teil der ISO 10993 legt Anforderungen fest und gibt Anleitungen zu Verfahren, die bei der Probenvorbereitung und bei der Auswahl von Referenzmaterialien für die biologische Prüfung von Medizinprodukten nach einem oder mehreren Teilen der ISO 10993-Reihe zu befolgen sind.
Dieser Teil der ISO 10993 bezieht sich insbesondere auf die:
Auswahl der Prüfmuster,
Auswahl repräsentativer Teile eines Medizinproduktes,
Probenvorbereitung,
Kontrollen der Prüfmethoden,
Auswahl und Anforderungen an die Referenzmaterialien und
Herstellung der Extrakte.
Dieser Teil der ISO 10993 ist nicht anwendbar auf Materialien oder Produkte, die lebende Zellen enthalten.
Évaluation biologique des dispositifs médicaux - Partie 12: Préparation des échantillons et matériaux de référence (ISO 10993-12:2007)
Biološko ovrednotenje medicinskih pripomočkov - 12. del: Priprava vzorcev in referenčni materiali (ISO 10993-12:2007)
General Information
Relations
Standards Content (Sample)
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.Biological evaluation of medical devices - Part 12: Sample preparation and reference materials (ISO 10993-12:2007)Evaluation biologique des dispositifs médicaux - Partie 12: Préparation des échantillons et des matériaux de référence (ISO 10993-12:2007)Biologische Beurteilung von Medizinprodukten - Teil 12: Proben-vorbereitung und Referenzmaterialien (ISO 10993-12:2007)Ta slovenski standard je istoveten z:EN ISO 10993-12:2007SIST EN ISO 10993-12:2008en11.100.20ICS:SIST EN ISO 10993-12:20051DGRPHãþDSLOVENSKI
STANDARDSIST EN ISO 10993-12:200801-april-2008
EUROPEAN STANDARDNORME EUROPÉENNEEUROPÄISCHE NORMEN ISO 10993-12November 2007ICS 11.100.20Supersedes EN ISO 10993-12:2004
English VersionBiological evaluation of medical devices - Part 12: Samplepreparation and reference materials (ISO 10993-12:2007)Évaluation biologique des dispositifs médicaux - Partie 12:Préparation des échantillons et matériaux de référence(ISO 10993-12:2007)Biologische Beurteilung von Medizinprodukten - Teil 12:Proben-vorbereitung und Referenzmaterialien (ISO 10993-12:2007)This European Standard was approved by CEN on 30 September 2007.CEN members are bound to comply with the CEN/CENELEC Internal Regulations which stipulate the conditions for giving this EuropeanStandard the status of a national standard without any alteration. Up-to-date lists and bibliographical references concerning such nationalstandards may be obtained on application to the CEN 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 translationunder the responsibility of a CEN member into its own language and notified to the CEN Management Centre has the same status as theofficial versions.CEN members are the national standards bodies of Austria, Belgium, Bulgaria, Cyprus, Czech Republic, Denmark, Estonia, Finland,France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal,Romania, Slovakia, Slovenia, Spain, Sweden, Switzerland and United Kingdom.EUROPEAN COMMITTEE FOR STANDARDIZATIONCOMITÉ EUROPÉEN DE NORMALISATIONEUROPÄISCHES KOMITEE FÜR NORMUNGManagement Centre: rue de Stassart, 36
B-1050 Brussels© 2007 CENAll rights of exploitation in any form and by any means reservedworldwide for CEN national Members.Ref. No. EN ISO 10993-12:2007: E
Relationship between this European Standard and the Essential Requirements of EU Directives 93/42/EEC on medical devices and 90/385/EEC on active implantable medical devices
This European Standard has been prepared under a mandate given to CEN by the European Commission and the European Free Trade Association to provide a means of conforming to Essential Requirements of the New Approach Directives 93/42/EEC on medical devices and 90/385/EEC on active implantable medical devices.
Once this standard is cited in the Official Journal of the European Communities under that Directive and has been implemented as a national standard in at least one Member State, compliance with the clauses of this standard given in Table ZA.1 confers, within the limits of the scope of this standard, a presumption of conformity with the corresponding Essential Requirements of that Directive and associated EFTA regulations.
Table ZA.1 — Correspondence between this International Standard and Directives 93/42/EEC on medical devices and 90/385/EEC on active implantable medical devices
Clause(s)/sub-clause(s) of this International Standard Essential Requirements (ERs) of Directives 93/42/EEC and 90/385/EEC
Qualifying remarks/Notes 1, 7, 8, 9, 10 93/42/EEC: Annex I, 11.7
1, 7, 8, 9, 10 90/385/EEC: Annex I.1 and 11.9
WARNING — Other requirements and other EU Directives may be applicable to the product(s) falling within the scope of this standard.
Reference numberISO 10993-12:2007(E)© ISO 2007
INTERNATIONAL STANDARD ISO10993-12Third edition2007-11-15Biological evaluation of medical devices — Part 12: Sample preparation and reference materials Évaluation biologique des dispositifs médicaux — Partie 12: Préparation des échantillons et matériaux de référence
ISO 10993-12:2007(E) PDF disclaimer This PDF file may contain embedded typefaces. In accordance with Adobe's licensing policy, this file may be printed or viewed but shall not be edited unless the typefaces which are embedded are licensed to and installed on the computer performing the editing. In downloading this file, parties accept therein the responsibility of not infringing Adobe's licensing policy. The ISO Central Secretariat accepts no liability in this area. Adobe is a trademark of Adobe Systems Incorporated. Details of the software products used to create this PDF file can be found in the General Info relative to the file; the PDF-creation parameters were optimized for printing. Every care has been taken to ensure that the file is suitable for use by ISO member bodies. In the unlikely event that a problem relating to it is found, please inform the Central Secretariat at the address given below.
©
ISO 2007 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 either ISO at the address below or ISO's member body in the country of the requester. ISO copyright office Case postale 56 • CH-1211 Geneva 20 Tel.
+ 41 22 749 01 11 Fax
+ 41 22 749 09 47 E-mail
copyright@iso.org Web
www.iso.org Published in Switzerland
ii © ISO 2007 – All rights reserved
ISO 10993-12:2007(E) © ISO 2007 – All rights reserved iiiContents Page Foreword.iv Introduction.vi 1 Scope.1 2 Normative references.1 3 Terms and definitions.1 4 General requirements.3 5 Reference materials.4 5.1 General.4 5.2 Certification of RMs for biological safety testing.4 6 Use of RMs as experimental controls.4 7 Test sample selection.5 8 Test sample and RM preparation.5 9 Selection of representative portions from a device.5 10 Preparation of extracts of samples.6 10.1 General.6 10.2 Containers for extraction.6 10.3 Extraction conditions and methods.6 10.4 Extraction conditions for hazard identification and risk estimation in the exaggerated-use condition.8 11 Records.9 Annex A (informative)
Experimental controls.10 Annex B (informative)
General principles on and practices of test sample preparation and sample selection.12 Annex C (informative)
Principles of test sample extraction.14 Bibliography.17
ISO 10993-12:2007(E) iv © ISO 2007 – All rights reserved 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 10993-12 was prepared by Technical Committee ISO/TC 194, Biological evaluation of medical devices. This third edition cancels and replaces the second edition (ISO 10993-12:2002), 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 in vitro cytotoxicity ⎯ Part 6: Tests for local effects after implantation ⎯ Part 7: Ethylene oxide sterilization residuals ⎯ 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
ISO 10993-12:2007(E) © ISO 2007 – All rights reserved v⎯ Part 16: Toxicokinetic study design for degradation products and leachables ⎯ Part 17: Establishment of allowable limits for leachable substances ⎯ Part 18: Chemical characterization of materials ⎯ Part 19: Physico-chemical, morphological and topographical characterization of materials [TS] ⎯ Part 20: Principles and methods for immunotoxicology testing of medical devices [TS] Future parts will deal with other relevant aspects of biological testing.
ISO 10993-12:2007(E) vi © ISO 2007 – All rights reserved Introduction This part of ISO 10993 specifies methods of sample preparation and the selection of reference materials in the biological evaluation of medical devices. Sample preparation methods should be appropriate for both the biological evaluation methods and the materials being evaluated. Each biological test method requires the selection of materials, extraction solvents and conditions. This part of ISO 10993 is based on existing national and international specifications, regulations and standards wherever possible. It is periodically reviewed and revised.
INTERNATIONAL STANDARD ISO 10993-12:2007(E) © ISO 2007 – All rights reserved 1Biological evaluation of medical devices — Part 12: Sample preparation and reference mat
...
Questions, Comments and Discussion
Ask us and Technical Secretary will try to provide an answer. You can facilitate discussion about the standard in here.