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CEN

EN ISO 10993-7:2008/AC:2009

(Corrigendum)

Biological evaluation of medical devices - Part 7: Ethylene oxide sterilization residuals - Technical Corrigendum 1 (ISO 10993-7:2008/Cor 1:2009)

Biological evaluation of medical devices - Part 7: Ethylene oxide sterilization residuals - Technical Corrigendum 1 (ISO 10993-7:2008/Cor 1:2009)

Biologische Beurteilung von Medizinprodukten - Teil 7: Ethylenoxid- Sterilisationsrückstände (ISO 10993-7:2008/Cor 1:2009)

Évaluation biologique des dispositifs médicaux - Partie 7: Résidus de stérilisation à l'oxyde d'éthylène - Rectificatif technique 1 (ISO 10993-7:2008/Cor 1:2009)

Biološko ovrednotenje medicinskih pripomočkov - 7. del: Ostanki po sterilizaciji z etilenoksidom - Popravek 1 (ISO 10993-7:2008/Cor 1:2009)

Ta del ISO 10993 določa dopustne meje za ostanke etilenoksida (EO) in etilen klorohidrina (ECH) na posameznem medicinskem pripomočku, steriliziranem z etilenoksidom; postopke za merjenje EO in ECH; in metode za ugotavljanje skladnosti, da se pripomočki lahko sprostijo. Dodatne informacije in vodilo ter prikaz delovnih postopkov, ki razlagajo uporabo standarda, so vključeni v informativne dodatke. Ta standard ne zajema pripomočkov, steriliziranih z etilenoksidom, ki niso v stiku z bolnikom (npr. diagnostičnih preskusnih sistemov in vitro).

General Information

Status
Published
Publication Date
14-Nov-2009
ICS
11.100.20 - Biological evaluation of medical devices
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
6060 - Definitive text made available (DAV) - Publishing
Start Date
15-Nov-2009
Completion Date
15-Nov-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
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 10993-7:2009/AC:2010 - Biological evaluation of medical devices - Part 7: Ethylene oxide sterilization residuals - Technical Corrigendum 1 (ISO 10993-7:2008/Cor 1:2009)

Relations

Corrects
EN ISO 10993-7:2008 - Biological evaluation of medical devices - Part 7: Ethylene oxide sterilization residuals (ISO 10993-7:2008)
Effective Date
22-Aug-2009
Revised
prEN ISO 10993-7 - Biological evaluation of medical devices - Part 7: Ethylene oxide sterilization residuals (ISO/DIS 10993-7:2024)
Effective Date
28-Jan-2023

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ISO 10993 - Biological Evaluation of Medical Devices Package
ISO 10993 - Biological Evaluation of Medical Devices Package
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2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.Biologische Beurteilung von Medizinprodukten - Teil 7: Ethylenoxid- Sterilisationsrückstände (ISO 10993-7:2008/Cor 1:2009)Évaluation biologique des dispositifs médicaux - Partie 7: Résidus de stérilisation à l'oxyde d'éthylène - Rectificatif technique 1 (ISO 10993-7:2008/Cor 1:2009)Biological evaluation of medical devices - Part 7: Ethylene oxide sterilization residuals - Technical Corrigendum 1 (ISO 10993-7:2008/Cor 1:2009)11.100.20Biological evaluation of medical devicesICS:Ta slovenski standard je istoveten z:EN ISO 10993-7:2008/AC:2009SIST EN ISO 10993-7:2009/AC:2010en01-marec-2010SIST EN ISO 10993-7:2009/AC:2010SLOVENSKI
STANDARD
EUROPEAN STANDARD NORME EUROPÉENNE EUROPÄISCHE NORM
EN ISO 10993-7:2008/AC
November 2009
Novembre 2009
November 2009 ICS 11.100.20 English version Version Française Deutsche Fassung
Biological evaluation of medical devices - Part 7: Ethylene oxide sterilization residuals - Technical Corrigendum 1 (ISO 10993-7:2008/Cor 1:2009)
Évaluation biologique des dispositifs médicaux - Partie 7: Résidus de stérilisation à l'oxyde d'éthylène - Rectificatif technique 1 (ISO 10993-7:2008/Cor 1:2009)
Biologische Beurteilung von Medizinprodukten - Teil 7: Ethylenoxid- Sterilisationsrückstände (ISO 10993-7:2008/Cor 1:2009) This corrigendum becomes effective on 15 November 2009 for incorporation in the three official language versions of the EN.
Ce corrigendum prendra effet le 15 novembre 2009 pour incorporation dans les trois versions linguistiques officielles de la EN.
Die Berichtigung tritt am 15.November 2009 zur Einarbeitung in die drei offiziellen Sprachfassungen der EN in Kraft.
EUROPEAN COMMITTEE FOR STANDARDIZATION
COMITÉ EUROPÉEN DE NORMALISATION EUROPÄISCHES KOMITEE FÜR NORMUNG
Management Centre:
Avenue Marnix 17,
B-1000 Brussels © 2009 CEN All rights of exploitation in any form and by any means reserved worldwide for CEN national Members. Tous droits d'exploitation sous quelque forme et de quelque manière que ce soit réservés dans le monde entier aux membres nationaux du CEN. Alle Rechte der Verwertung, gleich in welcher Form und in welchem Verfahren, sind weltweit den nationalen Mitgliedern von CEN vorbehalten. Ref. No.:EN ISO 10993-7:2008/AC:2009 D/E/FSIST EN ISO 10993-7:2009/AC:2010
...

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This document specifies the process and requirements for the toxicological risk assessment of medical device constituents. The methods and criteria used to assess whether exposure to a constituent is without appreciable harm are also specified. The toxicological risk assessment can be part of the biological evaluation of the final product, as described in ISO 10993-1.
The process described in this document applies to chemical characterization information obtained in line with ISO 10993-18. When a toxicological risk assessment of either the compositional information or analytical chemistry data (e.g. extractable data or leachable data) are required to determine whether the toxicological risks related to the constituents are negligible or tolerable.
The process described in this document is not intended to apply to circumstances where the toxicological risk has been estimated by other means, such as:
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This document specifies the minimum requirements to be satisfied to ensure and demonstrate that proper provision has been made for the welfare of animals used in animal tests to assess the biocompatibility of materials used in medical devices. It is aimed at those who commission, design and perform tests or evaluate data from animal tests undertaken to assess the biocompatibility of materials intended for use in medical devices, or that of the medical devices themselves.
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This document provides general principles for the systematic evaluation of the potential and observed degradation of medical devices through the design and performance of in vitro degradation studies. Information obtained from these studies can be used in the biological evaluation described in the ISO 10993 series.
This document is applicable to both materials designed to degrade in the body as well as materials that are not intended to degrade.
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This document specifies requirements and gives guidance on the procedures in the preparation of samples and the selection of reference materials for medical device testing primarily in biological test systems primarily in accordance with one or more parts of the ISO 10993 series.
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This document specifies:
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—          the identification of gaps in the available data set on the basis of a risk analysis;
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—          the assessment of the biological safety of the medical device.
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This document is applicable to biological evaluation of all types of medical devices including active, non-active, implantable and non-implantable medical devices.
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—          breakage of a medical device or medical device component which exposes body tissue to new or novel materials.
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