SIST EN ISO 10993-7:2009/AC:2010
(Corrigendum)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
- Withdrawn
- Publication Date
- 10-Feb-2010
- Withdrawal Date
- 27-May-2026
- Technical Committee
- VAZ - Healthcare
- Current Stage
- 9900 - Withdrawal (Adopted Project)
- Start Date
- 28-May-2026
- Due Date
- 20-Jun-2026
- Completion Date
- 28-May-2026
- Directive
- Not Harmonized90/385/EEC - Active implantable medical devicesOJ Ref: C 183 OJ Date: 07-Jul-2010
Not Harmonized93/42/EEC - Medical devicesOJ Ref: C 183 OJ Date: 07-Jul-2010
Relations
- Effective Date
- 01-Jul-2026
- Effective Date
- 01-Mar-2010
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Frequently Asked Questions
SIST EN ISO 10993-7:2009/AC:2010 is a corrigendum published by the Slovenian Institute for Standardization (SIST). Its full title is "Biological evaluation of medical devices - Part 7: Ethylene oxide sterilization residuals - Technical Corrigendum 1 (ISO 10993-7:2008/Cor 1:2009)". This standard covers: 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)
SIST EN ISO 10993-7:2009/AC:2010 is classified under the following ICS (International Classification for Standards) categories: 11.100.20 - Biological evaluation of medical devices. The ICS classification helps identify the subject area and facilitates finding related standards.
SIST EN ISO 10993-7:2009/AC:2010 has the following relationships with other standards: It is inter standard links to SIST EN ISO 10993-7:2026, SIST EN ISO 10993-7:2009. Understanding these relationships helps ensure you are using the most current and applicable version of the standard.
SIST EN ISO 10993-7:2009/AC:2010 is associated with the following European legislation: EU Directives/Regulations: 90/385/EEC, 93/42/EEC; Standardization Mandates: M/BC/CEN/89/9. When a standard is cited in the Official Journal of the European Union, products manufactured in conformity with it benefit from a presumption of conformity with the essential requirements of the corresponding EU directive or regulation.
SIST EN ISO 10993-7:2009/AC:2010 is available in PDF format for immediate download after purchase. The document can be added to your cart and obtained through the secure checkout process. Digital delivery ensures instant access to the complete standard document.
Standards Content (Sample)
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.
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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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