EN ISO 10993-7:2008/AC: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
• 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: 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: FprEN ISO 10993-7 - Biological evaluation of medical devices - Part 7: Ethylene oxide sterilization residuals (ISO/FDIS 10993-7:2025)
• Effective Date: 28-Jan-2023

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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