DIN EN ISO 10993-7 Berichtigung 1-2011 Biological evaluation of medical devices - Part 7 Ethylene oxide sterilization residuals (ISO 10993-7 2008) German version EN ISO 10993-7 200.pdf

1、June 2011 Translation by DIN-Sprachendienst.English price group 99No part of this translation may be reproduced without prior permission ofDIN Deutsches Institut fr Normung e. V., Berlin. Beuth Verlag GmbH, 10772 Berlin, Germany,has the exclusive right of sale for German Standards (DIN-Normen).ICS 1

2、1.100.20!$t(Z“1810555www.din.deDThis corrigendum should be filed together withthe translation of the standard to which it refersand a corresponding note made on thetranslation.DIN EN ISO 10993-7 Corrigendum 1Biological evaluation of medical devices Part 7: Ethylene oxide sterilization residuals (ISO

3、 10993-7:2008);Corrigendum 1 to English translation of DIN EN ISO 10993-7:2009-02Biologische Beurteilung von Medizinprodukten Teil 7: Ethylenoxid- Sterilisationsrckstnde (ISO 10993-7:2008);Berichtigung 1 zur englischen bersetzung DIN EN ISO 10993-7:2009-02valuation biologique des dispositifs mdicaux

4、 Partie 7: Rsidus de strilisation loxyde dthylne (ISO 10993-7:2008);Corrigendum 1 la traduction anglaise de DIN EN ISO 10993-7:2009-02www.beuth.deDocument comprises pagesIn case of doubt, the German-language original shall be considered authoritative.307.11 DIN EN ISO 10993-7 Cor. 1:2011-06 This Cor

5、rigendum is based on EN ISO 10993-7:2008/AC:2009. In the English version of DIN EN ISO 10993-7:2009-02 the following corrections are to be made: Re Foreword Insert the following: Foreword This document (EN ISO 10993-7:2008/AC:2009) has been prepared by Technical Committee ISO/TC 194 “Biological eval

6、uation of medical devices” in collaboration with Technical Committee CEN/TC 206 “Biological evaluation of medical devices” the secretariat of which is held by NEN. Endorsement notice The text of ISO 10993-7:2008/Cor 1:2009 has been approved by CEN as EN ISO 10993-7:2008/AC:2009 without any modificat

7、ion. Re Foreword Correct the title of Part 1 to read as follows: Part 1: Evaluation and testing within a risk management process Re Subclause 5.3 “Procedure for product release using residue dissipation curves” Second paragraph, second sentence should read: Dissipation of EO from most materials and

8、devices follows first-order kinetics, i.e. (lnEO) (time after sterilization). Re Equation (A.5) Equation (A.5) should read as follows: () ()2222y xyySxynnn=(A.5) Re Equation (A.6) Equation (A.6) should read as follows: yn= (A.6) 2 DIN EN ISO 10993-7 Cor. 1:2011-06 3 Re F.2.2 “Intraocular lens limits

9、” First paragraph, third sentence should read as follows: This is necessary to prevent documented irritation responses of EO to ocular tissue (see References 44, 117, 118, 119 and 167). Second paragraph, third sentence should read as follows: In such cases, References 44, 117, 118 and 119 indicate t

10、hat the level of ECH that results in ocular toxicity is about four times greater than the corresponding EO level. Re Subclause F.2.5 “Devices used in cardiopulmonary bypass procedures” First paragraph, delete the following sentences: At this UTF, the allowable limit would increase to 21 mg EO. The EO limit reflects manufacturers current ability to remove EO from these rather large devices. Re Subclause J.1.1 Footnote 9) should read as follows: 1 mmHg = 133,322 Pa or 760 mmHg = 101,325 kPa.