1、 December 2006DIN EN 556-1 Corrigendum 1 ICS 11.080.01 Sterilization of medical devices Requirements for medical devices to be designated “STERILE” Part 1: Requirements for terminally sterilized medical devices Corrigendum 1 to English version of DIN EN 556-1:2002-03 Sterilisation von Medizinprodukt
2、en Anforderungen an Medizinprodukte, die als STERIL“ gekennzeichnet werden Teil 1: Anforderungen an Medizinprodukte, die in der Endpackung sterilisiert wurden Berichtigung 1 zur englischen Fassung DIN EN 556-1:2002-03 Document comprises 2 pages No part of this standard may be reproduced without prio
3、r permission of DIN Deutsches Institut fr Normung e. V., Berlin. Beuth Verlag GmbH, 10772 Berlin, Germany, has the exclusive right of sale for German Standards (DIN-Normen). English price group 99 www.din.de www.beuth.de !,vqe“04.07 9837866This corrigendum should be filed together withthe translatio
4、n of the standard to which it refers and a corresponding note made on the translation. DIN EN 556-1 Corr 1:2006-12 2 This Corrigendum is based on EN 556-1:2001/AC:2006, issued by CEN. In the English version of DIN EN 556-1:2002-03 the following corrections are to be made: Re Note to 4.1 Delete the s
5、econd sentence (beginning “Such permission requires”) and replace it by the following: “Such permission depends on the individual situation, including consideration of the risk management activities (see, for example, EN ISO 14971) undertaken by the manufacturer of the medical device.” Re Bibliography Delete reference 7 to EN 1441 and replace it with 7 EN ISO 14971:2000, Medical devices Application of risk management to medical devices (ISO 14971:2000)
