AnnexA(normative).PDFVIP

Annex A (normative) Test soil and method for surgical instruments, Austria 附录A （提供资料） 奥地利手术器械的测试污物及方法 A.1 Reference The test methods using a heparinized blood test soil for testing and evaluating the cleaning efficacy of automated WDs for surgical instruments as an optional type test and operational test are based on [34] and were adapted or complemented for this presentation. A.1参考文献 用肝素化血液测试污物来测试和评价手术器械自动化WD清洁效力的测试方法，以此作为典型试验和操作试验的一个选择， 是以参考文献[34]为依据，并为这一规范进行了修改或补充。 A.2 Materials blood freshly drawn from a laboratory sheep; heparin; NOTE 1 An example of a suitable product is: Liquemin 5000, Roche AG, Emil-Barell-Str. 1, 79639 Grenzach-Wyhlen, 1) Germany. protamin sulphate or hydrochloride; NOTE 2 An example of a suitable product is: Protamin ICN 1000, ICN Pharmaceuticals Germany GmbH, Bolongarostr. 82-84, 1) 65929 Frankfurt/Main, Germany. NOTE 3 An example of a suitable testkit ready for use is available at Acila AG, Opelstra?e 14, 64546 M?rfelden-Walldorf, 1) Germany. optional: cleaning-indicators for ordinary surgical instruments; NOTE 4 An example of a suitable product is: TOSI-check, BAG Biologische Analysensysteme GmbH, Amtsgerichtsstra?e 1) 1-5, 35423 Lich, Germany. cleaning-indicators for instruments for minimal invasive surgery. NOTE 5 An example of a suitable product is: TOSI-LumCheck, BAG Biologische Analysensysteme GmbH, Amtsgerichtsstra?e 1) 1-5, 35423 Lich, Germany. A.2材料 ‐ 取自实验室绵羊的新鲜血液 ‐ 肝素 注1：适当产品的一个例子是：肝素钠5000 ，罗氏公司，Emil-Barell-Str. 1, 79639 Grenzach-W