ISO 11140-4-2001 保健品消毒 化学指示物 蒸汽穿透试验包装的2级指示物.pdf

标准号：ISO 11140-4-2001
实施状态：作废
中文名称：保健品消毒  化学指示物  蒸汽穿透试验包装的2级指示物
英文名称：Sterilization of health care products - Chemical indicators - Part 4: Class 2 indicators for steam penetration test packs
发布日期：2001-05
被替代标准：ISO 11140-4-2007
代替标准：ISO/FDIS 11140-4-2000
采用标准：DIN EN 867-4-2001,IDT;GOST R ISO 11140-4-2006,IDT
起草单位：ISO/TC 198
标准简介：This part of ISO 11140 specifies the performance requirements for a Class 2 indicator to be used as an alternative to the Bowie and Dick test for steam sterilizers for wrapped health care goods (instruments, etc. and porous loads).
An indicator complying with this part of ISO 11140 incorporates a specified material which is used as a test load. This test load may, or may not, be re-usable. This part of ISO 11140 does not specify requirements for the test load, but specifies the performance of the indicator system in combination with the test load with which it is intended to be used: The indicator specified in this part of ISO 11140 is intended to identify poor steam penetration but does not in-dicate necessarily the cause of this poor steam penetration.
This part of ISO 11140 does not include test methods to establish the suitability of these indicators for use in steriliz-ers in which the air removal stage does not include evacuation below atmospheric pressure.
NOTE  The Bowie and Dick Test is performed to demonstrate conformance of a steam sterilizer for wrapped health care goods to EN 285 and may be used as a routine test of performance of such a sterilizer (see ISO 11134). The test procedure is described in EN 285.
文件格式：PDF
文件大小：321.34KB
文件页数：40
（以上信息更新时间为：2019-11-23）



文档语言及版本参照下方封面截图：