BS EN 868-8-2009 灭菌医疗装置的包装.符合EN 285标准的蒸汽灭菌器用再用灭菌容器.要求和测试方法.pdf
《BS EN 868-8-2009 灭菌医疗装置的包装.符合EN 285标准的蒸汽灭菌器用再用灭菌容器.要求和测试方法.pdf》由会员分享,可在线阅读,更多相关《BS EN 868-8-2009 灭菌医疗装置的包装.符合EN 285标准的蒸汽灭菌器用再用灭菌容器.要求和测试方法.pdf(22页珍藏版)》请在三一文库上搜索。
1、 W - - - - - - - - - - - - - 7 - - 7 -7-7- - - 7- -7- -7- - - 7- - $ - - 1 mm when tested in accordance with Annex C. If a permanent deformation is measured, performance characteristics of the container (in particular sterile barrier properties) shall be demonstrated to remain unchanged. EN 868-8:20
2、09 (E) 7 4.2.6 Stacking capability 4.2.6.1 The top and base of each container shall be sufficiently strong to allow stacking and shall be fitted with means to ensure that all containers of the same nominal size and of the same provenance shall stack securely. After the test in accordance with Annex
3、D, the container shall show no permanent deformation 1 mm and shall have unchanged performance characteristics. When tested in accordance with Annex E, the tested container shall remain stacked. 4.2.6.2 The containers shall be designed and constructed so that when stacked and loaded into the sterili
4、zer in the manner specified by the manufacturer they will allow free passage of steam and/or air between containers. Compliance shall be tested by the performance tests carried out as described in Annex C to F. 4.2.7 Sterilant Port 4.2.7.1 Each container shall be provided with a sterilant port in on
5、e or more of its principle surfaces. 4.2.7.2 The sterilant port shall be designed to meet the following requirements: a) It shall permit the attainment of the specified sterilization conditions. Compliance shall be tested in accordance with Annex F. b) It shall permit adequate drying when processed
6、in a sterilizer conforming to EN 285. Compliance shall be tested in accordance with Annex G. c) It shall permit microbial barrier properties during removal, transport and subsequent storage as specified in EN ISO 11607-1:2006, 5.1.10 b). Compliance shall be tested in accordance with applicable barri
7、er tests (see EN ISO 11607-1:2006). NOTE A condensate drain is considered to be a sterilant port. 4.2.8 Load A full size container, i.e. of one sterilization module size, shall be designed and constructed to allow a total load of up to 10 kg to be sterilized in a sterilizer conforming to EN 285. Fra
8、ctional sizes shall accommodate proportionally smaller loads. NOTE National or regional legislation on occupational health and work safety may require a limitation or restriction of the acceptable weight to handle. 4.3 Service life The sterilization container and its components shall, when processed
9、 in accordance with the provided instructions for use, meet all requirements during its useful life as it is stated by the manufacturer. NOTE 1 The manufacturers instructions include also important information on service, cleaning procedures, the manner of inspection and acceptance criteria, mainten
10、ance and replacement of components (see e.g. ISO 11607-1:2006, 5.1.10) EN 868-8:2009 (E) 8 NOTE 2 500 cycles are considered a minimum as a useful life for containers and 100 cycles as a minimum for specific components like gaskets. For demonstration of compliance, using accelerated aging protocols s
11、hall be regarded as sufficient challenge until data from real-time aging studies are available. NOTE 3 For guidance on determination of useful life, see Annex H. 4.4 Material requirements 4.4.1 The container and its components shall be able to withstand (both chemical and physical) steam sterilizati
12、on in a sterilizer conforming to EN 285 without any adverse effects on the container or its components. Compliance with EN ISO 11607-1:2006, 5.3 shall be tested: a) in a container which has been subjected to the stated number of use cycles; and b) on a container which has been subjected to 5 use-cyc
13、les, stored under ambient conditions with the lid closed for 6 months and then subjected to 5 further use-cycles. 4.4.2 The container and its reusable components shall be able to withstand proper cleaning procedures as indicated by the manufacturer without adverse effect to the container or its comp
14、onents. Compliance with EN ISO 11607-1 shall be tested: a) in a container which has been subjected to the stated number of cleaning procedures as indicated by the manufacturer; and b) on a container which has been subjected to 5 use-cycles, stored under ambient conditions with the lid closed for 6 m
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