医用灭菌器检测

发布时间：2024-06-21 作者：中析研究所浏览：

YY/T 0698.5-2009终灭菌医疗器械包装材料.第5部分:透气材料与塑料膜组成的可密封组合袋和卷材.要求和试验方法

YY/T 0698的本部分规定了用符合YY/T 0698第3部分、第6部分、第7部分、第9部分或第10部分透气材料和符合本部分4.2.2规定的塑料膜组成的可密封组合袋和卷材的要求和试验方法。本部分未对ISO 11607-1的通用要求增加要求，这样，4.2～4.5中的专用要求可用以证实符合ISO 11607-1的一项或多项要求，但不是其全部要求。本部分规定的可密封组合袋和卷材适用于终灭菌的医疗器械的包装。可密封组合袋和卷材作为预成形无菌屏障系统，重要的是使使用者在打开包装前能看到内装物，以便于无菌操作。

YY/T 1402-2016医疗器械蒸汽灭菌过程挑战装置适用性的测试方法

本标准规定了证实过程挑战装置在除气及蒸汽渗透方面比其模拟的医疗器械更难达到灭菌条件的测试方法。该过程挑战装置适用于符合GB 8599-2008要求的大型灭菌器和YY 0646-2008要求的小型灭菌器（含B型周期）。本标准中确认合格的过程挑战装置仅对被模拟的医疗器械有效。本标准没有规定过程挑战装置的设计及材料。

NF S98-012-2014医用灭菌器.低温蒸汽和甲醛灭菌器.试验和要求

La présente Norme européenne spécifie les exigences et les essais relatifs aux stérilisateurs à la vapeur et au formaldéhyde à basse température, utilisant comme agent stérilisant un mélange à basse température de vapeur d'eau et de formaldéhyde et fonctionnant uniquement à une pression inférieure à la pression atmosphérique.

TS EN 1422-2014医用灭菌器. 环氧乙烷灭菌器. 要求和试验方法

TS EN 1422-2016医用灭菌器. 环氧乙烷灭菌器. 要求和试验方法

This Standard specifies the requirements and the relevant tests for automatically controlled sterilizers employing ethylene oxide (EO) gas as the sterilant, either as a pure gas or a mixture with other gases, being used for the sterilization of medical devices and their accessories. This Standard specifies requirements for ethylene oxide sterilizers (EO-sterilizers) working at super or sub-atmospheric pressure for: ? the performance and design of sterilizers to ensure that the process is capable of sterilizing medical devices; ? the equipment and controls of these sterilizers necessary for the validation and routine control of the sterilization processes. The test loads described in this European Standard are selected to represent a number of loads for the evaluation of the performance of EO sterilizers for medical devices. However, specific loads may require the use of other test loads. This Standard does not specify those tests which are necessary to determine the probability of a processed product being sterile, nor the routine quality control tests required prior to release of sterile product. These topics are addressed in prEN ISO 11135:2012. This Standard does not specify requirements for occupational safety associated with the design and operation of EO sterilization facilities. NOTE 1 For further information on safety, see examples in the Bibliography. National or regional regulations can exist. This Standard does not cover sterilizers which employ the injection of EO or mixtures containing EO directly into packages or into a flexible chamber. NOTE 2 See EN ISO 14937. This Standard is not intended as a checklist for suitability of an existing EO sterilizer when assessing compliance with prEN ISO 11135:2012. This standard is not intended to be applied retrospectively. This Standard does not cover analytical methods for determining levels of residual EO and/or its reaction products. NOTE 3 For further information see ISO 10993-7.

TS EN 14180-2014医用灭菌器. 低温蒸汽和甲醛灭菌器. 要求和试验方法

This Standard specifies requirements and tests for LTSF sterilizers, which use a mixture of low temperature steam and formaldehyde as sterilizing agent, and which are working below ambient pressure only

TS EN 14180-2015医用灭菌器. 低温蒸汽和甲醛灭菌器. 要求和试验方法

DIN 58948-17-2016消毒.低温消毒器.第17部分:低温蒸汽甲醛和甲醛消毒器及其电源的安装和操作用要求

This standard specifies requirements for the installation and operation of low temperature steam and formaldehyde sterilizers and their supply sources for use in health care facilities, primarily for the sterilization of thermolabile medical decvices.

DIN EN 1422-2014医用灭菌器.环氧乙烷灭菌器.要求和试验方法;德文版本EN 1422-2014

This European Standard specifies the requirements and the relevant tests for automatically controlled sterilizers employing ethylene oxide (EO) gas as the sterilant, either as a pure gas or a mixture with other gases, being used for the sterilization of medical devices and their accessories. This European Standard specifies requirements for ethylene oxide sterilizers (EO-sterilizers) working at super or sub-atmospheric pressure for:

the performance and design of sterilizers to ensure that the process is capable of sterilizing medical devices;

the equipment and controls of these sterilizers necessary for the validation and routine control of the sterilization processes.

The test loads described in this European Standard are selected to represent a number of loads for the evaluation of the performance of EO sterilizers for medical devices. However, specific loads may require the use of other test loads. This European Standard does not specify those tests which are necessary to determine the probability of a processed product being sterile, nor the routine quality control tests required prior to release of sterile product. These topics are addressed in prEN ISO 11135:2012. This European Standard does not specify requirements for occupational safety associated with the design and operation of EO sterilization facilities. NOTE 1 For further information on safety, see examples in the Bibliography. National or regional regulations can exist. This European Standard does not cover sterilizers which employ the injection of EO or mixtures containing EO directly into packages or into a flexible chamber. NOTE 2 See EN ISO 14937. This European Standard is not intended as a checklist for suitability of an existing EO sterilizer when assessing compliance with prEN ISO 11135:2012. This standard is not intended to be applied retrospectively. This European Standard does not cover analytical methods for determining levels of residual EO and/or its reaction products