醫用滅菌器檢測

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YY/T 0698.5-2009終滅菌醫療器械包裝材料.第5部分:透氣材料與塑料膜組成的可密封組合袋和卷材.要求和試驗方法

YY/T 0698的本部分規定了用符合YY/T 0698第3部分、第6部分、第7部分、第9部分或第10部分透氣材料和符合本部分4.2.2規定的塑料膜組成的可密封組合袋和卷材的要求和試驗方法。本部分未對ISO 11607-1的通用要求增加要求，這樣，4.2～4.5中的專用要求可用以證實符合ISO 11607-1的一項或多項要求，但不是其全部要求。本部分規定的可密封組合袋和卷材適用于終滅菌的醫療器械的包裝。可密封組合袋和卷材作為預成形無菌屏障系統，重要的是使使用者在打開包裝前能看到內裝物，以便于無菌操作。

YY/T 1402-2016醫療器械蒸汽滅菌過程挑戰裝置適用性的測試方法

本標準規定了證實過程挑戰裝置在除氣及蒸汽滲透方面比其模擬的醫療器械更難達到滅菌條件的測試方法。該過程挑戰裝置適用于符合GB 8599-2008要求的大型滅菌器和YY 0646-2008要求的小型滅菌器（含B型周期）。本標準中確認合格的過程挑戰裝置僅對被模擬的醫療器械有效。本標準沒有規定過程挑戰裝置的設計及材料。

NF S98-012-2014醫用滅菌器.低溫蒸汽和甲醛滅菌器.試驗和要求

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醫用滅菌器. 環氧乙烷滅菌器. 要求和試驗方法

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

TS EN 1422-2016醫用滅菌器. 環氧乙烷滅菌器. 要求和試驗方法

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醫用滅菌器. 低溫蒸汽和甲醛滅菌器. 要求和試驗方法

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醫用滅菌器. 低溫蒸汽和甲醛滅菌器. 要求和試驗方法

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

DIN 58948-17-2016消毒.低溫消毒器.第17部分:低溫蒸汽甲醛和甲醛消毒器及其電源的安裝和操作用要求

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醫用滅菌器.環氧乙烷滅菌器.要求和試驗方法;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