发布时间:2024-05-27 17:49:26 - 更新时间:2024年06月29日 15:22
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本标准规定了带有真空阶段(预真空)的蒸汽灭菌器进行蒸汽渗透测试用的过程挑战装置及指示物系统的要求、试验方法。本标准所指的蒸汽渗透测试是基于GB 8599—2008和YY 0646—2008的规定。本标准适用过程挑战装置及指示物系统,包括多孔负载过程挑战装置及指示物系统和空腔负载过程挑战装置及指示物
Specification of process challenge devices and indicator systems for steam penetration testing
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
Test method to demonstrate the suitability of the process challenge device(PCD)during steam sterilization
Sterilization of health care products — Chemical indicators — Part 6: Type 2 indicators and process challenge devices for use in performance testing of small steam sterilizers
This document specifies the performance requirements and test methods for hollow devices and porous devices as well as the chemical indicators
Sterilization of health care products - Chemical indicators - Part 6: Type 2 indicators and process challenge devices for use in performance testing of small steam sterilizers (ISO 11140-6:2022)
GB 18282的本部分规定了用于已包装的和多孔的负载灭菌用蒸汽灭菌器蒸汽渗透测试中所使用的化学指示物的要求。作此用途的指示物即为ISO 11140-1中所述的二类指示物。 符合GB 18282的本部分要求的指示物应结合符合EN 285要求的标准测试包一并使用。GB 18282的本部分对标准测试包
Sterilization of health care products-Chemical indicators-Part3:Class 2 indicator systems for use in the Bowie and Dick-type steam penetration test
This European Standard specifies the performance requirements for a Class B indicator to be used as an alternative to the Bowie and Dick test
Non-biological systems for use in sterilizers - Specification for indicators as an alternative to the Bowie and Dick test for the detection of steam penetration
GB 18282的本部分规定了二类指示物的性能要求,在针对医疗保健包装产品(如器械和多孔性负载等)灭菌用蒸汽灭菌器进行的BD类测试中,该二类指示物可供选择使用。 符合GB 18282的本部分要求的指示物结合有一种特殊材料作为测试负载。测试负载可以一次性使用,也可以重复使用。GB 18282
Sterilization of health care products-Chemical indicators-Part 4:Class 2 indicators as an alternative to the Bowie and Dick-type test for detection of steam penetration
Sterilization of health care products - Chemical indicators - Class 2 indicator systems for use in the Bowie and Dick-type steam penetration test
ISO 11140-3:2007 specifies the requirements for chemical indicators to be used in the steam penetration test for steam sterilizers for wrapped goods
Sterilization of health care products - Chemical indicators - Class 2 indicator systems for use in the Bowie and Dick-type steam penetration test
This part of ISO 11140 specifies the requirements for chemical indicators to be used in the steam penetration test for steam sterilizers for wrapped
Sterilization of health care products - Chemical indicators - Class 2 indicator systems for use in the Bowie and Dick-type steam penetration test
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
Sterilization of health care products - Chemical indicators - Part 4: Class 2 indicators for steam penetration test packs
Sterilization of health care products - Chemical indicators - Part 3: Class 2 indicator systems for use in the Bowie and Dick-type steam penetration test
Sterilization of health care products - Chemical indicators - Part 3 : class 2 indicator systems for use in the Bowie and Dick-type steam penetration test
Sterilization of health care products - Chemical indicators - Part 3: Class 2 indicator systems for use in the Bowie and Dick-type steam penetration test (ISO 11140-3:2007); German version EN ISO 11140-3:2007, Corrigendum to DIN EN ISO 11140-3:2007-07; Ge
本标准规定了过氧化氢低温等离子体灭菌过程挑战装置(PCD)的试验原理、检测方 法、 测试结果评价及注意事项。 本标准适用于生物过程挑战装置、化学过程挑战装置、生物化学 综合过程挑战装置
Test method of the process challenge device(PCD)during low-temperature plasma of hydrogen peroxide
本标准规定了带有真空阶段(预真空)的蒸汽灭菌器进行蒸汽渗透测试用的过程挑战装置及指示物系统的要求、试验方法。本标准所指的蒸汽渗透测试是基于GB 8599—2008和YY 0646—2008的规定。本标准适用过程挑战装置及指示物系统,包括多孔负载过程挑战装置及指示物系统和空腔负载过程挑战装置及指示物
Specification of process challenge devices and indicator systems for steam penetration testing
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
Test method to demonstrate the suitability of the process challenge device(PCD)during steam sterilization
Sterilization of health care products — Chemical indicators — Part 6: Type 2 indicators and process challenge devices for use in performance testing of small steam sterilizers
This document specifies the performance requirements and test methods for hollow devices and porous devices as well as the chemical indicators
Sterilization of health care products - Chemical indicators - Part 6: Type 2 indicators and process challenge devices for use in performance testing of small steam sterilizers (ISO 11140-6:2022)
GB 18282的本部分规定了用于已包装的和多孔的负载灭菌用蒸汽灭菌器蒸汽渗透测试中所使用的化学指示物的要求。作此用途的指示物即为ISO 11140-1中所述的二类指示物。 符合GB 18282的本部分要求的指示物应结合符合EN 285要求的标准测试包一并使用。GB 18282的本部分对标准测试包
Sterilization of health care products-Chemical indicators-Part3:Class 2 indicator systems for use in the Bowie and Dick-type steam penetration test
This European Standard specifies the performance requirements for a Class B indicator to be used as an alternative to the Bowie and Dick test
Non-biological systems for use in sterilizers - Specification for indicators as an alternative to the Bowie and Dick test for the detection of steam penetration
GB 18282的本部分规定了二类指示物的性能要求,在针对医疗保健包装产品(如器械和多孔性负载等)灭菌用蒸汽灭菌器进行的BD类测试中,该二类指示物可供选择使用。 符合GB 18282的本部分要求的指示物结合有一种特殊材料作为测试负载。测试负载可以一次性使用,也可以重复使用。GB 18282
Sterilization of health care products-Chemical indicators-Part 4:Class 2 indicators as an alternative to the Bowie and Dick-type test for detection of steam penetration
Sterilization of health care products - Chemical indicators - Class 2 indicator systems for use in the Bowie and Dick-type steam penetration test
ISO 11140-3:2007 specifies the requirements for chemical indicators to be used in the steam penetration test for steam sterilizers for wrapped goods
Sterilization of health care products - Chemical indicators - Class 2 indicator systems for use in the Bowie and Dick-type steam penetration test
This part of ISO 11140 specifies the requirements for chemical indicators to be used in the steam penetration test for steam sterilizers for wrapped
Sterilization of health care products - Chemical indicators - Class 2 indicator systems for use in the Bowie and Dick-type steam penetration test
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
Sterilization of health care products - Chemical indicators - Part 4: Class 2 indicators for steam penetration test packs
Sterilization of health care products - Chemical indicators - Part 3: Class 2 indicator systems for use in the Bowie and Dick-type steam penetration test
Sterilization of health care products - Chemical indicators - Part 3 : class 2 indicator systems for use in the Bowie and Dick-type steam penetration test
Sterilization of health care products - Chemical indicators - Part 3: Class 2 indicator systems for use in the Bowie and Dick-type steam penetration test (ISO 11140-3:2007); German version EN ISO 11140-3:2007, Corrigendum to DIN EN ISO 11140-3:2007-07; Ge
本标准规定了过氧化氢低温等离子体灭菌过程挑战装置(PCD)的试验原理、检测方 法、 测试结果评价及注意事项。 本标准适用于生物过程挑战装置、化学过程挑战装置、生物化学 综合过程挑战装置
Test method of the process challenge device(PCD)during low-temperature plasma of hydrogen peroxide