消毒类医疗器械检测

📅 发布时间:2024-05-27 👤 来源:北检院 👁 阅读:

T/CAS 404-2020 家用和似用途水平食具

1 范围 本标准规定了家用和类似用途医疗器械消毒水平食具消毒柜的术语和定义、分类与命名、技术要求、试验方法、检验规则及标志、包装、运输和贮存。 本标准适用于额定电压220V~240V,额定频率50Hz,以电能作为主要能源的家用和类似用途医疗器械消毒水平食具消毒柜(以下简称“消毒柜”)。 本标准

Household and similar disinfecting tableware cabinets that reach the level for disinfecting medical items

DS/EN 556:1995 .标上“已”标签的的要求

1 This European Standard specifies the requirements for a terminally-sterilized medical device to be labelled 'STERILE'. NOTE. For the purposes

Sterilization of medical devices - Requirements for medical devices to be labelled "Sterile"

NF S98-136:2009 .机构预备工作的相关风险管理

Sterilisation of medical devices - Risk management related to the preparation of sterile medical devices within health establishments.

AS/NZS 4815 Set:2008 (全套)

Sterilising Medical instruments Set

EN 556-2:2003 .标明为""的的要求.第2部分:处理的的要求

This European Standard specifies the requirements for an aseptically processed medical deviceto be designated 'STERILE'.NOTE ForThe purpose

Sterilization of medical devices Requirements for medical devices to be designated STERILE Part 2: Requirements for aseptically processed medical devices

EN 556-2:2015 .标明为 的要求.第2部分:处理的的要求

This European Standard specifies the requirements for an aseptically processed medical device to be designated 'STERILE'. NOTE For the purpose

"Sterilization of medical devices - Requirements for medical devices to be designated ""STERILE"" - Part 2: Requirements for aseptically processed medical devices"

NF S98-107-1*NF EN 556-1:2002 对要标明"已"字样的的要求 第1部分:定期要求

Sterilization of medical devices - Requirements for medical devices to be designated STERILE - Part 1 : requirements for terminally sterilized medical devices

BS EN ISO 17664:2004 .生产商提供的可再的处理信息

ISO 17664:2004 specifies the information to be provided by the medical device manufacturer on the processing of medical devices claimed

Sterilization of medical devices - Information to be provided by the manufacturer for the processing of resterilizable medical devices

GB 27949-2020 剂通用要求

本标准规定了医疗器械消毒、灭菌用化学消毒剂的原料要求、技术要求、检验方法、使用方法、标识、包装、储存及运输要求。 本标准适用于医疗器械用消毒剂。 本标准不适用于带消毒因子发生装置的消毒器械及气体类或在特定条件下气(汽)化后发挥作用的消毒、灭菌产品

General requirements of disinfectant of medical instruments

GB/T 27949-2011 剂卫生要求

本标准规定了医疗器械消毒剂的技术要求、试验方法、使用方法、标志、标签和说明书及注意事项。 本标准适用于医疗器械消毒、灭菌用消毒剂。 本标准不适用于带消毒因子发生装置的消毒器械及气体类或在特定条件下气化后发挥作用的消毒、灭菌产品

Hygienic requirements for medical items disinfection

ISO 17664:2004 .生产商提供的可重复的处理信息

This standard specifies the information to be provided by the medical device manufacturer on the processing of medical devices claimed

Sterilization of medical devices - Information to be provided by the manufacturer for the processing of resterilizable medical devices

DIN EN 556-2:2004 .标有""字样的的要求.第2部分:经菌处理的的要求

Sterilization of medical devices - Requirements for medical devices to be designated "STERILE" - Part 2: Requirements for aseptically processed medical devices; German version EN 556-2:2003

GB 27949-2011 剂通用要求

General Requirements for Disinfectants for Medical Devices

GOST R ISO 20857-2016 . 干热. 方法的制定, 确认和常规控制要求

Sterilization of medical devices. Dry heat. Requirements for development, validation and routine control of a sterilization process for medical devices

NF S98-107-2:2004 .对标有""字样的的要求.第2部分:经菌处理的的要求

"Sterilization of medical devices - Requirements for medical devices to be designated ""STERILE"" - Part 2 : requirements for aseptically processed medical devices".

T/CAS 404-2020 家用和似用途水平食具

1 范围 本标准规定了家用和类似用途医疗器械消毒水平食具消毒柜的术语和定义、分类与命名、技术要求、试验方法、检验规则及标志、包装、运输和贮存。 本标准适用于额定电压220V~240V,额定频率50Hz,以电能作为主要能源的家用和类似用途医疗器械消毒水平食具消毒柜(以下简称“消毒柜”)。 本标准

Household and similar disinfecting tableware cabinets that reach the level for disinfecting medical items

DS/EN 556:1995 .标上“已”标签的的要求

1 This European Standard specifies the requirements for a terminally-sterilized medical device to be labelled 'STERILE'. NOTE. For the purposes

Sterilization of medical devices - Requirements for medical devices to be labelled "Sterile"

NF S98-136:2009 .机构预备工作的相关风险管理

Sterilisation of medical devices - Risk management related to the preparation of sterile medical devices within health establishments.

AS/NZS 4815 Set:2008 (全套)

Sterilising Medical instruments Set

EN 556-2:2003 .标明为""的的要求.第2部分:处理的的要求

This European Standard specifies the requirements for an aseptically processed medical deviceto be designated 'STERILE'.NOTE ForThe purpose

Sterilization of medical devices Requirements for medical devices to be designated STERILE Part 2: Requirements for aseptically processed medical devices

EN 556-2:2015 .标明为 的要求.第2部分:处理的的要求

This European Standard specifies the requirements for an aseptically processed medical device to be designated 'STERILE'. NOTE For the purpose

"Sterilization of medical devices - Requirements for medical devices to be designated ""STERILE"" - Part 2: Requirements for aseptically processed medical devices"

NF S98-107-1*NF EN 556-1:2002 对要标明"已"字样的的要求 第1部分:定期要求

Sterilization of medical devices - Requirements for medical devices to be designated STERILE - Part 1 : requirements for terminally sterilized medical devices

BS EN ISO 17664:2004 .生产商提供的可再的处理信息

ISO 17664:2004 specifies the information to be provided by the medical device manufacturer on the processing of medical devices claimed

Sterilization of medical devices - Information to be provided by the manufacturer for the processing of resterilizable medical devices

GB 27949-2020 剂通用要求

本标准规定了医疗器械消毒、灭菌用化学消毒剂的原料要求、技术要求、检验方法、使用方法、标识、包装、储存及运输要求。 本标准适用于医疗器械用消毒剂。 本标准不适用于带消毒因子发生装置的消毒器械及气体类或在特定条件下气(汽)化后发挥作用的消毒、灭菌产品

General requirements of disinfectant of medical instruments

GB/T 27949-2011 剂卫生要求

本标准规定了医疗器械消毒剂的技术要求、试验方法、使用方法、标志、标签和说明书及注意事项。 本标准适用于医疗器械消毒、灭菌用消毒剂。 本标准不适用于带消毒因子发生装置的消毒器械及气体类或在特定条件下气化后发挥作用的消毒、灭菌产品

Hygienic requirements for medical items disinfection

ISO 17664:2004 .生产商提供的可重复的处理信息

This standard specifies the information to be provided by the medical device manufacturer on the processing of medical devices claimed

Sterilization of medical devices - Information to be provided by the manufacturer for the processing of resterilizable medical devices

DIN EN 556-2:2004 .标有""字样的的要求.第2部分:经菌处理的的要求

Sterilization of medical devices - Requirements for medical devices to be designated "STERILE" - Part 2: Requirements for aseptically processed medical devices; German version EN 556-2:2003

GB 27949-2011 剂通用要求

General Requirements for Disinfectants for Medical Devices

GOST R ISO 20857-2016 . 干热. 方法的制定, 确认和常规控制要求

Sterilization of medical devices. Dry heat. Requirements for development, validation and routine control of a sterilization process for medical devices

NF S98-107-2:2004 .对标有""字样的的要求.第2部分:经菌处理的的要求

"Sterilization of medical devices - Requirements for medical devices to be designated ""STERILE"" - Part 2 : requirements for aseptically processed medical devices".

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