无菌试验隔离 标准查询与下载

JB/T 20175-2017 无菌隔离器

本标准规定了无菌隔离器的术语和定义、分类和标记、要求、试验方法、检验规则、标志、使用说明书、包装、运输和贮存。 本标准适用于无菌生产及无菌检查使用的无菌隔离器(以下简称“隔离器

Aseptic isolators

JB/T 20175-2016 无菌隔离器

Sterile isolator

T/CALAS 72-2019 实验动物 无菌猪隔离器

用途、结构类型和尺寸、要求、试验方法、检验规则标志、包装、运输、储存

Laboratory animals - Isolator of germ-free pigs

BS EN ISO 13408-6:2021 保健品的无菌加工 隔离系统

Aseptic processing of health care products. Isolator systems

NF S98-117-6/A1:2013 保健产品的无菌加工 - 第6部分: 无菌隔离系统 - 修正本1

Aseptic processing of health care products - Part 6: isolator systems - Amendment 1

ISO 13408-6:2006/Amd 1:2013 保健产品的无菌加工.第6部分:无菌隔离系统.修改件1

Aseptic processing of health care products - Part 6: Isolator systems; Amendment 1

ANSI/AAMI/ISO 13408-6:2005 保健品无菌加工 第6部分：隔离系统

Specifies the requirements for isolator systems used for aseptic processing and offers guidance on qualification, bio-decontamination, validation

Aseptic processing of health care products - Part 6:Isolator systems

DS/ISO 13408-6:2021 保健品无菌加工 第6部分：隔离系统

Aseptic processing of health care products – Part 6: Isolator systems

NF EN ISO 13408-6:2021 保健品无菌加工第 6 部分：隔离系统

Aseptic processing of health products - Part 6: isolator systems

348药典 四部-2020 9000 指导原则 9206 无菌检查用隔离系统验证指导原则

无

9000 Guidelines 9206 Guidelines for the Validation of Isolation Systems for Sterility Testing

329药典 四部-2015 9000 指导原则 9206 无菌检查用隔离系统验证指导原则

无

9000 Guidelines 9206 Guidelines for the Validation of Isolation Systems for Sterility Testing

NF S98-117-6:2011 保健品无菌处理.第6部分:隔离器系统.

Aseptic processing of health care products - Part 6 : isolator systems.

DS/EN ISO 13408-6:2011 保健品的无菌加工 第6部分：隔离系统

ISO 13408-6:2005 specifies the requirements for isolator systems used for aseptic processing and offers guidance on qualification, bio-decontamination

Aseptic processing of health care products - Part 6: Isolator systems

DS/EN ISO 13408-6/A1:2013 保健品的无菌加工 第6部分：隔离系统

ISO 13408-6:2005 specifies the requirements for isolator systems used for aseptic processing and offers guidance on qualification, bio-decontamination

Aseptic processing of health care products - Part 6: Isolator systems

UNI EN ISO 13408-6:2021 保健品的无菌加工 第6部分：隔离系统

Aseptic processing of health care products - Part 6: Isolator systems