ASTM F2475-05 医疗器件包装材料的生物可兼容性评价的标准指南
The compatibility of packaging materials with a medical device is a requirement of many regulatory bodies. Since most medical devices
Standard Guide for Biocompatibility Evaluation of Medical Device Packaging Materials
NF S92-013:1996 体外诊断系统.医疗用和生物试样的运输包装件.要求.试验
In vitro diagnostic systems. Transport packages for medical and biological specimens. Requirements, tests.
NF X30-507:2018 医疗废物包装 医疗废物 感染性医疗废物内袋纸箱
Packaging for medical waste - Medical waste - Cardboard box with inner bag for infectious medical waste
DB11/T 1032-2013 医疗废物一次性包装箱
Medical waste disposable packing box
KS T 5011-2020 包装.医疗器械运输包装的试验方法
Packaging—Complete, filled transport packages —Test methods for transport packaging of medical devices
CSN 77 0126-1982 医疗药品包装．一般规范
Zpracovatel a oborové normaliza?ní st?edisko: Institut manipula?ních, dopravních, obalov?ch a skladovacích systém?, Praha -Ing. K. Lustig, Ing.
Packages for pharmaceutics General specifications
CSN 77 0125-1982 医疗药品包装．一般规范
Zpracovatel a oborové normaliza?ní st?edisko: Institut manipula?ních, dopravních, obalov?ch a skladovacích systém?, Praha -Ing. B. Ryant Pracovn
Packaging of pharmaceutics General specifications
DIN 96042:2006 医疗器械. 包装. 技术规范
Medical instruments - Packaging - Technical specification
T/SHBX 005-2023 《可灭菌医疗器械包装膜》
本文件规定了可灭菌医疗器械包装膜（以下简称：包装膜）的产品分类、要求、试验方法、检验规则、标识标志、包装、运输、贮存等
Sterilizable packaging films for medical devices
GB/T 19633-2005 最终灭菌医疗器械的包装
1.1 本标准规定了用于最终灭菌医疗器械包装(或是在工厂中生产，或是在医疗保健机构中生产)的一次性使用材料和可再次使用的容器的要求(见第6章)。 1.2 本标准概述了最终灭菌医疗器械制造者对包装过程开发和确认的主要要求(见第7章)。成型和密封被认为是最关键的过程，但其他过程操作也能
Packaging for terminally sterilized medical devices
GOST 1179-1993 医疗用敷料包扎包.技术条件
Medical bandaging packets. Specifications
GOST 22972-1978 医疗包装箱 一般技术要求
Medical packing cases. General technical requirements
CSN 77 0127-1982 医疗药品气候影响防护包装
Zpracovatel a oborové normaliza?ní st?edisko: Institut manipula?ních, dopravních, obalov?ch a skladovacích systém?, Praha -Ing. A. Fuchsov
Protective packaging of pharma- ceutics against climatic effects
BB/T 0059-2012 医疗器械吸塑包装用共挤膜
Co-extruded film for medical device blister packaging
EN 1041:2008+A1:2013 医疗装置制造商提供的信息 包含修改件A1,2013
This European Standard specifies requirements for information to be supplied by a manufacturer for medical devices regulated by Council Directive 90
Information supplied by the manufacturer of medical devices
ASTM F2475-05 医疗器件包装材料的生物可兼容性评价的标准指南
The compatibility of packaging materials with a medical device is a requirement of many regulatory bodies. Since most medical devices
Standard Guide for Biocompatibility Evaluation of Medical Device Packaging Materials
NF S92-013:1996 体外诊断系统.医疗用和生物试样的运输包装件.要求.试验
In vitro diagnostic systems. Transport packages for medical and biological specimens. Requirements, tests.
NF X30-507:2018 医疗废物包装 医疗废物 感染性医疗废物内袋纸箱
Packaging for medical waste - Medical waste - Cardboard box with inner bag for infectious medical waste
DB11/T 1032-2013 医疗废物一次性包装箱
Medical waste disposable packing box
KS T 5011-2020 包装.医疗器械运输包装的试验方法
Packaging—Complete, filled transport packages —Test methods for transport packaging of medical devices
CSN 77 0126-1982 医疗药品包装．一般规范
Zpracovatel a oborové normaliza?ní st?edisko: Institut manipula?ních, dopravních, obalov?ch a skladovacích systém?, Praha -Ing. K. Lustig, Ing.
Packages for pharmaceutics General specifications
CSN 77 0125-1982 医疗药品包装．一般规范
Zpracovatel a oborové normaliza?ní st?edisko: Institut manipula?ních, dopravních, obalov?ch a skladovacích systém?, Praha -Ing. B. Ryant Pracovn
Packaging of pharmaceutics General specifications
DIN 96042:2006 医疗器械. 包装. 技术规范
Medical instruments - Packaging - Technical specification
T/SHBX 005-2023 《可灭菌医疗器械包装膜》
本文件规定了可灭菌医疗器械包装膜（以下简称：包装膜）的产品分类、要求、试验方法、检验规则、标识标志、包装、运输、贮存等
Sterilizable packaging films for medical devices
GB/T 19633-2005 最终灭菌医疗器械的包装
1.1 本标准规定了用于最终灭菌医疗器械包装(或是在工厂中生产，或是在医疗保健机构中生产)的一次性使用材料和可再次使用的容器的要求(见第6章)。 1.2 本标准概述了最终灭菌医疗器械制造者对包装过程开发和确认的主要要求(见第7章)。成型和密封被认为是最关键的过程，但其他过程操作也能
Packaging for terminally sterilized medical devices
GOST 1179-1993 医疗用敷料包扎包.技术条件
Medical bandaging packets. Specifications
GOST 22972-1978 医疗包装箱 一般技术要求
Medical packing cases. General technical requirements
CSN 77 0127-1982 医疗药品气候影响防护包装
Zpracovatel a oborové normaliza?ní st?edisko: Institut manipula?ních, dopravních, obalov?ch a skladovacích systém?, Praha -Ing. A. Fuchsov
Protective packaging of pharma- ceutics against climatic effects
BB/T 0059-2012 医疗器械吸塑包装用共挤膜
Co-extruded film for medical device blister packaging
EN 1041:2008+A1:2013 医疗装置制造商提供的信息 包含修改件A1,2013
This European Standard specifies requirements for information to be supplied by a manufacturer for medical devices regulated by Council Directive 90
Information supplied by the manufacturer of medical devices
编辑：北检院编辑部
