C08 标志、包装、运输、贮存 标准查询与下载

ISO 17351:2013 包装.药品包装上的盲文

Packaging - Braille on packaging for medicinal products

ANSI/NCPDP 20130401-2013 NCPDP专业标准2013年4月1日

NCPDP Specialized Standard 20130401

BB/T 0059-2012 医疗器械吸塑包装用共挤膜

Co-extruded film for medical device blister packaging

BS EN ISO 15223-1:2012 医疗器械.用于医疗器械标签、作标记和提供信息的符号.通用要求

Medical devices. Symbols to be used with medical device labels, labelling and information to be supplied. General requirements

ISO 15223-1:2012 医疗器械.用于医疗器械标签、作标记和提供信息的符号.第1部分:通用要求

Medical devices - Symbols to be used with medical device labels, labelling and information to be supplied - Part 1: General requirements

DIN EN ISO 15378:2012 药品的主要包装材料.以良好加工实践(GMP)为参考ISO 9001-2008应用的特殊要求

Primary packaging materials for medicinal products - Particular requirements for the application of ISO 9001:2008, with reference to Good Manufacturing Practice (GMP) (ISO 15378:2011); German version EN ISO 15378:2011

NF S93-200:2012 药品的主要包装材料.以良好加工实践(GMP)为参考ISO 9001-2008应用的特殊要求

Primary packaging materials for medicinal products - Particular requirements for the application of ISO 9001:2008, with reference to Good Manufacturing Practice (GMP).

BS EN ISO 15378:2011 医药产品用主要包装材料.ISO 9001-2008应用的特定要求,根据优良制造规范(GMP)

Primary packaging materials for medicinal products. Particular requirements for the application of ISO 9001:2008, with reference to Good Manufacturing Practice (GMP)

ISO 15378:2011 医用制品的包装原材料.根据良好加工规范(GMP)应用ISO 9001-2008的特殊要求

Primary packaging materials for medicinal products - Particular requirements for the application of ISO 9001:2008, with reference to Good Manufacturing Practice (GMP)

SN/T 3062.3-2011 进口医疗器械灭菌包装.第3部分：透气材料与塑料膜组成的可密封组合袋和卷材要求和试验方法

SN/T 3062的本部分规定了用于灭菌医疗器械包装的密封袋和卷材的试验方法和要求。 本部分的主要目的是为无菌屏障或包装系统建立起相应标准以保证灭菌的医疗器械的无菌状态。 本部分规定的所有器械均为一次性使用。

Packaging materials for terminally sterilized medical devices for import. Part 3:Sealable pouches and reels of porous materials and plastic film construction. Requirements and test methods

SN/T 3062.4-2011 进口医疗器械灭菌包装.第4部分：材料和预成型无菌屏障系统要求

SN/T 3062的本部分规定了进口医疗器械灭菌包装材料和预成型无菌屏障系统要求和检测方法。 本部分适用于对进口医疗器械灭菌包装材料和预成型无菌屏障系统的检验。 本部分不包括无菌屏障系统的有关药物/设备组合和各阶段生产控制质量保证体系的要求。

Pachaking materials for terminally sterilized medical devices for import.Part 4:Requirements for materials and sterile barrier systems of importing medical device sterilization packaging

SN/T 3061-2011 进口医疗器械灭菌包装检验操作规程

Operational Procedures for Sterilization Packaging Inspection of Imported Medical Devices

SN/T 3062.1-2011 进口医疗器械灭菌包装.第1部分：成形、密封和装配过程的确认要求

SN/T 3062的本部分规定了进口医疗器械灭菌包装过程的开发与确认要求。这些过程包括了预成形无菌屏障系统、屏障系统和包装系统的成形、密封和装配。 本部分适用于对进口医疗器械灭菌预成形无菌屏障系统、屏障系统和包装系统的成形、密封和装配的确认。 本部分不包括无菌制造医疗器械包装要求。

Packing materials for terminally sterilized medical devices for import. Part 1:Validation requirements for forming,sealing and assembly processes

SN/T 3062.2-2011 进口医疗器械灭菌包装.第2部分：纸袋-要求和试验方法

SN/T 3062的本部分规定了用于进出口医疗器械的纸袋的要求和试验方法,其目的是保障最终灭菌医疗器械的无菌要求。 本部分所规定的用于进口医疗器械的纸袋只适用于灭菌包装唯一用途。

Pachaking materials for terminally sterilized medical devices for import.Part 2:Paper bags.Requirements and test methods

JIS T 3217:2011 人体血液及血液成分袋式塑料容器

Plastic collapsible containers for human blood and blood components

JIS T 3233:2011 血样采集用一次性真空容器

Evacuated single-use containers for venous blood specimen collection

DIN EN 15986:2011 医疗器械标签上的使用符号 含邻苯二甲酸盐的医疗器械标签要求 德文版本EN 15986-2011

Symbol for use in the labelling of medical devices - Requirements for labelling of medical devices containing phthalates; German version EN 15986:2011, with CD-ROM

NF S99-015*NF EN 15986:2011 医疗器械标签用符号.含邻苯二甲酸盐医疗器械的标签要求

Symbol for use in the labelling of medical devices - Requirements for labelling of medical devices containing phthalates.

BS EN 15986:2011 医疗设备标记用符号.含有邻苯二甲酸盐医疗设备的标记要求

This European Standard specifies requirements for the labelling of a medical device or parts of a medical device to indicate the presence of phthalates, when required by Annex I of Directive 93/42/EEC Section 7.5, 2 paragraph. This specifically includes the format of a symbol to be used in the labelling. This European Standard does not specify the requirements for information to be supplied with medical devices, which are addressed by EN 980 and EN 1041. This European Standard does not specify the requirements of the 1 and of the 3 paragraphs of Essential Requirement 7.5.

Symbol for use in the labelling of medical devices. Requirements for labelling of medical devices containing phthalates

ASTM D7709-11 药瓶和水泡包装水蒸气透过性(WVTR)的标准试验方法

The purpose of these test methods is to obtain reliable values for WVTR that can be used to discriminate among barrier packages for pharmaceutical products. These test methods will establish a WVTR value that represents the water vapor transmission of the container closure system being evaluated. They are intended for use in evaluating or comparing, or both, the water vapor barrier performance of alternative packages for use in packaging of pharmaceutical products. While these methods were developed for a specific, limited application, they should be suitable for most types and sizes of consumer packages.1.1 The three test methods described herein are for measurement of water vapor transmission rates (WVTRs) of high-barrier multiple-unit containers (bottles), high-barrier single-unit containers (blisters), and quasi-barrier single-unit containers used for packaging pharmaceutical products. The containers are tested closed and sealed. These test methods can be used for all consumer-sized primary containers and bulk primary containers of a size limited only by the dimensions of the equipment and the weighing capacity and sensitivity of the balance. 1.2 These test methods are intended to be of sufficient sensitivity and precision to allow clear discrimination among the levels of barrier packages currently available for pharmaceutical products. 1.3 There are three methods: Method A is for bottles, Method B is for formed barrier blisters, and Method C is for formed quasi-barrier blisters. Methods B and C can be adapted for use with flexible pouches. 1.4 These test methods use gravimetric measurement to determine the rate of weight gain as a result of water vapor transmission into the package and subsequent uptake by a desiccant enclosed within the package. The packages are exposed to environments typical of those used for accelerated stability testing of drug products in the package (typically 40°C/75 % relative humidity [RH]). 1.5 For these methods, balance sensitivity, amount of desiccant, number of blisters per test unit, and weighing frequency were developed in an experiment based on Test Methods E96/E96M. 1.6 Test Methods E96/E96M gives specific instruction on the interactions among weighing frequency, number of data points necessary to establish steady state, minimum weight gain in a weighing period, and balance sensitivity. 1.7 The test methods in this standard were developed specifically for pharmaceutical bottles and blisters as closed container-closure systems. The experiment from which the methods were developed provided an inter-laboratory study from which the precision and bias statement was written. The packages in the study were small bottles and blisters used regularly for pharmaceutical solid oral dosage forms. 1.8 In spite of the specific nature of their application, the test methods in this standard should be suitable for other pharmaceutical packages and most types and sizes of other consumer packages. 1.9 The values stated in SI units are to be regarded as the standard. No other units of measurement are included in this standard. The units of measure for bottles are milligrams per bottle per day (mg/bottle-day) and for blisters, milligrams per blister cavity per day (mg/cavity-day). These units may be used for both standard and referee testing. 1.10 This standard does not purport to address all of the safety concerns, if any, associated with its use. It is the responsibility of the user of this standard to establish appropriate safety and health practice......

Standard Test Methods for Measuring Water Vapor Transmission Rate (WVTR) of Pharmaceutical Bottles and Blisters