C08 标志、包装、运输、贮存 标准查询与下载

ASTM F2475-11 医用装置包装材料生物兼容性评定指南

The compatibility of packaging materials with a medical device is a requirement of many regulatory bodies. Since most medical devices are used or implanted in, around or on the human body, these devices must do no harm. Therefore, the packaging materials that come in contact with the medical device must also be evaluated and determined to be safe for use with the human body in that they have no negative impact on the physical, chemical or biological properties of the device. . This evaluation may include both a study of relevant experience with and actual testing of packaging materials. Such an evaluation may result in the conclusion that no testing is needed if the material has a demonstrable history of safe use in the specific role that is the same as that of the package under design.The medical device manufacturer determines the need for appropriate testing, with consideration of the device/package interactions, if any. The responsibility of the packaging supplier is typically limited to the performance of cytotoxicity testing.1.1 This guide provides information to determine the appropriate testing for biocompatibility of materials (or packaging materials) in sterile barrier systems used to contain a medical device. 1.2 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 practices and to determine the applicability of regulatory limitations prior to use.

Standard Guide for Biocompatibility Evaluation of Medical Device Packaging Materials

ASTM D4774-11e1 麻醉学中使用者用药物标签的标准规格

The objective of this specification is to facilitate identification of drugs in syringes filled by the user. The use of colors is intended only as an aid in identification of drug groups and does not absolve the user from the duty to read the label to correctly identify the drug prior to use. The user may alternatively use black and white labels rather than these colored labels.1.1 This specification covers the size, color, pattern, and type used on labels applied to unlabeled syringes filled by the users or their agents to identify the drug content. This specification is not intended to cover labels applied by the drug manufacturer. 1.2 The values stated in SI units are to be regarded as the recommended values. The use of inch-pound system values, not being exact equivalents, may result in nonconformance with the standard. 1.3 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 practices and determine the applicability of regulatory limitations prior to use.FIG. 1 Standard Background Colors for User Applied Syringe Drug LabelsFIG. 2 Label for an Antagonist DrugFIG. 3 Reversed Plate Printing Used to Identify "SUCCINYLcholine," "EPINEPHrine," and Beta Blockers, "ESMOlol," "LABATolol," and "METOprolol" NoteBold upper-case type is shown for first or first and second syllables of the drug name.FIG. 4 Optional PrintingFIG. 5 Drug Name and DosageFIG. 6 Alternative Label Showing Concentration in Percent and mg/mL

Standard Specification for User Applied Drug Labels in Anesthesiology

ASTM D7709-11e1 医药瓶和泡罩水蒸气透过率(WVTR)测定的标准试验方法

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

BB/T 0057-2010 运输用可充气填充袋

本标准规定了运输用可充气填充袋(以下简称可充气填充袋)的术语和定义、规格、要求、试验方法、检验规则及标志、包装、运输和储存。本标准适用于填充集装器具横向空隙的可充气填充袋的设计、生产、检验与验收。

Pneumatic Dunnage Bag for Transportation

BB/T 0056-2010 聚氨酯现场发泡包装设备

本标准规定了聚氨酯现场发泡包装设备的术语和定义、产品型式与型号标注、要求、试验方法、检验规则及标志、包装、运输和储存。本标准适用于聚氨酯现场发泡包装设备(简称发泡机)的设计、制造与检验。

Polyurethane Foam in-Place Packaging Equipment

YY/T 0698.6-2009 最终灭菌医疗器械包装材料 第6部分：用于低温灭菌过程或辐射灭菌的无菌屏障系统生产用纸 要求和试验方法

Packaging materials for terminally sterilized medical devices-Part 6: Requirements and test methods for paper used in the production of sterile barrier systems for low-temperature sterilization processes or radiation sterilization

NF X30-502:2010 医疗保健废弃物的封装.牙科汞齐废弃物封装.试验和规范.

Packaging for medical care waste - Dental amalgam waste packaging - Tests and specifications.

SN/T 2745-2010 医用包装盘泄漏性无损检测试验方法 二氧化碳法

本标准规定了二氧化碳示踪气体法对医用包装盘泄漏性进行无损检测的试验方法。 本标准适用于检测不密封的及空的医用包装盘在生产设计和制造过程中产生的直径最小为50μm的针孔泄漏，及相同尺寸的裂缝。

Test method for non-destructive detection of leaks in medical packaging trays.CO tracer gas method

DIN EN 15823:2010 包装.药品包装上的盲文.德文版本EN 15823-2010

Packaging - Braille on packaging for medicinal products; German version EN 15823:2010

NF H00-016:2010 包装.医药产品包装上的盲文

Packaging - Braille on packaging for medicinal products.

BS EN 15823:2010 包装.药品用包装上的盲文

This European Standard specifies requirements and provides guidance for the application of Braille to the labelling of medicinal products.

Packaging - Braille on packaging for medicinal products

BS ISO 15375:2010 医用输液瓶.多用途悬吊装置.试验方法和要求

Medical infusion bottles - Suspension devices for multiple use - Requirements and test methods

BS EN ISO 15747:2010 静脉注射用塑料容器

This International Standard contains requirements that relate to the safe handling and the physical, chemical and biological testing of plastic containers for parenterals. This International Standard is applicable to plastic containers for parenterals having one or more chambers and having a total nominal capacity in the range of 50 ml to 5 000 ml such as film bags or blow-moulded plastic bottles for direct administration of infusion (injection) solutions.

Plastic containers for intravenous injections

NF S99-014-2*NF ISO 15223-2:2010 医疗器械.医疗器械标签、作标记和提供信息用符号.第2部分:符号的制定、筛选和批准

Medical devices - Symbols to be used with medical device labels, labelling and information to be supplied - Part 2 : symbol development, selection and validation.

ASTM F2097-10 医用产品用一级软包装的设计和评估标准指南

This design and evaluation guide describes multiple categories for evaluating flexible medical packages and packaging materials. These include safety, barrier properties, durability, package and seal integrity, visibility and appearance, processing, printing ink properties, and package performance. The intent of this design and evaluation guide is to evaluate all cited categories and select those that are applicable. Once the product has been characterized and the sterilization methodology has been defined, there are numerous sets of requirements for any specific package. This design and evaluation guide provides an avenue for assessing these requirements and choosing test methods for both evaluating the package design and monitoring package compliance. Note 18212;Many of the standards included in this guide are consensus standards that are recognized by the United States Food and Drug Administration (FDA). Selection and use of a U.S. FDA recognized consensus standard is voluntary and the sole responsibility of the user in determining its applicability. For further information, consult the U.S. FDA Medical Device Standards Program at http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/Standards/default.htm. Product characterization shall include mass or weight, geometry (length and width, height, and shape) and product composition. All categories must be considered for applicability. The Summary of Test Methods for Medical Packaging Design and Evaluation (Fig. 1) provides a compact graphical presentation of the test methods referenced in this guide. Test Description and Applicability (see Table 1): Table 1 lists the test methods commonly used to evaluate flexible medical packaging. The test methods are used in two phases. Package Design: Characterization of the Materials and Evaluation of the Resultant Package8212;This is referred to as “R&D Evaluation” in Table 1. Testing during this phase is characterized by the generation of quantitative data on the performance of the component materials and the package assembly. These test methods are lengthy, making them inappropriate for the manufacturing environment where rapid response is required for process control. Often, they are expensive and require specialized equipment not readily available at a medical packaging or device manufacturing facility. Package Compliance: Routine Monitoring of Adherence to Specifications8212;This is referred to as “Compliance Testing” in Table 1. Testing during this phase must be rapid, inexpensive, and readily implemented in a manufacturing environment. The objective is not to develop design data, but to ensure that the design specifications are being met. These test methods do not necessarily make direct measurements of critical values, but detect variations in material, process, or product that are indicative of all critical characteristics. It is important to note that no individual test method is entirely predictive of final package performance. Filled packages must be evaluated under conditions of use. Once the design of the package and/or packaging materials has been determined, it may be appropriate to create a package and/or material specification. Guides F99 or F2559 may provide useful guidance.1.1 This guide provides direc......

Standard Guide for Design and Evaluation of Primary Flexible Packaging for Medical Products

ANSI/AAMI/ISO 15223-2:2010 医疗器械.用于医疗器械标签、作标记和提供信息的符号.第2部分:符号的制定、筛选和批准

Specifies a process for developing, registering, and validating symbols for use in the labeling of medical devices.

Medical devices - Symbols to be used with medical device labels, labelling and information to be supplied - Part 2: Symbol development, selection and validation

DIN ISO 8536-7:2009 医用输液设备.第7部分:输液瓶铝.塑料组合帽(ISO 8536-7:2009)

This part of ISO 8536 specifies caps made of aluminium-plastics combinations intended for use on infusion bottles which are in accordance with ISO 8536-1.

Infusion equipment for medical use - Part 7: Caps made of aluminium-plastics combinations for infusion bottles (ISO 8536-7:2009)

DIN ISO 10985:2009 输液瓶和注射管用铝.塑合成盖.要求和测试方法(ISO 10985:2009)

This International Standard specifies general requirements and test methods for caps made of aluminium-plastics combinations in accordance with ISO 8536-7 or ISO 8362-6 intended for use respectively on infusion bottles as specified in ISO 8536-1 and/or injection bottles as specified in ISO 8362-1 and ISO 8362-4.

Caps made of aluminium-plastics combinations for infusion bottles and injection vials - Requirements and test methods (ISO 10985:2009)

BS EN 868-4:2009 最终灭菌医疗器械的包装.纸袋.试验方法和要求

Packaging for terminally sterilized medical devices - Paper bags - Requirements and test methods

BS EN 868-8:2009 最终灭菌医疗器械的包装.符合EN 285标准的蒸汽灭菌器的重复使用灭菌容器.试验方法和要求

Packaging for terminally sterilized medical devices - Re-usable sterilization containers for steam sterilizers conforming to EN 285: Requirements and test methods