C08 标志、包装、运输、贮存 标准查询与下载

DIN EN ISO 3826-2:2008 人类血液及血液成分用塑料可折叠容器.第2部分:用于标签和说明手册上的图形符号

This part of ISO 3826 addresses symbols that may be used to convey certain items of information related to medical devices dedicated to blood collection processes and storage. The information may be required on the device itself, as part of the label, or provided with the device. Many countries require that their own language be used to display textual information with medical devices. This raises problems to device manufacturers and users. The symbols specified in this part of ISO 3826 do not replace current national regulatory requirements. Manufacturers seek to take costs out of labelling by reducing or rationalizing variants. This results in a major problem of translation, design and logistics when multiple languages are included on a single label or piece of documentation. As other medical devices, blood medical devices, labelled in a number of different languages, can experience confusion and delay in locating the appropriate language. This part of ISO 3826 proposes solutions to these problems through the use of internationally recognized symbols with precisely defined meanings. This part of ISO 3826 is primarily intended to be used by manufacturers of medical devices dedicated to the blood collection, process storage and distribution, who market identical products in countries having different language requirements for medical device labelling. This part of ISO 3826 may also be of assistance to different stages of the blood supply chain, e.g.: - distributors of blood collection devices (manual or automated) or other representatives of manufacturers; - blood centres and distribution centres to simplify and secure the operating procedures. The use of these symbols is primarily intended for the medical device rather than the therapeutic product. This part of ISO 3826 does not specify requirements relating to the size and colour of symbols although the symbols specified have been specially designed so as to be clearly legible when reproduced in the space typically available on the labels of blood treatment and transfusion devices, and also so as to be suitable for on-line printing. Several of the symbols specified in this part of ISO 3826 may be suitable for application in other areas of medical technology.

Plastics collapsible containers for human blood and blood components - Part 2: Graphical symbols for use on labels and instruction leaflets (ISO 3826-2:2008); English version of DIN EN ISO 3826-2:2008-11

BS PD CEN/TR 15753:2008 包装.医疗产品用包装散页印刷品.视觉缺陷人员用盲文和其它版式

This European Technical Report addresses the provision of information for medicinal products in alternative formats suitable for blind and partially sighted people.

Packaging — Package leaflets for medicinal products — Braille and other formats for visually impaired people

DIN-Fachbericht CEN/TR 15753:2008 包装.医疗产品用包装散页印刷品.视觉缺陷人员用盲文和其它版式

Packaging - Package leaflets for medicinal products - Braille and other formats for visually impaired people; German version CEN/TR 15753:2008

DIN EN ISO 3826-3:2008 人体血液和血液成分用可折叠塑料容器.第3部分:带综合特征的采血袋系统(ISO 3826-3-2006)

This part of ISO 3826 specifies requirements, including performance requirements, for integrated features on plastic, collapsible, non-vented, sterile containers (blood bag systems). Blood bag systems need not contain all of the integrated features identified in this document. The integrated features refer to: -- leucocyte filter; -- pre-donation sampling device; -- top-and-bottom bag; -- platelet storage bag; -- needle stick protection device. In addition to ISO 3826-1, which specifies the requirements of conventional containers, this part of ISO 3826 specifies additional requirements for blood bag systems using multiple units. This part of ISO 3826 does not cover automated blood collection systems. Unless otherwise specified, all tests specified in this part of ISO 3826 apply to the plastic container as prepared ready for use. Use chemical, physical and biological tests in accordance with ISO 3826-1, where applicable.

Plastics collapsible containers for human blood and blood components - Part 3: Blood bag systems with integrated features (ISO 3826-3:2006); English version of DIN EN ISO 3826-3:2008-03

HJ 421-2008 医疗废物专用包装袋 容器和警示标志标准

本标准规定了医疗废物专用包装袋、利器盒才周转箱（桶）的技术要求以及相应的试验方法和检验规则，并规定了医疗废物警示标志。 本标准适用于医疗废物专用包装袋、容器的生产厂家、运输单位和医疗废物处置单位。

Standard of packaging bags,containers and warning symbols specific tomedical waste

NF S93-200:2008 药品的主要包装材料.以良好加工实践(GMP)为参考ISO 9001-2000应用的特殊要求

Primary packaging materials for medicinal products - Particular requirements for the application of ISO 9001:2000, with reference to Good Manufacturing Practice (GMP).

ANSI/HL7 V3 MRDACM, R 1-2008 HL7版本3标准:病史档案.数据存取授权.第1版

The Data Consent topic CMET and messages will allow a patient to consent to their health information being collected, accessed, used or disclosed, or to rescind such consent. There is support for a health care provider to gain emergency access and support for a patient to utilize ashared secret' in managing their consent. Used in conjunction with the masking messages from the Shared Message Domain, the Data Consent messages will provide a patient the appropriate tools to manage their health information. This version of the document includes improved documentation, vocabulary, business name changes for the Shared secret as agreed in reconciliation.

HL7 Version 3 Standard: Medical Records; Data Access Consent, Release 1

ASTM D6398-08 增强标签上药物名称的识别的标准实施规程

Medication errors occur when users are confused by the similar size, shape, color, typeface, and layout of labels that are used for a range of a manufacturer's drugs with widely dissimilar actions or potencies. The human visual system uses shape, size, color, and typeface in the initial recognition of a labeled drug. (See 9.1-9.3.) The use of this human visual system has been described in 21 CFR 429.12 for the labeling of insulin. Using the similar label design, color, and typeface throughout a product line makes identifying an individual drug more difficult. The objective of this practice is to provide guidance for the design of drug labels which will enable users to easily distinguish between drugs of differing action or potency. See Note 1. Note 18212;For specific requirements for these labels and other features of labels for OTC human drugs, see 21 CFR 201.66.1.1 This practice covers the shape, size, color, layout, typeface, and barcoding on drug container labels intended for prescription product packaging such as might be used in hospitals, pharmacies, and nursing centers. 1.1.1 This practice does not apply to bulk product shipping containers; in-process transfer containers; or primary, secondary, or tertiary finished goods containers. 1.2 This practice does not apply to over-the-counter drug product labeling. 1.3 This practice does not apply to retail product labeling. 1.4 The values stated in SI units are to be regarded as the standard. The values given in parentheses are for information only.

Standard Practice to Enhance Identification of Drug Names on Labels

DIN EN 15178:2007 急救产品的识别要素

This European Standard specifies requirements for an area on the packaging - the product identification field - marked by a symbol, where clear product identification element(s) is (are) present. This European Standard applies to products that are the subject of emergency enquiries to the poison information centres. This European Standard does not apply to medicinal products (human and veterinary drugs) (see [2], [3]) and medical devices (see [4], [5]), as information requirements are already covered.

Elements for the identification of products in emergency enquiries; German version EN 15178:2007

DIN EN ISO 15378:2007 药品的主要包装材料.以良好加工实践(GMP)为参考ISO 9001-2000应用的特殊要求

This International Standard specifies requirements for a quality management system where an organization needs to demonstrate its ability to provide primary packaging materials for medicinal products, which consistently meet customer requirements, including regulatory requirements and International Standards applicable to primary packaging materials. In this International Standard the term "/f appropriate" is used several times. When a requirement is qualified by this phrase, it is deemed to be "appropriate" unless the organization can document a justification otherwise. ISO 9001:2000, Quality management systems -- Requirements 1.1 General This International Standard specifies requirements for a quality management system where an organization a) needs to demonstrate its ability to consistently provide product that meets customer and applicable regulatory requirements, and b) aims to enhance customer satisfaction through the effective application of the system, including processes for continual improvement of the system and the assurance of conformity to customer and applicable regulatory requirements. NOTE In this International Standard, the term "product" applies only to the product intended for, or required by, a customer.

Primary packaging materials for medicinal products - Particular requirements for the application of ISO 9001:2000, with reference to Good Manufacturing Practice (GMP) (ISO 15378:2006); German and English version EN ISO 15378:2007

BS EN 15178:2007 急救产品的识别要素

This European Standard specifies requirements for an area on the packaging – the product identification field – marked by a symbol, where clear product identification element(s) is (are) present. This European Standard applies to products that are the subject of emergency enquiries to the poison information centres. This European Standard does not apply to medicinal products (human and veterinary drugs) (see [2], [3]) and medical devices (see [4], [5]), as information requirements are already covered.

Elements for the identification of products in emergency enquiries

NF X30-506:2007 医疗保健废弃物.传染性液体医疗保健废弃物的包装.规范和试验

Health care waste - Packaging for infectious liquid health care waste - Specifications and tests.

BS DD 264:2007 包装.医学产品用盲文和其他型式

DD 264:2007 is a Draft for Development (DD) that specifies the requirements and provides guidance for the application of Braille to the labelling of medicinal products. The provision of information on medicinal products in alternative formats, suitable for blind and partially-sighted people, is also addressed. The labelling of medicinal products (and associated package information leaflet; see Annexes A and B) placed on the market and incorporating Braille in accordance with this Draft for Development meets the requirements of the UK implementation [4] [5], of the European Directive 2001/83/EC Article 56 (a) as amended by Directive 2004/27/EC [1]. The general principles in DD264 Draft for Development can be applied in other sectors, as appropriate

Packaging - Braille and other formats for medicinal products

SANS 11607-2:2007 最终消毒医疗设备的包装.第2部分:成型、密封及装配过程的验证要求

Specifies the requirements for development and validation of processes for packaging medical devices that are terminally sterilized. These processes include forming, sealing, and assembly of preformed sterile barrier systems, sterile barrier systems and packaging systems.

Packaging for terminally sterilized medical devices Part 2: Validation requirements for forming, sealing and assembly processes

SANS 11607-1:2007 最终消毒医疗设备的包装.第1部分:材料、无菌屏障系统及包装的系统要求

Specifies the requirements and test methods for materials, preformed sterile barrier systems, sterile barrier systems and packaging systems that are intended to maintain sterility of terminally sterilized medical devices until the point of use.

Packaging for terminally sterilized medical devices Part 1: Requirements for materials, sterile barrier systems and packaging systems

DIN EN ISO 11607-1 Berichtigung 1:2007 最终灭菌医学设备的封装.第1部分:原材料、无菌阻隔系统和包装系统的要求

Packaging for terminally sterilized medical devices - Part 1: Requirements for materials, sterile barrier systems and packaging systems (ISO 11607-1:2006); German version EN ISO 11607-1:2006, Corrigenda to DIN EN ISO 11607-1:2006-07

ASTM E1714-07 通用保健识别符特性的标准指南(UHID)

Recent experience with computer-based patient records (CPRs) has revealed many valuable potential benefits, but it has also become apparent that the effective application of this technology creates some new problems. CPRs offer the option for lifelong linkage of all records on a patient, from birth to death. Such longitudinal record linkage would make the patient’s entire past health history retrievable. This could make possible a quantum leap in the clinical practice of health care, but a reliable patient identifier is essential to make large-scale regional and nationwide record linkage feasible. The design of a patient identifier system is not a simple task. Incorrect record linkage would create confusion, at least, or possibly cause serious consequences. To gain the benefits from such an identifier, it must be used by all relevant organizations. A universal patient identifier system must resist unauthorized access to confidential clinical data.Furthermore, the creation of personal identifiers for the entire population must be a cost-effective process in light of ongoing fiscal constraints. The creation and administration of personal identifiers for the entire population must be accomplished at a cost that is widely accepted as affordable and justified. Last, but not least, a time pressure exists. The solution to the patient identifier challenge should use technology to facilitate rapid deployment of the system to permit the expeditious implementation of CPRs. A companion document, Guide E 2553, provides the implementation strategy concerning how to actually implement the UHID system.1.1 This guide covers a set of requirements outlining the properties required to create a universal healthcare identifier (UHID) system. Use of the UHID is expected to initially be focused on the population of the United States but there is no inherent limitation on how widely these identifiers may be applied.1.2 This guide sets forth the fundamental considerations for a UHID that can support at least four basic functions effectively:1.2.1 Positive identification of patients when clinical care is rendered;1.2.2 Automated linkage of various computer-based records on the same patient for the creation of lifelong electronic health care files;1.2.3 Provision of a mechanism to support data security for the protection of privileged clinical information; and1.2.4 The use of technology for patient records handling to keep health care operating costs at a minimum.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.

Standard Guide for Properties of a Universal Healthcare Identifier (UHID)

ASTM D4267-07 小容积(100毫升或低于100毫升)非肠道药物包装容器用标签的标准规范

1.1 This specification covers the orientation, the size of type used, and the contrast of the copy with the label background on immediate drug containers having a volume of 100 mL or less.1.2 The values stated in SI units are to be regarded as the standard. The values given in parentheses are for information only.

Standard Specification for Labels for Small-Volume (100 mL or Less) Parenteral Drug Containers

ASTM F2097-07 医疗产品用基本柔软包装的设计和评估用标准指南

1.1 This guide provides directions for the design and evaluation of primary flexible packages for medical products. The package materials must be selected appropriately for manufacturing process, end use, and the product being packaged.1.2 This guide provides a compendium of test methods. Specific individual test methods must be selected based on the pertinent characteristics of the specific product to be packaged and the purpose for testing, research and development, or compliance. Not all test methods will be applicable.1.3 This guide does not address acceptability criteria, which need to be determined jointly by the package producer and the medical products manufacturer.1.4 This guide does not assess the product to be packaged; the sterilization method to be used; or package performance through sterilization, distribution, and handling.

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

ASTM D5022-07 装有使用前应稀释药物浓缩溶液的玻璃瓶和小玻璃瓶的识别标准规范

1.1 This specification deals with identification of small volume containers of drugs intended to be diluted before parenteral administration, as follows:1.1.1 Container shape,1.1.2 Labeling statements.1.1.3 Vial closures and Flip-Off, type caps, and1.1.4 Ampoule marking.

Standard Specification for Identification of Vials and Ampoules Containing Concentrated Solutions of Drugs to be Diluted Before Use