GB/T 14232.2-2015 in English

《GB/T 14232.2-2015人体血液及血液成分袋式塑料容器 第2部分：用于标签和使用说明书的图形符号》由TC106（全国医用输液器具标准化技术委员会）归口，主管部门为国家药品监督管理局。
GB14232的本部分给出的符号可用来表达用于血液采集过程和贮存的医疗器械某些信息。这些信息可以要求出示在器械上作为标签的一部分,或随器械提供。有些国家要求使用本国语言文字表述医疗器械的信息。这给制造商和使用者带来了一系列问题。
本部分规定的符号不替代现行国家法规的要求。
制造商们投入了大量的人力和财力来编制其标识,以便让不同语言的人都能看懂。随之带来的主要问题是,当一份标签或文件上包括多种语言时,在翻译、版式和条理性方面都存在许多问题。用户要找到相应语言也比较费时,且易引起不解。本部分的目的是通过使用国际间公认并给出确切含义的符号,来解决这些问题。
本部分主要预期作用是,为血液的采集、处理、贮存和运输的医疗器械制造商对其销售到不同语言的国家中医疗器械上进行标签。
本部分还可能有助于血液供应链不同阶段,如:
―――血液采集器械(手工采或机采)的销售商或其他制造商的代理;
―――血液中心和配送中心简化和确定其操作程序。
这些符号主要预期用于上述医疗器械,不用于其他治疗性产品。
本部分不规定符号的规格和颜色的要求,尽管这些规定的符号已专门设计成,当复制到血液处理和输血器械的标签上的可用空白处时能够清晰识别,且适合于在线印刷。
本部分规定的某些符号可能适用于其他医疗技术领域。

Plastics Collapsible Containers for Human Blood and Blood Components — Part 2: Graphical Symbols for Use on Labels and Instruction Leaflets

1 Scope

This part of GB 14232 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 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 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 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 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 may be suitable for application in other areas of medical technology.

2 Normative References

The following referenced documents are indispensable for the application of this document. For dated references, only the edition cited applies. For undated references, the latest edition of the referenced document (including any amendments) applies.

ISO 15223-1 Medical Devices — Symbols to be Used with Medical Device Labels, Labelling and Information to be Supplied — Part 1: General Requirements

3 Terms and Definitions

For the purposes of this document, the following terms and definitions apply.

3.1
basic symbol
graphical representation of a particular object or feature

3.2
compound symbol
graphical representation of a concept formed by the combination of two or more basic symbols

Foreword II
Introduction III
1 Scope
2 Normative References
3 Terms and Definitions
4 Requirements for Graphical Symbols and Their Use
Annex A (Informative) Illustrative Examples of Symbols Used in the Labelling of Medical Devices Used for Blood Treatment and Transfusion
Annex B (Informative) Symbols as Applied to Properties of Blood or Blood Components Containers
Bibliography