GB/T 14232.2-2015 English PDF (GBT14232.2-2015)

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GB/T 14232.2-2015: Plastics collapsible containers for human blood and blood components -- Part 2: Graphical symbols for use on labels and instruction leaflets
GB/T 14232.2-2015
Plastics collapsible containers for human blood and blood components - Part 2. Graphical symbols for use on labels and instruction leaflets
ICS 11.040.20
C31
National Standards of People's Republic of China
Human blood and blood components bag plastic containers
Part 2. label and instructions for use for graphics symbols
Part 2. Graphicalsymbolsforuseonlabelsandinstructionleaflets
(ISO 3826-2.2008, IDT)
Issued on. 2015-12-10
2016-09-01 implementation
Administration of Quality Supervision, Inspection and Quarantine of People's Republic of China
Standardization Administration of China released
Foreword
GB 14232 "human blood and blood components plastic bag containers", is divided into the following sections.
--- Part 1. Conventional blood bags; (mandatory);
--- Part 2. For graphic labels and instructions for use of the symbol; (recommended);
--- Part 3. blood bag system with special components. (Mandatory).
This is Part 2 GB 14232's.
This section drafted in accordance with GB/T 1.1-2009 given rules.
This section uses the translation method identical with ISO 3826-2.2008 "human blood and blood components bag plastic containers - Part 2.
Graphics on label and instructions for use of the symbol. "
Consistency correspondence between this part of international documents and normative references of our files are as follows.
YY/T 0466.1-2009 symbol "medical device used with medical device labels, labeling and information - Part 1. General requirements
Demand "(ISO 15223-1.2007, IDT)
This part is proposed by the China Food and Drug Administration.
This part of the National Technical Committee of Standardization for medical infusion set (SAC/TC106) centralized.
This section is drafted. Shandong Hengxin detection technology development center, Shanghai Blood Center.
The main drafters of this section. Wu Ping, Jiang Yueqin, Liucheng Hu.
introduction
GB 14232 purpose of this section is.
--- Reduction will require many languages translated into national languages;
--- Simplified risk of using labels blood treatment and infusion devices and rationalize, thereby reducing misunderstanding under critical circumstances, increase the risk of
The safety, reduce the required number of trained medical personnel;
--- Promote the transfer and processing of blood transfusion equipment internationally.
These graphical symbols of many symbols from the symbol itself should be able to understand its meaning, while others require the use of symbols or understanding
To understand its meaning after use a background instrument. If appropriate, the meaning of the symbol should be explained in the accompanying documents provided. appendix
A provides an example of how to use GB 14232 of this Part symbol. These examples are merely for illustration in line with the GB 14232
Use requirements of this part, but not the only way.
Human blood and blood components bag plastic containers
Part 2. label and instructions for use for graphics symbols
1 Scope
This part of the symbol given in GB 14232 can be used to express the process for blood collection and storage of medical devices certain information. These ones
Information can be required to produce as part of the label on the instrument or supplied with the device. Some countries require the use of national languages express
Information on medical devices. This gives manufacturers and users to bring a series of problems.
Symbols specified in this standard does not replace existing national regulations.
Manufacturers have put a lot of manpower and financial resources to prepare its identity, so that people can understand different languages. And brought home
To the problem is that when the file includes a label or multiple languages, translation, layout and rational aspects of many problems. To users
Find the appropriate language and time-consuming, and can lead to puzzled. The purpose of this section is through the use of internationally recognized and give the exact meaning of the symbol
Number, to solve these problems.
The main role of this part is expected for blood collection, processing, storage and medical device manufacturers to transport their sales in different languages
The label on the Medical Devices countries.
This section may also contribute to different stages of the blood supply chain, such as.
--- Blood collection instrument (artisanal mining or machine) sales or other manufacturer's agents;
--- Blood centers and distribution centers streamline and determine its operating procedures.
These symbols are primarily intended for use in the medical instruments, it is not used for other therapeutic products.
This section does not specify the size and color of the sign requirements, even though the symbol of these provisions has been specially designed to, when copied to the handling and blood
When the space available on the label transfusion equipment capable of clearly identified, and suitable for online printing.
Some of the symbols of this Part may apply to other medical technology.
2 Normative references
The following documents for the application of this document is essential. For dated references, only the dated version suitable for use herein
Member. For undated references, the latest edition (including any amendments) applies to this document.
Symbols - Part 1 ISO 15223-1 for medical equipment with medical device labels, labeling and information. General requirements
(Medicaldevices-Symbolstobeusedwithmedicaldevicelabels, labelingandinformationtobesup-
plied-Part 1. Generalrequirements)
3 Terms and Definitions
The following terms and definitions apply to this document.
3.1
Basic symbols basicsymbol
It represents a particular object or feature icon.
3.2
Combined symbols compoundsymbol
By two or more basic symbols and forms a conceptual diagram.
Claim 4 graphical symbols and their use
4.1 Use of symbols
In use, the symbol should be shown in Table 1 and Table 2 is consistent, in particular thickness, orientation, and whether the lines of the shaded area.
NOTE. ISO and IEC Joint maintain "graphical symbols for equipment," the online database. The library covers the ISO 7000 and IEC 60417 all graphical symbols.
In this database, each graphic symbol contains an identification number, a title (English and French), GIF and PDF format graphics, as well as a
Some other applicable data. Many search engines can easily navigate and retrieve graphical symbols. ISO Store or by IEC Web
Store standardization bodies or where countries are entering the method of this database.
Depending on the product and packaging specific circumstances and the size of the symbols and labeling information should be able to normal or corrected vision at 215lx illuminance
In a suitable distance vision to see.
4.2 Symbolism
The system should be able to sign up the composite sign (see 4.4) basic symbols (see 4.3) composition.
Note. Appendix A gives a description of an example of the symbol system for blood treatment and infusion equipment labels.
4.3 Basic symbols
Basic symbols can be used alone, it can also be composed of a combination of symbols (see section 4.4).
Table 1 for the appropriate use of basic symbols express basic information
No. Symbol title and description ISO 7000 registration number
4.3.1
Blood or blood components container
On the medical device or blood processing applications. indicates that the process or
Final container for storing whole blood or blood components.
ISO 7000-2703
4.3.2
Needle apheresis program
On the medical device or blood processing app...