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GB/T 14232.2-2015 PDF in English


GB/T 14232.2-2015 (GB/T14232.2-2015, GBT 14232.2-2015, GBT14232.2-2015)
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GB/T 14232.2-2015English125 Add to Cart 0-9 seconds. Auto-delivery. Plastics collapsible containers for human blood and blood components -- Part 2: Graphical symbols for use on labels and instruction leaflets Valid


Standards related to: GB/T 14232.2-2015

GB/T 14232.2-2015: PDF in English (GBT 14232.2-2015)

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 applications. representation of the medical device
Mechanical apheresis using the twin needle program.
ISO 7000-2753
4.3.3
Single Needle apheresis program
On the medical device or blood processing applications. representation of the medical device
Armed with a single needle apheresis programs.
ISO 7000-2754
Table 1 (continued)
No. Symbol title and description ISO 7000 registration number
4.3.4
Whole blood
On the medical device or blood processing applications. that at any point
Before processing stage presence of whole blood.
ISO 7000-2718
4.3.5
Erythrocyte concentrates
On the medical device or blood processing applications. expressed from whole blood
Erythrocyte concentrates obtained after heart exists.
ISO 7000-2712
4.3.6
plasma
On the medical device or blood processing applications. expressed from whole blood
After the heart was the presence of plasma.
ISO 7000-2707
4.3.7
White Coat
On the medical device or blood processing applications. Indicates a white film
Presence (white layer of white blood cells and blood by centrifugation of whole blood
Small plates of the mixture).
ISO 7000-2704
4.3.8
Platelet concentrate
On the medical device or blood processing applications. Indicates a platelet
Concentrate exist.
ISO 7000-2709
4.3.9
Anticoagulants
On the medical device or blood processing applications. that anticoagulant
exist.
ISO 7000-2701
Table 1 (continued)
No. Symbol title and description ISO 7000 registration number
4.3.10
deal with
On the medical device or blood processing applications. it indicates a process
process. The symbol must be used in combination with other symbols to identify
Type process.
ISO 7000-2706
4.3.11
Leukocyte filter
On the medical device or blood processing applications. indicates that the filter designed
Door for reducing blood components or whole blood leukocytes.
ISO 7000-2720
4.3.12
Reduce pathogen
On the medical device or blood processing applications. showing reduced disease
The original body.
ISO 7000-2716
4.4 combined symbol
Symbol combination by two or more basic symbols (see 4.3) components.
If necessary, these symbols should be converted, ie white to black or black to white. To be able to build and replicate a combination
symbol.
Table 2 shows the proper use of a combination of symbolic expression of basic information
No. Symbol title and description ISO 7000 registration number
"Solution" is a combination of symbols
4.4.1
Add solution
On the medical device or blood processing applications. it indicates that the container has
For mixing with other blood components present in solution.
ISO 7000-2700
TABLE 2 (cont.)
No. Symbol title and description ISO 7000 registration number
4.4.2
Anticoagulant solution
On the medical device or blood processing applications. it indicates that the container has
Anticoagulant solution exists.
ISO 7000-2702
4.4.3
Saline solution
On the medical device or blood processing applications. it indicates that the container has
For mixing with other blood components saline solution exists.
ISO 7000-2714
"Blood or blood components container," the combination of symbols
4.4.4
Buffy coat container
On the medical device or blood processing applications. indicates that the container
In the final or interim storage white film. (Buffy coat of whole blood is centrifuged
By the white blood cells and platelets in the mixture obtained after).
ISO 7000-2705
4.4.5
Plasma container
On the medical device or blood processing applications. indicates that the container
In the final or temporary storage of plasma.
ISO 7000-2708
4.4.6
Platelet container
On the medical device or blood processing applications. indicates that the container
In the final or temporary storage of platelet concentrates.
ISO 7000-2710
4.4.7
Processing vessel
On the medical device or blood processing applications. indicates that the final content
A device for implementing the process.
ISO 7000-2711
TABLE 2 (cont.)
No. Symbol title and description ISO 7000 registration number
4.4.8
RBC container
On the medical device or blood processing applications. indicates that the container
In the final or temporary storage of red blood cells.
ISO 7000-2713
4.4.9
Whole blood vessel
On the medical device or blood processing applications. indicates that the container
In the final or interim storage of whole blood.
ISO 7000-2719
"Blood and blood components processed" combination of symbols
4.4.10
Leukocyte filter
On the medical device or blood processing applications. that for the whole
Blood or blood components leukocyte filtration process.
ISO 7000-2721
4.4.11
Pathogen reduction processes
On the medical device or blood processing applications. it indicates the treated
Cheng will reduce pathogens.
ISO 7000-2717
Note 1. 4.4.4 ~ 4.4.9 combined symbols prescribed by the basic symbols, respectively, and basic symbols 4.3.4,4.3.5,4.3.6,4.3.7,4.3.8 4.3.1 and 4.3.10
Combination.
Note 2. Since it is desirable to make the specifications of the same symbol, the symbol of the corresponding basic symbols slash blood density and the number of different combinations of symbols slash.
Use the same density and number of slash slash symbol combination will result in too dense.
Note 3. 4.4.10 and 4.4.11 combined symbols prescribed by the basic symbols are composed of the basic symbols 4.3.10 4.3.11 and 4.3.12.
4.5 Other symbols
Where applicable, the blood transfusion process and other symbols used in its label medical devices shall comply with ISO 15223-1.
Appendix A
(Informative)
Blood treatment and infusion illustrate examples of medical devices use the symbol on its label
A.1 blood and blood components container. Separate label
Figure A.1 blood and blood components container with exemplary individual labels 1
Figure A.2 blood and blood components container with exemplary individual labels 2
A.2 container solution. a separate label
Figure A.3 solution container with a separate tag example
A.3 blood and blood components container. shipping carton label integration
Integration of the shipping carton label the example of Figure A.4 blood and blood components container 1
Figure A.5 expressed as GB -band samples branch shown in FIG 14232.3-2011 pre-donation sampling means
RBC filter type leukocyte and platelet storage bags and blood collection bags top and bottom of the blood bag system Example 2
Appendix B
(Informative)
More symbolic representation of blood and blood components container
A plurality of symbols (basic and combined) characterizing blood and blood components container, if appropriate, by a group of blood bag labels, for example.
--- Nominal capacity of the container;
--- Name of the vessel and the volume of the solution;
--- The container volume of collected blood products;
--- Name and parameters for processing blood products.
Figure B.1 shows the appropriate format.
Explanation.
1 --- Total capacity of the container;
2 --- name of the vessel and the volume of the solution;
3 --- volume of whole blood collection container;
4 --- name and parameters for processing the process of blood products.
Figure B.1 When using a plurality of symbols on a label format system
references
[1] ISO 7000 Graphical symbols for equipment - Index and synopsis
[2] IEC 60417-DB-12M equipment - Graphical symbols IEC 60417, all published online database of graphical symbols
December Subscribe
[3] IEC 60417ISO 7000-DB-12M equipment - Graphical symbols IEC 60417 and ISO 7000 in all published diagram
Symbol online database subscriptions in December
......
 
Source: Above contents are excerpted from the PDF -- translated/reviewed by: www.chinesestandard.net / Wayne Zheng et al.