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YY/T 1618-2018: Single-use needles for human venous blood specimen collection
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Single-use needles for human venous blood specimen collection
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Standard similar to YY/T 1618-2018
YY/T 1566.1 | YY/T 1556 | YY/T 1550.2 | YY/T 1628 | YY/T 1617 | Basic data
| Standard ID | YY/T 1618-2018 (YY/T1618-2018) |
| Description (Translated English) | Single-use needles for human venous blood specimen collection |
| Sector / Industry | Medical Device & Pharmaceutical Industry Standard (Recommended) |
| Classification of Chinese Standard | C31 |
| Classification of International Standard | 11.040.20 |
| Word Count Estimation | 18,136 |
| Date of Issue | 2018-09-28 |
| Date of Implementation | 2019-10-01 |
| Regulation (derived from) | State Drug Administration Announcement No. 72 of 2018 |
| Issuing agency(ies) | State Drug Administration |
YY/T 1618-2018: Single-use needles for human venous blood specimen collection
---This is a DRAFT version for illustration, not a final translation. Full copy of true-PDF in English version (including equations, symbols, images, flow-chart, tables, and figures etc.) will be manually/carefully translated upon your order.
Single-use needles for human venous blood specimen collection
ICS 11.040.20
C31
People's Republic of China Pharmaceutical Industry Standard
Single use human venous blood sample collection needle
Published on.2018-09-28
2019-10-01 implementation
State Drug Administration issued
Foreword
This standard was drafted in accordance with the rules given in GB/T 1.1-2009.
Please note that some of the contents of this document may involve patents. Publication of this document
The organization is not responsible for identifying these patents.
This standard was proposed by the State Drug Administration.
This standard is under the jurisdiction of the National Medical Syringe (Needle) Standardization Technical Committee (SAC/TC95).
This standard was drafted. Zhejiang Kangdelai Medical Devices Co., Ltd., Shandong Xinhua Ande Medical Supplies Co., Ltd., Shanghai Medical
Therapeutic equipment testing institute.
The main drafters of this standard. Zhang Honghui, Zhang Qian, Nie Yucai, Du Qin, Li Wei.
Introduction
The single-use human venous blood sample collection needle is used together with the disposable vacuum venous blood sample collection container, and is collected from the human vein.
Blood sample for blood analysis.
The traditional single-use human venous blood sample collection needle is invisible to return blood. In recent years, there is visible one-time use of the human body.
The blood sample collection needle appears in the clinic. Because of the special nature of the disposable venous blood sample collection needle for visible blood return, this standard does not have
Give coverage. However, this standard recommends that manufacturers who use the venous blood sample collection needle for single-use blood return to actively use the phase in this standard.
Terms and conditions.
Rubber sleeve resilience is an important performance indicator. The drafting unit developed a testing machine to test the rubber sleeve resilience and enter the data.
After collecting and comparing, the basic data of the rubber sleeve resilience was obtained. However, the performance of the test machine has yet to be improved, and the drift range of the test data
There is a certain gap with the design requirements. In view of the current rubber sleeve resilience test method and test machine is not mature, this standard will test its side
The performance of the method, the resilience of the test machine and the rubber sleeve is given in the form of an informative appendix. After the test method, test equipment and required parameters are determined,
This standard is included as a normative clause when it is revised.
Single use human venous blood sample collection needle
1 Scope
This standard specifies the venous puncture needle tube nominal outer diameter of 0.5mm~0.9mm disposable human venous blood sample collection needle (to
The requirements of the "acquisition needle" are referred to below.
This standard does not apply to the requirement of visible blood return for one-time use of human venous blood sample collection needle, but encourages visible return blood disposable users.
Manufacturers of venous blood sample collection needles actively use the relevant provisions of this standard.
2 Normative references
The following documents are indispensable for the application of this document. For dated references, only dated versions apply to this article.
Pieces. For undated references, the latest edition (including all amendments) applies to this document.
GB/T 6682 Analytical laboratory water specifications and test methods
GB/T 14233.1-2008 Medical infusions, blood transfusions, injecting machines - Test methods - Part 1
GB/T 14233.2-2005 Methods of test for infusions, blood trans
GB 15810 single use sterile syringe
GB/T 16886.1 Biological evaluation of medical devices - Part 1. Evaluation and testing in the process of risk management
GB 18279.1 Sterilization of ethylene oxide for health care products - Part 1. Development, validation and routine control
System requirements
GB 18280 Health care products sterilization confirmation and routine control requirements radiation sterilization
GB/T 18457 Stainless steel needle tube for medical devices
YY/T 0296 Disposable needle identification color mark
YY/T 0466.1 Medical devices for use in medical devices - Labels, markings and information provided - Part 1 . General requirements
The Pharmacopoeia of the People's Republic of China (2015 Edition)
3 Classification and naming
3.1 Classification
The collection needle is divided into the following two types according to its structure.
a) Hard-connected acquisition needle (two-way needle type), the type code is H, as shown in Figure 1;
b) Soft connection acquisition needle (butterfly needle type), the type code is S, as shown in Figure 2.
Note. Figure 1 and Figure 2 show the typical structure of the collection needle. Other structures can be used as long as the same effect is achieved.
3.2 Naming
The names of the parts of the collection needle are shown in Figure 1 and Figure 2.
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