YY/T 0612-2022Single-use receptacles for human arterial blood specimen collection (English PDF)
一次性使用人体动脉血样采集器(动脉血气针)
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Issued by
NMPA
Level / Type
Industry · Recommended
Issue date
July 1, 2022
Implementation date
July 1, 2023
Scope
YY/T 0612-2022 is the English-translated version of 一次性使用人体动脉血样采集器(动脉血气针).
YY/T 0612-2022 is the Chinese pharmaceutical industry standard covering single-use receptacles for human arterial blood specimen collection. It was issued on 1 July 2022 and has been in force since 1 July 2023, replacing YY 0612-2007.
The document is under the responsibility of the National Medical Products Administration. This page is published from the official record of the 2022 edition. The figures, limits and tables the standard contains are those of the document itself, delivered in full with the English translation.
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Document preview — YY/T 0612-2022
National Standard of the People's Republic of China
- Replacing
- YY 0612-2007
Issued by: National Medical Products Administration of the People's Republic of China
Contents
- 1 Scope
- 2 Normative references
- 3 Terms and definitions
- 4 Physical performance
- 4.1 Sample container
- 4.2 Blood collection needle
- 4.3 Sealing parts
- 4.4 Blood collection performance of the pre-set type blood sample collector
- 4.5 Needlestick protection device
- 5 Biological performance
- 5.1 Biocompatibility
- 5.2 Sterility
- 5.3 Blood collection needle
- 6 Chemical performance
- 6.1 General
- 6.2 Heavy metals
- 6.3 Acidity and alkalinity
- 6.4 Residual ethylene oxide
- 7 Additives
- 7.1 Identification
- 7.2 Content
- 7.3 Ionic balance
- 8 Marking and labelling
- 9 Packaging
- Annex A (normative) Test method for the blood collection performance of the pre-set type blood sample collector
- A.1 Principle
- A.2 Synthetic blood
- A.3 Test apparatus
- A.4 Air venting
- A.5 Positive pressure tightness
- A.6 Negative pressure tightness
- A.7 Expression of the results
- Annex B (informative) Formulation of the synthetic blood
- B.1 Composition
- B.2 Preparation
Document data
Chinese classification (CCS): C31.
Estimated length of the Chinese original: 16,157 words.
3 Terms and definitions
4 Physical performance
5 Biological performance
6 Chemical performance
7 Additives
8 Marking and labelling
9 Packaging
......
This preview omits tables, figures, formulas and parts of the technical clauses. The complete document — 15 pages — is available in the English PDF.
Similar standards
Editions of YY/T 0612
| Edition | Title | Revision | Status |
|---|---|---|---|
| YY/T 0612-2022 | Single-use receptacles for human arterial blood specimen collection | current edition | Current |
| YY 0612-2007 | Single-use receptacles for human arterial blood specimen collection | previous edition | Superseded |
This page sells the current edition, YY/T 0612-2022. Earlier editions are listed for reference only.
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YY/T 0612-2022
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