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YY/T 0612-2022 English PDF

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YY/T 0612-2022: (Disposable human arterial blood sample collector (arterial blood gas needle))
Status: Valid

YY/T 0612: Evolution and historical versions

Standard IDContents [version]USDSTEP2[PDF] delivered inStandard Title (Description)StatusPDF
YY/T 0612-2022English309 Add to Cart 4 days [Need to translate] (Disposable human arterial blood sample collector (arterial blood gas needle)) Valid YY/T 0612-2022
YY 0612-2007English519 Add to Cart 3 days [Need to translate] Single-use receptacles for human arterial blood specimen collection Obsolete YY 0612-2007

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Basic data

Standard ID YY/T 0612-2022 (YY/T0612-2022)
Description (Translated English) (Disposable human arterial blood sample collector (arterial blood gas needle))
Sector / Industry Medical Device & Pharmaceutical Industry Standard (Recommended)
Classification of Chinese Standard C31
Word Count Estimation 16,153
Issuing agency(ies) State Drug Administration

YY 0612-2007: Single-use receptacles for human arterial 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 receptacles for human arterial blood specimen collection ICS 11.040.20 C31 People's Republic of China pharmaceutical industry standards Disposable Human Arterial Blood Specimen Collection (Arterial blood gas needle) Posted 2007-07-02 2008-08-01 implementation State Food and Drug Administration issued

Foreword

Appendix A of this standard is a normative appendix. Appendix B, Appendix C and Appendix D are informative appendices. This standard by the National Standardization Technical Committee Infusion equipment for medical and centralized. This standard drafting units. Shandong Medical Devices Product Quality Inspection Center, Becton Dickinson Medical Devices Co., Ltd.. The main drafters of this standard. Song Jinzai, Luo Hongyu, Jiangyun Dan, Wu Ping. Disposable Human Arterial Blood Specimen Collection (Arterial blood gas needle)

1 Scope

This standard specifies the definitions 3.1 and 3.2 with a single-use human blood gas analysis of arterial blood sampling device (often called "blood gas needle") Requirements. This standard does not include requirements for venous blood specimen collection container and peripheral blood collection container.

2 Normative references

The following documents contain provisions which, through reference in this standard and become the standard terms. For dated references, subsequent Amendments (not including errata content) or revisions do not apply to this standard, however, encourage the parties to the agreement are based on research Whether the latest versions of these documents. For undated reference documents, the latest versions apply to this standard. GB/T 1962.2 syringes, needles and other medical equipment - 6% (Luer) taper fittings - Part 2. Lock fittings (GB/T 1962.2-2001, idt ISO 594-2.1998) GB/T 14233.1-1998 Infusion, transfusion, injection equipment - Part 1. Chemical analysis GB 15810 single-use sterile syringes (GB 15810-2001, eqv ISO 7886-1.1993) GB 15811-time use of sterile needles (GB 15811-2001, eqv ISO 7864.1993) GB/T 16886.1 Biological evaluation of medical devices - Part 1. Evaluation and testing (GB/T 16886.1-2001, idt ISO 10993-1.1997) YY/T 0313 Medical Polymer Co., packaging, labeling, transportation and storage YY 0466 medical devices for medical equipment marking, labeling, and information provided by the symbol (YY 0466-2003, ISO 15223. 2000, IDT)

3 Terms and Definitions

GB 15810, GB 15811 of the terms and definitions as well as the following terms and definitions apply to this standard. 3.1 Member consists of a blood collection needle and the reservoir sampler (containing additives) and sealed, blood sample collection and storage appliances for the collected blood samples for Blood gas analysis. 3.2 Before the first blood sample reservoir piston preset to blood volume, arterial blood pressure of the patient by blood during the automatic injector flow into the reservoir. Note 1. The structural characteristics of the default type blood collection device is defined in this standard piston sampler has a reservoir capable of blocking liquid air filters, blood collection period Through which exhaust air. Once the filter has been soaked in blood, it will also block the air. Note 2. Some blood collection is designed to either a preset blood, but also blood. 3.3 Blood samples were collected only by a negative pressure device features (such as sliding piston) to achieve prick blood collection device.

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