YY 0613-2007Blood component separation sets for single use - Centrifuge bag type (English PDF)

Foreword

The standard of Appendices B and C are normative appendices, Appendix A is an information appendix.

Introduction

This standard disposable blood component bag using a centrifugal separator (hereinafter referred to as separator) including piping system and bags system, Used to collect platelets, plasma and red blood cells and other components, it can also be used to separate blood mononuclear cells.

When the separator and the blood component separator used in conjunction with the quality of the blood components obtained by the quality of blood donors of blood, blood components division From quality machines, video quality separator, the separator and the blood component separation machine fit and operation of the operator level, and other factors ring. The standard structure factors affect the separation of blood components is not covered, and the manufacturer recommends the use of joint research in this area, so Blood components processed in line with GB 18469-2001 "quality of whole blood and blood components requirements." Appendix A gives a common separator basic configuration on the market today, only management and consumers to identify products. Disposable blood component bag using a centrifugal separator

1 Scope

This standard specifies the order in Appendix A separator shown as the main structural features of disposable blood component bag using a centrifugal separator (to Hereinafter referred to as separator) requirements, these separator and supporting the use of blood component separator for collecting human blood component separation, reinfusion And storage.

The standards required by the general separator piping system and bags system.

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 6682 analytical laboratory use specifications and test methods (GB/T 6682-1992, neq ISO 3696. 1987)

GB 8369 disposable blood transfusion (GB 8369-2005, ISO 1135-4:2004, MOD)

GB 14232.1-2004 human blood and blood components bag plastic containers - Part 1. Conventional blood bags (ISO 3826-1. 2003, IDT)

GB/T 14233.1-1998 Infusion, transfusion, injection equipment - Part 1. Chemical analysis

GB/T 14233.2-2005 Infusion, transfusion, injection equipment test methods - Part 2. Biological test methods

GB/T 16886.1 Biological evaluation of medical devices - Part 1. Evaluation and testing (GB/T 16886.1-2001, idt ISO 10993-1:1997)

GB/T 16886.4 Biological evaluation of medical devices - Part 4. Selection of tests for interactions with blood (GB/T 16886.4-2003, ISO 10993-4:2002, IDT)

GB 19335-2003 disposable products general technical conditions to survive

YY/T 0313 Medical Polymer Co., packaging, labeling, transportation and storage (YY/T 0313-1998)

YY 0326.1-2002 disposable centrifugal plasma separator Part 1.

YY 0326.2-2002 Centrifugal plasma separator for single use - Part 2. Plasma line

YY 0326.3-2005 disposable centrifugal plasma separator Part 3. plasma bags

YY 0328-2002 disposable blood collection machine

YY 0466 medical equipment used with medical device labels, signs and symbols provide information (YY 0466-2003, ISO 15233. 2000, IDT)

YY 0584-2005 disposable cup centrifugal blood component separator People's Republic of China Pharmacopoeia (2005 edition)

3 Product Structure

3.1 splitter by pipeline system and bags system. Appendix A gives examples of common separator structure.

3.2 pipeline system consists of hoses, multi-lumen tube, tubing, control boxes, drip chamber, but also lose the filter, trapping and blood gas, etc. in whole or in part.