1 Scope
This standard specifies the requirements for blood components separation sets for single use, centrifuge bag type (hereinafter referred to as “separation sets”) whose structural features are mainly those of the separation sets shown in Annex A. These separation sets are used together with the blood component separation system for collection, separation, retransfusion and storage of human blood components.
The separation sets specified in this standard are generally composed of tubing system and bag system.
2 Normative references
The following normative documents contain provisions which, through reference in this text, constitute provisions of this standard. For dated references, subsequent amendments (excluding corrections), or revisions, of any of these publications do not apply. However, parties to agreements based on this standard are encouraged to investigate the possibility of applying the latest editions of the standards indicated below. For undated references, the latest edition applies.
GB/T 1962.2 Conical fittings with a 6% (Luer) taper for syringes, needles and certain other medical equipment - Part 2: Lock fittings (GB/T 1962.2-2001; idt ISO 594-2: 1998)
GB/T 6682 Water for analytical laboratory use - Specification and test methods (GB/T 6682-1992, neq ISO 3696:1987)
GB 8369 Transfusion sets for single use (GB 8369-2005, ISO 1135-4: 2004, MOD)
GB 14232.1-2004 Plastics collapsible containers for human blood and blood components - Part 1: Conventional containers (ISO 3826-1: 2003, IDT)
GB/T 14233.1-1998 Test methods for infusion, transfusion, injection equipments for medical use - Part 1: Chemical analysis methods
GB/T 14233.2-2005 Test methods for infusion, transfusion, injection equipment for medical use - 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 Blood flow products for single use - General specification
YY/T 0313 Package, label, transport and storage for medical polymer products (YY/T 0313-1998)
YY 0326.1-2002 Plasmapheresis centrifuge apparatus for single use - Part 1: Centrifuge bowl
YY 0326.2-2002 Plasmapheresis centrifuge apparatus for single use - Part 2: Plasma tubing
YY 0326.3-2005 Plasmapheresis centrifuge apparatus for single use - Part 3: Containers for plasma
YY 0328-2002 Single use blood-taking set for blood processing equipment
YY 0466 Medical devices - Symbols to be used with medical device labels, labelling and information to be supplied (YY 0466-2003, ISO 15233:2000, IDT)
YY 0584-2005 Blood components separation sets for single use, centrifuge bowl type
Pharmacopoeia of the People’s Republic of China (Volume II) (2005 Edition)
3 Product structure
3.1 The separation sets consist of a tubing system and a bag system. The structure examples of common separation sets are given in Annex A.
3.2 The tubing system consists of a hose, multi-chamber tube, pump tube, monitoring box, drip chamber, retransfusion filter, gas interceptor and blood taking set in whole or in part.
3.3 The bag system mainly consists of blood bags (such as collection bags, separation bags, transfer bags, platelet preservation bags, plasma bags, red blood cell bags, whole blood bags and sample bags).
Foreword i
Introduction ii
1 Scope
2 Normative references
3 Product structure
4 Materials
5 Physical requirements
6 Chemical requirements
7 Biological requirements
8 Inspection rules
9 Marking and labels
10 Packaging
11 Blood anticoagulant and sodium chloride injection
Annex A (Informative) Examples for application of separation sets
Annex B (Normative) Methods for testing physical properties
Annex C (Normative) Methods for preparing chemical test solution
Bibliography
