1 Scope
This standard specifies requirements for single-use transfusion sets for medical use in order to ensure their compatibility with containers for blood and blood components as well as with intravenous equipment.
Secondary aims of this standard are to provide guidance on specifications relating to the quality and performance of materials used in transfusion sets and to present designations for transfusion set components.
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 to, 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 most recent editions of the normative documents indicated below. For undated references, the latest edition of the normative document referred to applies.
GB/T 1962.1-2001 Conical fittings with a 6%(Luer) taper for syringes, needles and certain other medical equipment — Part 1: General requirement (GB/T 1962.1-2001, idt ISO 594-1:1986)
GB/T 1962.2-2001 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 6682-1992 Water for laboratory use — Specifications (neq ISO 3696:1987)
GB/T 14233.1 Test methods for infusion transfusion injection equipments for medical use — Part 1: Chemical analysis methods
GB/T 14233.2 Test methods for infusion, transfusion, injection equipment for medical use — Part 2: Biological test methods
GB 15811-2001 Sterile hypodermic needles for single use (eqv ISO 7864:1993)
YY 0466 Medical devices — Symbols to be used with medical device labels labelling and information to be supplied (YY 0466-2003, ISO 15223:2000, IDT)
ISO 14644-1:1999 Cleanrooms and associated controlled environments — Part 1: Classification of air cleanliness
3 General Requirements
3.1 Nomenclature for components of the transfusion set
The nomenclature for components of transfusion sets is given in Figure 1. An air-inlet device as shown in Figure 2 is required for use with rigid containers for blood and blood components.
