1.       Scope

This standard specifies the general specification for Blood Flow Products for Single Use.

This standard is applicable to blood flow products and their connected auxiliary tubes, in which PVC is a main material, including fluid flow and pressure monitoring tubes and so forth (hereinafter referred to as blood flow products).

Relevant provisions in product standards take precedence over this standard.

2.       Normative references

The following normative documents contain provisions which, through reference in this text, constitute provisions of this standard. For dated references, all the subsequent modification lists (excluding corrigendum) or revised editions are not applicable to this standard. However, the parties reaching an agreement according to this standard are encouraged to study whether the latest editions of these documents can be used. For undated references, the latest editions are applicable to this standard.

GB/T 1962 (all parts) Conical fittings with a 6% (Luer) taper for syringes, needles and certain other medical equipment

GB/T 14233.1-1998 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 15593 Plasticized polyvinyl chloride (PVC) compounds for transfusion (infusion) equipment

GB 15811Sterile hypodermic needles for single use

GB/T 16886.1 Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process

YY/T 0313 Package, label, transport and storage for medical polymer products