1 Scope
This standard specifies general requirements for and test methods of silicone tubes (hereinafter referred to as "the tubes") and elastomeric parts for infusion and transfusion.
The products to which this standard is applicable include (but not limited to):
——Repeatedly-used in vitro transferring tubes for venoclysis liquid;
——Silicone elastomeric parts in disposable blood processing products: such as pump tube, sealing gasket for valve or flow control unit and injection moldings etc.;
——Silicone elastomeric parts for disposable infusion equipment, such as injection moldings, silicone reservoir for infusion pump etc.;
——Pump tube, valve and injection moldings etc. in the disposable pressure transfusion tubes.
This standard excludes the silicone catheter and artificial heart-lung machine pump tube which are inserted or implanted in the human body.
2 Normative References
The following documents contain provisions which, through reference in this standard, constitute provisions of this standard. For dated references, subsequent amendments (excluding any correction of) to, or revisions of, any of these publications do not apply. However, all parties coming to an agreement according to this standard are encouraged to study whether the latest editions of these documents are applicable. For undated references, the latest editions of the documents referred to apply.
GB/T 528 "Rubber, Vulcanized or Thermoplastic--Determination of Tensile Stress-strain Properties" (GB/T 528-1998, eqv ISO 37: 1994)
GB/T 529 "Rubber, Vulcanized or Thermoplastic--Determination of Tear Strength" (Trouser, Angle and Crescent Test Pieces) (GB/T 529-1999, eqv ISO 34-1: 1994)
GB/T 531 "Rubber--Determination of Indentation Hardness by Means of Pocket Hardness Meters" (GB/T 531-1999, idt ISO 7619: 1986)
GB/T 3512 "Rubber, Vulcanized or Thermoplastic-accelerated Ageing and Heat Resistance Tests--Air-oven Method"(GB/T 3512-2001, eqv ISO 188: 1998)
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 "Package, Label, Transport and Storage for Medical Polymer Product"
YY 0466 "Devices-Symbols to be Used with Medical Device Labels, Labelling and Information to Be Supplied" (YY 0466-2003, ISO 15223: 2000, IDT)
3 Product Classification
Foreword I
1 Scope
2 Normative References
3 Product Classification
4 Requirements
5 Packing and Mark
Appendix A (Normative) Steam Resistance Test
Appendix B (Normative) Physical Test
Appendix C (Normative) Dissolved Matter Test
