1 Scope
This Standard specifies technical requirements for haemodialysers, haemodiafilters, haemofilters and haemoconcentrators, hereinafter collectively referred to as “the device”, for use in humans.
This Standard is not applicable to:
- extracorporeal blood circuits;
- plasmafilters;
- haemoperfusion devices;
- vascular access devices;
- blood pump;
- pressure monitors for the extracorporeal blood circuit;
- air detection devices;
- systems to prepare, maintain or monitor dialysis fluid;
- systems used to perform therapy of haemodialysis, haemofiltration or haemodiafiltration;
- reprocessing procedures and equipment.
Note: Requirements for the extracorporeal blood circuit for haemodialysers, haemodiafilters and haemofilters are specified in YY 0267-2016.
2 Normative References
The following referenced documents are indispensable for the application of this Document. For dated references, only the edition cited applies. For undated references, the latest edition of the referenced document (include any amendments) 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, ISO 594-2:1998,IDT)
GB/T 14233.1-2008 Test Methods for Infusion, Transfusion, Injection Equipment for Medical Use - Part 1: Chemical Analysis Methods
GB/T 16886.1 Biological Evaluation of Medical Devices - Part 1: Evaluation and Testing within a Risk Management Process(GB/T 16886.1-2011; ISO 10993-1:2009, IDT)
Pharmacopoeia of People's Republic of China, Edition 2010
3 Requirements
3.1 Biological evaluation
Biological evaluation on hazard of part directly or indirectly contacted to blood in product shall be conducted.
3.2 Sterility
The product shall be free from any bacterium after the confirmed sterilization process.
3.3 Non-pyrogeneity
The product shall be free from pyrogenicity.
3.4 Mechanical characteristics
Foreword I
1 Scope
2 Normative References
3 Requirements
4 Test Methods
5 Labelling
Appendix A (Informative) Technical Differences between this Standard and ISO 8637: 2010 and their Reasons
References
