This standard specifies the terms and definitions, type and model designation, requirements, test method, inspection rules, marking, packaging, transportation and storage of disposable membrane plasmaseparator and plasma component separator.
This standard is applicable to disposable membrane plasmaseparator and plasma component separator. The disposable membrane plasmaseparator, hereinafter referred to as plasmaseparator, is used in conjunction with plasmaseparation system to treat various immunological diseases, metabolic disorder and some toxic action and other diseases. The disposable membrane plasma component separator, hereinafter referred to as plasma component separator, is suitable for double filter plasma exchange therapy, which is used in conjunction with plasmaseparator to separate certain relative molecular mass from the separated plasma by membrane separation.
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 (including any amendments) applies.
GB/T 191 Packaging — Pictorial Marking for Handling of Goods
GB/T 1962.2 The Conical Fittings with a 6% (Luer) Taper For Syringes, Needles and Certain Other Medical Equipment — Part 2: Lock Fittings
GB/T 13074 Terms of Blood Purification
GB/T 14233.1-2008 Test Methods for Infusion, Transfusion, Injection Equipments for Medical Use — Part 1: Chemical Analysis Methods
GB/T 16886.1 Biological Evaluation of Medical Devices — Part 1: Evaluation and Testing
GB/T 16886.4 Biological Evaluation of Medical Devices — Part 4: Selection of Tests for Interactions with Blood
GB/T 16886.5 Biological Evaluation of Medical Devices — Part 5: Tests for In Vitro Cytotoxicity
GB/T 16886.10 Biological Evaluation of Medical Devices — Part 10: Tests for Irritation and Delayed-type Hypersensitivity
GB/T 16886.11 Biological Evaluation of Medical Devices — Part 11: Tests for Systemic Toxicity
YY/T 0466.1 Medical Devices — Symbols to be Used with Medical Device Labels, Labelling and Information to be Supplied — Part 1: General Requirements
Pharmacopoeia of the People's Republic of China (Edition 2015)
3 Terms and Definitions
For the purposes of this document, the terms and definitions given in GB/T 13074 and the following apply.
3.1
plasmaseparation
process of separating plasma and formed element in blood
3.2
plasmaseparation system
device consisting of hemodynamic system, monitoring system, capacity balancing system and plasmaseparator, etc.
3.3
plasma component separation
process of separating different relative molecular mass substances in plasma.
