YY 0465-2009 in English

1 Scope

This standard specifies the terms and definitions, requirements, test method, inspection rules, marking, packaging, transportation and storage of disposable membrane plasmaseparator.

This standard is applicable to disposable membrane plasmaseparator, hereinafter referred to as plasmaseparator. The plasmaseparator is used in conjunction with plasmaseparation system to treat critically ill patients suffering from various immunological diseases, metabolic disorder and some toxic action, etc.

2 Normative References

The following normative documents contain provisions which, through reference in this standard, constitute provisions of this standard. For dated references, subsequent amendments (excluding corrections) 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 investigate the possibility of applying the most recent editions of the normative documents indicated below. For undated references, the latest editions apply.

GB/T 191 Packaging—Pictorial Marking for Handling of Goods
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 16886.1-2001, idt ISO 10993-1:1997)
GB/T 16886.4 Biological Evaluation of Medical Devices—Part 4: Selection of Tests for Interactions with Blood (GB/T 16886.4-2003, ISO 10993-4:2002, IDT)
GB/T 16886.5 Biological Evaluation of Medical Devices—Part 5: Tests for In Vitro Cytotoxicity (GB/T 16886.5-2003, ISO 10993-5:1999, IDT)
GB/T 16886.10 Biological Evaluation of Medical Devices—Part 10: Tests for Irritation and Delayed-type Hypersensitivity (GB/T 16886.10-2005, ISO 10993-10:2002, IDT)
GB/T 16886.11 Biological Evaluation of Medical Devices—Part 11: Tests for Systemic Toxicity (GB/T 16886.11-1997, idt ISO 10993-11:1993)
Pharmacopoeia of the People's Republic of China (Edition 2005)

3 Terms and Definitions

For the purposes of this standard, the terms and definitions given in GB/T 13074 and the followings 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.

Foreword i
1 Scope
2 Normative References
3 Terms and Definitions
4 Classification and Designation
5 Requirements
6 Test Method
7 Inspection Rules
8 Marking
9 Packaging, Transportation and Storage
Annex A (Normative) Method for Determination of Particle Content in Plasmaseparator
Annex B (Normative) Determination of Permeability of Plasmaseparator
Annex C (Normative) Method for Determination of Protein Sieving Coefficient of Plasmaseparator