YY 0465-2019 in English

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Clause 5 of this standard is mandatory.

This standard is drafted in accordance with the rules given in the GB/T 1.1-2009.

This standard replaces YY 0465-2009 Disposable Membrane Plasmaseparator. In addition to a number of editorial changes, the following technical deviations have been made with respect to the YY 0465-2003 (the previous edition):

— addition of the requirements and test methods for particle shedding from the external cavity (see 5.5 and 6.5);

— addition of the requirements and test methods for endotoxin (see 5.10 and 6.10);

— addition of the requirements and test methods for separation of hemoglobin content in plasma with plasmaseparator (see 5.11 and 6.11);

— addition of the requirements and test methods for filtration rate of plasma components of plasma component separator (see 5.13.3 and 6.13.3);

— addition of the requirements and test methods for protein sieving coefficient of plasma component separator (see 5.13.3 and 6.13.3);

— addition of the requirements and test methods for validity period (see 5.15 and 6.15);

— modification of the test methods for pyrogen (see 6.9; Edition 2009, 6.7.3).

Attention is drawn to the possibility that some of the elements of this document may be the subject of patent rights. The issuing body of this document shall not be held responsible for identifying any or all such patent rights.

This standard was proposed by the National Medical Products Administration.

This standard is under the jurisdiction of SAC/TC 158 (National Technical Committee 158 on Extracorporeal Circuit Equipments of Standardization Administration of China).

The previous editions of this standard are as follows:

— YY 0465-2003, YY 0465-2009.

Disposable Membrane Plasmaseparator and Plasma Component Separator


1 Scope

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.

4 Type and Model Designation

4.1 Type

Hollow-fiber plasmaseparator is adopted.

4.2 Model designation

Model designation is shown in Figure 1.


Figure 1 Model designation



5 Requirements

5.1 Appearance

The enclosure shall be transparent and smooth, and there must be no visible impurities in the fluid passage.

5.2 Effective membrane area of plasmaseparator and plasma component separator

The effective membrane area of plasmaseparator and plasma component separator shall not be less than 90% of the nominal area.

5.3 Blood chamber capacity of plasmaseparator and plasma component separator

The blood chamber capacity of plasmaseparator and plasma component separator shall be within the range specified by the manufacturer.

5.4 Basic dimensions of plasmaseparator and plasma component separator

5.4.1 Blood chamber inlet/outlet dimensions of plasmaseparator and plasma component separator

The blood chamber inlet/outlet dimensions of plasmaseparator and plasma component separator shall be in accordance with those specified in Figure 2.

Note: Except where the plasmaseparator, plasma component separator and the extracorporeal blood circuit are designed as an integral system
Dimensions in millimetres

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