YY 0465-2019Medical Devices — Disposable membrane plasmaseparator and plasma component separator (English PDF)

4.1 Type

4.2 Model designation

Model designation is shown in Figure 1.

5.5 Particles shedding

The inner/outer cavity of plasmaseparator and plasma component separator shall be clean; the number of particles of 15 μm to 25 μm in 100 mL of eluent shall not be more than 200, and that of particles larger than 25 μm shall not be more than 100.

5.6 Chemical properties

5.6.1 Reducing substances (readily oxidizable substance)

The difference between the volume of potassium permanganate solution [c (KMnO4) = 0.002 mol/L] consumed by 20 mL of test fluid and the same batch of blank control fluid shall not exceed 2.0 mL.

5.6.2 Metal ions

5.6.2. […]

5.6.3 PH value

The difference between the pH values of the test fluid and the same batch of blank control fluid shall not be more than 1.5.

5.6.5 UV absorbance

The absorbance of test fluid shall not be larger than 0.1.

5.6.6 Ethylene oxide residual quantity

5.7 Biological safety

The plasmaseparator and plasma component separator shall be subject to biological evaluation according to GB/T 16886.1.

5.8 Sterility

The plasmaseparator and plasma component separator shall be sterile.

5.9 Pyrogen

The plasmaseparator and plasma component separator shall be pyrogen-free.

5.10 Endotoxin

The endotoxin content in plasmaseparator and plasma component separator shall be less than 0.5 EU/mL. 5. […]

5.12 Sealing property

5.12.1 Tolerable pressure inside the membrane

The blood chamber membrane of plasmaseparator and plasma component separator shall be able to withstand a test pressure up to 1.5 times the maximum positive pressure specified for the product.

5.12.2 Tolerable pressure outside the membrane

Shall be able to withstand a test pressure up to 1.5 times the maximum positive pressure specified for the product, and the negative pressure shall be 1.5 times of the maximum negative pressure specified for the product.

5.13 Permeability

5.13.2 Protein sieving coefficient of plasmaseparator

The sieving coefficient of total protein shall not be less than 0.80 and that of albumin shall not be less than 0.85.

5.13.3 Plasma filtration rate of plasma component separator

The plasma filtration rate shall comply with the manufacturer’s requirements.

5.13.4 Protein sieving coefficient of plasma component separator

The protein sieving coefficient of plasma component separator shall comply with the manufacturer’s requirements.

5.15 Validity period

The product characteristics shall be proven after storage for a period corresponding to the expiry date.

6.1 Appearance

It shall comply with the requirements of 5.1 through observation via normal or corrected vision under an average illumination of 300 lx to 750 lx without magnification. 6.2 Effective membrane area of plasmaseparator and plasma component The effective membrane area of plasmaseparator and plasma component separator is calculated according to Formula (1) and shall comply with the requirements of 5.2.

S = nπDL×10-6 ……………………………………(1) where S—the effective membrane area, m2; n—the number of hollow fiber. D—the inner diameter of hollow fiber, mm; L—the effective length of hollow fiber, mm; 6.3 Blood chamber capacity of plasmaseparator and plasma component separator Fill the blood side and filtrate side with filling fluid without bubble after degassing and keep still for 60 min; make the filtrate side enclosed, drain the water at blood side with pressurized air (about 50 kPa) and measure (the penetration amount from filtrate side to blood side shall be deducted). The requirements of 5.3 shall be met. 6.4 Basic dimensions of plasmaseparator and plasma component separator 6.4.1 Blood chamber inlet/outlet dimensions of plasmaseparator and plasma Measurement with the general or special measuring tools; the results shall meet the requirements of 5.4.1. 6.4.2 Filtrate chamber inlet/outlet dimensions of plasmaseparator and plasma Measurement with the general or special measuring tools; the results shall meet the

6.5 Particles shedding

It shall be carried out according to Annex A and the requirements of 5.5 shall be met.

6.6 Chemical properties

6.6.1 Preparation of test fluid

Assemble and pre-rinse according to the product instructions, connect the product and glass beaker to form a circulation system, seal up the filtrate outlet with a stopper, add laboratory water at a ratio of about 500 mL of laboratory water per 1 m2 of nominal fiber area and maintain at 37℃±1℃; make the water circulate for 2 h at a flow rate of 1 L/h by acting on a silicone tube, which is as short as possible, using a peristaltic pump. Take 50 mL of circulating fluid, dilute it to 1 000 mL and keep for subsequent use. […]

6.12 Sealing property

6.13 Permeability

7.2 Quality certificate

The quality certificate shall be marked with the followings: a) Manufacturer's or registrant’s name; b) Product name and model; c) Inspection date.

7.3 External package marking

The external package shall be marked with the followings: a) Manufacturer's or registrant’s name and address; b) Product name and model; c) Quantity; d) Gross weight; e) Volume (length × width × height); f) Production batch No. g) Production date, service life or expiry date; […]

7.4 Operating instructions

The operating instructions shall cover the following items: a) Product name and model; b) Name, registered address, production address and contact information of the manufacturer or registrant, as well as the after-sale service organization; c) Production license No. of medical appliance manufacturer (if applicable) and medical appliance registration certificate No.; d) Specification No.; e) Contraindications, applicable indications, precautions and other contents to be warned or reminded; f) Interpretations of graphics, symbols and abbreviations, etc. used on the label of the medical appliance;

g) Instructions for installation and use or drawings of auxiliary equipment necessary; h) General procedures during normal use; i) Pre-rinse procedure; j) Description of necessary, special or unique procedures when required; k) Description of blood flow direction, and recommended maximum/minimum blood flow rate; l) Description of permeability (the manufacturer shall specifies blood flow, plasma flow and transmembrane pressure); m) Detailed description of special cases; n) Sterilization method and period of validity, special storage conditions and method, as well as description of treatment on preserving fluid; o) Maximum transmembrane pressure.

8.1 Packaging

Each separator shall be separately packed and sealed, and a copy of operating instructions and inspection certificate respectively shall be provided.

8.3 Storage

The packed separator shall be stored in a cool, dry, ventilated and clean place with relative humidity no more than 80% and free from corrosive gas. Under the specified storage conditions, the validity period of sterilization for the separator shall meet the requirements of the manufacturer.

A.1 Principle

The method for determination of particle content in separator is to assess the level of contamination by collecting and counting the particles in the eluent on the passage surface after washing the fluid passage of the inner cavity.

A.2 Test connection diagram

Test connection as shown in Figure A.1.

of sample. A.2.3 Filter unit: arranged with millipore membrane with diameter of 50 mm and pore size of 0.45 μm.

A.2.4 Rinsing fluid: sodium chloride injection.

A.2.5 Connecting hose: 1 m long, 3.5 mm to 4 mm in outer diameter.

A.2.6 Three-way switch

A.3 Test procedure

A.3.1 The filter unit is connected with the infusion bottle containing sodium chloride through the bottle stopper puncture device and with three-way switch at the bottom with lower hose connected to the sampling cup of particle counter. A.3.2 Wash the filter, three-way switch and hose with 100 mL of rinsing fluid. A.3.3 Under about 1 m static head or a method that can provide considerable power, first open the fluid inlet a, close the fluid inlet end b, make the flushing fluid pass through the hose 100 mL, and the outflow fluid flow into the sampling cup; firstly, open the fluid inlet b and close the fluid inlet a, so that the flushing fluid will pass through the hose 100 mL and the outflow fluid will flow into the same sampling cup. The outflow fluid is the background fluid. Measure the number of particles in 100 mL of background fluid. A.3.4 Repeat the procedure in A.3.3 and take the average of two counts as the particle content in 100 mL of background fluid. A.3.5 Seal up the gas inlet and connect the inlet end of plasmaseparator with the other joint of the three-way switch. A.3.6 Under about 1 m static head, first open the fluid inlet a, close the fluid inlet end b, make the flushing fluid pass through the separator 100 mL, and the outflow fluid flow into the sampling cup; […]

A.4 Expression of Results

The difference between the readings of particles in eluent and background fluid is the content of particles in eluent.

B.1 Purpose

Measurethe plasma/plasma component filtration rate of separator.

B.2 Equipment and apparatus

B.2.2 500 mL measuring cylinder.

B.2.3 Negative-pressure pump.

B.2.4 1 000 mL fluid cylinder.

B.2.5 Auxiliary tubes of plasmaseparator and plasma component separator.

B.3 Test fluid

B.5 Expression of results

Record the filtrate volume at 3 min.

C.1 Test solution

Fresh anticoagulant ox blood or ox plasma.

C.2 Determination of protein concentration

Protein concentration may be determined by the relevant methods using a diagnostic kit with registration certificate or by preparing the following reagents.