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The Guidance of Sample provision for biological test for manufactures |
source:This site release time: 2018-05-24 11:24:36 Browsing：318次 Font size: [大]
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| Test for systemic toxicityAcute systemic toxicity test1 Thickness |
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st items
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Test methods
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sample quantity
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The requirements of sample preparation
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Remarks
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Tests for in vitro cytotoxicity
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Extract Test
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1.Thickness<0.5mm, 30cm2; 2.0.5mm2; 3.Thickness>1.0mm,6.25cm2; 4.Irregular shaped solid devices,1g; 5.Irregular shaped porous devices,0.5g.
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1.If the clinical application of the final product requires sterile, the manufacturer should provide the test sample in the same condition. 2．If the manufacture fails to provide the final product, the identical material should be provided with the same origin, processing and sterilization whicha are consistent with the final product.
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Agar diffusion Test
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1.Four solid material samples should be Provided,with the same size as the sample preparation requires; 2. If the sample preparation fails to meet the requirements,the number of samples should be provided the same as the extract method.
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1.Solid materials can be prepared as 5mm in diameter and 2mm of thickness of the original film, the weight should be no more than 3.5g; 2.Solidification materials can be prepared in a shape of cylinder with 5mm in diameter and 5mm in thickness, the weight should be no more than 3.5g;
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Filter Diffusion Test
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The same as the agar diffusion method.
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The same as the agar diffusion test.
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Test for sensitization
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The guinea pig maximization test
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1.Thickness<0.5mm,120cm2; 2.0.5mm2; 3.Thickness>1.0mm,25cm2; 4. Irregular shaped solid devices,4g; 5.Irregular shaped porous devices,2g.
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No special requirements.
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The quantity is for a single extract.
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The closed patch test
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1.Thickness<0.5mm,300cm2; 2.0.5mm2; 3.Thickness>1.0mm,62.5cm2; 4.Irregular shaped solid devices,10g; 5.Irregular shaped porous devices,5g.
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Test for irritation
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Intracutaneo-us reactivity test
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1.Thickness<0.5mm,36cm2; 2.0.5mm2; 3.Thickness>1.0mm,7.5cm2; 4. Irregular shaped solid devices,1.2g; 5.Irregular shaped porous devices,0.6g.
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No special requirements.
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The quantity is for a single-exp-osure stimulation test.
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Skin irritation test
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1.Thickness<0.5mm,30cm2; 2.0.5mm23.Thickness>1.0mm，6.25cm2; 4.Irregular shaped solid devices,1g; 5.Irregular shaped porous devices,0.5g.
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Oral mucosa irritation test
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1.Thickness<0.5mm,36cm2; 2.0.5mm2; 3.Thickness>1.0mm,7.5cm2; 4.Irregular shaped solid devices,1.2g; 5.Irregular shaped porous devices,0.6g; 6.The materials provided for preparation .
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If the solid sample is provided, the sample should be no more than 5mm in diameter,with smooth edges.
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The quantity if for a single-exp-osure stimulation test.
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Test for genotoxicity
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Ames test
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1.Thickness<0.5mm,30cm2; 2.0.5mm2; 3.Thickness>1.0mm,6.25cm2; 4.Irregular shaped solid devices,1g; 5.Irregular shaped porous devices,0.5g.
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No special requirements.
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The quantity is for a single extract.
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Chromosome aberration test
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1.Thickness<0.5mm,180cm2; 2.0.5mm2; 3.Thickness>1.0mm,37.5cm2; 4.Irregular shaped solid devices,6g; 5.Irregular shaped porous devices,3g.
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No special requirements.
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Micronucleus test
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The same as the chromosome aberration test.
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No special requirements.
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The quantity is for a single extract.
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TK test
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1.Thickness<0.5mm,30cm2; 2.0.5mm2; 3.Thickness>1.0mm,6.25cm2; 4.Irregular shaped solid devices,1g; 5.Irregular shaped porous devices,0.5g.
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No special requirements.
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Test for implantation
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Subcutaneous implantation
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1.Implantation period for 4 weeks: It is recommended at least 12 samples; 2.Implantation period for 12 weeks: It is recommended at least 24 samples; 3.Implantation period for 26 weeks: It is recommended at least 36 samples; 4.Implantation period for 52 weeks: It is recommended at least 48 samples.
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1.The film material should be made into the test sample , with diameter of 10 to 12mm, thickness of 0.3 to 1mm. 2.The bulk material should be made into the test sample with diameter of 1.5mm, length of 5mm with spherical ends. 3.Grooved material should be made into the test sample with diameter of 4mm, and length of 7mm. 4.Non-solid materials ( including powder ) should be loaded into a polyethylene, polypropylene or tetrafluoroethylene tube with diameter of 1.5mm, length of 5mm.
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The final products should be provided; Selection of the method and period for implantati-on should be determined by the properties of products.
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Muscle implantation
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1.Implantation period for 4 weeks: It is recommended at least 12 samples; 2.Implantation period for 12 weeks: It is recommended at least 24 samples; 3.Implantation period for 26 weeks: It is recommended at least 36 samples; 4.Implantation period for 52 weeks: It is recommended at least 48 samples.
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The material can be made into a test sample with width of 1～3mm, length of 10mm，covering with rounded edges and smooth spherical ends.
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Bone implantation
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1.Implantation period for 4 weeks: It is recommended at least 12 samples; 2.Implantation period for 12 weeks: It is recommended at least 24 samples; 3.Implantation period for 26 weeks: It is recommended at least 36 samples; 4.Implantation period for 52 weeks: It is recommended at least 48 samples.
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1.Solid materials can be prepared into the test samples with diameter of 2 mm, length of 6 mmor into 2～4.5mm threaded orthopedic bone implants. 2.Materials can also be made into other shapes according to the properties and research purposes, such as rods, etc.
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Test for systemic toxicity
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Acute systemic toxicity test
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1. Thickness <0.5mm,36cm2; 2.0.5mm< Thickness <1.0mm,18cm2; 3. Thickness >1.0mm,7.5cm2; 4. Irregular solid devices,1.2g; 5. Irregular porous devices,0.6g.
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No special requirements.
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The quantity is for venous injection or intraperito-neal injection.
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Short-term systemic toxicity test via oral route
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1. Thickness <0.5mm,540cm2; 2.0.5mm< Thickness <1.0mm,270cm2; 3. Thickness >1.0mm,115cm2; 4. Irregular shaped solid devices,18g; 5. Irregular shaped porous devices,9g; 6. For the paste, rubber-like or soluble materials,18g.
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Solid particulate materials can also be provided with particle size of less than 200μm,18g.
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The quantity is for a single extract.
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Subacute systemic toxicity test
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1.By oral route： 1.1. Thickness <0.5mm,22500cm2; 1.2.0.5mm2; 1.3. Thickness >1.0mm,4700cm2; 1.4. Irregular shaped solid devices,750g; 1.5.Irregular shaped porous devices,380g.
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No special requirements.
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2. By venous route： 2.1. Thickness <0.5mm,660 cm2（mice）/5900cm2（rats）; 2.2.0.5mm< Thickness <1.0mm,330cm2（mice）/3000cm2（rats）; 2.3. Thickness >1.0mm,140cm2（mice）/1300cm2（rats）; 2.4. Irregular shaped solid devices,22 g（mice）/180 g（rats）; 2.5. Irregular shaped porous devices,11 g（mice）/90 g（rats）.
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The blood compatibi-lity tests cannot be performed by using mice (except the haematological test).
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Subchronic systemic toxicity test
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1By oral route： 1.1. Thickness <0.5mm,147000cm2; 1.2.0.5mm2; 1.3. Thickness >1.0mm,31000cm2; 1.4. Irregular shaped solid devices,4900g; 1.5. Irregular shaped porous devices, 2500g.
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No special requirements.
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The blood compatibi-lity test cannot be performed by using mice (except the haematological test).
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2.By venous route： 2.1. Thickness <0.5mm,2520cm2（mice）/25200 cm2（rats）; 2.2.0.5mm< Thickness <1.0mm,1260cm2（mice）/12600 cm2（rats）; 2.3. Thickness >1.0mm,525cm2（mice）/5250 cm2（rats）; 2.4. Irregular shaped solid devices,84 g（mice）/840 g（rats）; 2.5. Irregular porous devices,42 g（mice）/420 g（rats）.
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Test for Pyrogen
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Rabbit Test
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1. Thickness <0.5mm,450cm2; 2.0.5mm< Thickness <1.0mm,225cm2; 3. Thickness >1.0mm,94cm2; 4. Irregular shaped solid devices,15g; 5. Irregular shaped porous devices,7.5g.
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No special requirements.
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Test forinteraction with blood
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PTT test
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1. The surface area of the sample should be no less than 40 cm2 or 2g; 2. If the requirement of the surface area is met, it would be better tosend at least three independent and integrate final product packages; 3.It is recommended to provide negative controls(commercially available with similar texture, surface processing, shape, size (thickness) and specifications to the test sample;at least three independent and integrate final product packages are recommended.
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No special requirements.
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The sample and the negative controls are shared with the three tests .
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PT test
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FIB test
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Platelets test
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1. The surface area of the sample should be no less than 40 cm2 or 2g; 2. If the requirement of the surface area is met, it would be better to send at least three independent and integrate final product packages; 3. It is recommended to provide negative controls(commercially available with similar texture, surface processing, shape, size (thickness) and specifications to the test sample;at least three independent and integrate final product packages are recommended.
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No special requirements.
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RBC couting test
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1. The surface area of the sample should be no less than 40 cm2 or 2g; 2. If the requirement of the surface area is met, it would be better to send at least three independent and integrate final product packages; 3. It is recommended to provide negative controls(commercially available with similar texture, surface processing, shape, size (thickness) and specifications to the test sample;at least three independent and integrate final product packages are recommended.
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No special requirements.
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The sample and the negative controls are shared with the three tests .
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WBC couting test
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RET couting test
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C3a test
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1. The surface area of the sample should be no less than 40 cm2 or 2g; 2. If the requirement of the surface area is met, it would be better to send at least three independent and integrate final product packages; 3. It is recommended to provide negative controls(commercially available with similar texture, surface processing, shape, size (thickness) and specifications to the test sample;at least three independent and integrate final product packages are recommended.
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The sample and the negative controls are shared with the three tests .
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C5a test
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Thrombosis test
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Two independent and integrate final product packages are recommended as well as negative controls. It is also recommended that negative controls should be commercially available, with similar texture, surface processing, shape, size (thickness) and specifications to the test sample.
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No special requirements.
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The tests above are commonly performed as a routine. For further information about sample
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