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TEST GROUP: IMPLANTATION
- IMPLANTATION TEST
- SUBCHRONIC TOXICITY TEST
- CHRONIC TOXICITY TEST
- GONADOTOXICITY
Laboratory of experimental patomorphology
Moscow Medicine Academy n.a. I.M.Sechenov
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Tests with the initial product:
Cytological and histological studies of the implantation area of rabbits (implantation into the joint cavity) were performed.
Subchronic toxicity was studied on white rats by subcutaneous administration of the material.
Chronic toxicity was studied on dogs after subcutaneous administration.
The gonadotropic effect was evaluated as histological structure of the reproductive organs of male rats.
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Tests with the initial product:
Low tissue reaction in early period and a high degree biocompatibility of the material up to 12-14 months were noted.
General toxic effect of the material within 2.5 and 18 months was not revealed.
Deviations of the norm of the gonad structure within 2.5 and 18 months were not detected.
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File 1 subchronic toxicity and gonadotoxicity_initial product
File 1 chronic toxicity and gonadotoxicity_initial product
File 3 implantation test_initial product
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Implantation test with product 1 modification:
Cytological and histological studies of the implantation area of rabbits (implantation into the joint cavity) were performed. |
Implantation test with product 1 modification:
There are no inflammatory, dystrophic and necrotic events in early period up to 3 months.
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File 3 implantation test_1 modification |
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TEST GROUP: ACUTE TOXICITY
- ACUTE TOXICITY TEST
- Hemolytic action TEST
- Sensitizing action TEST
- Mutagenic action TEST
Testing Laboratory of All-Russian Research and Testing Institute of Medical Equipment Health Ministry
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Tests with the initial product:
Acute toxicity was studied on white mice by intraperitoneal administration of the material.
The hemolytic effect of material extracts on isolated rabbit erythrocytes “in vitro” was studied.
Sensitizing effect on white rats (immunological response of mast cell degranulation) was studied.
The mutagenic effect was investigated by using micronucleus test on a hip bone marrow preparations of white mice.
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Tests with the initial product:
Administration of a dose of 50 ml/kg of body weight haven’t lead to death and clinical signs of intoxication.
Extracts from all tested samples did not show hemolytic activity.
Sensitizing effect or mutagenic activity of the material were not detected.
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Acute toxicity study_initial product
Hemolytic action study_initial product
Sensitizing action study_initial product
Mutagenic action study_initial product
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CYTOTOXIC TESTS
Research Institute of Biomedical Chemistry n.a. V.N. Orekhovich
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Tests with the initial product:
Cytotoxicity on the PC12 rat phaeochromocytoma cell line by using the MTT assay was studied.
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Tests with the initial product:
The cytotoxic effect of the material was not detected.
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Cytotoxic action study_initial product
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TEST GROUP: BIOLOGICAL SAFETY
- TOXICOLOGICAL TEST
- LOCAL IRRITATIVE EFFECT TEST
- HEMOLITIC ACTIVITY TEST
Research Institute of Physico-Chemical Medicine of Federal Medical-Biological Agency (Russian Federation)
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Tests with product 1 modification:
A integrated periodic study of samples in a sanitary-chemical test, acute toxicity, hemolytic activity in vitro, local irritative effect, sterility and apyrogenicity of sample in the toxicological test.
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Tests with product 1 modification:
The material is chemically stable, extracts do not have adverse effects on biological objects. The values of these indicators do not go beyond acceptable levels.
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Toxicology 2008_1 modification
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Tests with product 2 modification:
A integrated study of samples in a sanitary-chemical test, acute toxicity, hemolytic activity in vitro, local irritant effect, sterility and apyrogenicity of sample in the toxicological test. |
Tests with product 2 modification:
The material is non-toxic, sterile and pyrogen-free. The values correspond to the requirements.
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Toxicology 2015_2 modification |
Current biological safety tests:
An integrated study of samples in the sanitary-chemical test, acute toxicity, cytotoxicity, local irritant effect. |
Current biological safety tests:
The material is chemically stable, non-toxic, sterile and pyrogen-free, extracts do not have adverse effects on biological objects. The values correspond to the requirements.
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Toxicology 2019 |
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TEST GROUP: RESEARCH OF ANTI-CONTAMINATION PROPERTIES OF SILVER IONS IN MATERIAL
- RESEARCH OF ANTIBACTERIAL PROPERTIES IN VITRO
- TEST OF PRESERVATIVES ANTIBACTERIAL ACTIVITY IN VITRO
Laboratory of clinical microbiology and hospital infections control Moscow Medicine Academy n.a. I.M. Sechenov
Testing Laboratory OLFARM
Testing Laboratory Scientific Production Association LAL-Center
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Tests with the initial product:
A bacteriological study of properties of HBIS material in comparison with the material without silver ions with 4 bacterial strains.
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Tests with the initial product:
Viable bacteria from sowing of lack growth zones were not found.
The material with silver ions has bactericidal properties in vitro.
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Research of antibacterial properties initial product
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Tests with product 2 modification:
Microbiological tests for the anti-contamination effect of silver ions in the HBIS material: identification of the preservatives’ antimicrobial activity, and of antimicrobic action under the conditions of testing for microbiological purity and sterility.
Study of the HBIS material in the LAL- test: detection of endotoxins level. |
Tests with product 2 modification:
The anti-contamination effect of silver ions in the HBIS material was confirmed.
The efficacy of silver ions as an antimicrobial preservative was confirmed Silver ions do not possess antibacterial action when sterility conditions are broken.
The material is pyrogen-free.
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Test of preservatives antibacterial activity_2 modification |