YY/T 0878.3-2019 PDF EnglishUS$199.00 · In stock · Download in 9 seconds
YY/T 0878.3-2019: Test for complement activation of medical devices - Part 3：Assay for the product of complement activation (C3a and SC5b-9) Delivery: 9 seconds. True-PDF full-copy in English & invoice will be downloaded + auto-delivered via email. See step-by-step procedure Status: Valid
Similar standardsYY/T 0878.3-2019: Test for complement activation of medical devices - Part 3：Assay for the product of complement activation (C3a and SC5b-9)---This is an excerpt. Full copy of true-PDF in English version (including equations, symbols, images, flow-chart, tables, and figures etc.), auto-downloaded/delivered in 9 seconds, can be purchased online: https://www.ChineseStandard.net/PDF.aspx/YYT0878.3-2019 Test for enhance activation of medical devices - Part 3.Assay for the product of enhance activation (C3a and SC5b-9) ICS 11.040.01 C30 People's Republic of China Pharmaceutical Industry Standard Medical device complement activation test Part 3. Complement activation products Determination of (C3a and SC5b-9) Testforcomplementactivationofmedicaldevices-Part 3.Assayforthe Productofcomplementactivation(C3aandSC5b-9) Published on.2019-07-24 2020-08-01 implementation State Drug Administration issued ForewordYY/T 0878 "Medical Device Complement Activation Test" includes the following parts. --- Part 1. Serum full complement activation; --- Part 2. Serum bypass pathway complement activation; --- Part 3. Determination of complement activation products (C3a and SC5b-9). This part is the third part of YY/T 0878. This part is drafted in accordance with the rules given in GB/T 1.1-2009. Please note that some of the contents of this document may involve patents. The issuing organization of this document is not responsible for identifying these patents. This part is proposed by the State Drug Administration. This part is under the jurisdiction of the National Technical Committee for Standardization of Medical Device Biology Evaluation (SAC/TC248). This section drafted by. Shandong Province Medical Device Product Quality Inspection Center, Sichuan University (Sichuan Medical Device Biomaterials and Product Inspection Test center). The main drafters of this section. Liu Chenghu, Fan Chunguang, Liang Jie, Yuan Wei, Li Qiu.introductionThe selection strategy for the blood compatibility test of medical devices/materials is given in GB/T 16886.4. This part of YY/T 0878 is in vitro. The specific test method for complement activation products can be used as a supplement to the medical device/material complement activation test in GB/T 16886.4. After the medical device/material is in contact with blood, it may activate the complement system in the blood, and the production of effector molecules may cause the body to be severely acute and chronic. The reaction also affects the blood compatibility of the medical device/material. C3a is a small molecule formed by the activation of complement C3 molecule and can be mediated. Acute inflammatory response of the body. SC5b-9 is a co-terminal product C5b-9 produced by activation of the complement system and formation of S protein in serum A hydrophilic, non-lytic cell-active macromolecular fragment or a macromolecular fragment without lytic cell membrane activity. By detecting C3a molecules or The content of SC5b-9 molecule can reflect the activation of the complement system in serum. In vitro supplement as described in this section of YY/T 0878 A method for determining a body activation product that can be used to assess whether a medical device/material has a potential complement activation. Medical device complement activation test Part 3. Complement activation products Determination of (C3a and SC5b-9)1 ScopeThis section of YY/T 0878 specifies methods for the determination of complement activation products (C3a and SC5b-9) in the blood by enzyme-linked immunosorbent assay. This section applies to the evaluation of the activation potential of medical devices/materials in vitro. The test system established in this section is applicable to human serum or anticoagulated plasma. If animal blood is used, the test is carried out after demonstrating its suitability.2 Normative referencesThe following documents are indispensable for the application of this document. For dated references, only dated versions apply to this article. Pieces. For undated references, the latest edition (including all amendments) applies to this document. GB/T 16886.1 Biological evaluation of medical devices - Part 1. Evaluation and testing in the process of risk management GB/T 16886.4 Biological evaluation of medical devices - Part 4. Selection of test for interaction with blood GB/T 16886.12 Biological evaluation of medical devices - Part 12. Sample preparation and reference materials3 Terms and definitionsThe terms and definitions defined in GB/T 16886.1, GB/T 16886.4 and GB/T 16886.12 apply to this document. 4 test principle (taking C3a as an example) C3a levels in serum or anticoagulated plasma were determined by double antibody sandwich (ELISA). Coating micropores with purified rat C3a antibody The plate is made into a solid phase antibody, and then human serum or anticoagulated plasma is sequentially added to the microwell of the coated monoclonal antibody. Horseradish peroxidase (HRP)-labeled C3a antibody, forming an antibody-antigen-enzyme-labeled antibody complex, after thorough washing, adding substrate tetramethylbenzidine (TMB) color development. TMB is converted to blue under the catalysis of HRP and converted to the final yellow color by the action of an acid. The depth of the color There was a positive correlation between the concentration of C3a in serum or anticoagulated plasma. The absorbance (OD value) was measured at 450 nm using a microplate reader and passed the standard. The curve calculates the concentration of human C3a in serum or anticoagulated plasma.5 reagents and materials5.1 Reagents 5.1.1 Human C3a or SC5b-9 kits should be supplied and verified by a qualified supplier. 5.1.2 Fresh healthy human serum or anticoagulated plasma. Note. After the test is finished, the blood and blood contact items are treated according to relevant regulations. YY/T 0878.3-2019 Test for enhance activation of medical devices - Part 3.Assay for the product of enhance activation (C3a and SC5b-9) ICS 11.040.01 C30 People's Republic of China Pharmaceutical Industry Standard Medical device complement activation test Part 3. Complement activation products Determination of (C3a and SC5b-9) Testforcomplementactivationofmedicaldevices-Part 3.Assayforthe Productofcomplementactivation(C3aandSC5b-9) Published on.2019-07-24 2020-08-01 implementation State Drug Administration issuedForewordYY/T 0878 "Medical Device Complement Activation Test" includes the following parts. --- Part 1. Serum full complement activation; --- Part 2. Serum bypass pathway complement activation; --- Part 3. Determination of complement activation products (C3a and SC5b-9). This part is the third part of YY/T 0878. This part is drafted in accordance with the rules given in GB/T 1.1-2009. Please note that some of the contents of this document may involve patents. The issuing organization of this document is not responsible for identifying these patents. This part is proposed by the State Drug Administration. This part is under the jurisdiction of the National Technical Committee for Standardization of Medical Device Biology Evaluation (SAC/TC248). This section drafted by. Shandong Province Medical Device Product Quality Inspection Center, Sichuan University (Sichuan Medical Device Biomaterials and Product Inspection Test center). The main drafters of this section. Liu Chenghu, Fan Chunguang, Liang Jie, Yuan Wei, Li Qiu.introductionThe selection strategy for the blood compatibility test of medical devices/materials is given in GB/T 16886.4. This part of YY/T 0878 is in vitro. The specific test method for complement activation products can be used as a supplement to the medical device/material complement activation test in GB/T 16886.4. After the medical device/material is in contact with blood, it may activate the complement system in the blood, and the production of effector molecules may cause the body to be severely acute and chronic. The reaction also affects the blood compatibility of the medical device/material. C3a is a small molecule formed by the activation of complement C3 molecule and can be mediated. Acute inflammatory response of the body. SC5b-9 is a co-terminal product C5b-9 produced by activation of the complement system and formation of S protein in serum A hydrophilic, non-lytic cell-active macromolecular fragment or a macromolecular fragment without lytic cell membrane activity. By detecting C3a molecules or The content of SC5b-9 molecule can reflect the activation of the complement system in serum. In vitro supplement as described in this section of YY/T 0878 A method for determining a body activation product that can be used to assess whether a medical device/material has a potential complement activation. Medical device complement activation test Part 3. Complement activation products Determination of (C3a and SC5b-9)1 ScopeThis section of YY/T 0878 specifies methods for the determination of complement activation products (C3a and SC5b-9) in the blood by enzyme-linked immunosorbent assay. This section applies to the evaluation of the activation potential of medical devices/materials in vitro. The test system established in this section is applicable to human serum or anticoagulated plasma. If animal blood is used, the test is carried out after demonstrating its suitability.2 Normative referencesThe following documents are indispensable for the application of this document. For dated references, only dated versions apply to this article. Pieces. For undated references, the latest edition (including all amendments) applies to this document. GB/T 16886.1 Biological evaluation of medical devices - Part 1. Evaluation and testing in the process of risk management GB/T 16886.4 Biological evaluation of medical devices - Part 4. Selection of test for interaction with blood GB/T 16886.12 Biological evaluation of medical devices - Part 12. Sample preparation and reference materials3 Terms and definitionsThe terms and definitions defined in GB/T 16886.1, GB/T 16886.4 and GB/T 16886.12 apply to this document. 4 test principle (taking C3a as an example) C3a levels in serum or anticoagulated plasma were determined by double antibody sandwich (ELISA). Coating micropores with purified rat C3a antibody The plate is made into a solid phase antibody, and then human serum or anticoagulated plasma is sequentially added to the microwell of the coated monoclonal antibody. Horseradish peroxidase (HRP)-labeled C3a antibody, forming an antibody-antigen-enzyme-labeled antibody complex, after thorough washing, adding substrate tetramethylbenzidine (TMB) color development. TMB is converted to blue under the catalysis of HRP and converted to the final yellow color by the action of an acid. The depth of the color There was a positive correlation between the concentration of C3a in serum or anticoagulated plasma. The absorbance (OD value) was measured at 450 nm using a microplate reader and passed the standard. The curve calculates the concentration of human C3a in serum or anticoagulated plasma.5 reagents and materials5.1 Reagents 5.1.1 Human C3a or SC5b-9 kits should be supplied and verified by a qualified supplier. 5.1.2 Fresh healthy human serum or anticoagulated plasma. Note. After the test is finished, the blood and blood contact items are treated according to relevant regulations. ......Source: Above contents are excerpted from the full-copy PDF -- translated/reviewed by: www.ChineseStandard.net / Wayne Zheng et al. 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