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YY/T 0878.2-2015: Test for complement activation of medical devices - Part 2: Serum alternative pathway complement activation
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Test for complement activation of medical devices - Part 2: Serum alternative pathway complement activation
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YY/T 0878.2-2015
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Basic data | Standard ID | YY/T 0878.2-2015 (YY/T0878.2-2015) | | Description (Translated English) | Test for complement activation of medical devices - Part 2: Serum alternative pathway complement activation | | Sector / Industry | Medical Device & Pharmaceutical Industry Standard (Recommended) | | Classification of Chinese Standard | C30 | | Classification of International Standard | 11.040.01 | | Word Count Estimation | 14,180 | | Date of Issue | 2015-03-02 | | Date of Implementation | 2016-01-01 | | Quoted Standard | GB/T 16886.1; GB/T 16886.4; YY/T 0878.1 | | Regulation (derived from) | The State Food and Drug Administration Announcement 2015 No. 8 | | Issuing agency(ies) | State Food and Drug Administration | | Summary | This Standard specifies the test methods for medical devices in vitro alternative pathway of complement activation. This section applies to solid samples. This section, the term "serum" and "complement" to GM, which means the serum used as a source of complement. This section does not refer to a single function of complement components, modification or consumption, and plasma-derived complement. | YY/T 0878.2-2015: Test for complement activation of medical devices - Part 2: Serum alternative pathway complement activation
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Test for complement activation of medical devices Part 2. Serum alternative pathway complement activation
ICS 11.040.01
C30
People's Republic of China pharmaceutical industry standards
Medical devices complement activation test
Part 2. Serum alternative pathway of complement activation
Part 2. Serumalternativepathwaycomplementactivation
Issued on. 2015-03-02
2016-01-01 implementation
China Food and Drug Administration released
Foreword
YY/T 0878 "Medical Devices complement activation test" intended to divide part of the publication, currently plans to release the following components.
--- Part 1. Full serum complement activation;
--- Part 2. Serum alternative pathway of complement activation;
--- Part 3. serum classical pathway of complement activation.
This section YY/T Section 20878 of.
This section drafted in accordance with GB/T 1.1-2009 given rules.
Please note that some of the content of this document may involve patents. Release mechanism of the present document does not assume responsibility for the identification of these patents.
This part is proposed by the China Food and Drug Administration.
This part of the National Biological evaluation of medical devices Standardization Technical Committee (SAC/TC248) centralized.
This part mainly drafted by. State Food and Drug Administration Jinan Medical Device Quality Supervision and Inspection Center, the State Food and Drug
Governor Administration Beijing Medical Device Quality Supervision and Inspection Center, the State Food and Drug Administration of Tianjin Medical Device Quality Supervision and Inspection Center.
The main drafters of this section. Regulation of. Wang Ke radium, LANGUAGE AND CULTURE, Jiang Hua, Wang Hui, Rui.
Introduction
GB/T 16886.4 gives the medical device or material selection strategy blood compatibility tests. This section is an in vitro alternative pathway of complement
The specific test method body activation can be used as supplementary GB/T 16886.4 in medical devices or materials complement activation tests.
YY/T 0878.1 solid materials and full complement activation test provides a guide, but does not distinguish between the classical pathway and the alternative pathway. Headquarters
Blood-contacting medical devices into solid material or the alternative pathway of complement activation of specific assays used to screen medical devices or solid material
Potential complement activation.
Medical devices complement activation test
Part 2. Serum alternative pathway of complement activation
1 Scope
YY/T 0878 This section gives the test methods for medical devices in vitro alternative pathway of complement activation.
This section applies to solid samples.
This section, the term "serum" and "complement" to GM, the mean serum used as a complement source.
This section does not refer to a single component of the complement function, modification or consumption, and plasma-derived complement.
Note. Non-solid samples when using this method, should determine the applicability of the method.
2 Normative references
The following documents for the application of this document is essential. For dated references, only the dated version suitable for use herein
Member. For undated references, the latest edition (including any amendments) applies to this document.
GB/T 16886.1 Biological evaluation of medical devices - Part 1. Evaluation of the risk management process and Test
GB/T 16886.4 Biological evaluation of medical devices - Part 4. Selection of tests for interactions with blood
YY/T 0878.1 complement activation test medical devices - Part 1. the full serum complement activation
3 Terms and Definitions
GB/T 16886.1, terms and definitions GB/T 16886.4 defined apply to this document.
4 Symbols and Abbreviations
The following symbols and abbreviations apply to this document.
Ab. antibody (hemolysin) (Antibody, hemolysin)
BBS. barbital buffered saline (Barbitalbufferedsaline)
BBS-G. barbital buffered saline - Gel (Barbitalbufferedsaline-gelatin)
BBS-G-EGTA/Mg (MgBuffer). barbital buffered saline - and Mg2 gel containing EGTA (magnesium buffer) (Barbitalbuff-
eredsaline-gelatinEGTAMg2)
BBS-GM (CaBuffer). barbiturate buffer salts - salt gel (calcium buffer) (Barbitalbufferedsaline-gelatinmet-
als)
C '. complement (Complement)
C4 (-). no guinea pig serum C4 activity (GPSC4-deficientguineapigserum)
Note. If not from genetics to produce serum C4 (Complement fourth component) obtained in guinea pigs.
Of EDTA. ethylenediaminetetraacetic acid, disodium salt. dihydrate (Ethylenediaminetetraaceticacid, disodiumsalt. di-
hydrate)
EGTA. ethylene glycol bis-aminoethyl ether tetraacetic acid, tetrasodium salt [Ethyleneglyco-bis (b-aminoethylether) -N, N, N8,
N8-tetraaceticacid, tetrasodiumsalt]
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