YY/T 0878.2-2015Test for complement activation of medical devices - Part 2: Serum alternative pathway complement activation (English PDF)

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.

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.

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.

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]