YY/T 0878.1-2013Complement activation test for medical devices - Part 1: Serum complement activation (English PDF)

Foreword

YY/T 0878 the general title "medical devices complement activation test", includes the following components.

--- Part 1. Full serum complement activation;

--- Part 2. alternative pathway of complement activation;

--- Part 3. the classical pathway of complement activation.

Other aspects related to complement activation test will have the rest of the standard. This section YY/T Section 10878 of. This section drafted in accordance with GB/T 1.1-2009 given rules.

YY/T 0878 this part of the reference ASTM F1984-1999 "solid material within the whole serum complement activation trial standards" Making. This portion ASTM F1984-1999 compared with the following differences.

--- For ASTM F1984-1999 made editorial changes, delete some of the information content is not applicable;

--- Increased the preamble;

--- Added Appendix A liquid preparation of reagents and buffers.

Introduction

GB/T 16886.4 given medical equipment/Materials blood compatibility test methods and test selection strategy, but only given Selection principle. YY/T 0878 is part of the full complement in vitro activation of specific test methods can be used as GB/T 16886.4 TCM Treatment equipment/materials complement activation supplementary tests.

As an important component of blood, the effector molecule produced after activation of the complement system will directly affect medical equipment/materials, blood compatibility.

Inappropriate activation of complement may cause serious acute body/chronic reaction. YY/T in vitro described in this section of the 0878 full complement excited Evaluation Method of live action, can be used to screen medical equipment/materials whether complement activation potential.

1 Scope

YY/T 0878 This section gives a full complement of medical devices in vitro activation of the test method, this method is suitable for 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

3 Terms and Definitions

GB/T 16886.1 terms and definitions GB/T 16886.4 defined apply to this document.

4 Abbreviations

The following abbreviations apply to this document. Ab. antibody (hemolysin)

BBS. barbital buffer

BBS-G. barbital buffer - gelatin

BBS-GM. barbital buffer - calcium and magnesium ion gelatin C '. activated complement

EDTA. ethylenediaminetetraacetic acid disodium salt dihydrate

HS. human serum

PVDF. PVDF RBC. RBC Preparation of sheep RBC 5 5.1 commercially available sheep red blood cells (SRBC) stored in Alsever solution, 4 °C storage. Storage of more than eight weeks or visual inspection of the second When supernatant washes among hemoglobin, the cells were discarded.

Note: All centrifugation steps were performed at 4 °C condition. Unless otherwise indicated, all reagents, test tubes and cell preparations were kept on ice.

5.2 5mLSRBC centrifuged for 10min at 1000g.