YY/T 0878.1-2013 English PDF

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YY/T 0878.1-2013: Test for complement activation of medical devices. Part: Serum whole complement activation
Status: Valid

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YY/T 0878.1-2013	259	Add to Cart	3 days	Test for complement activation of medical devices. Part: Serum whole complement activation	Valid

Similar standards

YY/T 0841   YY/T 1057   YY/T 0708   YY/T 0870.8   YY/T 0870.7   YY/T 0878.3   

Basic data

Standard ID: YY/T 0878.1-2013 (YY/T0878.1-2013)
Description (Translated English): Test for complement activation of medical devices. Part: Serum whole 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: 11,153
Quoted Standard: GB/T 16886.1; GB/T 16886.4
Regulation (derived from): State Food and Drug Administration announcement 2013 No. 36; industry standard for filing Notice 2013 No. 12 (No. 168 overall)
Issuing agency(ies): State Food and Drug Administration
Summary: This standard specifies: Medical Devices full complement activation in vitro test methods. This standard applies to solid samples. "serum" and "complement" are general terms. This standard does not involve a single complement components features, modifica

YY/T 0878.1-2013: Test for complement activation of medical devices. Part: Serum whole complement activation

---This is a DRAFT version for illustration, not a final translation. Full copy of true-PDF in English version (including equations, symbols, images, flow-chart, tables, and figures etc.) will be manually/carefully translated upon your order.
Test for complement activation of medical devices.Part. Serum whole complement activation ICS 11.040.01 C30 People's Republic of China pharmaceutical industry standards Medical devices complement activation test Part 1. the full serum complement activation Part 1. Serumwholecomplementactivation Issued on. 2013-10-21 2014-10-01 implementation China Food and Drug Administration released

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 ASTMF1984-1999 "solid material within the whole serum complement activation trial standards" Making. This portion ASTMF1984-1999 compared with the following differences. --- For ASTMF1984-1999 made editorial changes, delete some of the information content is not applicable; --- Increased the preamble; --- Added Appendix A liquid preparation of reagents and buffers. 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. Participated in the drafting of this section. Shanghai Biological Materials Research and Testing Center; Chinese Academy of Medical Sciences Institute of Blood Transfusion. The main drafters of this section. Regulation of. Wang Ke radium, Liucheng Hu, Ding Tingting, Sun Jiao, Wang Hong.

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. Medical devices complement activation test Part 1. the full serum complement activation

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 ℃ 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 ℃ condition. Unless otherwise indicated, all reagents, test tubes and cell preparations were kept on ice. 5.2 5mLSRBC centrifuged for 10min at 1000g. ......

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