YY/T 0878.2-2015 English PDF

US$299.00 · In stock
Delivery: <= 3 days. True-PDF full-copy in English will be manually translated and delivered via email.
YY/T 0878.2-2015: Test for complement activation of medical devices - Part 2: Serum alternative pathway complement activation
Status: Valid

Standard ID	USD	BUY PDF	Lead-Days	Standard Title (Description)	Status
YY/T 0878.2-2015	299	Add to Cart	3 days	Test for complement activation of medical devices - Part 2: Serum alternative pathway 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 0878.2-2015 (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

---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 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] ......

Image     

Tips & Frequently Asked Questions:

Question 1: How long will the true-PDF of YY/T 0878.2-2015_English be delivered?

Answer: Upon your order, we will start to translate YY/T 0878.2-2015_English as soon as possible, and keep you informed of the progress. The lead time is typically 1 ~ 3 working days. The lengthier the document the longer the lead time.

Question 2: Can I share the purchased PDF of YY/T 0878.2-2015_English with my colleagues?

Answer: Yes. The purchased PDF of YY/T 0878.2-2015_English will be deemed to be sold to your employer/organization who actually pays for it, including your colleagues and your employer's intranet.

Question 3: Does the price include tax/VAT?

Answer: Yes. Our tax invoice, downloaded/delivered in 9 seconds, includes all tax/VAT and complies with 100+ countries' tax regulations (tax exempted in 100+ countries) -- See Avoidance of Double Taxation Agreements (DTAs): List of DTAs signed between Singapore and 100+ countries

Question 4: Do you accept my currency other than USD?

Answer: Yes. If you need your currency to be printed on the invoice, please write an email to Sales@ChineseStandard.net. In 2 working-hours, we will create a special link for you to pay in any currencies. Otherwise, follow the normal steps: Add to Cart -- Checkout -- Select your currency to pay.