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YY/T 0618-2017 (YYT 0618-2017)

YY/T 0618-2017_English: PDF (YYT0618-2017)
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YY/T 0618-2017English679 Add to Cart 6 days Test methods for bacterial endotoxins of medical devices—Routine monitoring and alternatives to batch testing YY/T 0618-2017 Valid YY/T 0618-2017

BASIC DATA
Standard ID YY/T 0618-2017 (YY/T0618-2017)
Description (Translated English) Test methods for bacterial endotoxins of medical devices--Routine monitoring and alternatives to batch testing
Sector / Industry Medical Device & Pharmaceutical Industry Standard (Recommended)
Classification of Chinese Standard C30
Classification of International Standard 11.040.01
Word Count Estimation 34,390
Date of Issue 2017-02-28
Date of Implementation 2018-01-01
Older Standard (superseded by this standard) YY/T 0618-2007
Drafting Organization Shandong Province Medical Device Product Quality Inspection Center, the State Food and Drug Administration Tianjin Medical Device Quality Supervision and Inspection Center, Shanghai Songli Biological Technology Co., Ltd.
Administrative Organization National Medical Device Biology Evaluation Standardization Technical Committee (SAC/TC 248)
Proposing organization China Food and Drug Administration
Issuing agency(ies) State Food and Drug Administration

YY/T 0618-2017
Test methods for bacterial endotoxins of medical devices-Routine monitoring and alternatives to batch testing
ICS 11.040.01
C30
People's Republic of China Pharmaceutical Industry Standard
Replacing YY/T 0618-2007
Medical device bacterial endotoxin test method
Routine monitoring and skipping batch inspection
Published on.2017-02-28
2018-01-01 implementation
State Food and Drug Administration issued
Foreword
This standard was drafted in accordance with the rules given in GB/T 1.1-2009.
This standard replaces YY/T 0618-2007 "Bacterial endotoxin test method routine monitoring and jump batch test", and YY/T 0618-
The main differences in.2007 are as follows.
--- The standard name was changed to. routine monitoring and jumping test of bacterial endotoxin test method for medical devices;
--- Modified the scope;
--- Added terminology, endotoxin working standards (see 3.4); geometric mean endpoint (see 3.11); survey test (see 3.14);
(see 3.21);
--- Revised "Appendix B Test Methods, General Surveillance and Jump Test Guidelines";
--- Added "Appendix C Excess Limit (OOS) and Failure Investigation Guide".
Please note that some of the contents of this document may involve patents. The issuing organization of this document is not responsible for identifying these patents.
This standard was proposed by the State Food and Drug Administration.
This standard is under the jurisdiction of the National Medical Device Biology Evaluation Standardization Technical Committee (SAC/TC248).
This standard was drafted. Shandong Medical Device Product Quality Inspection Center, State Food and Drug Administration Tianjin Medical Device Quality
Supervision and Inspection Center, Shanghai Songli Biotechnology Co., Ltd.
The main drafters of this standard. Sun Lingqi, Wang Wei, Zhu Lili, Jiang Hua, He Hongbing, Wu Xujun.
The previous versions of the standards replaced by this standard are.
---YY/T 0618-2007.
introduction
A pyrogen is any substance that can cause fever. The release of many medical products requires a pyrogen test. Pyrogens can be divided into two categories. micro
Biopyrogens (eg, bacteria, fungi, viruses) and non-microbial pyrogens (eg, drugs, device materials, steroids, plasma products). Heat found
Most of the original endotoxin is a Gram-negative bacterium. Although Gram-positive bacteria, fungi and viruses may be pyrogens, they are pyrogenic
The mechanism is different (systemic action) and the degree of action is lower than that of Gram-negative bacteria. This standard only includes Gram-negative bacterial endotoxin test.
Endotoxin is a high molecular weight lipopolysaccharide (LPS) component of the outer wall of Gram-negative bacteria, such as contaminating human blood or tissue, endotoxin
It can cause fever, meningitis and rapid decrease in blood pressure. When Gram-negative bacteria decompose or cleave, they are mainly composed of proteins, phospholipids and LPS.
The outer wall components of the cells are continuously released into the environment. Endotoxin contamination is difficult to prevent because it is widely found in nature and is stable in nature.
The smaller volume can be passed through a conventional sterilizing filter.
Medical products can be made pyrogenic without the following measures.
1) Production techniques that prevent or control endotoxin aggregation;
2) Depyrogenation by endotoxin inactivation (such as dry heat) or physical removal (such as washing, distillation, ultrafiltration).
This standard focuses on products that are produced without the need to remove the pyrogen step as part of the production process.
The purpose of this standard is to present requirements and guidelines for bacterial endotoxin testing. Includes selection of test product units, selection of test techniques
Selection and confirmation, use of routine test techniques and interpretation of test results. This standard also includes production to support the selection of jump test.
Run confirmation requirements.
Appendix A, Appendix B, and Appendix C contain the following information, respectively.
--- Background and history of endotoxin testing (see Appendix A);
--- Guide to endotoxin test methods (see