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Chemicals. Validation basic requirements of alternative methods for in vitro toxicological testing
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Basic data
| Standard ID | SN/T 3526-2013 (SN/T3526-2013) |
| Description (Translated English) | Chemicals. Validation basic requirements of alternative methods for in vitro toxicological testing |
| Sector / Industry | Commodity Inspection Standard (Recommended) |
| Classification of Chinese Standard | G09 |
| Classification of International Standard | 13.300 |
| Word Count Estimation | 8,894 |
| Adopted Standard | OECD ENV/JM/MONO(2005)14, MOD |
| Regulation (derived from) | AQSIQ notification issued in 2013 on the first batch of 179 entry-exit inspection and quarantine of industry standards; industry standard for filing Notice 2013 No. 9 (No. 165 overall) |
| Issuing agency(ies) | General Administration of Customs |
| Summary | This standard specifies the chemicals in vitro toxicity testing alternative methods to verify the basic requirements. Verify that this standard applies to all kinds of chemicals in vitro toxicity testing alternative methods. |
SN/T 3526-2013: Chemicals. Validation basic requirements of alternative methods for in vitro toxicological testing
---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.
Chemicals. Validation basic requirements of alternative methods for in vitro toxicological testing
People's Republic of China Entry-Exit Inspection and Quarantine Standards
In vitro toxicity testing of chemicals for Validation of Alternative Methods
basic requirements
Issued on. 2013-03-01
2013-09-16 implementation
People's Republic of China
The State Administration of Quality Supervision, Inspection and Quarantine released
Foreword
This standard was drafted in accordance with GB/T 1.1-2009 given rules.
This standard reference Organisation for Economic Co-operation and Development (OrganizationforEconomicCooperationandDevelopment,
OECD) Guidelines document OECDENV/JM/MONO (2005) 14. "Test Method hazard assessment new or updated international verification and
Receiving guidance document "(Guidancedocumentonthevalidationandinternationalacceptanceofneworupdated
testmethodsforhazardassessment) (in English).
This standard is proposed and managed by the National Certification and Accreditation Administration Committee.
This standard was drafted. Chinese Academy of Inspection and Quarantine, China National Accreditation Center.
The main drafters of this standard. Cheng Yan, Cui Yuan, He Ping, Falls Apart, Xie Wenping.
In vitro toxicity testing of chemicals for Validation of Alternative Methods
basic requirements
1 Scope
This standard specifies the chemical toxicity in vitro Test Validation of Alternative Methods of basic requirements.
Verify This standard applies to all kinds of chemicals in vitro toxicity testing alternative methods.
2 Terms and definitions
The following terms and definitions apply to this document.
2.1
Alternative alternative
Improve trial design and improve test efficiency, to reduce the number of animals required for certain (alternative reduction), reduce animal stress (excellent
Of substitution), and a complete cessation of the use of experimental animals (absolute substitute).
2.2
Alternative test alternativestesting
Free use of organs, cultured cells or organelles, biological simulation system to reduce, refine or replace traditional animal testing, toxicological
Pharmacological evaluation, assessment and test the effectiveness of other life science research.
2.3
Verify validation
For certain purposes, of a method or procedure to assess the reliability and relevance of the process.
3 Verify basic requirements
3.1 key step validation process
Figure 1 from test development to validate test methods to optimize critical point steps.
3.2 Principles for the Validation
3.2.1 Test principle of the method described.
3.2.2 Test Method describe the relationship between the end and purpose of biological indicators.
Details of the program 3.2.3 Test Method.
3.2.4 Test Method in the laboratory and laboratory reproducibility confirmed.
3.2.5 Test Method of instructions required to run based test performed with reference substance, and the substance should be applied by reference to the representative of the test method thereof
Quality type.
3.2.6 Test run of the method should have been assessed, assessment and information of interest related species and the presence of related toxicity test information
Related.
3.2.7 ideal, all support the testing method validation data should comply with Good Laboratory Practice (GLP) principles.
3.2.8 All test methods to support validation of data should be experts.
...