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RB/T 040-2020: (Guidelines for Biosafety Risk Management of Pathogenic Microorganism Laboratories)
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| RB/T 040-2020 | English | 629 |
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(Guidelines for Biosafety Risk Management of Pathogenic Microorganism Laboratories)
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RB/T 040-2020
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Basic data | Standard ID | RB/T 040-2020 (RB/T040-2020) | | Description (Translated English) | (Guidelines for Biosafety Risk Management of Pathogenic Microorganism Laboratories) | | Sector / Industry | Chinese Industry Standard (Recommended) | | Classification of Chinese Standard | A00 | | Word Count Estimation | 27,210 | | Date of Issue | 2020-08-26 | | Date of Implementation | 2020-12-01 | | Regulation (derived from) | National Certification and Accreditation Administration Announcement No. 21 of 2020 | | Issuing agency(ies) | National Certification and Accreditation Administration | RB/T 040-2020: (Guidelines for Biosafety Risk Management of Pathogenic Microorganism Laboratories)
---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.
(Guidelines for Biosafety Risk Management of Pathogenic Microorganism Laboratories)
ICS 03:120:20
A00
The People's Republic of China Certification and Accreditation Industry Standard
Guidelines for Biosafety Risk Management of Pathogenic Microorganism Laboratories
2020-08-26 released
2020-12-01 implementation
Issued by the National Certification and Accreditation Administration Commission
Table of contents
Preface Ⅲ
1 Scope 1
2 Normative references 1
3 Terms and definitions 1
4 Principle 3
5 Implementation process 4
5:1 Overview 4
5:2 Task Source 4
5:3 Preparation for implementation 5
5:4 Risk management implementation 6
5:5 Reassessment 10
Appendix A (informative appendix) Common methods of laboratory biosafety risk assessment 11
Appendix B (informative appendix) Laboratory Biosafety Risk Assessment Matrix 13
Appendix C (informative appendix) Reference example for the implementation of risk assessment of pathogenic microorganism experimental activities 15
References 24
Foreword
This standard was drafted in accordance with the rules given in GB/T 1:1-2009:
This standard was proposed and managed by the National Certification and Accreditation Administration Committee:
Drafting organizations of this standard: China National Accreditation Center for Conformity Assessment, China Animal Health and Epidemiology Center, China Construction Science Research
Institute Co:, Ltd:, Academy of Military Medicine, Chinese Center for Disease Control and Prevention, Wuhan Institute of Virology, Chinese Academy of Sciences, China Agricultural
Harbin Veterinary Research Institute, Chinese Academy of Agricultural Sciences, Lanzhou Veterinary Research Institute, Chinese Academy of Agricultural Sciences, China Customs Science and Technology Research Center, China Certification
Recognized associations:
The main drafters of this standard: Wang Rong, Wang Junwei, Cao Guoqing, Zhai Peijun, Zhou Yongyun, Lu Bing, Zhao Chihong, Song Donglin, Fu Binyou, Wu Donglai,
Tang Jiangshan, Gu Qiang, Li Muyang, Fu Yue:
Guidelines for Biosafety Risk Management of Pathogenic Microorganism Laboratories
1 Scope
This standard provides guidelines for the principles and implementation process of biosafety risk management carried out by pathogenic microorganism laboratories (hereinafter referred to as "laboratory"):
Use guide:
This standard applies to pathogenic microorganism laboratories carrying out risk management work, and can also be used to supervise and manage the risk of laboratory biosafety:
Evaluation and assessment of risk management:
2 Normative references
The following documents are indispensable for the application of this document: For dated reference documents, only the dated version applies to this article
Pieces: For undated references, the latest version (including all amendments) applies to this document:
GB 19489-2008 General requirements for laboratory biosafety
GB/T 23694-2013 Risk Management Terminology
WS233-2017 General Guidelines for Biosafety of Pathogenic Microorganism Laboratories
3 Terms and definitions
The following terms and definitions defined in GB/T 23694-2013 apply to this document: For ease of use, the following is repeated
Certain terms and definitions in GB/T 23694-2013:
3:1
Biological agents
Microorganisms and biologically active substances:
[GB 19489-2008, definition 2:4]
3:2
Risk
The impact of uncertainty on goals:
Note 1: Risk is usually expressed by a combination of the consequences of an event (including changes in circumstances) and the possibility of an event:
Note 2: Rewrite GB/T 23694-2013, definition 2:1:
3:3
Biorisk
The impact of uncertainty associated with biological factors on the target:
3:4
Riskmanagement
In terms of risk, direct and control the coordination activities of the organization:
[GB/T 23694-2013, definition 3:1]
3:5
Risksource
Internal elements that may individually or jointly cause risks:
Note: The source of risk can be tangible or intangible:
[GB/T 23694-2013, definition 4:5:1:2]
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