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RB/T 086-2022Guidelines for Evaluation of Biosafety Laboratory Operation and Maintenance (English PDF)

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Issued by

National Certification and Accreditation Administration

Level / Type

National · Recommended

Issue date

October 11, 2022

Implementation date

January 1, 2023

Scope

RB/T 086-2022 (Guidelines for Evaluation of Biosafety Laboratory Operation and Maintenance) is available as an English-translated PDF.

RB/T 086-2022 — This document provides an evaluation of biosafety laboratory facility equipment management, building facility operation and maintenance, and key protective equipment operation and maintenance. guide.

This document is applicable to the operation and maintenance evaluation of Level 3 and Level 4 biosafety laboratories, and may be implemented by reference to Level 1 and Level 2 biosafety laboratories.

When the mobile biosafety laboratory involves the building facilities or key protective equipment specified in this document, its operation and maintenance evaluation can also refer to this document. document.

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Document preview — RB/T 086-2022

National Standard of the People's Republic of China

ICS
03.120.20
Classification
A 00

Issued by: National Certification and Accreditation Administration

Contents

  • Preface
  • 1 Scope
  • 2 Normative references
  • 3 Terms and Definitions
  • 4 Ratings
  • 4.1 Evaluation Principle
  • 4.2 Evaluation method
  • 4.3 Evaluation elements
  • 4.4 Evaluation organization
  • 5 Laboratory Facility Equipment Management
  • 5.1 General provisions
  • 5.2 People Management
  • 5.3 Files and System
  • 5.4 Emergency management
  • 5.5 Outsourced management
  • 6 Operation and maintenance of building facilities
  • 6.1 General provisions
  • 6.2 Indoor environment
  • 6.3 Enclosure structure
  • 6.4 Ventilation and air conditioning system
  • 6.5 Water supply and drainage system
  • 6.6 Electrical system
  • 6.7 Gas supply system
  • 6.8 Monitoring system
  • 7 Operation and maintenance of key protective equipment
  • 7.1 General provisions
  • 7.2 Personal protection and technical support equipment
  • 7.3 Protective barrier equipment
  • 7.4 Item delivery equipment
  • 7.5 Disinfection and sterilization equipment
  • Appendix A (Informative) Biosafety Laboratory Operation and Maintenance Evaluation Checklist
  • Appendix B (Normative) Air Conditioning System Maintenance
  • Appendix C (informative) Suggestions on the maintenance cycle of air filters at all levels of the ventilation and air conditioning system
  • Reference

Foreword

This document is in accordance with the provisions of GB/T 1.1-2020 "Guidelines for Standardization Work Part 1: Structure and Drafting Rules for Standardization Documents" drafting.

Please note that some contents of this document may refer to patents. The issuing agency of this document assumes no responsibility for identifying patents.

1 Scope

This document provides an evaluation of biosafety laboratory facility equipment management, building facility operation and maintenance, and key protective equipment operation and maintenance.

guide.

This document is applicable to the operation and maintenance evaluation of Level 3 and Level 4 biosafety laboratories, and may be implemented by reference to Level 1 and Level 2 biosafety laboratories.

When the mobile biosafety laboratory involves the building facilities or key protective equipment specified in this document, its operation and maintenance evaluation can also refer to this document.

document.

2 Normative references

The contents of the following documents constitute the essential provisions of this document through normative references in the text. Among them, dated references for documents, only the version corresponding to the date is applicable to this document; for undated reference documents, the latest version (including all amendments) is applicable to this document.

GB 14925 Experimental animal environment and facilities GB 19489 General Requirements for Laboratory Biosafety GB 50346 Technical Specifications for Biosafety Laboratory Buildings GB 50365 Air Conditioning and Ventilation System Operation Management Standard RB/T 040 Guidelines for Biosafety Risk Management in Pathogenic Microorganism Laboratories RB/T 199 Technical Specifications for Biosafety Performance Evaluation of Laboratory Equipment Disinfection Technical Specifications (Ministry of Health of the People's Republic of China, 2002)

3 Terms and Definitions

The following terms and definitions apply to this document.

Patrol inspection

Conduct regular inspections and checks on the operating status of facilities and equipment.

run operation

Perform daily start-stop control, parameter setting, status monitoring and optimal adjustment of facilities and equipment to ensure that the biosafety laboratory is in a safe state.

Full and efficient working condition.

maintenance

The work carried out to ensure the normal operation of facilities and equipment, to improve operational reliability, eliminate hidden dangers, and prolong lifespan.

Carry out comprehensive testing and evaluation of the engineering and technical indicators of the biosafety laboratory that has been completed and accepted.

......
This preview omits tables, figures, formulas and parts of the technical clauses. The complete document — 22 pages — is available in the English PDF.

Referenced standards

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