RB/T 199-2015 in English

Technical code for evaluating biosafety performance of laboratory equipment

1 Scope

This standard specifies the requirements for biosafety performance evaluation of 12 kinds of biosafety-related equipment in the laboratory.

This standard is applicable to the biosafety performance evaluation of equipment involved in biosafety laboratories. This standard may also serve as reference for the biosafety performance evaluation of the equipment involved hereof when used in places such as hospitals and pharmaceutical factories.

2 Normative references

The following referenced documents are indispensable for the application of this document. For dated references, only the edition cited applies. For undated references, the latest edition of the referenced documents (including any amendment) applies.

GB 18466-2005 Discharge standard of water pollutants for medical organization
GB 19489 Laboratories - General requirements for biosafety
GB 50346 Architectural and technical code for biosafety laboratories
GB 50591 Code for construction and acceptance of cleanroom
EJ/T 1096 Containment enclosures: Classification according to leak tightness and associated checking method
JG 170 Biosafety cabinet
YY 0569 Class II biological safety cabinets
Technical specification for disinfection (Edition 2002) issued by the Ministry of Health of the People's Republic of China

3 Terms and definitions

For the purposes of this document, the terms and definitions given in YY 0569 and JG 170 as well as the followings apply.

3.1
biosafety performance of equipment
equipment performance that protects people and the environment from pathogenic microbial hazards

3.2
animal isolated equipment
general term for negative pressure isolation devices used in animal biosafety laboratories to prevent the leakage of pathogenic microorganisms, effectively prevent animal escape, and breed animals

Note: It is revised from GB 50346-2011, Definition 2.0.9.

3.3
individually ventilated cage, IVC
individually ventilated containment barrier with breeding box as the unit; wherein, clean air is delivered into each independent cage to maintain a certain pressure and cleanliness in the breeding environment, so as to avoid animal pollution by the environment (positive pressure) or environmental pollution by animals (negative pressure)

Note 1: It is revised from GB 50346-2011, Definition 2.0.8.

Note 2: This equipment is used to breed animals that are clean and specific pathogen-free or non-infected (free of negative pressure) . The negative pressure individually ventilated cage is used to breed infected animals in the biosafety laboratory.

3.4
gas (vapor) disinfection equipment
equipment used to kill or clear pathogenic microorganisms on a transmission medium by the gas (vapor) generated by disinfectant to achieve disinfection

3.5
airtight door
airtight door usually with leaf and frame integrated, and with gap sealed by a mechanical pressing device or an inflatable sealing ring

Note: It is revised from GB 50346-2011, Definition 2.0.10.

3.6
exhaust high efficiency filtration units
filtration unit used in specific biorisk environment to remove harmful bio-aerosol in exhaust, which has the functions of in-situ disinfection and leak detection

Foreword i
Introduction ii
1 Scope
2 Normative references
3 Terms and definitions
4 Equipment evaluation requirements
4.1 Evaluation of biosafety cabinet
4.2 Evaluation of animal isolated equipment
4.3 Evaluation of individually ventilated cage
4.4 Evaluation of pressure steam sterilizer
4.5 Evaluation of gas (vapor) disinfection equipment
4.6 Evaluation of airtight door
4.7 Evaluation of exhaust high efficiency filtration unit
4.8 Evaluation of positive pressure suit
4.9 Evaluation of life support system
4.10 Evaluation of chemical shower disinfection device
4.11 Evaluation of wastewater disinfection equipment
4.12 Evaluation of animal residue treatment system (including alkaline hydrolysis treatment and refining treatment)
Bibliography