RB/T 010-2019General requirements for evaluation of laboratory animal barrier and isolator devices (English PDF)

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 Regulatory Commission.

Drafting organizations of this standard. China National Accreditation Center for Conformity Assessment, National Engineering and Technology Research Center for Biological Protection Equipment, China Agricultural Science College of Harbin Veterinary Research Institute, Chinese Academy of Medical Sciences Institute of Medical Laboratory Animals.

Introduction

Experimental animal barriers and isolation devices are important equipment in the process of animal feeding and experimentation. There are many types of them, for example, feeding and cleaning experiments Animal equipment, for breeding sterile laboratory animals, equipment for breeding infected laboratory animals, etc., involving biological safety, experimental conditions, animal welfare at present, there is a lack of systematic and consistent evaluation requirements for benefits, environmental safety, occupational health and safety, etc.

This standard can be used as the basis for the evaluation of various experimental animal barriers and isolation devices, and can be used for the development and use of experimental animal barriers and isolation devices.

Use and evaluator's reference.

This standard is a general requirement for evaluation, and should also meet corporate standards and national regulations for this type of product.

General requirements for the evaluation of laboratory animal barriers and isolation devices

1 Scope

This standard specifies the general requirements for the evaluation of barriers and isolation devices for laboratory animals, including the types of laboratory animal devices and general requirements for evaluation.

Request, on-site inspection and evaluation report.

This standard applies to the evaluation of barriers or isolation devices for experimental animals.

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 4793.1 Safety requirements for electrical equipment for measurement, control and laboratory use-Part 1: General requirements GB 14925 Laboratory Animal Environment and Facilities GB 50346 Technical Code for Biological Safety Laboratory Building GB 50447 Technical Code for Laboratory Animal Facilities Building JG170 Biological Safety Cabinet RB/T 199 Laboratory equipment biosafety performance evaluation technical specifications YY0569 Class II biological safety cabinet

3 Terms and definitions

The following terms and definitions apply to this document.

Experimental animal barrier device There is no requirement for airtightness, and it is used to raise or use equipment for laboratory animals that form a barrier environment with the external environment (large environment).

Note. Including the box, ventilation filter system, transmission device and other components, its internal environment (small environment) is controlled.

Experimental animal isolation device it has air-tightness requirements and is used for breeding or using equipment for laboratory animals isolated from the external environment (large environment).

Note. Including the box, ventilation and filtration system, transmission device, isolation operation device and other components, its internal environment (small environment) is controlled.

Transfer device

A supporting device used to transfer items and laboratory animals in and out of laboratory animal barriers or isolation devices.

4 Types of barriers or isolation devices for experimental animals