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GB/T 27416-2014Laboratory animal institutions - General requirements for quality and competence (English PDF)

实验动物机构 质量和能力的通用要求

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Issued by

General Administration of Quality Supervision, Inspection and Quarantine; Standardization Administration of the PRC

Level / Type

National · Recommended

Issue date

September 3, 2014

Implementation date

October 1, 2014

Scope

GB/T 27416-2014 is the English-translated version of 实验动物机构 质量和能力的通用要求.

GB/T 27416-2014 is the Chinese standard "Laboratory animal institutions - General requirements for quality and competence". Its scope clause reads: This standard specifies the laboratory animal facility organization, management and operation of quality, safety, animal welfare, occupational health and other aspects to be met basic requirements.

Including a variety of sources for animal experiments and experimental animals mentioned in this standard. This standard applies to all persons engaged in animal breeding and production organizations engaged in animal experiments. Its clauses include terms and definitions.

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Document preview — GB/T 27416-2014

National Standard of the People's Republic of China

ICS
65.020.30
Classification
B 44

Issued by: General Administration of Quality Supervision, Inspection and Quarantine; Standardization Administration of the PRC

Contents

  • Introduction
  • 1 Scope
  • 2 Normative references
  • 3 Terms and definitions
  • 4 Management System
  • 4.1 Organization and Management
  • 4.3 file management system
  • 4.4 Management Manual
  • 5 4.5 program files
  • 4.6 Description and procedures
  • 4.7 Safety Manual
  • 4.8 Record
  • 4.9 Identification System
  • 4.11 Work Plan
  • 4.13 does not meet the terms of the identification and control
  • 4.14 Corrective Action
  • 4.15 Precautions
  • 4.17 Internal Audit
  • 4.18 Management Review
  • 4.19 emergency management and incident reporting
  • 5 Laboratory Animal Facility
  • 5.1 Planning and Design
  • 5.2 requires the construction of
  • 6 Animal Feeding
  • 6.1 General
  • 6.2 Environmental Control and Monitoring
  • 6.3 Animal Behavior Management
  • 6.4 Animal identification
  • 6.5 Monitoring animal genetic characteristics and genetic manipulation
  • 6.6 Animal Nutrition and Health
  • 6.8 Waste Management
  • 6.9 Management of animals during the holiday
  • 21 7.1 Purchasing Animals
  • 7.2 Packaging and transport of animals
  • 7.3 animal disease prevention and control
  • 7.4 animal disease treatment and care
  • 8 Occupational Health and Safety
  • 8.1 General
  • 8.2 Risk Assessment
  • 8.3 Hazard Management and Control
  • 8.4 Code of Conduct
  • 8.5 staff competency requirements and training
  • 8.6 facility design and operation management to ensure
  • 8.7 Equipment Inspection and performance guarantee
  • 8.8 Personal Protective Equipment
  • 8.9 Occupational health care
  • 8.10 occupational health and safety information communication
  • 8.11 occupational health and safety performance monitoring
  • Annex B (informative) reduce animal use, optimization and substitution principle

1 Scope

This standard specifies the laboratory animal facility organization, management and operation of quality, safety, animal welfare, occupational health and other aspects to be met basic requirements. Including a variety of sources for animal experiments and experimental animals mentioned in this standard.

This standard applies to all persons engaged in animal breeding and production organizations engaged in animal experiments.

2 Normative references

The following documents for the application of this standard is essential. For dated references, only the dated version suitable for use herein

Member. For undated references, the latest edition (including any amendments) applies to this document.

GB 14925-2010 Laboratory Animal Facilities and Environment

GB 19489-2008 General requirements for laboratory biosafety

GB/T 24001 Environmental management systems - Requirements with guidance for use

GB/T 27025 testing and calibration laboratories General requirements

GB/T 28001 Occupational Health and Safety Management System Requirements

GB/T 28002 Occupational Health and Safety Management System Implementation Guide

GB 50346-2011 biological safety laboratory construction technical specifications

GB 50447-2008 Laboratory Animal Facility Construction Specification

3 Terms and definitions

3.1 Animal experiments

For the purpose of any acceptable use of experimental animals, a process that may cause animals pain, suffering, anguish, persistent loss

Injury, pregnancy and maternity.

Note 1. The experimental procedure including the former experiment and after the experiment. Before the experiment process means an animal preparation, including animal tag; a prepared experiment

The animals were used until no longer required for further experiments animals were observed so far; refers to the process of the experiment does not need to be used for animal experiments of the

Configuration process.

Note 2. Does not include practicing veterinarians in clinical behavior.

Note 3. The purpose of animal experiments should be consistent with the principles of national laws and regulations and international practice.

3.2 Experimental animals

Accordance with relevant standards specially bred and reared intended for experiments or for other scientific purposes animals.

Note 1. nurture and rearing animals may need to allow the competent authorities.

Note 2. The animals need genetic backgrounds are definite or whose sources are clear, and the exercise of control over their carrying microbes, parasites, and health status.

Note 3. In view of our language habits, when no special distinction, generalized experimental animals with experiments on animals (see 3.5 of this standard).

3.3 Environmental enrichment

To the experimental animals as much as possible to meet its environmental and nature items.

NOTE. Environmental enrichment is also known as environmental richness.

GB/T 43051 | GB/T 39760 | GB/T 35892 | GB/T 14926.20 | GB/T 14926.19 | GB/T 14926.1 | […]

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This preview omits tables, figures, formulas and parts of the technical clauses. The complete document — 39 pages — is available in the English PDF.

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