GB/T 14710-2009: Environmental requirement and test methods for medical electrical equipment

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Scope

This Standard specifies the medical electrical equipment’s (hereinafter referred to as
equipment) environment test purposes, environment grouping, transportation test,
adaptability to power supply, reference test conditions, special circumstances, test
procedures, test sequence, test requirements, test methods, and detailed-rules that
need to be specified when quoting this Standard.
This Standard is applicable to all electrical equipment or electrical systems in
conformity with the definitions of medical equipment.
Note. E.g. that medical electrical equipment as defined in GB 9706.1, the electrical equipment for
laboratory as specified in GB 4793.1, and medical electrical system as defined in GB 9706.15.
This Standard aims at evaluating the adaptability of equipment to various service
environment, and simulated storage and transportation environment.

Basic Data

Standard ID	GB/T 14710-2009 (GB/T14710-2009)
Description (Translated English)	Environmental requirement and test methods for medical electrical equipment
Sector / Industry	National Standard (Recommended)
Classification of Chinese Standard	C30
Classification of International Standard	11.040
Word Count Estimation	13,162
Date of Issue	2009-11-15
Date of Implementation	2010-05-01
Older Standard (superseded by this standard)	GB/T 14710-1993
Quoted Standard	JTG B01-2003
Regulation (derived from)	National Standard Approval Announcement 2009 No.13 (Total No.153)
Issuing agency(ies)	General Administration of Quality Supervision, Inspection and Quarantine of the People's Republic of China, Standardization Administration of the People's Republic of China
Summary	This standard specifies the purpose of medical electrical equipment (hereinafter referred to as Equipment) environmental testing, environmental groups, transport test, ability to adapt to the power supply, benchmark test conditions, special circumstances, test procedures, test sequence, test requirements, test methods and references to the standards should be stipulated rules. This standard applies to all medical devices comply with the definition of electrical equipment or electrical system.