GB/T 21417.1-2008
Active
National standards
GB/T 21417.1-2008 Clinical infrared thermometers—Part 1:Ear
GB/T 21417.1-2008 Clinical infrared thermometers—Part 1:Ear
Basic Information
Standard Code:
GB/T 21417.1-2008
Standard Type:
National standards
Standard Status:
Active
is_force_gb:
no
CCS Name:
Normal diagnostic instruments
ICS Name:
Diagnostic equipment
Publish Date:
2008-01-22
Implement Date:
2008-09-01
Pages:
15 pages
Scope
This part of GB/T 21417 specifies the terms and definitions, requirements, test methods, inspection rules and markings, user manuals, packaging, transportation, and storage of infrared ear thermometers for medical use. This part applies to infrared ear thermometers for medical use (hereinafter referred to as "thermometers") that measure the infrared radiation exchange between the ear cavity of the object being measured and the detector, and make appropriate corrections, then display the temperature of a specific part of the body. The thermometer displays the subject's body temperature by measuring the thermal radiation in the ear cavity.
Development Information
Referenced Standards
GB/T 191-2000 Packaging—Pictorial marking for handling of goods
GB/T 2829-2002 Sampling procedures and tables for periodic inspection by attributes (Apply to inspection of process stability)
GB/T 14710-1993 The environmental requirements and test methods for medical electrical equipment
GB/T 16886.1-2001 Biological evaluation of medical devices—Part 1:Evaluation and testing
GB 9706.1-1995 Medical electrical equipment—Part 1:General requirements for safety
GB 9706.1-2007 Medical electrical equipment—Part 1:General requirements for safety
GB 9706.1-2020 Medical electrical equipment—Part 1:General requirements for basic safety and essential performance
GB 9969.1-1998 General principles for preparation of instructions for use of industrial products
Adopt standards
BS EN 12470-5:2003
Related Standards
GB 11243-2000
Replaced
GB 1588-2001
Replaced
GB 1588-2001 Clinical thermometer
YY 0109-2003
Replaced
YY 0109-2003 Medical ultrasonic nebulizer
YY 0455-2003
Replaced
YY 0455-2003 Medical electrical equipment—Part 2:Particular requirments for the safety of infant radiant warmers
YY/T 1036-2004
Active
YY/T 1036-2004 Impression tonometers
GB/T 19665-2005
Replaced