GB 11243-2000
Replaced
GB/T 21416-2008
Active
National standards
GB/T 21416-2008 Clinical electronic thermometer
GB/T 21416-2008 Clinical electronic thermometer
Basic Information
Standard Code:
GB/T 21416-2008
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:
11 pages
Scope
This standard specifies the terms and definitions, requirements, test methods, inspection rules, and markings for medical electronic thermometers, as well as the user manual, packaging, transportation, and storage for these devices. This standard applies to digital medical electronic thermometers used for intermittent monitoring of human body temperature (hereinafter referred to as "thermometers"). These thermometers are intended for use by medical institutions or households to measure body temperature, and can be used on various parts of the human body, including the armpit, mouth, and anus.
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 14233.1-1998 Infusion,transfusion,injection equipment for medical use—Part 1:Chemical analysis methods
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
YY/T 0149-1993 Test method for corrosion resistance of stainless steel medical instruments
Adopt standards
EN 1112-00
Related Standards
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