GB/T 21416-2008 (English Version) PDF

Standard No.: GB/T 21416-2008
Language: Chinese, Available in English version
Release Date: 2008
Published By: General Administration of Quality Supervision, Inspection and Quarantine of the People‘s Republic of China
Latest: GB/T 21416-2008

Scope: This standard specifies the terms and definitions, requirements, test methods, inspection rules and signs, instructions for use, packaging, transportation and storage of medical electronic thermometers. This standard applies to digital medical electronic thermometers for intermittent monitoring of human body temperature (hereinafter referred to as thermometers), which are used in medical departments or households to measure human body temperature, and can be used in different parts of the human body such as armpits, mouth, and anus.

GB/T 21416-2008 Referenced Document

GB 9706.1 Medical electrical equipment—Part 1: General requirements for basic safety and essential performance*， 2020-04-09 Update
GB 9969.1 General principles for preparation of instructions for use of industrial products
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/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)
YY/T 0149-1993 Test method for corrosion resistance of stainless steel medical devices