GB/T 21417.1-2008 (English Version) PDF

Standard No.: GB/T 21417.1-2008
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 21417.1-2008

Scope: This part of GB/T 21417 specifies the terms and definitions, requirements, test methods, inspection rules and signs, instructions for use, packaging, transportation and storage of ear cavity medical infrared thermometers. This part applies to ear cavity medical infrared thermometers (hereinafter referred to as thermometers) that measure the infrared radiation exchange with the ear cavity of the measured object and the appropriate correction value through the detector, and output and display the temperature of a certain part of the body. The thermometer displays the body temperature of the measured object by measuring the thermal radiation of the ear cavity.

GB/T 21417.1-2008 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 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)