GB/T 21416-2008 English PDF

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GB/T 21416-2008: Clinical electronic thermometer [including MODIFICATION 1]
Status: Valid

Standard ID	USD	BUY PDF	Lead-Days	Standard Title (Description)	Status
GB/T 21416-2008	329	Add to Cart	3 days	Clinical electronic thermometer [including MODIFICATION 1]	Valid

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Basic data

Standard ID: GB/T 21416-2008 (GB/T21416-2008)
Description (Translated English): Clinical electronic thermometer [including MODIFICATION 1]
Sector / Industry: National Standard (Recommended)
Classification of Chinese Standard: C38
Classification of International Standard: 11.040.55
Word Count Estimation: 14,133
Date of Issue: 2008-01-22
Date of Implementation: 2008-09-01
Quoted Standard: GB/T 191-2000; GB/T 2829-2002; GB 9706.1; GB 9969.1
Adopted Standard: EN 1112-2000, NEQ
Regulation (derived from): National Standard Approval Announcement 2008 No.2 (Total No.115)
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 terms and definitions of medical electronic thermometer, requirements, test methods, inspection rules and signs, manual, packaging, transport and storage. This standard applies to intermittent monitoring body temperature digital medical electronic thermometer, the thermometer for the health sector or household use for measuring body temperature, can be used in human armpit, different parts of the anus, etc., mouth.

GB/T 21416-2008: Clinical electronic thermometer [including MODIFICATION 1]

---This is a DRAFT version for illustration, not a final translation. Full copy of true-PDF in English version (including equations, symbols, images, flow-chart, tables, and figures etc.) will be manually/carefully translated upon your order.
Clinical electronic thermometer ICS 11.040.55 C38 National Standards of People's Republic of China Medical electronic thermometer Posted 2008-01-22 2008-09-01 implementation Administration of Quality Supervision, Inspection and Quarantine of People's Republic of China Standardization Administration of China released

Table of Contents

Introduction Ⅲ 1 Scope 1 2 Normative references 1 3 Terms and definitions 4 requires 2 Test Method 4 5 6 Inspection rules 6 7 signs, instructions, packaging, transportation and storage 7

Foreword

Chapter 6 of this standard are recommended, the rest are all mandatory technical content. And it shall GB 9706.1 "Medical electrical equipment - Part 1 Part I. General Requirements for Safety "supporting the use of. Medical electronic thermometer is an intermittent electronic equipment to monitor a patient's temperature. In order to standardize the technical characteristics of the product, to ensure that products are Efficacy and safety standard is formulated as the basis for production and quality control. This standard is not equivalent to the technical requirements EN1112-00 "intermittent measure a patient's temperature thermometer electronic medical standards." This standard was proposed by the State Food and Drug Administration. This standard by the National Standardization Technical Committee medical appliances (SAC/TC10) centralized. This standard was drafted. State Food and Drug Administration Guangzhou Medical Device Quality Supervision and Inspection Center, in Guangdong Province Drug Administration Bureau of Medical Devices Department. The main drafters of this standard. Huang Xiulian, Yang Xiaoling, Lu subdivision, Chen Lihua, Zhang Yang, Yan Lin. Medical electronic thermometer

1 Scope

This standard specifies the terms and definitions of medical electronic thermometer, requirements, test methods, inspection rules and signs, instructions, packaging, Transportation and storage. This standard applies to intermittent monitoring body temperature digital medical electronic thermometer (hereinafter referred to as the thermometer), the thermometer for the health sector Or family use for measuring body temperature, can be used in different parts of the body under the arms, mouth, anus and so on.

2 Normative references

The following documents contain provisions which, through reference in this standard and become the standard terms. For dated references, subsequent Amendments (not including errata content) or revisions do not apply to this standard, however, encourage the parties to the agreement are based on research Whether the latest versions of these documents. For undated reference documents, the latest versions apply to this standard. GB/T 191-2000 Packaging - Pictorial signs (eqv ISO 780.1997) GB/T 2829-2002 periodic inspection Sampling procedures and tables (suitable for process stability test) GB 9706.1 Medical Electrical Equipment Part 1. General requirements for safety (GB 9706.1-2007, IEC 60601-1. 1988, IDT) GB 9969.1 Instructions General Industrial Products GB/T 14233.1-1998 Infusion, transfusion, injection equipment - Part 1. Chemical analysis GB/T 14710-1993 Medical electrical equipment environmental requirements and test methods GB/T 16886.1-2001 Biological evaluation of medical devices - Part 1. Evaluation and testing (idt ISO 10993-1.1997) YY/T 0149-1993 stainless steel medical equipment corrosion test methods

3 Terms and Definitions

The following terms and definitions apply to this standard. 3.1 By using a sensor or a circuit to measure the temperature of the electronic apparatus is displayed. 3.2 Immersion bath thermometer from the beginning to the thermometer at the maximum allowable temperature within the error range display duration. 3.3 Containing component temperature measurement sensor for carrying out a predetermined position sensor mounting temperature measurement. 3.4 According to the output of a measurable amount (e.g., resistive, force, etc.), providing means temperature output function. 3.5 With automatic temperature control, a device constant temperature source. ......

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