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GB 9706.219-2021 English PDF

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GB 9706.219-2021: Medical electrical equipment - Part 2-19: Particular requirements for the basic safety and essential performance of infant incubators
Status: Valid
Standard IDUSDBUY PDFLead-DaysStandard Title (Description)Status
GB 9706.219-2021589 Add to Cart 5 days Medical electrical equipment - Part 2-19: Particular requirements for the basic safety and essential performance of infant incubators Valid

Similar standards

YY/T 1933   YY/T 1712   GB 9706.227   GB 9706.222   GB 9706.216   GB 9706.218   

Basic data

Standard ID: GB 9706.219-2021 (GB9706.219-2021)
Description (Translated English): Medical electrical equipment - Part 2-19: Particular requirements for the basic safety and essential performance of infant incubators
Sector / Industry: National Standard
Classification of Chinese Standard: C39
Word Count Estimation: 32,347
Issuing agency(ies): State Administration for Market Regulation, China National Standardization Administration

GB 9706.219-2021: Medical electrical equipment - Part 2-19: Particular requirements for the basic safety and essential performance of infant incubators


---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.
Medical electrical equipment - Part 2-19.Particular requirements for the basic safety and essential performance of infant incubators ICS 11.040.55 CCSC39 National Standards of People's Republic of China Replace GB 11243-2008 Medical electrical equipment Part 2-19.Infant incubator Special requirements for basic safety and basic performance (IEC 60601-2-19.2016, MOD) Released on 2021-10-11 2023-05-01 implementation State Administration for Market Regulation Issued by the National Standardization Management Committee

Table of contents

Foreword Ⅲ Introduction Ⅴ 201.1 Scope, purpose and related standards 1 201.2 Normative references 2 201.3 Terms and Definitions 2 201.4 General requirements 4 201.5 General requirements for ME equipment testing 4 201.6 Classification of ME equipment and ME systems 5 201.7 ME equipment identification, marking and documentation 5 201.8 Protection of ME equipment against electric shock hazard 6 201.9 Protection of ME equipment and ME systems against mechanical hazards 6 201.10 Protection against unwanted or excessive radiation hazards (sources) 8 201.11 Protection against over-temperature and other hazards (sources) 8 201.12 Accuracy of controllers and instruments and protection against dangerous outputs 9 201.13 Dangerous conditions and fault states of ME equipment 14 201.14 Programmable Medical Electrical System (PEMS) 14 201.15 Structure of ME equipment 14 201.16 ME System 16 201.17 Electromagnetic compatibility of ME equipment and ME systems 16 202 Electromagnetic compatibility requirements and testing 16 Appendix 18 Appendix AA (informative) Special guide and principle description 19 References 26 Figure.201.101 Position 3 of the air temperature sensor Figure.201.102 Incubator temperature change 4 Figure.201.103 Weight test device layout 12 Figure AA.1 Illustration of the main requirements of this document 19 Table.201.101 Supplementary basic performance requirements 4

Foreword

This document is in accordance with the provisions of GB/T 1.1-2020 "Guidelines for Standardization Work Part 1.Structure and Drafting Rules of Standardization Documents" Drafting. This document is part 2-19 of GB 9706 "Medical Electrical Equipment". GB 9706 has released the following parts. ---Part 1.General requirements for basic safety and basic performance; ---Part 1-3.General requirements for basic safety and basic performance Parallel standard. Radiation protection of diagnostic X-ray equipment; ---Part 2-1.Specific requirements for the basic safety and basic performance of electron accelerators with an energy of 1MeV to 50MeV; ---Part 2-2.Special requirements for the basic safety and basic performance of high-frequency surgical equipment and high-frequency accessories; ---Part 2-3.Special requirements for basic safety and basic performance of shortwave treatment equipment; ---Part 2-5.Special requirements for the basic safety and basic performance of ultrasonic physical therapy equipment; ---Part 2-6.Special requirements for the basic safety and basic performance of microwave therapy equipment; ---Part 2-8.Special requirements for the basic safety and basic performance of therapeutic X-ray equipment with an energy of 10kV to 1MV; ---Part 2-11.Special requirements for the basic safety and basic performance of gamma beam therapy equipment; ---Part 2-12.Special requirements for the basic safety and basic performance of intensive care ventilators; ---Part 2-13.Special requirements for the basic safety and basic performance of the anesthesia workstation; ---Part 2-16.Specific requirements for the basic safety and basic performance of hemodialysis, hemodiafiltration and hemofiltration equipment; ---Part 2-17.Special requirements for the basic safety and basic performance of automatic control brachytherapy after-installation equipment; ---Part 2-18.Specific requirements for the basic safety and basic performance of endoscopic equipment; ---Part 2-19.Special requirements for basic safety and basic performance of infant incubators; ---Part 2-24.Special requirements for basic safety and basic performance of infusion pumps and infusion controllers; ---Part 2-25.Special requirements for basic safety and basic performance of electrocardiograph; ---Part 2-26.Special requirements for the basic safety and basic performance of EEG machines; ---Part 2-27.Special requirements for basic safety and basic performance of ECG monitoring equipment; ---Part 2-28.Special requirements for the basic safety and basic performance of medical diagnostic X-ray tube components; ---Part 2-29.Specific requirements for the basic safety and basic performance of radiotherapy simulators; ---Part 2-36.Special requirements for the basic safety and basic performance of in vitro lithotripsy equipment; ---Part 2-37.Special requirements for the basic safety and basic performance of ultrasonic diagnostic and monitoring equipment; ---Part 2-39.Special requirements for the basic safety and basic performance of peritoneal dialysis equipment; ---Part 2-43.Special requirements for the basic safety and basic performance of interventional X-ray equipment; ---Part 2-44.Special requirements for the basic safety and basic performance of X-ray computed tomography equipment; ---Part 2-45.The basic safety and basic performance of mammography equipment and mammography stereotaxic devices Require; ---Part 2-54.Special requirements for the basic safety and basic performance of X-ray photography and fluoroscopy equipment; ---Part 2-60.Special requirements for basic safety and basic performance of dental equipment; ---Part 2-63.Special requirements for the basic safety and basic performance of extraoral imaging dental X-ray machines; ---Part 2-65.Specific requirements for the basic safety and basic performance of dental X-ray machines for intraoral imaging. This document replaces GB 11243-2008 "Medical Electrical Equipment Part 2.Special Requirements for the Safety of Infant Incubators", and is in line with GB 11243-2008 Compared with.2008, in addition to structural adjustments and editorial changes, the main technical changes are as follows. ---The concept and requirements of basic performance have been added (see.201.4. ---Changed the definition of "air temperature controlled incubator" (see.201.3.201, 2.1.103 in.2008 edition); ---Changed the illustration of the temperature sensor (see Figure.201.101, Figure 102 in the.2008 edition); ---Added "infant" terms and definitions (see.201.3.208); --- Changed the terminology and revised "incubator" to "infant incubator" (see.201.3.209, 2.1.101 of the.2008 edition); ---Added relevant requirements for weight scales (see.201.12.1.112); ---Added the requirements of the programmable medical electrical system (PEMS) (see.201.14); --- Increase the electromagnetic compatibility requirements and testing of ME equipment and ME systems (see Chapter 202). This document is revised and adopted IEC 60601-2-19.2016 "Medical Electrical Equipment Part 2-19.Basic Safety and Basics of Infant Incubators" Specific requirements for this performance". The technical differences between this document and IEC 60601-2-19.2016 and the reasons are as follows. ---Regarding normative reference documents, this document has made adjustments with technical differences to adapt to my country's technical conditions and adjustments. The situation is collectively reflected in.201.2 "Normative Reference Documents", and the specific adjustments are as follows. ● Replace IEC 60601-1-2 with YY9706.102-2021 which is modified to adopt international standards. --- Change.201.3208 in.201.1.2 to.201.309. ---Because there are 147 terms and definitions in GB 9706.1-2020, the 3.139 in.201.1.4 is changed to 3.147. --- Change.201.12.1.108 in.201.7.9.2.8 to.201.12.1.107. The following editorial changes have been made to this document. ---Replace the international documents in the references with standards-adoption relations with Chinese documents, as follows. ● Replace IEC 61672-1 with GB/T 3785.1 which is equivalent to adopting international standards; ● Replace IEC 60601-2-20 with YY9706.220 modified to adopt international standards; ● Replace IEC 80601-2-35 with YY9706.235 modified to adopt international standards; ● Replace IEC 60601-2-50 with YY9706.250 modified to adopt international standards. --- Change.201.12.1.104 in.201.12.1.104 of the informative appendix AA to.201.12.1.103. ---The term index of the international standard text has been deleted. Please note that some of the contents of this document may involve patents. The issuing agency of this document is not responsible for identifying patents. This document was proposed and managed by the State Drug Administration. The previous releases of this document and the replaced documents are as follows. ---First released in 1989 as GB 11243-1989; --- It was first revised in.2000 and incorporated the contents of GB 11242-1989; ---The second revision in.2008; ---This is the third revision.

Introduction

Medical electrical equipment safety standards are also known as the 9706 series of standards, which consist of general standards, parallel standards, special standards, guidelines and interpretations. ---General standards. Medical electrical equipment should be generally applicable to safety standards, that is, equipment that meets the definition of medical electrical equipment should meet this Basic standard requirements. ---Parallel standards. Medical electrical equipment should be generally applicable to safety standards, but in most cases it is limited to certain specific functions or features. Sexual equipment only needs to meet the requirements of such standards. ---Special standards. safety standards that a certain type of medical electrical equipment should apply, and not all medical electrical equipment have special standard. ---Guidelines and explanations. application guidelines and explanations for the relevant requirements in the standards involved. In the GB 9706 series of standards, in addition to the published standards and this document, the standards that have been included in the plan are as follows. ---Part 2-4.Special requirements for basic safety and basic performance of cardiac defibrillators. The purpose is to establish the basic Special requirements for safety and basic performance. ---Part 2-22.Special requirements for basic safety and basic performance of laser equipment for surgery, plastic surgery, treatment and diagnosis. The purpose is Establish special requirements for basic safety and basic performance of laser equipment for surgery, plastic surgery, treatment and diagnosis. ---Part 2-66.Special requirements for basic safety and basic performance of hearing equipment and hearing equipment system. The purpose is to establish listening Specific requirements for the basic safety and basic performance of force equipment and hearing equipment systems. This document relates to the basic safety and basic performance requirements of infant incubators. This document revises and supplements GB 9706.1-2020 "Medical Electrical Equipment Part 1.General Requirements for Basic Safety and Basic Performance. In this document, the asterisk (*) is used as the first character of the title or the beginning of the paragraph or table title, which means that there is a related item in Appendix AA. Dedicated guides and principle explanations related to the project. The relevant content of Appendix AA is not only helpful for the correct use of this document, but also can be added in a timely manner. The process of revising standards due to changes in clinical practice or technological development. Medical electrical equipment Part 2-19.Infant incubator Special requirements for basic safety and basic performance 201.1 Scope, purpose and related standards In addition to the following, Chapter 1 of the general standard applies. 201.1.1 Scope replace. This document applies to the basic safety and basic performance requirements of infant incubators, such as the equipment defined in.201.3.209 in this document. Also called ME equipment. If a chapter or article clearly states that it is only applicable to ME equipment or ME systems, the title and the text of the chapter or article will explain. if not In this case, the relevant chapters or articles apply to both ME equipment and ME systems. In addition to 7.2.13 and 8.4.1 in the general standards, the expected physiological effects of ME equipment or ME systems within the scope of this document are caused by The hazard (source) is not specifically required in this document. Note. See General Standard 4.2. This document specifies the safety requirements for infant incubators, but if the manufacturer states the risks posed by hazards in its risk management documents Compared with the treatment benefit of the device, it is at an acceptable level, then a special clause is used to demonstrate the compliance of equivalent safety Alternative methods are deemed to be compliant. This document does not apply to. ---Medical heating equipment for heating through blankets, pads and mattresses, see YY9706.235; ---Infant radiant warmer, see IEC 60601-2-21; ---Infant transfer incubator, see YY9706.220; ---Infant light therapy equipment, see YY9706.250. 201.1.2 Purpose replace. The purpose of this document is to specify the basic safety and basic performance requirements for infant incubators defined in.201.3.209, which is the largest Minimize the risk to patients and operators, and specify tests to identify whether they meet the requirements. 201.1.3 Parallel standards Supplement. This document refers to Chapter 2 of the General Standard and the applicable parallel standards listed in.201.2 of this document. YY9706.102 is applicable after Chapter 202 is revised. GB 9706.103 and YY/T 9706.110 are not applicable. 201.1.4 *Specific standards replace. In the 9706 series of standards, the special standards can be modified, replaced or deleted according to the special ME equipment under consideration, the general standards and parallel standards The requirements contained in the standards, and may increase other basic safety and basic performance requirements. The requirements of specific standards take precedence over the requirements of general standards.
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