GB 11243-2000
Replaced
YY 9706.220-2021
Active
Industry standards-Medicine
YY 9706.220-2021 Medical electrical equipment—Part 2-20:Particular requirements for the basic safety and essential performance of infant transport incubators
YY 9706.220-2021 Medical electrical equipment—Part 2-20:Particular requirements for the basic safety and essential performance of infant transport incubators
Basic Information
Standard Code:
YY 9706.220-2021
Standard Type:
Industry standards
Standard Status:
Active
is_force_gb:
no
CCS Name:
Medical electronic instruments and equipment
ICS Name:
Diagnostic equipment
Publish Date:
2021-03-09
Implement Date:
2023-05-01
Publisher:
国家药品监督管理局
Technical Committee:
全国医用电器标准化技术委员会医用电子仪器标准化分技术委员会(SAC/TC 10/SC 5)
Pages:
36 pages
Scope
本部分适用于婴儿转运培养箱的基本安全和基本性能的要求,如婴儿转运培养箱,也称为ME设备。
如果一章或一条明确指出仅适用于ME设备或ME系统,标题和章或条的正文会说明。如果不是这种情况,与此相关的章或条同时适用于ME设备和ME系统。
除通用标准7.2.13和8.4.1外,本部分范围内ME设备或ME系统的预期生理效应中所导致的危险(源)在本部分中没有具体要求。
注: 参见通用标准的4.2。
本部分规定了婴儿转运培养箱的安全要求,但如果制造商在其风险管理文档中说明危险所带来的风险与设备的治疗收益相比,是处于一个可接受的水平,那么通过一个特别条款来展示等效安全性的符合性替代方法可被视为符合。
本部分不适用:
——通过毯子、衬垫和床垫供热的医用加热设备,详情请参见YY 0834;
——不属于婴儿转运培养箱的婴儿培养箱,详情请参见GB 11243;
——婴儿辐射保暖台;详情请参见YY 0455;
——婴儿光治疗设备;详情请参见YY 0669。
Development Information
Drafting Units:
宁波戴维医疗器械股份有限公司、上海市医疗器械检测所、上海德尔格医疗器械有限公司
Drafting Persons:
林定余、洪伟、陈惠铭、卓越、郭永兵、严粹人
Same series standard
YY 9706.102-2021 Medical electrical equipment—Part 1-2:General requirements for basic safety and essential performance—Collateral standard:Electromagnetic compatibility—Requirements and tests
YY/T 9706.106-2021 Medical electrical equipment—Part 1-6:General requirements for basic safety and essential performance—Collateral Standard:Usability
YY 9706.108-2021 Medical electrical equipment—Part 1-8:General requirements for basic safety and essential performance-Collateral standard:General requirements,tests and guidance for alarm systems in medical electrical equipment and medical electrical systems
YY/T 9706.110-2021 Medical electrical equipment—Part 1-10:General requirements for basic safety and essential performance—Collateral Standard: Requirements for the development of physiologic closed-loop controllers
YY 9706.111-2021 Medical electrical equipment—Part 1-11:General requirements for basic safety and essential performance—Collateral Standard:Requirements for medical electrical equipment and medical electrical systems used in the home healthcare environment
YY 9706.112-2021 Medical electrical equipment—Part 1-12:General requirements for basic safety and essential performance—Collateral Standard:Requirements for medical electrical equipment and medical electrical systems intended for use in the emergency medical services environment
YY 9706.210-2021 Medical electrical equipment—Part 2-10:Particular requirements for the basic safety and essential performance of nerve and muscle stimulators
YY 9706.221-2021 Medical electrical equipment—Part 2-21:Particular requirements for the basic safety and essential performance of infant radiant warmers
YY 9706.233-2021 Medical electrical equipment—Part 2-33:Particular requirements for the basic safety and essential performance of magnetic resonance equipment for medical diagnosis
YY 9706.234-2021 Medical electrical equipment—Part 2-34:Particular requirements for the basic safety and essential performance of invasive blood pressure monitoring equipment
YY 9706.235-2021 Medical electrical equipment—Part 2-35:Particular requirements for the basic safety and essential performance of heating devices using blankets,pads or mattresses and intended for heating in medical use
YY 9706.240-2021 Medical electrical equipment—Part 2-40:Particular requirements for the basic safety and essential performance of electromyographs and evoked response equipment
YY 9706.247-2021 Medical electrical equipment—Part 2-47:Particular requirements for the basic safety and essential performance of ambulatory electrocardiographic systems
YY 9706.250-2021 Medical electrical equipment—Part 2-50:Particular requirements for the basic safety and essential performance of infant phototherapy equipment
YY 9706.252-2021 Medical electrical equipment—Part 2-52:Particular requirements for the basic safety and essential performance of medical beds
YY 9706.257-2021 Medical electrical equipment—Part 2-57:Particular requirements for the basic safety and essential performance of non-laser light source equipment intended for therapeutic,diagnostic,monitoring and cosmetic/aesthetic use
YY 9706.262-2021 Medical electrical equipment—Part 2-62:Particular requirements for the basic safety and essential performance of high intensity therapeutic ultrasound(HITU) equipment
YY 9706.269-2021 Medical electrical equipment—Part 2-69:Particular requirements for basic safety and essential performance of oxygen concentrator equipment
YY 9706.270-2021 Medical electrical equipment—Part 2-70:Particular requirements for basic safety and essential performance of sleep apnoea breathing therapy equipment
YY 9706.272-2021 Medical electrical equipment—Part 2-72:Particular requirements for basic safety and essential performance of home healthcare environment ventilators for ventilator-dependent patients
Replace the following standards
Referenced Standards
GB/T 321-1980 Preferred numbers and preferred number series
GB/T 321-2005 Preferred numbers—Series of preferred numbers
GB 3100-1993 SI units and recommendations for the use of their multiples and of certain other units
GB/T 3101-1993 Quantities and units—General principles
GB/T 3102.1-1993 Quantities and units—Space and time
GB/T 3102.2-1993 Quantities and units—Periodic and related phenomena
GB/T 3102.3-1993 Quantities and units—Mechanics
GB/T 3102.4-1993 Quantities and units—Heat
GB/T 3102.5-1993 Quantities and units—Electricity and magnetism
GB/T 3102.6-1993 Quantities and units—Light and related electromagnetic radiations
GB/T 3102.7-1993 Quantities and units—Acoustics
GB/T 3102.8-1993 Quantities and units—Physical chemistry and molecular physics
GB/T 3102.9-1993 Quantities and units—Atomic and nuclear physics
GB/T 3102.10-1993 Quantities and units—Nuclear reactions and ionizing radiation
GB/T 3102.11-1993 Mathematical signs and symbols for use in the physical sciences and technology
GB/T 3102.12-1993 Characteristic numbers
GB/T 3102.13-1993 Quantities and units—Solid state physics
GB/T 4728.1-2005 Graphical symbols for electrical diagrams—Part 1:General information
GB/T 4728.1-2018 Graphical symbols for electrical diagrams—Part 1:General information
GB/T 4728.2-1998 Graphical symbols for diagrams—Part 2 Symbol elements,qualifying symbols and other symbols having general application
GB/T 4728.2-2005 Graphical symbols for electrical diagrams—Part 2:Symbol elements,qualifying symbols and other symbols having general application
GB/T 4728.2-2018 Graphical symbols for electrical diagrams—Part 2:Symbol elements,qualifying symbols and other symbols having general application
GB/T 4728.3-1998 Graphical symbols for diagrams—Part 3 Conductors and connecting devices
GB/T 4728.3-2005 Graphical symbols for electrical diagrams—Part 3:Conductors and connecting devices
GB/T 4728.3-2018 Graphical symbols for electrical diagrams—Part 3:Conductors and connecting devices
GB/T 4728.4-1999 Graphical symbols for diagrams—Part 4:Basic passive components
GB/T 4728.4-2005 Graphical symbols for electrical diagrams—Part 4:Basic passive components
GB/T 4728.4-2018 Graphical symbols for electrical diagrams—Part 4:Basic passive components
GB/T 4728.5-2000 Graphical symbols for diagrams—Part 5:Semiconductors and electron tubes
GB/T 4728.5-2005 Graphical symbols for electrical diagrams—Part 5:Semiconductors and electron tubes
GB/T 4728.5-2018 Graphical symbols for electrical diagrams—Part 5:Semiconductors and electron tubes
GB/T 4728.6-2000 Graphical symbols for diagrams—Part 6:Production and conversion of electrical energy
GB/T 4728.6-2008 Graphical symbols for diagrams—Part 6:Production and conversion of electrical energy
GB/T 4728.6-2022 Graphical symbols for electrical diagrams—Part 6:Production and conversion of electrical energy
GB/T 4728.7-2000 Graphical symbols for diagrams—Part 7:Switchgear,controlgear and protective devices
GB/T 4728.7-2008 Graphical symbols for diagrams—Part 7:Switchgear,controlgear and protective devices
GB/T 4728.7-2022 Graphical symbols for electrical diagrams—Part 7:Switchgear,controlgear and protective devices
GB/T 4728.8-2000 Graphical symbols for diagrams—Part 8:Measuring instruments,lamps and signalling devices
GB/T 4728.8-2008 Graphical symbols for diagrams—Part 8:Measuring instruments,lamps and signaling devices
GB/T 4728.8-2022 Graphical symbols for electrical diagrams—Part 8:Measuring instruments,lamps and signalling devices
GB/T 4728.9-1999 Graphical symbols for diagrams—Part 9:Telecommunications:Switching and peripheral equipment
GB/T 4728.9-2008 Graphical symbols for diagrams—Part 9:Telecommunications:Switching and peripheral equipment
GB/T 4728.9-2022 Graphical symbols for electrical diagrams—Part 9:Telecommunications:Switching and peripheral equipment
GB/T 4728.10-1999 Graphical symbols for diagrams—Part 10:Telecommunications:Transmission
GB/T 4728.10-2008 Graphical symbols for diagrams—Part 10:Telecommunications:Transmission
GB/T 4728.10-2022 Graphical symbols for electrical diagrams—Part 10:Telecommunications:Transmission
GB/T 4728.11-2000 Graphical symbols for diagrams—Part 11:Architectural and topographical installation plans and diagrams
GB/T 4728.11-2008 Graphical symbols for diagrams—Part 11:Architectural and topographical installation plans and diagrams
GB/T 4728.11-2022 Graphical symbols for electrical diagrams—Part 11:Architectural and topographical
GB/T 4728.12-1996 Graphical symbols for electrical diagrams—Part 12:Binary logic elements
GB/T 4728.12-2008 Graphical symbols for diagrams—Part 12:Binary logic elements
GB/T 4728.12-2022 Graphical symbols for electrical diagrams—Part 12:Binary logic elements
GB/T 4728.13-1996 Graphical symbols for electrical diagrams Part 13:Analogue elements
GB/T 4728.13-2008 Graphical symbols for diagrams—Part 13:Analogue elements
GB/T 4728.13-2022 Graphical symbols for electrical diagrams—Part 13:Analogue elements
GB/T 5094.1-2002 Industrial systems, installations and equipment and industrial products—Structuring principles and reference designations—Part 1:Basic rules
GB/T 5094.1-2018 Industrial systems,installations and equipment and industrial products—Structuring principles and reference designations—Part 1:Basic rules
GB/T 5094.2-2003 Industrial systems, installations and equipment and industrial products—Structuring principles and reference designations—Part 2:Classification of objects and codes for classes
GB/T 5094.2-2018 Industrial systems,installations and equipment and industrial products—Structuring principles and reference designations—Part 2:Classification of objects and codes for classes
GB/T 5094.3-2005 Industrial systems, installations and equipment and industrial products—Structuring principles and reference designations—Part 3:Application guidelines
GB/T 5094.4-2005 Industrial systems, installations and equipment and industrial products—Structuring principles and reference designations—Part 4:Discussion of concepts
GB/T 5465.2-1996 Graphical symbols for use on electrical equipment
GB/T 5465.2-2008 Graphical symbols for use on electrical equipment—Part 2:Graphical symbols
GB/T 5465.2-2023 Graphical symbols for use on electrical equipment—Part 2:Graphical symbols
GB/T 6988.1-1997 Preparation of documents used in electrotechnology—Part 1:General requirements
GB/T 6988.1-2008 Preparation of documents used in electrotechnology—Part 1:Rules
GB/T 6988.1-2024 Preparation of documents used in electrotechnology—Part1:Rules
GB/T 6988.2-1997 Preparation of documents used in electrotechnology—Part 2:Function-oriented diagrams
GB/T 6988.3-1997 Preparation of documents used in electrotechnology—Part 3:Connection diagrams, tables and lists
GB/T 6988.4-2002 Preparation of documents used in electrotechnology—Part 4:Location and installation documents
GB/T 6988.5-2006 Preparation of documents used in electrotechnology—Part 5:Index
GB/T 6988.6-1993 Preparation of function charts for control systems
GB/T 7714-1987 Descriptive rules for bibliographic references
GB/T 7714-2005 Rules for content,form and structure of bibliographic references
GB/T 7714-2015 Information and documentation—Rules for bibliographic references and citations to information resources
GB/T 7714-2025 Information and documentation—Rules for bibliographic references and citations to information resources
GB/T 13394-1992 Letter symbols to be used in electrical technology—Symbols for quantities to be used for rotating electrical machines
GB/T 14559-1993 Symbols and units of variant quantities
GB/T 14691-1993 Technical drawings—Lettering
GB/T 14691.4-2005 Technical product documentation—Lettering—Part 4:diacritical and particular marks for the Latin alphabet
GB/T 14691.6-2005 Technical product documentation—Lettering—Part 6:Cyrillic alphabet
GB/T 15834-1995 Use of punctuations marks
GB/T 15834-2011 General rules for punctuation
GB/T 15835-1995 General rules for writing numerals in publications
GB/T 15835-2011 General rules for writing numerals in public texts
GB/T 16273.1-1996 Graphical symbols for use on equipment—Common symbols
GB/T 16273.1-2008 Graphical symbols for use on equipment—Part 1:Common symbols
GB/T 16273.2-1996 Graphical symbols for use on equipment—Common symbols for machine tools
GB/T 16273.3-1999 Graphical symbols for use on equipment—Common symbols for electric welding equipment
GB/T 16273.4-2001 Graphical symbols for use on equipment—Part 4:Symbols incorporating arrows
GB/T 16273.4-2010 Graphical symbols for use on equipment—Part 4:Symbols incorporating arrows
GB/T 16273.5-2002 Graphical symbols for use on equipment—Part 5:Common symbols for plastic machine
GB/T 16273.6-2003 Graphical symbols for use on equipment—Part 6:Common symbols for conveying, vehicle testing and loading machine
GB/T 16273.7-2010 Graphical symbols for use on equipment—Part 7:Common symbols for dental equipment
GB/T 16273.8-2010 Graphical symbols for use on equipment—Part 8:Common symbols for office equipment
GB/T 16499-1996 Guide to the drafting of electrical safety standards
GB/T 16499-2008 The preparation of safety publications and the use of basic safety publications and group safety publications
GB/T 16499-2017 Guide for the preparation of electrical and electronic safety publications and the use of basic safety publications and group safety publications
GB/T 16679-1996 Designations for signals and connections
GB/T 16679-2009 Industrial systems,installations and equipment and industrial products—Designation of signals
Adopt standards
IEC 60601-2-20:2009+AMD1:2016
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