YY 9706.112-2021
Active
Industry standards-Medicine
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 9706.112-2021 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
Basic Information
Standard Code:
YY 9706.112-2021
Standard Type:
Industry standards
Standard Status:
Active
is_force_gb:
no
CCS Name:
Medical devices
ICS Name:
Medical 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(SAC/TC 10)
Pages:
36 pages
Scope
本部分规定了预期在紧急医疗服务环境中使用的医用电气设备和医用电气系统(以下简称ME设备和ME系统)的基本安全和基本性能的要求。
本部分适用于按制造商的使用说明书中指出的,预期在紧急医疗服务环境(以下简称EMS环境)中使用的ME设备和ME系统。
注1:就本标准而言,制造商的预期已在使用说明书中指出。责任方和操作者必须意识到,任何超出制造商的预期用途的使用都可能对患者产生危险情况。
EMS环境包括:
——在紧急事件现场对尚未送往医院的受伤或患病患者进行处理和提供生命支持,以及在持续生命支持看护的同时,将患者送往合适的专业医疗机构接受进一步看护。
——在专业医疗机构之间转运过程中提供的监护、治疗或诊断。
本部分不适用于仅在符合YY9706.111中的家庭护理环境下使用,或仅在符合GB9706.1(且不符合YY9706.111或本部分)中的专业医疗机构下使用的ME设备和ME系统。ME设备和ME系统一般不会只用于一种环境。这些ME设备或ME系统可能用于多种使用环境,因此,如果它们也可能用于EMS环境,则包含在本标准的适用范围之内。
示例:可同时用于EMS环境和专业医疗机构环境的ME设备或ME系统。
注2:EMS环境用ME设备和ME系统可在电源不稳定的地方和室外环境条件下使用。
注3:本部分中带星号(*)的章和条在附录A中有相关原理说明。
Development Information
Drafting Units:
上海市医疗器械检测所、深圳迈瑞生物医疗电子股份有限公司、上海德尔格医疗器械有限公司
Drafting Persons:
何骏、邵凌云、李敏、王佩、顾征宇、叶莎莎
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 9706.210-2021 Medical electrical equipment—Part 2-10:Particular requirements for the basic safety and essential performance of nerve and muscle stimulators
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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
Referenced Standards
GB/T 2423.5-2019 Environmental testing—Part 2:Test methods—Test Ea and guidance:Shock
GB/T 2423.7-2018 Environmental testing—Part 2:Test methods—Test Ec:Rough handling shocks,primarily for equipment-type specimens
GB/T 2423.56-2018 Environmental testing—Part 2:Test methods—Test Fh:Vibration, broadband random and guidance
GB/T 4208-2017 Degrees of protection provided by enclosure(IP code)
GB 9706.1-2020 Medical electrical equipment—Part 1:General requirements for basic safety and essential performance
YY/T 0466.1-2016 Medical devices—Symbols to be used with medical device labels,labelling and information to be supplied—Part 1:General requirements
ISO 7000:2014
ISO 7010:2011+A1:2012+A2:2012+A3:2012+A4:2013+A5:2014
EUROCAE ED-14G
GB 4824-2004 Industrial, scientific and medical(ISM) radio-frequency equipment—Electromagnetic disturbance characteristics—Limits and methods of measurement
GB 4824-2013 Industrial,scientific and medical(ISM) radio-frequency equipment—Disturbance characteristics—Limits and methods of measurement
GB 4824-2019 Industrial,scientific and medical equipment—Radio-frequency disturbance characteristics—Limits and methods of measurement
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 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 9706.106-2021 Medical electrical equipment—Part 1-6:General requirements for basic safety and essential performance—Collateral Standard:Usability
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
HB 6167.6-2014 Environmental Conditions and Test Methods for Aircraft Onboard Equipment - Part 6: Vibration Test for Civil Aircraft Onboard Equipment
HB 6167.18-2014 Environmental Conditions and Test Methods for Aircraft Equipment - Part 18: Power Input Test for Civil Aircraft Equipment
HB 6167.23-2014 Civil Aircraft Onboard Equipment Environmental Conditions and Test Methods Part 23: Radiofrequency Energy Transmission Test
HB 6167.6-1989
HB 6167.23-1989 Environmental Conditions and Test Methods for Aircraft Onboard Equipment for Civil Aviation: RF Energy Transmission Test
HB 6167.18-1989
GB 4824-2025 Industrial, scientific and medical equipment—Radio-frequency disturbance characteristics—Limits and methods of measurement
Adopt standards
IEC 60601-1-12:2014
Related Standards
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GB 11235-1997
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GB/T 17257.1-1998
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GB/T 17257.2-1998
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GB/T 17257.2-1998 Urine collection bags—Part 2:Determination of dimensions
GB/T 17257.3-1998
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GB/T 17257.3-1998 Urine collection bags—Part 3:Verification of rated volume
GB/T 17257.4-1998
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