GB/T 17995-1999
Abolished
YY 9706.246-2023
Active
Industry standards-Medicine
YY 9706.246-2023 Medical electrical equipment—Part 2-46:Particular requirements for the basic safety and essential performance of operating tables
YY 9706.246-2023 Medical electrical equipment—Part 2-46:Particular requirements for the basic safety and essential performance of operating tables
Basic Information
Standard Code:
YY 9706.246-2023
Standard Type:
Industry standards
Standard Status:
Active
is_force_gb:
no
CCS Name:
Surgical room equipment
ICS Name:
Other medical equipment
Publish Date:
2023-01-13
Implement Date:
2026-01-15
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:
24 pages
Scope
GB 9706的本部分规定了ME设备和ME系统的基本安全和基本性能的通用要求。
本部分适用于医用电气设备和医用电气系统(以下简称ME设备和ME系统)。
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7.2.13和8.4.1外,本部分范围内的ME设备或ME系统的预期生理效应所导致的危险(源)在本部分中没有具体要求。
替换:
本文件规定了手术台的安全要求。无论这种手术台是否具有电气部件,包括传动装置。这种传动装置用于带有可拆卸台面的手术台的台面相对于手术台底部(或基座)的传动。
注: 参见通用标准的4.2。
本文件不适用于:
——患者牙科椅;
——检查椅和沙发;
——诊断和治疗设备的患者支撑系统(参见GB 9706.243);
——手术台加热毯(参见YY 9706.235);
——患者转移设备;
——输送台和床;
——医疗床(参见YY 9706.252);
——野外手术台。
如果手术台会和诊断/治疗设备组合使用,诊断和/或治疗设备的相关专用标准要求是适用的。
Development Information
Drafting Units:
南京迈瑞生物医疗电子有限公司、上海市医疗器械检验研究院
Drafting Persons:
岑建、徐超、陶华、张金淼、陈弸中
Same series standard
YY 9706.230-2023 Medical electrical equipment—Part 2-30:Particular requirements for the basic safety and essential performance of automated non-invasive sphygmomanometers
YY 9706.231-2023 Medical electrical equipment—Part 2-31:Particular requirements for the basic safety and essential performance of external cardiac pacemakers with internal power source
YY 9706.249-2023 Medical electrical equipment—Part 2-49:Particular requirements for the basic safety and essential performance of multifunction patient monitors
YY 9706.256-2023 Medical electrical equipment—Part 2-56:Particular requirements for basic safety and essential performance of clinical thermometers for body temperature measurement
YY 9706.261-2023 Medical electrical equipment—Part 2-61:Particular requirements for the basic safety and essential performance of pulse oximeter equipment
YY 9706.277-2023 Medical electrical equipment—Part 2-77:Particular requirements for the basic safety and essential performance of robotically assisted surgical equipment
YY 9706.278-2023 Medical electrical equipment—Part 2-78:Particular requirements for basic safety and essential performance of medical robots for rehabilitation,assessment,compensation or alleviation
YY 9706.279-2023 Medical electrical equipment—Part 2-79:Particular requirements for basic safety and essential performance of ventilatory support equipment for ventilatory impairment
YY 9706.280-2023 Medical electrical equipment—Part 2-80:Particular requirements for basic safety and essential performance of ventilatory support equipment for ventilatory insufficiency
YY 9706.284-2023 Medical electrical equipment—Part 2-84:Particular requirements for the basic safety and essential performance of ventilators for the emergency medical services environment
Replace the following standards
Referenced Standards
GB 9706.1-2020 Medical electrical equipment—Part 1:General requirements for basic safety and essential performance
GB 9706.103-2020 Medical electrical equipment—Part 1-3:General requirements for basic safety and essential performance—Collateral Standard:Radiation protection in diagnostic X-ray equipment
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
GB 9706.202-2021 Medical electrical equipment—Part 2-2:Particular requirements for the basic safety and essential performance of high frequency surgical equipment and high frequency surgical accessories
GB 9706.243-2021 Medical electrical equipment—Part 2-43:Particular requirements for the basic safety and essential performance of X-ray equipment for interventional procedures
Adopt standards
IEC 60601-2-46:2016
Related Standards
GB/T 18990.1-2003
Replaced
GB/T 18990.1-2003 Luteinizing hormone(LH)test strip—Part 1:Ovulation test strip
GB/T 18990.2-2003
Replaced
GB/T 18990.2-2003 Luteinizing hormone(LH) test strip—Part 2:Sterility test strip
GB/T 18990.3-2003
Replaced
GB/T 18990.3-2003 Luteinizing hormone(LH) test strip Part 3:Contraceptive test strip
YY 0476-2004
Abolished
YY 0476-2004 Irrigating solutions for ophthalmic surgery
YY 0477-2004
Replaced