GB 12259-1990
Abolished
YY 0306-2023
Pending
Industry standards-Medicine
YY 0306-2023 General technical requirements for heat radiation therapy equipment
YY 0306-2023 General technical requirements for heat radiation therapy equipment
Basic Information
Standard Code:
YY 0306-2023
Standard Type:
Industry standards
Standard Status:
Pending
is_force_gb:
no
CCS Name:
Physiotherapy and traditional Chinese medicine instruments and equipment
ICS Name:
Treatment equipment
Publish Date:
2023-09-05
Implement Date:
2026-09-15
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物理治疗设备分技术委员会(SAC/TC 10/SC 4)
Pages:
8 pages
Scope
本文件规定了热辐射类治疗设备（以下简称“设备”）的要求和试验方法。
本文件适用于热辐射类治疗设备。
本文件不适用于下述设备：
——热辐射能量不能直达患者体表的设备，如在传播过程中被非镂空结构或非透光材料遮挡；
——YY/T 0165中界定的以热传导方式对患者进行治疗的设备；
——YY 0323中界定的预期使组织产生变性和/或凝固性坏死的设备；
——YY/T 0902中界定的接触式远红外理疗设备。
Development Information
Replace the following standards
Referenced Standards
GB/T 7287-2008 Test method of infrared heater
GB 9706.1-2020 Medical electrical equipment—Part 1:General requirements for basic safety and essential performance
GB 9706.283-2022 Medical electrical equipment—Part 2-83:Particular requirements for the basic safety and essential performance of home light therapy 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
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 9706.257-2021 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
Related Standards
GB 12261-1990
Abolished
GB 12261-1990 Artificial heart-lung machine—Bubble oxygenator
GB 12262-1990
Abolished
GB 12262-1990 Artificial heart-lung machine—Heat exchanger
GB 2024-1994
Replaced
GB 2024-1994 Acupuncture needles
GB 10035-1994
Replaced
GB 10035-1994 The air-bag type sequential external counter-pulsation device
GB 16174.1-1996
Replaced