作废 YY 0903-2013
脑电生物反馈仪 脑电生物反馈仪 Electroencephalographic biofeedback equipment
发布日期:2013-10-21
实施日期:2014-10-01
分类信息
研制信息

归口单位: 国家医用电器标准化技术委员会物理治疗设备标准化分技术委员会(SAC/TC 10/SC 4)

起草单位: 国家食品药品监督管理局天津医疗器械质量监督检验中心、 广州市润杰医疗器械有限公司

起草人: 刘辉、 孙惠丽、 纪采彦、 胡志伟、 杨杰

标准简介

本标准适用于脑电生物反馈仪,该产品为由视听信息刺激和激发患者产生脑波信息,并依据脑波信息产生新的视听信息刺激患者,如此循环,以调节改善患者的大脑机能达到辅助治疗目的的仪器

相似标准/计划/法规
YY/T 1096-2007
温度生物反馈仪
Temperature biofeedback equipment
2007-01-31
YY/T 1095-2015
肌电生物反馈仪
Myoelectric biofeedback equipment
2015-03-02
UNE-EN 60601-2-26-2004
Medical electrical equipment -- Part 2-26: Particular requirements for the safety of electroencephalographs
医用电气设备第2-26部分:脑电图仪安全的特殊要求
2004-07-09
BS EN IEC 80601-2-26-2020
Medical electrical equipment-Particular requirements for the basic safety and essential performance of electroencephalographs
医用电气设备
2021-11-05
KS C IEC 80601-2-26
의료용 전기기기 — 제2-26부: 뇌파계의 기본안전 및 필수성능에 관한 개별 요구사항
医用电气设备第2-26部分:脑电图仪基本安全和基本性能的特殊要求
2021-12-28
GB 9706.226-2021
医用电气设备 第2-26部分:脑电图机的基本安全和基本性能专用要求
Medical electrical equipment—Part 2-26: Particular requirements for the basic safety and essential performance of electroencephalographs
2021-10-11
IEC 80601-2-26-2019
Medical electrical equipment — Part 2-26: Particular requirements for the basic safety and essential performance of electroencephalographs
医疗电气设备 - 第2-26部分:脑电图基本安全和基本表现的特殊要求
2019-05-22
IEC 80601-2-26-2019
Medical electrical equipment - Part 2-26: Particular requirements for the basic safety and essential performance of electroencephalograph
医疗电气设备 - 第2-26部分:脑电图基本安全和基本性能的特殊要求
2019-05-20
IEC 80601-2-26-2019+AMD1-2024 CSV
Medical electrical equipment - Part 2-26: Particular requirements for the basic safety and essential performance of electroencephalographs
医用电气设备.第2-26部分:脑电图仪的基本安全和基本性能的特殊要求
2024-02-14
IEC 80601-2-26-2019/AMD1-2024
Amendment 1 - Medical electrical equipment - Part 2-26: Particular requirements for the basic safety and essential performance of electroencephalographs
修改件1.医用电气设备.第2-26部分:脑电图仪基本安全和基本性能的特殊要求
2024-02-14
IEC 80601-2-26-2019/Amd 1-2024
Medical electrical equipment — Part 2-26: Particular requirements for the basic safety and essential performance of electroencephalographs — Amendment 1
医用电气设备第2-26部分:脑电图仪基本安全和基本性能的特殊要求修改1
2024-02-15
CAN/CSA C22.2 No.60601-2-26-14(R2018)
Medical Electrical Equipment - Part 2-26: Particular Requirements for the Safety of Electroencephalographs (IEC 60601-2-26:2012, MOD)
医用电气设备.第2-26部分:脑电图仪安全的特殊要求(IEC 60601-2-26-2012 MOD)
2014-03-01
CAN/CSA C22.2 NO.601.2.26-98
Medical Electrical Equipment - Part 2: Particular Requirements for the Safety of Electroencephalographs (Adopted IEC 601-2-26:1994) / Appareils electromedicaux - Partie 2: Regles particulieres de securite pour les electroencephalographes (norme CEI 601-2-26:1994 adoptee)
医用电气设备第2部分:脑电图仪安全的特殊要求
2000-02-12
DIN IEC 60601-2-26-DRAFT
Draft Document - Medical electrical equipment - Part 2-26: Particular requirements for basic safety and essential performance of electroencephalographs (IEC 62D/648/CD:2007)
文件草案.医用电气设备.第2-26部分:脑电图仪基本安全和基本性能的特殊要求(IEC 62D/648/CD:2007)
2008-02-01
AS 60601.2.26-2018
Medical electrical equipment, Part 2.26: Particular requirements for the basic safety and essential performance of electroencephalographs (IEC 60601-2-26:2012 (ED. 3.0), MOD)
医用电气设备 第2.26部分:脑电图仪基本安全和基本性能的特殊要求(IEC 60601-2-26-2012(第3.0版) MOD)
2018-09-27
DIN EN IEC 80601-2-26
Medical electrical equipment - Part 2-26: Particular requirements for the basic safety and essential performance of electroencephalographs (IEC 80601-2-26:2019); German version EN IEC 80601-2-26:2020
医用电气设备.第2-26部分:脑电图仪基本安全和基本性能的特殊要求(IEC 80601-2-26-2019);德国版本EN IEC 80601-2-26:2020
2022-04-01
DIN EN 60601-2-26-DRAFT
Draft Document - Medical electrical equipment - Part 2-26: Particular requirements for the basic safety and essential performance of electroencephalograph (IEC 62D/1488/CDV:2017); German version prEN 60601-2-26:2017
文件草案-医用电气设备-第2-26部分:脑电图仪基本安全和基本性能的特殊要求(IEC 62D/1488/CDV:2017);德文版prEN 60601-2-26:2017
2017-10-01
生物反馈

最后更新时间 2025-09-02