被代替 YY 0054-2003
血液透析、血液透析滤过和血液滤过设备 血液透析、血液透析滤过和血液滤过设备 Haemodialysis、haemodiafiltration and haemofiltration equipment
发布日期:2003-06-20
实施日期:2004-01-01
分类信息
研制信息

归口单位: 全国医用体外循环设备标准化技术委员会

起草单位: 国家食品药品监督管理局广州医疗器械质量监督检验中心

起草人: 陈嘉晔、 黄秀莲、 余青兰、 杨晓玲

标准简介
相似标准/计划/法规
UNE-EN 60601-2-16-1999
MEDICAL ELECTRICAL EQUIPMENT. PART 2-16: PARTICULAR REQUIREMENTS FOR THE SAFETY OF HAEMODIALYSIS, HAEMODIAFILTRATION AND HAEMOFILTRATION EQUIPMENT.
医用电气设备 第2-16部分:血液透析、血液透析过滤和血液过滤设备安全的特殊要求
1999-09-21
AS/NZS IEC 60601.2.16-2015
Medical electrical equipment, Part 2.16: Particular requirements for the basic safety and essential performance of haemodialysis, haemodiafiltration and haemofiltration equipment
医用电气设备第2.16部分:血液透析、血液透析滤过和血液滤过设备基本安全和基本性能的特殊要求
2015-09-14
AAMI/IEC 60601-2-16-2018
Medical electrical equipment - Part 2-16: Particular requirements for basic safety and essential performance of haemodialysis, haemodiafiltration and haemofiltration equipment
医用电气设备第2-16部分:血液透析、血液透析过滤和血液过滤设备的基本安全和基本性能的特殊要求
2020-07-22
KS C IEC 60601-2-16
의료용 전기기기 — 제2-16부: 인공신장기의 기본안전 및 필수성능에 관한 개별 요구사항
医疗电气设备 - 第2-16部分:血液透析 血液透析和血液过滤设备的基本安全和基本性能的特殊要求
2018-08-22
KS C IEC 60601-2-16
의료용 전기기기 — 제2-16부: 인공신장기의 기본 안전 및 필수 성능에 관한 개별 요구사항
医用电气设备.第2-16部分:血液透析、血液透析过滤和血液过滤设备的基本安全和基本性能的特殊要求
2022-12-28
GB 9706.216-2021
医用电气设备 第2-16部分:血液透析、血液透析滤过和血液滤过设备的基本安全和基本性能专用要求
Medical electrical equipment—Part 2-16: Particular requirements for the basic safety and essential performance of haemodialysis, haemodiafiltration and haemofiltration equipment
2021-08-10
IEC 60601-2-16-2025 RLV
Medical electrical equipment - Part 2-16: Particular requirements for the basic safety and essential performance of haemodialysis, haemodiafiltration and haemofiltration equipment
医用电气设备 第2-16部分:血液透析、血液透析滤过和血液滤过设备的基本安全和基本性能的特殊要求
2025-01-06
IEC 60601-2-16-2025
Medical electrical equipment - Part 2-16: Particular requirements for the basic safety and essential performance of haemodialysis, haemodiafiltration and haemofiltration equipment
医用电气设备 第2-16部分:血液透析、血液透析滤过和血液滤过设备的基本安全和基本性能的特殊要求
2025-01-06
CSA C22.2 NO.60601-2-16-19
Medical electrical equipment - Part 2-16: Particular requirements for the basic safety and essential performance of haemodialysis, haemodiafiltration and haemofiltration equipment (Adopted IEC 60601-1-16:2018, fifth edition, 2018-04, with Canadian deviations)
医用电气设备.第2-16部分:血液透析、血液透析滤过和血液滤过设备的基本安全和基本性能的特殊要求(采用IEC 60601-1-16:2018 第五版 2018-04 带加拿大偏差)
2019-09-01
DIN EN IEC 60601-2-16
Medical electrical equipment - Part 2-16: Particular requirements for the basic safety and essential performance of haemodialysis, haemodiafiltration and haemofiltration equipment (IEC 60601-2-16:2018); German version EN IEC 60601-2-16:2019
医用电气设备.第2-16部分:血液透析、血液透析滤过和血液滤过设备的基本安全和基本性能的特殊要求(IEC 60601-2-16-2018);德文版EN IEC 60601-2-16:2019
2020-05-01
血液透析滤过设备

最后更新时间 2025-08-30