SIS SS-IEC 601-2-12:1991 医疗电气设备．第2部分：医疗用肺通气器安全性特殊要求
This clause of the General Standard applies, except as follows: 1.1 R Scope Addition: This Particular Standard specifies safety requirements
Medical electrical equipment - Part 2: Particular requirements for the safety oflung ventilators for medical use
WS/T 654-2019 医疗器械安全管理
T/ZMDS 20003-2019 医疗器械网络安全风险控制 – 医疗器械网络安全能力信息
本标准对医疗器械网络安全风险控制中所涉及的网络安全能力进行了定义。 规定了医疗器械制造商在与医疗器械网路安全责任方进行沟通时，应该披露的信息。 网络安全能力一共包含20项内容，分别是：自动注销能力、审核控制能力、确定用户授权的能力、安全特性配置能力、网络安全升级能力、健康数据身份信息去除能力
Medical device security risk control – information of medical device security capabilities
GOST 30324.0.4-2002 医疗电气设备.第1部分.安全性通用要求.4.可编程的医疗电气体系安全性要求
Medical electrical equipment. Part 1. General requirements for safety. 4. Safety requirements for programmable medical electrical systems
IEC TR 60930:2008 管理、医疗、护理人员安全使用医疗电气设备和医疗电气系统用指南
This technical report is intended to lessen the RISK to PATIENTS, OPERATORS, and their surroundings by providing a code of safe application
Guidelines for administrative, medical, and nursing staff concerned with the safe use of medical electrical equipment and medical electrical systems
prEN 793-1992 医疗电气设备.医用电源的安全要求
Medical electrical equipment; particular requirements for safety of medical supply units
NF S95-143:1997 医疗用氧气浓缩器.安全要求
Oxygen concentrators for medical use. Safety requirements.
IEC 60601-1-1/AMD1:1995 医疗电气设备.第1部分:通用安全要求.1.副标准.医疗电气系统的安全要求.补充件1
Medical electrical equipment - Part 1: General requirement for safety - 1. Collateral standard: Safety requirements for medical electrical systems; Amendment 1
YY/T 0467-2003 医疗器械 保障医疗器械安全和性能公认基本原则的标准选用指南
本标准考虑并指明若干对评定医疗器械与安全和性能公认基本原则的符合性有用的重要标准和指南。 本标准由制造商、标准化部门、管理部门使用，并用于符合性评定
Medical devices-Guide to the selection of standards in support of recognized essential principles of safety and performance of medical devices
NF C74-010:1983 医用电气设备.医疗电器的安全.第1部分：一般规则
ELECTROMEDICAL EQUIPMENT. SAFETY OF MEDICAL ELECTRICAL EQUIPMENT. PART 1 : GENERAL REQUIREMENTS.
YY/T 0467-2016 医疗器械保障医疗器械安全和性能公认基本原则的标准选用指南
本标准考虑并确定对医疗器械安全和性能公认基本原则符合性评定有用的某些重要标准和指南。 本标准预期由制造商、标准化机构和监管机构用于符合性评定
Medical devices.Guidance on the selection of standards in support of recognized essential principles of safety and performance of medical devices
ISO/TR 16142:1999 医疗器械 医疗器械安全和性能公认基本原则的保障标准选用指南
Medical devices - Guidance on the selection of standards in support of recognized essential principles of safety and performance of medical devices
ISO/TR 16142:2006 医疗器械.医疗器械安全和性能公认基本原则的配套标准选用指南
This Technical Report considers and identifies certain significant standards and guides that can be useful in the assessment of conformity of medical
Medical devices - Guidance on the selection of standards in support of recognized essential principles of safety and performance of medical devices
KS P ISO TR 16142:2007 医疗器械.医疗器械安全和性能公认基本原则的配套标准选用指南
이 규격은 의료 기기의 안전과 성능에 관한 공인된 필수 원칙에 적합한지를 평가하는 데 유용
Medical devices－Guidance on the selection of standards in support of recognized essential principles of safety and performance of medical devices
BS EN 62366-1:2015 医疗器械. 医疗器械可用性工程应用
Medical devices. Application of usability engineering to medical devices
SIS SS-IEC 601-2-12:1991 医疗电气设备．第2部分：医疗用肺通气器安全性特殊要求
This clause of the General Standard applies, except as follows: 1.1 R Scope Addition: This Particular Standard specifies safety requirements
Medical electrical equipment - Part 2: Particular requirements for the safety oflung ventilators for medical use
WS/T 654-2019 医疗器械安全管理
T/ZMDS 20003-2019 医疗器械网络安全风险控制 – 医疗器械网络安全能力信息
本标准对医疗器械网络安全风险控制中所涉及的网络安全能力进行了定义。 规定了医疗器械制造商在与医疗器械网路安全责任方进行沟通时，应该披露的信息。 网络安全能力一共包含20项内容，分别是：自动注销能力、审核控制能力、确定用户授权的能力、安全特性配置能力、网络安全升级能力、健康数据身份信息去除能力
Medical device security risk control – information of medical device security capabilities
GOST 30324.0.4-2002 医疗电气设备.第1部分.安全性通用要求.4.可编程的医疗电气体系安全性要求
Medical electrical equipment. Part 1. General requirements for safety. 4. Safety requirements for programmable medical electrical systems
IEC TR 60930:2008 管理、医疗、护理人员安全使用医疗电气设备和医疗电气系统用指南
This technical report is intended to lessen the RISK to PATIENTS, OPERATORS, and their surroundings by providing a code of safe application
Guidelines for administrative, medical, and nursing staff concerned with the safe use of medical electrical equipment and medical electrical systems
prEN 793-1992 医疗电气设备.医用电源的安全要求
Medical electrical equipment; particular requirements for safety of medical supply units
NF S95-143:1997 医疗用氧气浓缩器.安全要求
Oxygen concentrators for medical use. Safety requirements.
IEC 60601-1-1/AMD1:1995 医疗电气设备.第1部分:通用安全要求.1.副标准.医疗电气系统的安全要求.补充件1
Medical electrical equipment - Part 1: General requirement for safety - 1. Collateral standard: Safety requirements for medical electrical systems; Amendment 1
YY/T 0467-2003 医疗器械 保障医疗器械安全和性能公认基本原则的标准选用指南
本标准考虑并指明若干对评定医疗器械与安全和性能公认基本原则的符合性有用的重要标准和指南。 本标准由制造商、标准化部门、管理部门使用，并用于符合性评定
Medical devices-Guide to the selection of standards in support of recognized essential principles of safety and performance of medical devices
NF C74-010:1983 医用电气设备.医疗电器的安全.第1部分：一般规则
ELECTROMEDICAL EQUIPMENT. SAFETY OF MEDICAL ELECTRICAL EQUIPMENT. PART 1 : GENERAL REQUIREMENTS.
YY/T 0467-2016 医疗器械保障医疗器械安全和性能公认基本原则的标准选用指南
本标准考虑并确定对医疗器械安全和性能公认基本原则符合性评定有用的某些重要标准和指南。 本标准预期由制造商、标准化机构和监管机构用于符合性评定
Medical devices.Guidance on the selection of standards in support of recognized essential principles of safety and performance of medical devices
ISO/TR 16142:1999 医疗器械 医疗器械安全和性能公认基本原则的保障标准选用指南
Medical devices - Guidance on the selection of standards in support of recognized essential principles of safety and performance of medical devices
ISO/TR 16142:2006 医疗器械.医疗器械安全和性能公认基本原则的配套标准选用指南
This Technical Report considers and identifies certain significant standards and guides that can be useful in the assessment of conformity of medical
Medical devices - Guidance on the selection of standards in support of recognized essential principles of safety and performance of medical devices
KS P ISO TR 16142:2007 医疗器械.医疗器械安全和性能公认基本原则的配套标准选用指南
이 규격은 의료 기기의 안전과 성능에 관한 공인된 필수 원칙에 적합한지를 평가하는 데 유용
Medical devices－Guidance on the selection of standards in support of recognized essential principles of safety and performance of medical devices
BS EN 62366-1:2015 医疗器械. 医疗器械可用性工程应用
Medical devices. Application of usability engineering to medical devices
编辑：北检院编辑部
