发布时间:2024-05-27 17:49:26 - 更新时间:2024年06月29日 15:22
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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
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
Medical electrical equipment. Part 1. General requirements for safety. 4. Safety requirements for programmable medical electrical systems
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
Medical electrical equipment; particular requirements for safety of medical supply units
Oxygen concentrators for medical use. Safety requirements.
Medical electrical equipment - Part 1: General requirement for safety - 1. Collateral standard: Safety requirements for medical electrical systems; Amendment 1
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
ELECTROMEDICAL EQUIPMENT. SAFETY OF MEDICAL ELECTRICAL EQUIPMENT. PART 1 : GENERAL REQUIREMENTS.
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
Medical devices - Guidance on the selection of standards in support of recognized essential principles of safety and performance of medical devices
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
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
Medical devices. Application of usability engineering to medical devices
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
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
Medical electrical equipment. Part 1. General requirements for safety. 4. Safety requirements for programmable medical electrical systems
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
Medical electrical equipment; particular requirements for safety of medical supply units
Oxygen concentrators for medical use. Safety requirements.
Medical electrical equipment - Part 1: General requirement for safety - 1. Collateral standard: Safety requirements for medical electrical systems; Amendment 1
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
ELECTROMEDICAL EQUIPMENT. SAFETY OF MEDICAL ELECTRICAL EQUIPMENT. PART 1 : GENERAL REQUIREMENTS.
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
Medical devices - Guidance on the selection of standards in support of recognized essential principles of safety and performance of medical devices
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
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
Medical devices. Application of usability engineering to medical devices