標準號:BS EN 61508-2-2010
中文標準名稱:電氣,電子,可編程電子安全性系統的功能安全性.電氣,電子,可編程電子安全性系統的要求
英文標準名稱:Functional safety of electrical/electronic/ programmable electronic safety-related systems. Requirements for electrical/electronic/ programmable electronic safety-related systems
標準類型:N18
發布日期:2010/6/30 12:00:00
實施日期:2010/6/30 12:00:00
中國標準分類號:N18
國際標準分類號:13.260;25.040.40;29.020
適用范圍:1.1 This part of the IEC 61508 seriesa) is intended to be used only after a thorough understanding of IEC 61508-1, which providesthe overall framework for the achievement of functional safety;b) applies to any safety-related system, as defined by IEC 61508-1, that contains at leastone electrical, electronic or programmable electronic element;c) applies to all elements within an E/E/PE safety-related system (including sensors,actuators and the operator interface);d) specifies how to refine the E/E/PE system safety requirements specification, developed inaccordance with IEC 61508-1 (comprising the E/E/PE system safety functionsrequirements specification and the E/E/PE system safety integrity requirementsspecification), into the E/E/PE system design requirements specification;e) specifies the requirements for activities that are to be applied during the design andmanufacture of the E/E/PE safety-related systems (i.e. establishes the E/E/PE systemsafety lifecycle model) except software, which is dealt with in IEC 61508-3 (see Figures 2to 4). These requirements include the application of techniques and measures that aregraded against the safety integrity level, for the avoidance of, and control of, faults andfailures;f) specifies the information necessary for carrying out the installation, commissioning andfinal safety validation of the E/E/PE safety-related systems;g) does not apply to the operation and maintenance phase of the E/E/PE safety-relatedsystems – this is dealt with in IEC 61508-1 – however, IEC 61508-2 does providerequirements for the preparation of information and procedures needed by the user for theoperation and maintenance of the E/E/PE safety-related systems;h) specifies requirements to be met by the organisation carrying out any modification ofthe E/E/PE safety-related systems;i) does not apply for medical equipment in compliance with the IEC 60601 series.
相關標準
《GB/T14233.2-2005》醫用輸液、輸血、注射器具檢驗方法第二部分:生物實驗方法 GB/T14233.2-2005
《GB/T 16886.1-2011》醫療器械生物學評價 第1部分 風險管理過程中的評價與試驗 GB/T 16886.1-2011
《GB/T 16886.1-2011》醫療器械生物學評價 第1部分 風險管理過程中的評價與試驗 GB/T 16886.1-2011
《GB/T14233.2-2005》醫用輸液、輸血、注射器具檢驗方法第二部分:生物實驗方法 GB/T14233.2-2005
《GB/T14233.2-2005》醫用輸液、輸血、注射器具檢驗方法第二部分:生物實驗方法 GB/T14233.2-2005
《GB/T 16886.1-2011》醫療器械生物學評價 第1部分 風險管理過程中的評價與試驗 GB/T 16886.1-2011
《GB/T 16886.1-2011》醫療器械生物學評價 第1部分 風險管理過程中的評價與試驗 GB/T 16886.1-2011
《GB/T14233.2-2005》醫用輸液、輸血、注射器具檢驗方法第二部分:生物實驗方法 GB/T14233.2-2005
《GB/T 16886.1-2011》醫療器械生物學評價 第1部分 風險管理過程中的評價與試驗 GB/T 16886.1-2011
《GB/T14233.2-2005》醫用輸液、輸血、注射器具檢驗方法第二部分:生物實驗方法 GB/T14233.2-2005
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