Regulations on the Dedication of Commercial Grade Items and Certification of Dedication Agency Article 2
The terminology used in these Regulations shall be respectively defined as follows:1. Critical Characteristics: Essential characteristics such as design, materials, functions of the Nuclear Grade Item which can be demonstrated through inspections, tests and/or analysis, etc. to provide reasonable assurance that the item can indeed perform its intended safety functions.2. Commercial Grade Item: An item not designed nor fabricated in accordance with the Nuclear Grade Item’s unique specifications.3. Dedicated Commercial Grade Item: A Commercial Grade Item demonstrated through specific dedication procedures whose characteristics are equivalent to the Critical Characteristics of the corresponding Nuclear Grade Item.4. Technical Evaluation: The evaluation process for establishing the Critical Characteristics and Acceptance Criteria in accordance with the item’s functional requirements and for confirming that all relevant requirements are specified in detail in the item’s procurement document.5. Dedication: The operation through the Technical Evaluation and the Acceptance Procedure to verify that the Commercial Grade Item’s characteristics are equivalent to the Critical Characteristics of the corresponding Nuclear Grade Item.6. Acceptance: The approach of the provision of reasonable assurance based on objective evidence that the Commercial Grade Item received is indeed the corresponding Dedicated Commercial Grade Item.7. Acceptance Criteria: Acceptance standard for an Item’s dedication results, established in accordance with the intended functional requirements for the Nuclear Grade Item.8. Environmental Qualification Test: A test performed to dedicate the characteristics of the randomly selected items from the same manufacturing batch, and under the simulated actual environmental conditions. The test results must assure that the same batch of items will be suitable for the actual environmental conditions. The main actual environmental conditions to be simulated shall include temperature, pressure, humidity, radiation and chemical effect, etc.9. Failure Modes and Effects Analysis: The evaluation of an item’s failure mechanism and its effect on the intended safety functions.10. Safety Functions: Those functions, as listed in the following, of a system, structure, or component of a nuclear reactor facility during normal service conditions, anticipated abnormal events, design basis accidents, external events, and natural phenomena must be assured.(1) The integrity of the reactor coolant pressure boundary,(2) The capability to shut down the reactor and to maintain its safe shutdown conditions, and(3) The capability to prevent or mitigate the consequences of accidents that could result in potential offsite radiation exposures exceeding the prescribed specific limits.11. International Nuclear Procurement Quality Assurance Organization: A non-profit international organization represented by international nuclear utilities operating nuclear power plants to conduct joint audits on dedicated commercial grade item suppliers or dedication agencies in accordance with Quality Assurance Criteria and Quality Assurance Program for nuclear power plants.12. Approved Suppliers List: A list established by the licensee after the licensee has reviewed the dedicated commercial grade item suppliers or dedication agencies that are qualified through joint audits by International Nuclear Procurement Quality Assurance Organization.13. Safety Hazard: Degradation of the safety functions to the structures, systems, and components of a nuclear facility that has caused significant reduction of protection to public health and safety.
中文原文 核能同級品零組件檢證作業及檢證機構認可管理辦法第2條
本辦法用詞定義如下：
一、關鍵特性：指核能級產品零組件之重要設計、材料及功能特性，可經由檢驗、測試及分析等方式之驗證，以對其能執行預期之安全功能提供合理之保證。
二、商業級零組件：指非依照核能級產品零組件之特殊規格而設計製造者。
三、核能同級品零組件：指商業級零組件經特定檢證程序，證實其特性與原核能級產品零組件關鍵特性相當者。
四、技術評估：指依據核能級產品零組件功能要求，訂定關鍵特性及允收準則，並確認其相關之需求均詳列於採購文件中之評估過程。
五、檢證：指經技術評估及允收程序，以證實商業級零組件之特性與核能級產品零組件關鍵特性相當之作業。
六、允收：指採用客觀證據提供合理之保證方式，以確認所接收之商業級零組件即為核能同級品零組件。
七、允收準則：指依據核能級產品零組件之預期安全功能要求，所訂定之檢證合格標準。
八、環境驗證測試：指在同一製造批次之商業級零組件中隨機取樣，應用模擬等效環境狀況執行零組件特性之驗證，驗證結果必須確保該批次零組件在實際環境下之適合性，其主要之環境條件包括溫度、壓力、溼度、輻射及化學等因素。
九、失效模式及影響分析：指評估組件之失效機制對安全功能所造成之影響。
十、安全功能：指核子反應器設施中安全相關結構、系統及組件，在正常運轉、可預見運轉事件、設計基準事故、外在事件及天然災害等狀況下，能確保下列功能：
（一）核子反應器冷卻水壓力邊界之完整性。
（二）使核子反應器設施停機，並維持在安全停機狀態。
（三）防止或減緩事故後廠外輻射劑量超出法規限值。
十一、國際性核能採購品保組織：指由核子反應器設施經營者組成聯合團隊，並遵循品質保證準則及品質保證方案規定，對核能同級品零組件供應廠商及檢證服務機構進行稽查之國際性非營利組織。
十二、合格廠商名單：指通過國際性核能採購品保組織執行聯合稽查之核能同級品零組件供應廠商及檢證服務機構，再由經營者審查後，建立之名單。
十三、安全危害：指核子反應器設施安全相關結構、系統及組件之安全功能劣化，而顯著降低對民眾健康及安全之保障。
一、關鍵特性：指核能級產品零組件之重要設計、材料及功能特性，可經由檢驗、測試及分析等方式之驗證，以對其能執行預期之安全功能提供合理之保證。
二、商業級零組件：指非依照核能級產品零組件之特殊規格而設計製造者。
三、核能同級品零組件：指商業級零組件經特定檢證程序，證實其特性與原核能級產品零組件關鍵特性相當者。
四、技術評估：指依據核能級產品零組件功能要求，訂定關鍵特性及允收準則，並確認其相關之需求均詳列於採購文件中之評估過程。
五、檢證：指經技術評估及允收程序，以證實商業級零組件之特性與核能級產品零組件關鍵特性相當之作業。
六、允收：指採用客觀證據提供合理之保證方式，以確認所接收之商業級零組件即為核能同級品零組件。
七、允收準則：指依據核能級產品零組件之預期安全功能要求，所訂定之檢證合格標準。
八、環境驗證測試：指在同一製造批次之商業級零組件中隨機取樣，應用模擬等效環境狀況執行零組件特性之驗證，驗證結果必須確保該批次零組件在實際環境下之適合性，其主要之環境條件包括溫度、壓力、溼度、輻射及化學等因素。
九、失效模式及影響分析：指評估組件之失效機制對安全功能所造成之影響。
十、安全功能：指核子反應器設施中安全相關結構、系統及組件，在正常運轉、可預見運轉事件、設計基準事故、外在事件及天然災害等狀況下，能確保下列功能：
（一）核子反應器冷卻水壓力邊界之完整性。
（二）使核子反應器設施停機，並維持在安全停機狀態。
（三）防止或減緩事故後廠外輻射劑量超出法規限值。
十一、國際性核能採購品保組織：指由核子反應器設施經營者組成聯合團隊，並遵循品質保證準則及品質保證方案規定，對核能同級品零組件供應廠商及檢證服務機構進行稽查之國際性非營利組織。
十二、合格廠商名單：指通過國際性核能採購品保組織執行聯合稽查之核能同級品零組件供應廠商及檢證服務機構，再由經營者審查後，建立之名單。
十三、安全危害：指核子反應器設施安全相關結構、系統及組件之安全功能劣化，而顯著降低對民眾健康及安全之保障。