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EAC certificae:安全理由Safety justification TR CU 032/2013 and TR CU 010/2011
来源: | 作者:上海经合 | 发布时间 :2021-10-20 | 1829 次浏览: | 分享到:
safety justification Safety justification is a mandatory document for confirming the compliance of products and equipment with the requirements of technical regulations TR CU 032/2013 and TR CU 010/2011. A safety justification (OB) is a document containing a risk analysis, as well as information from design, operational and technological documentation on the minimum necessary safety measures when working with this machine (equipment)

安全理由的制定 


安全理由是用于确认产品和设备符合海关联盟技术法规 TR CU 032/2013 TR CU 010/2011 要求的强制性文件。安全理由 (OB) 是一份文件,其中包含风险分析,以及设计、操作和技术文件中有关使用该机器(设备)时最低限度必要安全措施的信息。在制定安全案例的过程中,有必要考虑工作场所中的所有危险因素。安全理由的副本与测试报告一起上传到联邦国家信息系统,作为申请人接受EAC符合性声明的证据基础。申请人有义务自EAC符合性声明到期之日起保存测试报告和安全理由10 年。安全理由包含在技术文件中,在设备开发阶段准备,必须由开发者保存,安全理由的副本由设备制造商和运营组织保存。

设备的安全理由 TR CU 032/2013 的基本概念和 TR CU 010/2011 的第 2 条将设备的安全理由解释为包含风险分析的文件,以及来自设计、操作、技术文档的最低限度信息必要的安全措施、随附机器和(或)在设备生命周期的各个阶段,并辅以大修后运行阶段风险评估结果的信息。在设备的开发或设计阶段,证明在 TR 技术法规中建立要求的设备的安全性是合理的。对于修理过的设备,应通过制定技术和组织措施进行风险评估,以确保控制在安全理由规定的风险值内。机械和设备文件“安全理由”的类似指令 2006/42/EC 中的技术文件。在欧亚经济联盟的立法框架内,对安全理由的注册、执行、构建和内容没有标准要求。除了 TR CU 010/2011“关于机械和机械的安全性”中规定的要求外,对于有权制定安全理由的组织没有监管要求,也没有对准备安全理由的建立具体要求”

Development of a safety justification Safety justification is a mandatory document for confirming the compliance of products and equipment with the requirements of technical regulations TR CU 032/2013 and TR CU 010/2011. A safety justification (OB) is a document containing a risk analysis, as well as information from design, operational and technological documentation on the minimum necessary safety measures when working with this machine (equipment). In the process of developing a safety case, it is necessary to take into account all hazardous factors acting in the workplace. A copy of the safety justification is uploaded to the Federal State Information System together with the test report as an evidence base for the applicant to accept the declaration of conformity. The applicant is obliged to keep the test report and safety justification for 10 years from the date of expiration of the declaration of conformity. The safety justification is included in the technical documentation, is prepared at the stage of equipment development and must be kept by the developer, and a copy of the safety justification is kept by the equipment manufacturer and the operating organization.

 

Safety justification for equipment The basic concepts of TR CU 032/2013 and Article 2 of TR CU 010/2011 interpret the safety justification for equipment as a document containing a risk analysis, as well as information from design, operational, technological documentation on the minimum necessary safety measures, accompanying machines and (or) equipment at all stages of the life cycle and supplemented with information on the results of risk assessment at the stage of operation after overhaul. The safety of equipment for which the requirements are established in the TR is justified at the stage of development or design of equipment. With regard to the repaired equipment, a risk assessment should be carried out with the development of technical and organizational measures to ensure the values of this risk established in the safety justification. The analogue of the document "safety case" for machinery and equipment is the technical file in Directive 2006/42 / EC. There are no standard requirements for registration, execution, construction and content of a safety justification within the framework of the legislation of the Eurasian Economic Union. There are no regulatory requirements for an organization that has the right to develop a safety justification and there are no requirements for the preparation of a safety justification, with the exception of the requirements enshrined in TR CU 010/2011 "On the safety of machinery and equipment." Safety justification in accordance with GOST 33855 In Russia, at the national level, recommendations have been developed, and since September 1, 2017, GOST 33855-2016