俄罗斯测试认证集团/海关联盟EAC认证中心

Центр сертификации EAC Таможенного союза ​ООО ТЕСТ СЕРТ 

上海经合工业设备检测有限公司    俄语区域产品认证专家

021-36411223      eac@cu-tr.org   WeChat:18621862553
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 | 1133 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 Safety justification for equipment. Recommendations for preparation ". The GOST 33855-2016 standard applies to equipment, in the technical regulations for which a safety justification is provided, establishes the rules for the preparation of a safety justification for equipment used to confirm its compliance with the requirements, also establishes the rules for constructing, setting out a separate document "Safety justification", which is drawn up if the set technical documents do not fully confirm the safety of the equipment. For certain types of equipment, the rules for preparing a safety justification can be established in other standards, taking into account the requirements of TR that apply to these types of equipment. The set of documents justifying safety may include: - design documentation (drawings, specifications, calculations, etc.); - operational documentation; - acts and / or test reports; - analytical materials (analysis and / or risk assessment, analysis of operational reliability, etc.). The safety rationale for vessels and apparatus operating under excess pressure is the confirmation of their strength, stability and tightness during the design life using strength calculations and the fulfillment of a set of technical requirements interconnected with it. GOST 33855 recommends providing evidence of equipment compliance with technical regulations in tabular form.

 

general description of equipment 设备概述

1 scope (intended use, suspected misuse)

2 operating conditions

3 descriptions and explanations of the operation of the equipment

4 various modes of equipment operation

5 various intervention procedures

6 required training and user experience

7 Exposure to equipment hazards of others

main parameters and characteristics of equipment 设备主要参数及特点

1 technical characteristics and parameters of equipment operation for models and modifications of equipment

2 images of equipment with indication of overall, installation, connection or other dimensions

3 package

risk assessment 风险评估

1 risk analysis (identification of operational hazards, calculation of the degree of risk for each hazard)

2 comparison of the calculated risk value with the acceptable

3 residual risk after the developer has taken protective measures

4 indication of hazardous areas for operations

5 the likelihood of a hazardous event occurring (frequency and duration of exposure to the hazard, technical possibilities to prevent or limit harm)

6 the expected severity of the consequences (priority of risks, statistics by equipment group or by industry)

proof of equipment compliance with TR requirements 设备符合TR技术法规要求的证明

 

1 design solutions for commissioning, operation and disposal

2 information about the performed calculations, tests

3 list of possible equipment failures (critical, non-critical, criteria of limit states)

4 the number of the paragraph of the TR, which sets out the requirement

5 content of this requirement

6 Measures taken to meet this requirement

7 designation of the standard confirming the fulfillment of this requirement

National GOST 33855-2016 indicates how to proceed in cases when the manufacturer cannot provide documents justifying safety for the equipment being imported to confirm the equipment compliance with the requirements of technical regulations TR CU 032/2013 and TR CU 010/2011. Under such conditions, the "Safety Justification" is developed by the importer (seller) or a legal entity authorized in accordance with the established procedure by the manufacturer. Standard GOST 33855-2016 Justification of equipment safety. Recommendations for preparation "is intended for use by state control (supervision) bodies when conducting conformity assessment on the basis of clause 38 of TR CU 032/2013, which, in addition to confirming the conformity of equipment in the form of declaration or certification, establishes the need for conformity assessment in the form of state control (supervision) ... After the document "Safety Justification" is developed, it is necessary to undergo conformity confirmation as part of certification or declaration of products in accordance with the requirements of technical regulations.

How to assign a safety case number? National GOST 33855-2016 recommends adhering to the requirements of ESKD when drawing up a safety justification and refers in particular to GOST 2.105-95. In addition, the national GOST 33855-2016 was developed on the basis of GOST R 54122-2010, which explicitly states that the designation OB is assigned by the developer in accordance with GOST 2.201-80. GOST establishes a unified impersonal classification system for the designation of products and their design documents during the development, manufacture, operation and repair. The formation of the safety justification number is as follows: ABVG-XXXXXX-XXXOB, where ABVG is the 4-digit letter code of the organization that developed the design documents, XXXXXX is the code according to the ESKD classifier, XXX is the serial number, OB is the type of document. In the Russian Federation there is a "All-Russian Classifier of Products and Design Documents", OK 012-93. The structure of the classification characteristic code:

 

For example, let's take the code of the organization-developer of design documents - ABVG. Product code - 49182, which stands for pipeline valves / Shut-off and irreversible shut-off valves without built-in actuators / Ball valves / DU St. 50 to 200 mm incl. We choose the serial number of the safety justification 002. Thus, the final form of the safety justification number will be as follows: ABVG-49182-002OB

Rationale for the safety of a hazardous production facility In accordance with the requirements of Federal norms and rules in the field of industrial safety, a safety case for a hazardous production facility is developed in case of deviation from the current industrial safety requirements, or such requirements are insufficient, or such requirements have not been established. In order not to close previously built mines, mines that began their work before the entry into force of modern industrial safety requirements, and therefore do not comply with such rules, the necessary compensatory measures are taken to ensure the same safety of the mine as if these deviations from the rules did not have. Examination of the safety justification is carried out in the relevant expert organizations. To prepare OB for equipment, you need to know the exact scope of the equipment or machine, the principle of operation, technical characteristics, diagrams and drawings.





海关联盟EAC认证中心

上海经合工业设备检测有限公司

电话:021-36411293       

地址:中国上海浦东新区高科东路777号1号楼2017  

邮箱: eac@cu-tr.org   gost-r@163.com   

skype: gostchina   

手机和微信WeChat:18621862553

www.cu-tr.com   www.cu-tr.org  www.gost.org.cn  

 

                                               微信扫一扫                                          公众号关注