欧亚联盟EAEU、俄罗斯、乌兹别克斯/哈萨克斯坦/白俄罗斯/乌克兰医疗器械和药品注册咨询服务
Eurasian Economic Union Russia Uzbekistan Kazakhstan Belarus Ukraine Medical Device and Drug Registration Consulting Services
The Technical Regulation TR CU 010/2011 On safety of machinery and equipment stipulates minimum requirements for the safety of machinery and equipment during their entire lifecycle: during their design, manufacture, installation, storage, transport, commissioning, operation, decommissioning, and disposal. The focus is on protecting life, health, property and the environment.
Compliance with the requirements of the technical regulation TR CU 010/2011 On safety of machinery and equipment is a prerequisite for successful access to the Russian and Eurasian market.
Although the requirements of the Technical Regulation TR CU 010/2011 have been coordinated with the requirements of the Machinery Directive 2006/42/EC, they are not identical.
Adopted on October 18, 2011
Came into force on February 15, 2013
On March 15, 2015, the Technical Regulation TR CU 010/2011 rendered the national standards of the technical regulation such as GOST or Russian TR invalid.
The Technical Regulation TR CU 010/2011 applies to machines and equipment. According to the Technical Regulation TR ZU 010/2011, machines or equipment is
a series of continuous parts or components assembled for a concrete application (e.g. processing, transporting or packaging) into an overall unit, at least one of which is driven by a power source through corresponding driving mechanisms, control chains.
In addition equipment intended for use in industries with increased dangers is subject to conformity assessment under Technical Regulation TR ZU 010/2011.
Used machines as well as components/ spare parts do not fall under any EAC conformity assessments.
The conformity assessment with the requirements of TR CU 010/2011 On safety of machinery and equipment is carried out in the form of an EAC Certification or EAC Declaration.
The EAC certification of machinery and equipment is carried out by an accredited certification body.
The conformity assessment of machinery and equipment prior to commissioning in the form of an EAC Declaration is based on own evidence and with the involvement of an accredited body.
Upon request, the EAC Declaration can be replaced by an EAC Certification.
The accompanying documents for the conformity assessment of machinery and equipment shall be submitted in Russian language or in the official language of the member state of the customs union and should include:
detailed product description
product name
technical passport
safety assessment
instruction manual
technical drawings
technical data sheet
test reports
a copy of the quality management system certificate
According to TR CU 010/2011 the following devices are subject to EAC Certification: | According to TR CU 010/2011 the following devices are subject to the EAC Declaration: | According to TR CU 010/2011 no conformity assessment needed for: |
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It should be noted that the products, regardless of whether or not they are subject to conformity assessment according to Technical Regulation TR CU 010/201, might also comply with other directives, such as TR CU 004/2011 On the safety of low-voltage equipment or TR CU 020/2011 On electromagnetic compatibility.
The products that have been confirmed to conform with the requirements of TR CU 010/2011 are marked with the EAC sign of the customs union. Placing a product on the market without corresponding marking can be punished with a fine or confiscation.
The certificate for serial production is valid for 5 years.
联系我们:上海经合工业设备检测有限公司/俄罗斯EAC证机构中国代表处
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