口罩生产设备ce认证要求

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Placing on the market and putting into service 

贸易商/制造商首先投放市场和投入使用前的准备:

Before placing machinery on the market and/or putting it into service, the manufacturer or his authorised representative shall:在机械投放市场和(或)投入使用之前,制造商或其授权代表应做到如下几条:

    (a) ensure that it satisfies the relevant essential health and safety requirements set out in Annex I; 确保满足附录Ⅰ中规定的有关基本健康与安全要求;(见下方红字1)

    (b) ensure that the technical file referred to in Annex VII, part A is available; 确保能提供附录VII的A部分提到的技术文件;(见下方红字2)

    (c) provide, in particular, the necessary information, such as instructions; 尤其要提供必要的信息,如:说明书;

   (d) carry out the appropriate procedures for assessing conformity in accordance with Article 12; 根据第12条选择适当程序进行合格评定;

   (e) draw up the EC declaration of conformity in accordance with Annex II, part 1, Section A and ensure that it accompanies the machinery; 根据附录Ⅱ中第1部分A起草EC合格声明,确保其与机械在一起;(见下方红字3 EC合格声明样式)

  (f) affix the CE marking in accordance with Article 16. 按照第16条加贴CE标志。


1) ANNEX I 附录I

Essential health and safety requirements relating to the the design and construction of machinery 

与机械设计和制造有关的基本健康与安全要求(由于基本健康与安全的要求内容比较多,我们只总结以下几个制造商在设计机械设备时需要特别注意的几个点,详细ce认证过程这些要求亨欧认证公司会指导协助企业完成)


综合安全原则

    (a) Machinery must be designed and constructed so that it is fitted for its function, and can be operated, adjusted and maintained without putting persons at risk when these operations are carried out under the conditions foreseen but also taking into account any reasonably foreseeable misuse thereof.机械的设计和制造必须适合其功能,且在可预见的条件下和任何可合理预见的误用情况下对机械进行操作、调整和维护时,不会给人员带来风险。

The aim of measures taken must be to eliminate any risk throughout the foreseeable lifetime of the machinery including the phases of transport, assembly, dismantling, disabling and scrapping.采取这些措施的目的是必须消除机械在整个预期寿命周期内,包括运输、装配和拆卸、报废和拆毁阶段内的任何风险。

    (b) In selecting the most appropriate methods, the manufacturer or his authorised representative must apply the following principles, in the order given: 制造商或其授权代表必须按如下原则和顺序选择最合适的方法:

— Eliminate or reduce risks as far as possible (inherently safe machinery design and construction), 尽可能消除或减小风险(机械的本质安全设计和制造),

— Take the necessary protective measures in relation to risks that cannot be eliminated, 对不能消除的风险采取必要的保护措施,

— Inform users of the residual risks due to any shortcomings of the protective measures adopted, indicate whether any particular training is required and specify any need to provide personal protective equipment. 告知用户由于所采取保护措施的缺陷而造成的遗留风险,并说明是否需要专门的培训以及规定需要提供的个体防护设备。

 

2)ANNEX VII 附录VII

1. The technical file shall comprise the following: 技术文件应包含以下内容:

     (a) a construction file including: 结构文件,包含:

— A general description of the machinery, 机械的总描述,

— The overall drawing of the machinery and drawings of the control circuits, as well as the pertinent descriptions and explanations necessary for understanding the operation of the machinery, 机械的总体图、控制电路图,以及理解机器操作所必需的描述和解释,

— Full detailed drawings, accompanied by any calculation notes, test results, certificates, etc., required to check the conformity of the machinery with the essential health and safety requirements, 检查机械是否符合基本健康与安全要求所需的详细图样及计算记录、试验结果、证书等,

— The documentation on risk assessment demonstrating the procedure followed, including: 说明风险评价程序的文档,包括:

(i) A list of the essential health and safety requirements which apply to the machinery, 适用于该机械的基本健康与安全要求列表,

(ii) The description of the protective measures implemented to eliminate identified hazards or to reduce risks and, when appropriate, the indication of the residual risks associated with the machinery, 消除已经识别危险或减小风险的保护措施描述,必要时指出机械的遗留风险。

— The standards and other technical specifications used, indicating the essential health and safety requirements covered by these standards, 使用的标准和其他技术规范,指出这些标准涵盖的基本健康和安全要求,

— Any technical report giving the results of the tests carried out either by the manufacturer or by a body chosen by the manufacturer or his authorised representative, 给出制造商或者制造商或其授权代表选定机构进行的试验结果的技术报告,

— A copy of the instructions for the machinery, 机械的说明书副本,

— Where appropriate, the declaration of incorporation for included partly completed machinery and the relevant assembly instructions for such machinery, 适当时,包括半成品机械的组装声明和此类机械的相关装配说明,

— Where appropriate, copies of the EC declaration of conformity of machinery or other products incorporated into the machinery, 适当时,机械的EC合格声明副本或组装在机械内的其他产品,

— A copy of the EC declaration of conformity; EC合格声明的副本;

     (b) For series manufacture, the internal measures that will be implemented to ensure that the machinery remains in conformity with the provisions of this Directive. 对于成批生产,为确保机械始终符合本指令相关条款而将实施的内部措施。

The manufacturer must carry out necessary research and tests on components, fittings or the completed machinery to determine whether by its design or construction it is capable of being assembled and put into service safely. The relevant reports and results shall be included in the technical file. 制造商必须对组件、配件或已完成机械进行必要的研究和试验,以决定机械的设计或制造是否能够保证安全组装和投入使用。技术文件应包括相关的报告和结果。

 

3) EC declaration of conformity EC合格声明样式


4) 口罩机器引用欧盟协调标准

EN ISO 12100:2010

Safety of machinery — General principles for design — Risk assessment and risk reduction (ISO 12100:2010) 机械安全。设计的一般原则。风险评估和降低风险

EN 60204-1:2018

Safety of machinery — Electrical equipment of machines — Part 1: General requirements 机械安全。机械电气设备。第1部分:一般要求

EN ISO 13849-1:2015

Safety of machinery — Safety-related parts of control systems — Part 1: General principles for design (ISO 13849-1:2015) 机械安全。控制系统的安全相关部分。第1部分:设计的一般原则


5) 引用ce认证指令编号

Directive 2006/42/EC根据最新MD机械法规指南自2020年开始执行新指南要求Edition 2.2 of the MD Guide_v.24-10-2019 (clean) (LAST UPDATE) 其中MD+LVD的ce证书类型组合将被取消,也就是说机械ce证书中将不包括LVD指令。