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      CN EN

      Product Testing

      Applicable Products

      Personal protective equipment (PPE)

      Active implantable medical devices

      Medical devices

      In vitro diagnostic medical devices

      Electrical and electricity products

      WIFI, Bluetooth, wireless, Radio, equipment

      IT/AV multimedia products

      Household appliances

      Introduction

      If you want to trade in the EU, CE-marking is a mandatory conformity mark required for a wide variety of products. CE-marking indicates that your products comply with stringent EU product safety directives. However, achieving compliance can be a complex process. As a notified body for nearly all EU product safety directives, our CE-marking conformity assessment services provide you with the expertise you need to achieve compliance.


      Our CE-marking conformity assessment services include:

      1.Advice on the CE-marking process

      2.Conformity assessment

      3.Verification of design

      4.Type approval

      5.System audit and approval

      6.File and document assessment

      7.Production supervision and sample testing

      8.CE audits and electromagnetic compatibility (EMC) testing

      9.Training

      10.Risk analysis and assessment

      11.Technical files

      12.User manual and instruction card assessment

      13.Issuing your EC declaration of conformity

      14.Issuing your certificate of verification

      15.Contact us today to find out how our CE-marking services can help you reach the EU market.

      Standards

      Regulation (EU) 2016/425 Personal protective equipment (PPE)

      2014/53/EU Radio equipment

      2014/30/EU Electromagnetic compatibility

      90/385/EEC Active implantable medical devices

      93/42/EEC Medical devices

      98/79/EC In vitro diagnostic medical devices

      2009/48/EC Safety of toys

      2010/35/EU Transportable pressure equipment

      2014/29/EU Simple pressure vessels

      2014/68/EU Pressure equipment

      Regulation (EU) 2017/745 on medical devices

      Regulation (EU) 2017/746 on in vitro diagnostic medical devices


      Others

      About PPE


      In the EU 2 legal acts are published on PPE.

      Remark that on the 31st of March 2016 the new PPE Regulation 2016/425 was published. This regulation becomes applicable on the 21st of April 2018.

      The second one is the Directive 89/656 (Use Directive), this legislation lays down the minimum requirements concerning the use of PPE. The responsibilities of employers and employees concerning PPE for occupational use are covered by this Directive.

      The Blue Guide on the implementation of EU product rules 2016 was adopted on the 5th of April 2016 and is published in English  (other languages will follow)


      PPE protects its intended user against one or more hazards.

      Exposure to hazards may lead to injury.  3 Categories have been defined, depending on the degree of the risk

      ?category I = less serious injuries

      ?category II =  summarising the remaining degrees of seriousness of injuries. (so no Cat I or III)

      ?category III = very serious injuries leading to irreversible harm to health and/or death)


      In function of those categories, the manufacturers or their legal representative  in the EU have to follow a strick prodecure to put into the European market their PPE

      ?category I = simple design : declaration of conformity by the manufacturer on his own responsibility. So he has to confirm that PPE of simple design complies with the safety requirements of the Directive, the manufacturer is required to complete the EC Declaration of Conformity only.

      ?category II = declaration of conformity by the manufacturer after a notified body has drawn up an EC type-examination certificate for a PPE model

      ?category III =  declaration of conformity by the manufacturer after a notified body has drawn up an EC type-examination certificate for a PPE model and after a notified body (either the same one that drew up the EC type-examination certificate or another one) has carried out the quality control of the PPE manufactured

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