EC type-examination

EC Type-examination Certification Certification of design based on testing of physical samples versus standards/essential requirements EC Verification Certification 

Certification of individual production batches based on testing of all or samples of the batch versus standards/acceptance criteria 

The EC type-examination is the process that the manufacturer may use to obtain independent verification that a design conforms to essential requirements, when a certified QA system has not been applied to the design process. The manufacturer must submit an application to the notified body, accompanied by documentation on the device design and physical samples of the device. The Notified Body examines the 

EC Self Declaration (Annex VII) EC Self Declaration (Annex 

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Production QA is the process whereby the manufacturer adopts a quality system for the manufacture and final inspection of a device. ISO 13485 may also be used as the model in these circumstances, as the design and development elements may be omitted from this standard. The manufacturer must lodge an application with a Notified Body to have his/her system examined. The application must be accompanied by documentation on the quality system and information on any relevant EC type-examined devices. 

The notified body verifies the product s compliance with the technical documents and with standards, carries out the type tests according to these standards and issues the EC-type examination certificate. 

The notified body involved in the verifying procedure informs all the other EU-notified bodies about this EC-type examination certificate. 

The manufacturer or his EU-resident authorized representative stores a copy of the EC-type examination certificate and the technical documents for at least 10 years after the end of manufacturing this product. 

The manufacturer ensures and declares that the products comply with the design according to the EC-type examination certificate and fulfil the requirements given in the directive. 

Explosion protected electrical equipment for zone 1 (Group II, category 2 G) and the classical firedamp-proof apparatus for coal mines (Group I, category M2) are covered by the B module (EC-type examination) and by the C module (conformity to type) or the E module (product quality assurance). Alternatively, with respect to the B module, the notified body issues an EC-type examination certificate (in German EG-Baumusterpriifbescheinigung), whose marking mainly includes ... 

The result of such an assessment can be documented by PTB in an EC-type examination certificate, in an Expert s Statement (in German Gutachtliche Stellungnahme ) or in a Test Report according to apparatus configuration. 

The requirements for European Community (EC)-type certification are declaration of conformity and technical documentation files for all categories of gloves. For categories II and III, there are additional requirements EC-type examination testing by approved laboratories, certified by approved notified bodies and manufacturing under a formal EC quality assurance system. 

Conformity with the PED requires submission of the technieal file to a notified body who, when satisfied fliat it meets flie essential requirements, issues an EC Type Examination Certifieate fliat entitles the manufacturer to produce copies of the pressure system until the certificate expires. Dining the period of certification, the notified body conducts scheduled and unscheduled annual audits of the manufacturer s quality systems to ensure ongoing compliance. 

EC Type Examination Examination by a notified body for compliance of documentation and a sample of the product to be certified... 

In accordance with the conformity assessment procedure the protective systems have to be subjected to an EC-type examination according to annex III of the directive by a Notified Body. 

The proof of the resistance to flame transmission of the FA, the proof of the explosion-resistant design and the specification of the permissible T-Classes inside and outside the pump is delivered within an EC-type examination by a Notified Body. 

The Ex marking for protective systems and equipment of the category 1 is normally determined by the Notified Body according to the result of an EC-type examination. The Ex marking for non-electrical equipment of the categories 2 or 3, for example explosion-protected vacuum pumps, is determined by the manufacturer or by the supplier of this equipment. 

The manufacturer can arrange for a notified body to produce and issue an EC type examination certificate. This route is compulsory in the case of radio equipment. 

The Regulations provide a range of means for assessing conformity. However, as far as electrical equipment is concerned, conformity assessment through a notified body will be the norm, following much the same EC type examination processes and procedures that have been used in the past. There are, however, additional requirements for product quality control and third party audits. In the UK, the Electrical Equipment Certification Service (EECS) and SIRA Test and Certification Ltd already provide conformity assessment services, basing their assessments on the harmonised standards that already exist for explosion-protected electrical equipment the main standards are identified in Chapter 15. 

Category 1 electrical equipment and protective systems will have to be subject to EC type examination by a notified body for conformity to... 

These regulations require that no person should supply any gas appliance or fitting unless the appliance conforms to EC type examination and satisfies essential safety requirements listed in Schedule 3 of the regulations. Examples of some of these requirements are listed below ... 

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