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Electronic Test

Laboratory

When introduced to the market, medical devices in qualification class I must have an issued Declaration of Conformity, corresponding to the declaration of conformity of other electrical products. Medical devices in a higher qualification class than I according to the GD 54/2015 Coll. require evaluation by a notified body when introduced to the market. For an evaluation of conformity by a notified body it is necessary to provide:

  • request for an evaluation of conformity for medical device
  • technical documentation necessary to meet the basic requirements according to annex 1 of the government directive
  • design documentation of the product
  • a risk analysis
  • the results of clinical tests, evaluation, studies
  • the relevant tests of electrical safety and EMC by type of medical device including results
  • minimum requested of the documentation is listed in the requirements for CE certification

The Active medical (electro-medical) devices are electric/electro-mechanic apparatuses whose functioning relies on electricity or another power source. They are designed for employment in diagnosis, treatment, monitoring and healing of the patient. The employment target for electro-medical devices, in the healthcare fields of diagnosis therapy and assistance, for producers implies commitment into granting their safety and flawless functioning through all necessary testing and trials prior to obtaining brands and

The classification of medical devices in the European Union is outlined in Annex IX of the Council Directive 93/42/EEC. There are four classes, ranging from low risk to high risk.

The authorization of medical devices is guaranteed by a Declaration of Conformity. This declaration is issued by the manufacturer, but for products in Class Is, Im, IIa, IIb or III, it must be verified by a Certificate of Conformity issued by a Notified Body.

This means whatever type of device a manufacturer wishes to market in Europe, where CE marking is a legal requirement, we have the technical expertise to assist and provide appropriate conformity assessment services. Electrical / Electronic Product

Low Voltage Directive

Demonstrating the safety of electrical products is an essential requirement for entering the global market place. Electrical / Electronic Manufacturers seeking to enter the European market, which is one of the largest markets consisting of 30 countries, must demonstrate the safety of their appliances to enter the market place no matter where the matter the facility of manufacturers is located.

All electrical / electronic products imported or sold in European countries must be complied with the requirements of the Low Voltage Directive. Products labeled with CE marking are considered to comply with the requirements of all other applicable directives such as EMC directive as well as the Low Voltage Directive, so these products are legally accessible to EC member Country Market place.

EU Low Voltage Directive

The European Low Voltage Directive (LVD) contains the protection against electrical shock and other electrical hazards of electrical equipment within certain voltage ranges. The use of Low Voltage Directive is intended for electrical equipment which is designed and used at direct current between 75 and 1000 V and an alternating current between 50 and 1000 V.

The Necessity of LVD Certification

The European Union applies the Low Voltage Directive, 206/95/EC on the safety of electrical appliances. This guideline specify testing and evaluation procedures for electrical / electronic products. Safety standard in the filed of electrical product certification usually refers to Electrical Safety. This is to preventĀ  injury of human and loss of property from hazards that may be arisen in unforeseen or unpredicted circumstances.

CE / EMC Certified Products and Product Line-Target Products

Target includes all electrical or electronic equipment and facilities consisting of electrical components and is applicable to all equipment and facilities that may cause interference with electronic malfunction or may be affect in performance by such interference. Products with CE marking are customs clearance within the European Union territory, and these customs clearance products can be distributed in the European market without any discrimination. Customs receive clearance and declaration of conformity for CE marking and clearance.

Note : Electrical / Electronic products covered by Directive 2006/95/EC (European Electrical safety Guideline) are excluded from the scope of Machinery Directive.

Classification of Machinery Directive

European standards for machinery safety is divided into three categories; Standard A, Standard B, and Standard C. Products must meet the requirements of all three applicable standards.

Standard A (EN 414, EN 12100)

A basic safety standard that defines basic concepts, design principle, and general aspects.

Standard B ( EN 13850, EN 13849-1, EN 60204-1, etc)

Safety related standards applicable to machines that are widely classified in accordance with the use and purpose of the general machine.

1) The B1 standard specifies the specific aspects of safety(electricity, safety distance, surface temperature, noise, etc.).

2) The B2 standard specifies safety related devices and machine parts(emergency switch, pressure sensing system, etc.).

Standard C: Standard that specifies detailed safety requirements for a specific machine or a group of machines.

Required Preparatory Documents

  • Manual: User Manual, Service Manual (for professionals)
  • Parts List (copy of certificate of approved parts: CoC, AoC, Doc, type approval Certificates)
  • Catalogues: Finished products and Major parts
  • Drawing: Product, Assembly drawing, Main assembly drawing
  • Hydraulic pressure, pneumatic pressure, and electrical related materials
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