EN ISO 14971 : Risk Management in Medical DevicesEN ISO 14971 standard defines a process for manufacturers to identify risks that may arise in medical devices, to evaluate, control, and determine the effectiveness of these controls. The requirements of the standard can be applied to every stage of the medical devices life cycle.EN ISO 14971: 2012 risk management standard should be used in product ...
IEC 60601-1 : General requirements for basic safety and essential performanceIEC 60601-1 standard is a standard that contains the rules and requirements regarding the basic safety and required performance of electrical medical equipment and electrical medical systems. Addressing most of the risks associated with electronic medical devices, the TS EN 60601-1, IEC 60601-1 standard has become a de fa
IEC 61587-1Cabinets, Racks, Subracks and Chassis Under Indoor Condition Use and TransportationThis product, which is called Rack Cabinet / Cabinet in todays market, is used to ensure the order and security of electronic devices and computer systems used in offices or houses.As with every product, in this product, type tests should be carried out within the scope of TS EN / IEC 61587-1 in order to ...
IEC 60335-1 StandardHousehold and Similiar Electrical Appliances LVD Test: Under the TS EN / IEC 60335-1 standard, electrical devices that we use in all areas of our lives are critical for safety. In this regard, there are major directives around the world in terms of security experiments.Within the scope of 2014/35 / EU LVD (Low Voltage Directive) directive, TS EN / IEC 60335-1 standard is the ma...
WHAT IS PRODUCT CERTIFICATION?The product has the certificate indicates that the product conforms to the standards it adheres to and other international standards.Accordingly, products produced in accordance with product certification conditions have no harm to human health and the environment.The product certification service, known as the certificate of conformity to Turkish/International standa...
IEC 62208 STANDARD (Empty Enclosures for Low Voltage Switchgear and Controlgear - General Requirements)Since the thought that the housings should be periodically maintained by experts, regulations The technical procedures of the manufacturers of these products clearly state the conditions required to ensure that foreign elements and fluids are carried out without entering, in TS EN 62208. TS EN 6...
In our country, the Turkish Accreditation Agency (TÜRKAK) affiliated to the Ministry of Foreign Affairs provides the accreditation of conformity and assessment institutions. TÜRKAK was established on 27.10.1999 in Ankara. TÜRKAK ensures that compliance and evaluation institutions operate in accordance with national and international standards, and the acceptance of the documents they produce as a ...
As a result of the new approach process initiated by the European Union in 1985, today more than twenty directives define the health and safety requirements of products.While these directives define only the basic requirements and marking conditions, harmonized standards specially prepared for the product under the directivesIt includes details on scope, descriptions, structural requirements, docu...
