Manufacturers must comply with the MDD 93/42 / EEC Medical Device Directive to sell their medical products to Europe. EUROLAB has extensive experience in EMC and Safety tests required by the Medical Device Directive for medical electrical products.
Description of the Medical Device - for human use by the manufacturer and for diagnosis, prevention, monitoring, treatment or mitigation of the disease; diagnosis, monitoring, treatment, mitigation or compensation for an injury or handicap; research or modification of anatomy or a physiological process; conception control etc. All kinds of products produced for carrying purposes can be included in the medical device class.
EN 60601-1-6 - Part 1-6
Medical electrical devices - General requirements for basic safety and basic performance - Collateral standard: Availability
EN 60601-1-9 - Part 1-9
Medical electrical devices - General requirements for basic safety and basic performance - Collateral Standard: Environmentally friendly design requirements
EN 60601-1-11 - Part 1-11
General requirements for basic safety and basic performance - Collateral standard: Requirements for medical electrical equipment and medical electrical systems used in the home care environment
EN 60601-2-22 - Part 2-22
Special requirements for basic safety and basic performance of surgical, cosmetic, therapeutic and diagnostic laser equipment
EN 60601-2-3 - Part 2-3
Special requirements for basic safety and basic performance of shortwave therapy equipment
EN 60601-2-4 - Part 2-4
Special rules for basic safety and basic performance of cardiac defibrillators
EN 60601-2-37 - Part 2-37
Special requirements for basic safety and basic performance of ultrasonic medical diagnostic and monitoring equipment
EN 60601-1-8 - Part 1
General requirements for basic safety and basic performance - Collateral standard: General requirements, tests and guidance for medical electrical equipment and alarm systems in medical electrical systems
EN 80601-2-35 - Part 2-35
Special requirements for basic safety and basic performance of heating devices using blankets, pads, mattresses and for medical use heating
EN 60601-2-52 - Part 2-52
Special rules for the basic safety and basic performance of medical beds
EN 60601-2-57
Special requirements for the basic safety and basic performance of non-laser light source equipment for therapeutic, diagnostic, monitoring and cosmetic / aesthetic use
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EUROLABreporting and certification activities, United Accreditation Foundation (UAF), Turkish Accreditation Agency (TÜRKAK) ve Enterprise Accreditation Foundation (EAF) based on the accreditation provided by the accreditation body. The Enterprise Accreditation Foundation (EAF) accreditation body is also a signatory of the United Nations (UN GLOBAL COMPACT) organization.
