Medical Device Testing - Eurofins Scientific · Testing Services • Safety Testing • Safety...
2
Medical Device Testing Contact: Email: EE@eurofins.com www.eurofins.com/EE Testing Services • Safety Testing • Safety testing for active medical devices based on the international IEC 60601 standards family; including test reports and certificates according to CB Scheme and ILAC accreditation. • Safety testing for in vitro diagnostic medical devices to IEC 61010-2-101. • Product safety compliance in the United States and Canada (FDA and Health Canada) including OSHA NRTL requirements. • EMC Testing • Medical EMC testing for active medical devices based on the international IEC 60601 standards family; including test reports and certificates. • Radio/Wireless Testing • Ultra low power active medical implants (ULP- AMI). • Medical device RFID susceptibility testing. • WLAN, Bluetooth, ZigBee, GSM/GPRS, UMTS, Wireless Power Transfer (WPT), and LTE. • Mechanical & Climatic Environmental Simulation • Corrosion tests, IP tests, temperature shock, overpressure, temperature and altitude, faster decompression, shock and vibration. • Performance Testing • Functionality, energy efficiency, durability and reliability, performance according to FDA guidance documents, claims validation. • Other related testing services • Digital Testing Services (software, functionality, interoperability). • Cyber security testing. • Biocompatibility according to the ISO 10993 standards family and microbiological studies (GLP). • Chemical characterization for materials, extractable and leachable substances evaluation. * Where IEC standards are referred to, national and regional variations are also applicable including, but not limited to; ANSI/AAMI, UL, ISO, CAN/CSA, JIS, EN, ENV, BS EN, DD ENV and BS IEC. Please enquire on a case by case basis. Your industry, our focus The concept Electrical medical equipment, also known as “active medical devices”, are controlled by stringent regional and international approval procedures which include the required testing to be performed by approved and accredited laboratories. In the field of active medical devices, these requirements are documented under the IEC 60601* standards family. This is the base for the approval procedure of Medical Electrical Equipment in most global regulatory frameworks and for compliance with the Medical Device Directive (MDD) 93/42/EEC. In vitro Diagnostic Medical Equipment requirements are documented under IEC 61010* for compliance with the In Vitro Diagnostic Medical Devices (IVD) Directive 98/79/EC.
Transcript of Medical Device Testing - Eurofins Scientific · Testing Services • Safety Testing • Safety...
Medical Device Testing
Contact:Email: [email protected]/EE
Testing Services• Safety Testing
• Safety testing for active medical devices based on the international IEC 60601 standards family; including test reports and certificates according to CB Scheme and ILAC accreditation.
• Safety testing for in vitro diagnostic medical devices to IEC 61010-2-101.
• Product safety compliance in the United States and Canada (FDA and Health Canada) including OSHA NRTL requirements.
• EMC Testing• Medical EMC testing for active medical devices
based on the international IEC 60601 standards family; including test reports and certificates.
• Radio/Wireless Testing• Ultra low power active medical implants (ULP-
AMI).
• Medical device RFID susceptibility testing.
• WLAN, Bluetooth, ZigBee, GSM/GPRS, UMTS, Wireless Power Transfer (WPT), and LTE.
• Mechanical & Climatic Environmental Simulation• Corrosion tests, IP tests, temperature shock,
overpressure, temperature and altitude, faster decompression, shock and vibration.
• Performance Testing • Functionality, energy efficiency, durability and
reliability, performance according to FDA guidance documents, claims validation.
• Other related testing services• Digital Testing Services (software, functionality,
interoperability).
• Cyber security testing.
• Biocompatibility according to the ISO 10993 standards family and microbiological studies (GLP).
• Chemical characterization for materials, extractable and leachable substances evaluation.
* Where IEC standards are referred to, national and regional variations are also applicable including, but not limited to; ANSI/AAMI, UL, ISO, CAN/CSA, JIS, EN, ENV, BS EN, DD ENV and BS IEC. Please enquire on a case by case basis.
Your industry, our focus
The conceptElectrical medical equipment, also known as “active medical devices”, are controlled by stringent regional and international approval procedures which include the required testing to be performed by approved and accredited laboratories.
In the field of active medical devices, these requirements are documented under the IEC 60601* standards family. This is the base for the approval procedure of Medical Electrical Equipment in most global regulatory frameworks and for compliance with the Medical Device Directive (MDD) 93/42/EEC.
In vitro Diagnostic Medical Equipment requirements are documented under IEC 61010* for compliance with the In Vitro Diagnostic Medical Devices (IVD) Directive 98/79/EC.
Notified Body (NB)Our Certification Bodies in Finland (NB No. 0537) Germany (NB No. 0681) and Italy (NB No. 0477)are Notified Bodies under Directive 93/42/EEC, for both Active and Non-Active Medical Devices.
Conformity assessment procedures provided by Directive 93/42/EEC and updates:
• Annex III > EC Type Examination
• Annex IV > Verification
• Annex V > Production Quality Assurance
• Annex VI > Product Quality Assurance
• Annex II > Full Quality Assurance
For in vitro diagnostic medical devices, our certification body in Finland is a NB (No. 0537) under Directive 98/79/EC:
• Annex III > Design Examination
• Annex IV > Full Quality Assurance
Quality Management SystemsOur Certification Bodies in Italy (No. 133A), Finland (No. S021) and Germany (D-ZM-12092-01-00) are accredited Certification Bodies according to ISO 13485 Quality Management System for Medical Devices.
CB SchemeOur Certification Bodies in Germany, Switzerland and the United States are National Certification Bodies (NCB) and the test labs are Certification Body Testing Laboratories (CBTL) under the international certification body scheme (CB Scheme) for Medical Electrical Products.
US and Canada Certification ServicesOur labs in the United States (Eurofins MET):
• First NRTL (Nationally Recognized Testing Laboratory) licensed by the Occupational Safety and Health Administration of US (OSHA) for medical equipment.
• SCC (Standards Council of Canada) Certification Body.
• Eurofins MET-certified medical products Certification mark universally accepted in the US and Canada.
Medical Device Single Audit Program (MDSAP)Our certification body in Finland, acts in cooperation with a MDSAP recognized auditing organization, DQS Medizinprodukte GmbH, and can provide your organization with MDSAP certification.
Ef_M
edical_TestingC
ertificationFlyer-2018-v02
Medical Device CertificationThe conceptIn order to ensure safety and legally place medical devices on the market, manufacturers must comply with a broad range of stringent regulations and standards.
This includes the need to be certified by designated Notified Bodies (NB), recognized Certification Bodies and laboratories according to the classification of the medical device based on its associated potential risks.
