JavaScript is disabled. Please enable to continue!
Industrial >> Industries >> Medical Devices

Managing the Compliance of Medical Device Equipment and Products

Your industry, our focus

Index:

 

Medical Device

What is a Medical Device?

Medical Device means any instrument, apparatus, appliance, software, material or other article, whether used alone or in combination, including the software intended by its manufacturer to be used specifically for diagnostic and/or therapeutic purposes and necessary for its proper application, intended by the manufacturer to be used for human beings for the purpose of:

  • diagnosis, prevention, monitoring, treatment or alleviation of disease
  • diagnosis, monitoring, treatment, alleviation of or compensation for an injury or handicap
  • investigation, replacement or modification of the anatomy or of a physiological process
  • control of conception

The Medical Device does not achieve its principal intended action in or on the human body by pharmacological, immunological or metabolic means

(Definition as per European Directive 2007/47/EC)

Classification

Medical devices vary according to their intended use and indications. Examples range from simple tongue depressors, medical thermometers and disposable gloves to complex advanced devices such as programmable pacemakers with micro-chip technology, implants and prostheses

In addition, medical devices include in vitro diagnostic products, such as general purpose lab equipment, reagents, test kits, etc..

Certain electronic radiation emitting products with medical application and claims meet the definition of medical device. Examples include diagnostic ultrasound products, x-ray machines and medical lasers

Medical devices classification based on risk (acc. EU Directive):

•Class I

>

Low risk

•Class Im

(measuring device)

>

Low risk

•Class Is

(sterile device)

>

Low risk

•Class IIa

>

Medium risk

•Class IIb

>

Medium/High risk

•Class III

>

High risk

Medical Electrical Equipment

An active medical device means any medical device relying for its functioning on a source of electrical energy or any source of power other than that directly generated by the human body or gravity and which acts by converting this energy.

Worldwide medical devices are controlled by strictly adjusted regional approval procedures which include required testing by approved test laboratories.

In the field of electrical active medical devices these requirements are documented and internationally harmonized under the standard family IEC 60601-xx which is the base for the approval procedure of Medical Electrical Equipment in most regulatory frameworks all over the world.

Our Service Scope

Testing

Safety Testing

Our laboratories provide international safety testing requested for active medical devices according to IEC 60601-xx standards family including test reports and certificates according to CB Scheme and ILAC accreditation.

The competence of our labs is continuously supervised by regular inspections of IEC Assessors and other competent Authorities

Standards in our scope (non-exhaustive list): 

  • IEC 60601-1 – Basic standard
  • IEC 60601-1-4 and IEC 62304- PEMS
  • IEC 60601-1-6 and IEC 62366 – Usability
  • IEC 60601-1-8 – Alarm Systems
  • IEC 60601-1-11 – Home Health Care Environment
  • IEC 60601-2-10- Nerve and Muscle Stimulators
  • IEC 60601-2-27 ECG
  • IEC 60601-2-31- External Pacemaker
  • IEC 60601-2-40 EMG
  • IEC 60601-2-49 –Patient Monitoring
  • IEC 60601-2-66 – Hearing Aids
  • IEC 61010 series
  • IEC/ISO 80601-2-xx

Our labs also provide product safety compliance in the United States and Canada (FDA and Health Canada) including OSHA NRTL requirements cMETus

  • NRTL (Nationally Recognized Testing Laboratory) recognized by the Occupational Safety and Health Administration of US (OSHA) for medical equipment.
  • UL 60601-1
  • AAMI ES60601-1
  • CSA C22.2 No. 601.1
  • RESNA WC-1:2009
  • ISO 7176-9
  • FDA Guidance Documents and consensus standards necessary for FDA clearance (including IEC 60601, AAMI and ASTM standards)
  • Electrical wheelchairs to ANSI/RESNA/FDA
  • ...

EMC Testing

  • Radiated emissions
  • Conducted emissions
  • Harmonic current emissions
  • Flicker
  • Radiated immunity
  • Conducted immunity
  • Burst
  • Surge
  • Electrostatic discharge (ESD)
  • Voltage dips and interruptions (VDI)
  • Magnetic fields

In our scope (non-exhaustive list):

  • Medical EMC testing performed by our labs is typically to IEC 60601-1-2 for most devices.
  • Additions and/or deviations to the requirements of IEC 60601-1-2, as published in the appropriate IEC 60601-2-xx and IEC/ISO 80601-2-xx for particular devices and IEC 60601-1-xx for collateral standards
  • IEC 61326 series
  • ANSI ISO 14708-3- Implantable neurostimulators
  • Magnetic fields FDA requirements

Radio/Wireless Testing

As technology advances, it has abandoned wired communication interfaces in favour of wireless devices.

Regulatory changes and demanding testing procedures put wireless product manufacturers under pressure to adhere to updated market requirements. We help you navigate the complex process of complying with radio performance testing requirements to ensure your wireless & RF products are compliant, compatible, and reliable.

Different Technologies in our scope (non-exhaustive):

  • Ultra Low Power Active Medical Implants (ULP-AMI)
  • WLAN
  • Bluetooth Classic and Bluetooth Low Energy
  • Weithless, SigFox, LoRa
  • ZigBee
  • GSM/GPRS (2G)
  • UMTS/WCDMA (3G)
  • LTE (4G)
  • NB-IoT, LTE-M
  • Wireless Power Transfer (WPT)
  • LTE

RFID Testing

United States:

  • FCC Rule Part 15 or 90
  • UL 60950 for Tag Interrogators and NRTL Certification

Canada:

  • RSS-210
  • CSA 60950 and SCC Certification Body

Europe:

  • ETSI EN 301 489-1 and ETSI EN 301 489-3
  • ETSI 300-220
  • EN 60950

ISO RFID Testing: ISOO 18006-C

EPC Global RFID Testing:

  • Hardware Certification Program
  • Performance Test Center Accreditation Program
  • Software Certification Program
  • Approved RFID Testing Center (ARTC) Program
  • EPCIS Validation Portal (EPCIS VP)

RFID Blocking testing

Medical Device RFID Susceptibility Testing

Mechanical & Climatic Environmental Simulation

  • Corrosion tests, salt spray
  • Harmful gas SO2
  • Corrosive gas testing (NO2, SO2, Cl2, H2S)
  • UV aging
  • Dust and water IP tests
  • Temperature shock (Rate of temperature change < 20 sec, from-70 °C to 180 °C)
  • Temperature and altitude
  • Overpressure
  • Vacuum (faster decompression)
  • Combination trials with air-humidity
  • Shock and vibration

Performance Testing

  • Functionality
  • Energy Efficiency
  • Durability and reliability
  • Performance tests to many FDA Guidance Documents, AAMI and ANSI standards
  • Special tests to establish and/or validate claims on new medical devices
  • Unique testing facilities for special medical devices: electro-surgical devices, ultrasound equipment, electric wheelchairs,…
  • Litigation support testing, expert witness

Certification Services

CB Scheme

Our Certification Bodies in Germany, Switzerland and 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:

  • Eurofins Product Service GmbH (Germany)
  • Eurofins Electrosuisse Product Testing AG (Switzerland)
  • Eurofins MET (United States)

Quality Management Systems

Our Certification Bodies in Italy (No. 133A) and Germany (D-ZM-12092-01-00) are accredited Certification Bodies according to ISO 13485 (Quality Management System for Medical Devices):

  • Eurofins Product Testing Italy S.r.l. (Italy)
  • Eurofins Product Service GmbH (Germany)

Notified Body (NB)

In order to legally sell products in the EU market, medical device manufacturers must earn a CE mark to confirm compliance with the Medical Device Directive 93/42/EEC and supplementary Directive 2007/47/EC (MDD) to be classified according to potential risks associated ( Class I, II and III products).

Our Certification Bodies in Germany and Italy are notified as NB under Directive 93/42/EEC, both for Active and Non-Active Medical Devices:

  • Eurofins Product Testing Italy S.r.l. (Italy)
    Notified Body No.0477
  • Eurofins Product Service GmbH (Germany)
    Notified Body No.0681

The Notified Body provides Conformity assessment services to manufacturers in order to verify products compliance to applicable EU Directives and Standards

Conformity assessment procedures provided by Directive 93/42/EEC (and updates) are the following:

  • Annex III > EC Type Examination
  • Annex IV > EC Verification
  • Annex V > Production Quality Assurance
  • Annex VI > Product Quality Assurance
  • Annex II > Full Quality Assurance

EC Type Examination certificates (Annex III): EC certificate showing conformity of the Medical Device examined (type) with the essential requirements established in the directive

EC Verification certificates (Annex IV): the EC certificate that guarantees and declares that the production batch(statistical verification) or each product (individual verification) conforms to the type certified and to the applicable requirements of the directive

EC Declaration of Conformity - guarantee of quality of the manufacturing process or of the product (Annexes V-VI), limited solely to performance factors designed to secure and maintain sterility, the certificate that guarantees and declares that the quality system, with regard to sterility, is applied and complies with the requirements of the directive.

Eurofins Certification Body covers the following products (except Class III products):

  • General non-active, non-implantable medical devices
  • Non-active implants
  • Devices for wound care
  • Non-active dental devices and accessories
  • General active medical devices
  • Devices for imaging
  • Monitoring devices
  • Devices for radiation therapy and thermo therapy

Contact with our experts for detail of products and related conformity assessment procedures

Besides Medical Devices, other related Directives for which our labs are also Notified Body (NB):

  • Radio Equipment Directive 2014/53/EU
    • Eurofins Product Service GmbH (Germany)
    • Eurofins Product Testing Italy S.r.l. (Italy)
    • Eurofins MET (United States- MRA)
  • Electromagnetic Compatibility Directive 2014/30/EU
    • Eurofins Product Testing S.r.l. (Italy)
    • Eurofins York EMC Services (UK)
    • Eurofins Hursley EMC Services (UK)
  • Equipment and protective systems intended for use in potentially explosive atmospheres (ATEX Directive 2014/34/EU)
    • Eurofins Product Testing Italy S.r.l. (Italy)
    • Eurofins Electrosuisse Product Testing AG (Switzerland)
  • Machinery Directive 2006/42/EC
    • Eurofins Product Service GmbH (Germany)
    • Eurofins Product Testing Italy S.r.l. (Italy)
    • Eurofins Electrosuisse Product Testing AG (Switzerland)

US and Canada

Our labs in United States (Eurofins MET):

  • MET is the first NRTL (Nationally Recognized Testing Laboratory) recognized by OSHA (Occupational Safety and Health Administration of US) for medical equipment
  • SCC (Standards Council of Canada) Certification Body

Eurofins MET-certified medical products:

  • Universally accepted by medical equipment buyers in the US and Canada
  • Testing and certification according to:
    • UL 60601-1
    • AAMI ES60601-1
    • CSA C22.2 No. 601.1
    • RESNA WC-1:2009
    • ISO 7176-9

Contact Eurofins MET labs to find out more about their medical device testing & certification.

Other Related Services

  • Biocompatibility according to ISO 10933 standard family and microbiological studies (GLP)
  • Chemical Restricted substances testing
  • Chemical characterization
  • Physicochemical tests
  • Identification and quantification of degradation products
  • Extractable and leachable substances evaluation
  • Digital Testing Services:
    • Compliance to certain industry standards (eg. USB)
    • Software Testing: Functional, performance, stress
    • Test Automation: Automation of Regression Testing/repeatable tests to measure performance and stability
    • Interoperability
    • Cyber security
Contact Us
More Info
E&E Laboratories
Receive Our Medical Devices News!