IEC 60601 and International Type Approval

EMC Testing of Medical Devices: Turning Change into Opportunity

Medical Directive testing standard IEC 60601-1-2 became mandatory as of December 31, 2018, requiring companies to revisit their test strategies to be fully compliant. With over 20 years of Medical Directive experience, DEKRA Product Testing and Certification can help you support legacy test requirements or develop custom test plans based on specialized risk assessments. We can also help you navigate the Edition 4 grandfather clauses, which vary by country.

  • USA: The FDA requires Edition 4 for declarations of conformity, in support of premarket submissions, but some grandfathering is allowed.
  • European Union: The EU does not allow grandfathering of existing test results. Lack of compliance limits market access.

Key points of interest related to the new standard include:

  • You must submit a formal test plan to the test lab. Every verification/validation report must have a matching plan in accordance with ISO 13485:2016.
  • The Basic Safety and Essential Performance must be tested in the modes that are most likely to result in an unacceptable risk, requiring hazard analysis.
  • Test levels for the immunity requirements have been increased.

DEKRA uses a collaborative model to ensure even the most complex test plans are managed efficiently and with full transparency.

IEC 60601-1-2 Testing

In addition, DEKRA offers:

  • Specialists in both Testing and Certification and Medical Regulatory Services, ensuring a thorough understanding of risk-based design and testing, providing FCC/ISED, CE certification, International Type Approval for 180 countries, ISO 13485 and MDSAP certification.
  • Expertise in devising validation testing of RF wireless communications equipment, including WIFI, NFC, RFID, SRD, Bluetooth and Continua Health Alliance, ensuring medical grade health/sensor data flows from vital signs devices in a safe and secure manner.
  • Pre-certification testing and analysis, guiding you through product certifications that comply with quality and safety regulations required by international standards, specific industries, customized needs and different end users.
  • A US-based testing lab in Sterling, VA, just minutes from Dulles International Airport, as well as other facilities in Taiwan, Japan and Spain.

I have an IEC 60601 project to discuss

Richard Gencev

Richard Gencev

International Type Approval Sales Manager

separator
+1 669 210 3293
separator

DEKRA Product Testing

405 Glenn Drive

Suite 12

Sterling , VA 20164

International Type Approval: Your path to reach the global marketplace

You want to enter the market quickly, but the approval regulations vary significantly from country to country, making certification time consuming and difficult. DEKRA’s International Type Approval team has experience that helps both wireless and wired manufacturers streamline approval queries at every step in the value chain, including:

  • Assessment for market entry, ensuring products go through customs quickly and arrive to market on time.
  • Renewal alert service, providing notification of upcoming certificate expiration and managing the certificate renewal process.
  • Search for local representatives, acting as the local representative for local companies to issue the approval certificate.

DEKRA also offers a free monthly newsletter featuring the latest news on regulations, standards, approval procedures, radio interfaces, licensing conditions, marketing requirements and other topics impacting a wide range of wireless and broadband technologies.

I have an International Type Approval Project

Richard Gencev

Richard Gencev

International Type Approval Sales Manager

separator
+1 669 210 3293
separator

DEKRA Product Testing

405 Glenn Drive

Suite 12

Sterling , VA 20164

Share page