• Gossen Metrawatt

Functional tests in accordance with IEC 62353 & IEC 60601 – safety guaranteed

Safety for patients and users – testing in accordance with applicable standards Safety for patients and users – testing in accordance with applicable standards

Safety for Patients and Users

Functional Testing in Accordance with IEC 62353 & IEC 60601 – Guaranteed Safety

Medical devices are essential to modern patient care. This places a particular responsibility on users in hospitals, medical practices and care facilities. Compliance with strict safety standards, legal requirements and applicable standards is an obligation.

Regular safety inspections (STK) and metrological inspections (MTK) under the German Medical Devices Operator Ordinance (MPBetreibV), along with testing in accordance with IEC 62353 and IEC 60601, are required to ensure the safety of patients and medical staff.

Documentation that complies with applicable standards is an essential part of the required risk management process. Regular testing of electrical safety and functionality is essential to ensure that medical devices remain ready for use.

Challenges in medical technology Challenges in medical technology

Challenges

  • Ensuring patient safety: Malfunctions in medical devices can pose serious health risks. Regular testing identifies potential defects at an early stage.
  • Meeting legal requirements: Healthcare facilities must ensure that all tests are carried out in accordance with applicable standards and at the prescribed intervals.
  • Documentation and traceability: Complete documentation of test results in accordance with applicable standards to meet internal quality standards and regulatory requirements (MDR – EU 2017/745).
  • Minimising downtime: Efficient testing processes are essential to avoid disrupting day-to-day clinical operations.
  • Implementing DGUV V3 testing: Regular testing of electrical installations and equipment in accordance with applicable standards to prevent accidents caused by electric current.
Precision test instruments from GMC Instruments Precision test instruments from GMC Instruments

Solutions from GMC instruments

With modern test instruments from Gossen Metrawatt and Rigel, you can carry out testing in accordance with IEC 62353 and IEC 60601 precisely, safely and efficiently. Measurement data can be transferred directly into test reports, ensuring comprehensive documentation.

Reliable Functional Testing Across Key Test Areas

  • Electrical safety: SECULIFE ST series, RIGEL SAFETEST 60+, RIGEL 62353, RIGEL 288+
  • Defibrillators: RIGEL UniPuls 400, SECULIFE DF series
  • Electrosurgery: SECULIFE ES series, RIGEL UniTherm
  • Infusion: SECULIFE IF series, RIGEL MultiFlo
  • Ultrasound leakage current: SECULIFE UL
  • Ventilation: RIGEL VenTest
  • Ultrasound power: SECULIFE UP

The portfolio is complemented by powerful solutions such as the SECULIFE ST PRO, featuring an antimicrobial surface, integrated UDI management and flexible data entry options, as well as PatSim patient simulators for precise and realistic testing on the go.

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