Testing & verification
Launching medical, laboratory, and other types of equipment to market is a complex process, underpinned by rigorous testing and verification. Leveraging our in-house test laboratory, we streamline this process by conducting both design verification and pre-compliance testing under one roof. This not only enhances efficiency and speed but also ensures superior quality control.
Our services go beyond classic development services. We have our own test laboratory to perform potentially costly tests and require long lead times in external (accredited) test laboratories. Our alignment here is with IEC TR 62354, the general test procedures for medical electrical equipment. In our test laboratory, we perform critical tests in advance, thus ensuring a successful pass in accredited or CB test laboratories. Our wide range of services includes
- Testing of environmental conditions and humidity pre-treatment according to IEC 60601-1
- Radiated emission, wired immunity, and electrostatic discharge (ESD) according to IEC 60601-1-2
- Aging by repeated treatment according to IEC 60601-1 chapter 11.6.6
- Mechanical stability according to IEC 60601-1 chapter 9
We can test a wide range of standards either partially or fully. This includes laboratory equipment according to IEC 61010-1 and IEC 61326-1 as well as medical equipment according to IEC 60601-1 and its various subsections. Additionally, we can test equipment to ISO 80601-2-xx standards.
Standards tests covered
We can test excerpts or the entirety of the following standards in our internal test laboratory (list not conclusive):
- IEC 61010-1, Safety requirements for electrical equipment for measurement, control and laboratory use - General requirements
- IEC 61326-1, Electrical equipment for measurement, control and laboratory use - EMC requirements - General requirements
- IEC 60601-1, General requirements for basic safety and essential performance
General requirements for basic safety and essential performance:
- IEC 60601-1-2, Collateral Standard: Electromagnetic disturbances - Requirements and tests
- IEC 60601-1-6, Collateral standard: Usability
- IEC 60601-1-8, Collateral Standard: General requirements, tests and guidance for alarm systems in medical electrical equipment and medical electrical systems
- IEC 60601-1-9, Collateral Standard: Requirements for environmentally conscious design
- IEC 60601-1-10, Collateral Standard: Requirements for the development of physiologic closed-loop controllers
- IEC 60601-1-11, Collateral Standard: Requirements for medical electrical equipment and medical electrical systems used in the home healthcare environment
- IEC 60601-1-12, Collateral Standard: Requirements for medical electrical equipment and medical electrical systems intended for use in the emergency medical services environment
Particular requirements for basic safety and essential performance:
- ISO 80601-2-12, of critical care ventilators
- ISO 80601-2-13, of an anaesthetic workstation
- ISO 80601-2-55, of respiratory gas monitors
- ISO 80601-2-61, of pulse oximeter equipment
- ISO 80601-2-79, of ventilatory support equipment for ventilatory impairment
- ISO 80601-2-80, of ventilatory support equipment for ventilatory insufficiency
- ISO 80601-2-84, of ventilators for the emergency medical services environment
- ISO 80601-2-90, of respiratory high-flow therapy equipment
Test equipment
Splash water protection
IP (Ingress Protection)
Test station for IPX1 and IPX2
Dynamic climatic chamber
- 115 liters volume
- -40 to +180°C
- 10 to 98% relative humidity
Dynamic climatic chamber
- 720 liters volume
- -40 to +180°C
- 10 to 98% relative humidity
Negative pressure chamber
Ambient pressure simulation
up to 5000 meters above sea level
Preparation / Aging
Aging by repeated
reprocessing in steam sterilizer
ESD (Electrostatic Discharge)
up to 25kV
Radiated Emission
Radiated emission in LaplaCell
Resistance
Surge & Burst Generator - Resistance of equipment to surges, spikes, bursts and electromagnetic interference.
Tensile and compression test
max. 5 kN
Height gauge
up to 610 mm
Resolution 0.01 mm
In addition to the above-mentioned testing equipment, we have other tabletop devices at our disposal.
Application examples
Pre-compliance tests
Repetitions in accredited test laboratories can be avoided if product adaptations are implemented at an early stage with the help of the results from pre-compliance tests. This saves both costs and project lead times.
Environmental simulation
Environmental simulation capabilities help ensure that your device will perform as expected, even in extreme environmental conditions.
New product design
The new product design must be verified before market approval. This includes not only the technical requirements but also compliance with standards to prove the "state of the art". In particular, environmental simulations and mechanical tests are essential components of this verification activity, in addition to electromagnetic compatibility.
Own placing on the market
With our sister company IMT Analytics, we have direct experience in bringing products to market. This valuable experience provides a key advantage for our customers: Our extensive knowledge of regulatory requirements and quality standards enables a more efficient, faster, and safer launch of their products.
Component replacement
Comparative measurements can be used to better assess the risk associated with replacing discontinued components and second sources.
Analysis of device operation
Ensuring the compatibility of electronic devices with each other is not possible without an EMC laboratory. Interference from other devices can be simulated as well as the radiation of the device under test. This ensures that the presence of a cell phone, for example, does not interfere with the ventilator and is therefore an essential test to ensure patient and user safety.
Optimization of existing designs
Environmental simulation can be used to reproduce disturbances in device operation. Optimizations that continuously improve the device design are often made based on feedback from the market or from customers when environmental simulation leads to reproducible results and these help to better understand the device behavior.
Contact
Struggling with time-consuming and disjointed verification processes for your medical or laboratory equipment? Collaborate with us to reduce time to market while enhancing your product design reliability.
Thomas Schwendinger
Head of Regulatory Affairs
& Quality Management