Services available for Powered Instruments
Medical Device Sterilisation Validation
We validate your medical device sterilisation instructions, which can be moist heat, low temperature hydrogen peroxide or other process.
37 related Medical device resources related to Medical Device Sterilisation Validation
- 4-5 week typical lead time
- Simulated use/accumulation study
- BS EN ISO 17664-1:2021
- ISO 14937:2009
- BS EN ISO 17665:2024
IEC 60601-1 Testing and Certification
We support you in the testing and certification of your medical devices and systems according to national and international standards and regulations, e.g. by application of IEC 60601 series
15 related Medical device resources related to IEC 60601-1 Testing and Certification
- 4-6 week typical lead time
- ISO 17025 Accredited testing program
- IECEE CB Scheme testing and
- US-NRTL certification according to ANSI/AAMI ES60601- 1 and CAN/CSA-C22.2 No. 60601-1
- INMETRO certification for access to the Brazilian market
IEC 60601-1-2 EMC Testing
We offer EMC test program for active medical devices and/or systems, which defines emission and immunity criteria per IEC 60601-1-2
15 related Medical device resources related to IEC 60601-1-2 EMC Testing
- 2-4 week typical lead time
- ISO 17025 Accredited testing program
- IECEE CB Scheme testing and
- IEC 60601-1-2:2020 (ed. 4.1) – Medical electrical
equipment - Review and verification of EMC test plans, risk analysis, and user manuals
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