Services available for Disinfectant Wipes
We develop and implement a methodologically sound procedure to collect, appraise, and analyse clinical data pertaining to your medical device.
- 8-10 week typical lead time
- Comply with Article 61 and Part A of Annex XIV of MDR
- Pre- and Post-market clinical data
- Following MEDDEV 2.7.1 Rev 4
- CE & UKCA
Medical Device Material Compatibility Testing
We analyse test item materials at both sample and product level to assess process compatibility.
- Starts from 2-3 week typical lead time
- Spray tests, based on EN ISO 21530
- Soak tests, based on EN ISO 21530
- Contact tests, based on EN ISO 21530
- Wipe tests, based on BIFMA HCF 8.1-2017
Medical Device Cleaning Validation
We validate your medical device cleaning instructions, as detailed in your IFU, which can be manual or automated.
- 4-5 week typical lead time
- Simulated use/accumulation study
- AAMI ST98/ISO 15883-5
- Validated via residual analyte detection (Protein & ATP)
- High/Low level disinfection validation to AAMI TIR-12
Disinfection Wipes for Medical Devices
We will determine the efficacy of your medical device disinfectant wipe, as well as perform Material Compatibility tests.
- 2-3 week typical lead time
- UKAS accredited
- Bactericidal, fungicidal, yeasticidal
- Sporicidal, mycobactericidal