Test Labs Ltd services

Medical Device Testing Services

Accelerated and Real-Time Aging Testing Services for Medical Devices

Test Labs Ltd provides comprehensive accelerated and real-time aging testing services to evaluate the stability of products under various storage and use conditions. Accelerated aging testing simulates long-term aging processes by exposing products to elevated stress conditions, such as increased temperature and humidity, over a shorter period. This method allows for fast evaluation of shelf-life and performance, supporting data required for regulatory submissions such as 510(k) approvals. In contrast, real-time aging testing assesses product stability over time under controlled conditions closely mirroring normal usage environments, ranging from 20°C to 25°C. This dual approach ensures robust validation of long-term product efficacy and safety. Test Labs also specializes in medical device testing services, including biocompatibility, bioburden testing, and sterilization validation, following standards such as ASTM F1980 and ISO 11607-1:2019. Their facilities are equipped with cutting-edge microbiology and chemistry laboratories, alongside state-of-the-art test chambers, to support product development and regulatory compliance.

Medical Device Cleaning Validation Service

Test Labs Ltd provides a Medical Device Cleaning Validation service that ensures medical device cleaning protocols, as specified in the Instructions for Use (IFU), are accurately validated. This service is applicable to both manual and automated cleaning methods and complies with international standards such as ISO 17664, ISO 15883, ANSI/AAMI ST98, and ASTM F3208. It involves the use of appropriate test soils and residual analytes, like proteins and carbohydrates, to detect potential contaminants. The company offers industry-leading turnaround times, generally within a 2-4 week period, ensuring the timely validation of medical device cleaning processes. The validation process is crucial for the safety and efficacy of reprocessed medical devices and aims to deliver reliable data, facilitating compliance with healthcare regulations and standards. Test Labs Ltd is equipped with specialized laboratories for microbiological and chemical testing to support the process.