IEC 61010: Medical Laboratory Equipment Testing
Product Testing and Compliance for Medical Laboratory Equipment to IEC 61010
To ensure your equipment remains in compliance with the latest revision of 61010, our regulatory experts are dedicated to helping you identify areas of product non-compliance that will need to be addressed and retested prior to the standard’s enforcement deadline on October 1, 2013. Risk Management is a key component in your product evaluation to 61010-1, Third Edition and involves a three-step risk assessment including Risk Analysis, Risk Evaluation and Risk Reduction. Determine which risk management compliance method is right for your equipment; here are some examples from Clause 17 of 61010-1, Third Edition:
- ANSI B11.TR3
- IEC 61508
- ISO 14121-1
- ISO 14971
- SEMI S10-1296
We also offer alternatives to traditional testing, including Limited Product Certification and Field Labeling to provide a flexible, cost-effective solution for evaluating your laboratory equipment, regardless of quantity.
Intertek does not provide consulting services for management systems certification. Any consulting activities provided by Intertek are separate and independent from certification activities.