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.
*The Intertek legal entities that provide medical device management system certification services (including ISO 13485 and MDSAP) and Notified Body services (MDR 2017/745 and MDD 93/42/EEC) do not provide any consulting services. Clients who have used other Intertek legal entities’ consulting services are not eligible to receive management system certification services or Notified Body services from Intertek.