What is BS EN IEC 61326-2-6 about?
BS EN IEC 61326-2-6 is part 2-6 of the IEC 61326 standard. It details EMC requirements for In Vitro Diagnostic (IVD) medical equipment that assists in reducing the risk of electromagnetic interference and EMC failures.
BS EN IEC 61326-2-6 specifies minimum requirements for immunity and emissions regarding electromagnetic compatibility for IN VITRO DIAGNOSTIC (IVD) MEDICAL EQUIPMENT, taking into account the particularities and specific aspects of electrical equipment and their electromagnetic environment.
BS EN IEC 61326-2-6 provides information about EMC test plan, immunity requirements, emission requirements and home healthcare environment for checking EMC compatibility for IVD medical equipment.
Who is BS EN IEC 61326-2-6 for?
BS EN IEC 61326-2-6 on EMC requirement for In Vitro Diagnostic medical equipment applies to:
- In Vitro diagnostic medical equipment manufacturers
- In Vitro diagnostic medical device developers, suppliers, importers and manufacturers
- Institutions and commercial organizations performing biomedical research
- Electrical design engineer
- EMC Testing houses for electrical measuring devices
Why should you use IEC 61326-2-6?
If a reagent, calibrator, kit, specimen receptacle, software, instrument, apparatus, equipment, or system is used alone or in combination with other diagnostic items for in vitro use, it is a vitro diagnostic medical device (IVD). EMC testing is mandatory for electrical measuring equipment to meet all the regulatory EMC requirements for efficient and reliable performance.
BS EN IEC 61326-2-6 provides you with detailed information on the EMC test plan, immunity requirements, emission requirements and home healthcare environment for IVD medical equipment that helps you to create trustworthy, highly efficient and defect-free medical devices.
EMC testing for electrical measuring equipment is a compulsion in most countries, BS EN IEC 61326-2-6 is a standard that users can easily follow as it covers all the particular requirements and test plans for EMC testing which assist you to adhere to those compliance norms.
What’s changed since the last update?
BS EN IEC 61326-2-6:2021 supersedes BS EN IEC 61326-2-6:2013, which is now withdrawn.
BS EN IEC 61326-2-6:2021 has been updated with respect to IEC 61326-1:2020.