Medical Equipment Testing
Medical Equipment Safety Testing
Medical devices are heavily regulated due to the type of environment in which they are used and the potential severity of product failure. They must not compromise the clinical condition or safety of users or patients. Cranage EMC and Safety, based in North Shropshire near Birmingham, have experience evaluating medical equipment intended to be used in the diagnosis, treatment, or monitoring of a patient or for compensation or alleviation of disease, injury, or disability within a medical or home healthcare environment.
Our engineers work closely with customers to fully assess the medical devices for compliance against the applied standards for the country in which they will be sold, whether this is UKCA or CE marking in the UK and Europe or the global equivalent.
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Medical Product Testing Standards
Our EMC and Safety laboratories can support you in achieving compliance with the main medical product testing standards, such as BS EN/IEC 60601-1 and BS EN/IEC 60601-1-2, which are recognised in countries around the world and designed to control device safety.
Cranage EMC and Safety are UKAS accredited for these standards, as well as for the particular requirements BS EN/IEC 60601-1-11, BS EN/IEC 60601-2-10 and BS EN/IEC 61010-2-101; this means we have been independently assessed as technically competent to evaluate against the standards and make a statement on compliance against the standards. Cranage specialises in the assessment of Class I, IIa and IIb medical electrical equipment with type B, BF and CF applied parts.
Pre-Compliance
Cranage EMC and Safety also offer a pre-compliance service to identify potential issues at the design stage, which can help to save time and money during full medical device testing as any necessary changes can be made early in the process. The rules surrounding medical device product testing are particularly stringent due to patients often being connected to electrical devices or parts being under the skin if the device is invasive. Products must be put through rigorous testing; therefore, being prepared early will assist in getting your product compliant sooner.
Including a well-written test plan for your medical device testing is important. This plan should include details on basic safety, the intended use and environment of the device, and operating modes.
Primary Standards
The primary standard that applies to medical devices is BS EN / IEC 60601, which is a group of standards covering the electrical safety, essential performance and electromagnetic compatibility of medical electrical equipment. This group of standards include:
- BS EN / IEC 60601-1 – the base standard covering the general requirements.
- BS EN / IEC 60601-1-xx – these are the collateral standards.
- BS EN / IEC 60601-2-xx – the particular standards.
Common Testing
The team at Cranage have years of experience in carrying out medical device EMC and Safety testing to BS EN / IEC 60601, as well as the common ones required below:
- BS EN / IEC 60601-1 – General requirements for basic safety and essential performance.
- BS EN / IEC 60601-1-2 – EMC requirements and tests.
- BS EN / IEC 60601-2-2 – Basic safety and essential performance of high-frequency surgical equipment and high-frequency surgical accessories.
- BS EN / IEC 60601-2-10 – Safety requirements for nerve and muscle stimulators.
- BS EN / IEC 61010-1 – General requirements for safety.
- BS EN / IEC 61010-2-101 – Safety requirements for in vitro diagnostic medical equipment.
- BS EN / IEC 61326-2-6 – Electrical equipment for measurement, control and lab – EMC requirements. Particular requirements for IVD medical equipment.
