Medical & Therapeutic Devices

 

 

 

Some of the items tested include patient trolleys, hospital beds, wheelchairs and hoists, autoclaves, syringe pumps, ECG monitors, TENS devices, and a range of instruments for cardio-respiratory diagnostics and blood analysis. The global market for medical electrical equipment is rapidly growing and international harmonization of technical standards is important to improve access to new technologies.

In Europe the technical standards are set by the European Committee for Electrotechnical Standardization (CENELEC) and apply to the following EU Directives:-

Our accredited laboratory specialises in the assessment of Class 1, 2a and 2b medical electrical equipment with type B, BF and CF applied parts. Our engineers are trained and qualified to apply IEC60601-1 (2nd and 3rd Editions), IEC60601-1-2 (4th Edition) and have experience of evaluating electrical equipment intended to be used in the diagnosis, treatment or monitoring of a patient, or for compensation or alleviation of disease, injury or disability.

1) Medical Device Directive 93/42/EEC amended by 2001/104/EC

2) In vitro diagnostic Medical Devices Directive 98/79/EC

3) Restriction of Hazardous Substances (RoHS2) Directive 2011/65/EU

 

The term 'medical devices' covers a vast range of products, from highly sophisticated computerised medical equipment to simple wooden tongue depressors.

Core Competency

 

 

 

Services

 

 

 

• European Union (CE Marking)

• Canada (Device Licence)

• United States of America (PMA Approval or 510k Marketing Clearance)

• Australia (ARTG Number)

• Japan (Shounin or Todokede)

MDD IVD
IEC BS EN 60601-1
General requirements
for basic safety and essential performance
IEC BS EN 61010-1 General
requirements for safety
IEC BS EN 60601-2-10
Safety requirements
for nerve and muscle stimulators
IEC BS EN 61010-2-101
Safety requirements for in vitro diagnostic medical equipment
IEC BS EN 60601-1-2
EMC requirements and tests
IEC BS EN 61326-2-6
EMC requirements and tests

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Test My Product

 

 

 

CRANAGE can help with all your testing needs. For further details please contact the testing team on

+44 (0) 1630 658568 or email info@cranage.co.uk