Before a medical device can be sold on the market, whether it is in the UK, Europe or worldwide it is likely to need to meet the relevant required standards of safety, quality requirements and efficacy. The Medical Device Directive 93/42/EEC or FDA regulations are probably the best known regulatory requirements for medical devices however other parts of the world follow similar systems. Medical Devices are assessed for compliance depending on their type and classification (or risk). Within the EU there are three types of Medical Devices and four classifications ranging from low to high risk (Class I-III).
EMC Testing for Medical Devices
Our state of the art EMC test facilities are UKAS accredited and compliant to the medical EMC standard EN60601-1-2, which is required in order to comply with the EMC aspects of the medical device directive (MDD). Our commercial EMC test reports are accepted universally by Notified Bodies in the EU as well as by other bodies throughout the world.
EN60601-1-2 specifies various emissions and immunity tests to be carried out on the product either through radiated means or by conduction along the signal or power supply cables. In particular, patient coupled cables must be tested in specific ways to simulate connections to the human body as well as special requirements for life supporting equipment.
The test requirements of these standards include mains harmonic emissions, flicker, conducted RF emissions, radiated emissions, radiated immunity, conducted RF and transient type immunity tests on power and signal cables as well as ESD (Electrostatic Discharge).
The standard specifies higher level immunity requirements for life supporting equipment and lower immunity requirements for non-life supporting equipment. There is also a table in the standard for lower immunity levels and higher emissions limits for equipment used within a shielded location, if these levels are used it is essential that the actual RF shielding effectiveness and filter attenuation of the shielded location be verified to ensure that they meet or exceed the specified minimum values required.
As the standard refers back to CISPR 11 for emissions there are different emissions limits for different intended usage environments such as in a hospital or within the home where different limits apply and also for different types of ISM equipment where some intentional transmissions from the equipment may be required as part of its intended function.
Safety Testing for Medical Devices
IEC/EN 60601-1 is recognised by public health authorities in most countries and is the harmonised standard for medical equipment under the Medical Devices Directive 93/42/EEC. Before your product goes to market it will need to show compliance to the electrical safety standard and potentially the supplementary standard for specialised equipment. This process will ensure that your medical device does not possess any safety hazards to the user or patient that comes into contact with the product. Use of collateral standards is required by IEC/EN 60601-1. Typical collaterals being used are 60601-1-2 (covering EMC), 60601-2-6 for usability of medical devices and 60601-2-8 for alarms within medical devices.
The introduction of the new 60601-1 3rd Edition now requires manufacturers of medical electrical products to generate, hold and administer risk management through the whole product life cycle. Risk management in accordance with ISO 14971. The International standard for Application of Risk Management to Medical Devices is a mandatory requirement when demonstrating compliance to the 3rd Edition of 60601-1. Without this documentation, compliance to EN/IEC 60601-1 3rd Edition is not possible.
TRaC will continue to test to the 2nd Edition of EN/IEC 60601-1 as long as particular countries continue to recognise it.
TRaC can deliver medical testing for Safety and EMC from any of our UKAS accredited test laboratory or via testing on manufacturers premises. Through our ESQ services, TRaC can provide support and guidance on ISO 14971 risk management and its implementation into EN/IEC 60601-1 3rd Edition to ensure your timetable for compliance is met.
Environmental Testing and Analysis for Medical Devices
Medical devices and equipment generally operate within a benign environment, however, in today’s global market, the ability of a product to withstand various extremes of transportation and storage conditions are critical to its success. TRaC can offer a wide range of vibration and shock testing for medical products to simulate transport by rail, road, sea and air. TRaC also offer a wide variety of climatic conditions, from high and low temperatures, altitude and humidity, to ingress protection and salt corrosion to represent the wide range of storage environments your product may encounter before going into service. In addition to providing controlled test environments, TRaC can also simulate the mechanical environment using Finite Element Analysis (FEA) and Computational Fluid Dynamics (CFD) computer modelling techniques.
BS EN 60068 is a commonly used standard for testing medical products and typical tests called up in this standard include transportation vibration and climatic storage and operational conditions.
Radio/ R&TTE Testing
Medical devices are increasingly relying on radio technology to communicate and Health Alliance has defined ZigBee and Bluetooth as the technologies of choice for these devices. TRaC are the only company in the world to offer certification, qualification and regulatory for both Bluetooth and ZigBee devices.
Product Standard DECTEN 301 406, 47CFR Part 15 Subpart D, RSS-213 Bluetooth and ZigBee EN 300 328, FCC 15.2 47SRD EN 300 220, EN 300 330 and EN 300 330.
Medical devices that collect information such as Blood Pressure, or insulin levels and pass the information back to a central database may do so via an information portal. These portals tend to utilize xDSL technology and TRaC is the premier laboratory to provide this testing, with two dedicated DSL labs to provide a complete DSL test service.
Country Standard Europe TS 101 388, TS 101 135
France Telecom, ST/FTR&D/7670
Deutsche Telekom, 1 TR 112 UK British Telecom SIN346, ND1602UST1.413, TIA-968-AInternational G.992.1, G.992.2, G992.3, G.992.5
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