Essential Requirements
What are the general technical requirements to bring my medical device product to the European market?
DIRECTIVE 98/79/EC
(18 June 2009)
ANNEX I
ESSENTIAL REQUIREMENTS
B. DESIGN AND MANUFACTURING REQUIREMENTS
6.4. Protection against mechanical and thermal risks
6.4.1. Devices must be designed and manufactured in such a way as to protect the user against mechanical risks. Devices must be sufficiently stable under the foreseen operating conditions. They must be suitable to withstand stresses inherent in the foreseen working environment, and to retain this resistance during the expected life of the devices, subject to any inspection and maintenance requirements as indicated by the manufacturer.
Where there are risks due to the presence of moving parts, risks due to break-up or detachment, or leakage of substances, then appropriate protection means must be incorporated.
Any guards or other means included with the device to provide protection, in particular against moving parts, must be secure and must not interfere with access for the normal operation of the device, or restrict routine maintenance of the device as intended by the manufacturer.
6.4.2. Devices must be designed and manufactured in such a way as to reduce to the lowest possible level the risks arising from vibration generated by the devices, taking account of technical progress and of the means available for limiting vibrations, particularly at source, unless the vibrations are part of the specified performance.
6.4.3. Devices must be designed and manufactured in such a way as to reduce as far as possible the risks arising from the noise emitted, taking account of technical progress and of the means available to reduce noise, particularly at source, unless the noise emitted is part of the specified performance.
6.4.4. Terminals and connectors to electricity, gas or hydraulic and pneumatic energy supplies which the user has to handle must be designed and manufactured in such a way as to minimise all possible risks.
6.4.5. Accessible parts of the devices (excluding the parts of areas intended to supply heat or reach given temperatures) and their surroundings must not attain potentially dangerous temperatures under normal use.