Next meeting of the Advisory Board for Healthcare Standards (ABHS) will take place on 23-24 October 2018 in Brussels, Belgium at the CEN-CENELEC Meeting Centre.
Each CEN and CENELEC Technical Committee in the domain of medical equipment develops European Standards according to a well-defined, dedicated scope. CEN and CENELEC therefore cover a wide variety of medical topics, ranging from electrical medical equipment, syringes, ophthalmic optics and dentistry to air ambulances, in vitro diagnostic medical devices and sterilizers.
Access the full list of CEN and CENELEC Technical Committees operating in the area of medical equipment through the work programme.
- CEN-CLC/TC 3 - Quality management and corresponding general aspects for medical devices
- CEN/TC 55 - Dentistry
- CLC/TC 62 - Electrical equipment in medical practice
- CEN/TC 102 - Sterilizers and associated equipment for processing of medical devices
- CEN/TC 140 - In vitro diagnostic medical devices
- CEN/TC 170 - Ophthalmic optics
- CEN/TC 204 - Sterilization of medical devices
- CEN/TC 205 - Non-active medical devices
- CEN/TC 206 - Biological and clinical evaluation of medical devices
- CEN/TC 215 - Respiratory and anaesthetic equipment
- CEN/TC 216 - Chemical disinfectants and antiseptics
- CEN/TC 239 - Rescue systems
- CEN/TC 258 - Clinical investigation of medical devices
- CEN/TC 285 - Non-active surgical implants
- CEN/TC 293 - Assistive products for persons with disability
- CEN/TC 316 - Medical products utilizing cells, tissues and/or their derivatives
- CEN/TC 362 - Project Committee - Healthcare services - Quality management systems
- CEN/TC 367 - Project Committee - Breath-alcohol testers
- CEN-CLC/JTC 16 - CEN-CENELEC Joint Technical Committee on Active Implantable Medical Devices
A Sector Forum is a platform aiming at facilitating the exchange of information between the various stakeholders impacted by, involved in or interested in the European standardization activities in a particular domain. It also constitutes a convenient means of coordinating the standardization activities and identifying new standardization needs.
Following specific requests – called 'standardization requests' or 'mandates' – from the European Commission, CEN and CENELEC develop European Standards that support the European legislation in a number of domains. The mandated standards are called 'Harmonized Standards' and their references and titles are published in the 'Official Journal of the European Union'.
On 5 May 2017, the European Commission published the new Regulations in the field of medical devices in the Official Journal of the European Union:
In the field of medical equipment, CEN and CENELEC were mandated by the European Commission to develop Harmonized Standards in support of:
The following mandates from the European Commission to CEN and CENELEC in the field of medical equipment are currently ongoing (all mandates are accessible in pdf format):
- M/023 - Mandate for CEN/CENELEC concerning the development of European Standards relating to medical devices (complemented by M/295)
- M/295 - Standardization mandate to CEN/CENELEC concerning the development of European Standards relating to medical devices (complements M/023)
- M/252 - Standardization mandate to CEN/CENELEC concerning the development of European Standards relating to in vitro diagnostic medical devices
- M/467 - Standardization mandate addressed to CEN and CENELEC: modification and completion of EN 60601-2-52 to prevent entrapment of children and of adults with an atypical anatomy in medical beds and entrapment of children in medical cots
Check the latest lists of Harmonized Standards published in the Official Journal in support of the three medical Directives:
The DOs and DON'Ts for drafting harmonized standards in healthcare and medical devices - download the presentation