CEN/TC 285 - Non-active surgical implants
To standardize non-active surgical implants, including implant materials but not including dental implants and ophthalmic implants and, where appropriate, associated instrumentation to satisfy at least the essential requirements of the European Directive on Medical Devices, taking into account the work of CEN, CENELEC and ISO Technical Committees.
Neaktivni kirurški vsadki
To standardize non-active surgical implants, including implant materials but not including dental implants and ophthalmic implants and, where appropriate, associated instrumentation to satisfy at least the essential requirements of the European Directive on Medical Devices, taking into account the work of CEN, CENELEC and ISO Technical Committees.
General Information
Frequently Asked Questions
CEN/TC 285 is a Technical Committee within the European Committee for Standardization (CEN). It is named "Non-active surgical implants" and is responsible for: To standardize non-active surgical implants, including implant materials but not including dental implants and ophthalmic implants and, where appropriate, associated instrumentation to satisfy at least the essential requirements of the European Directive on Medical Devices, taking into account the work of CEN, CENELEC and ISO Technical Committees. This committee has published 87 standards.
CEN/TC 285 develops CEN standards in the area of S10 - SURGICAL IMPLANTS. The scope of work includes: To standardize non-active surgical implants, including implant materials but not including dental implants and ophthalmic implants and, where appropriate, associated instrumentation to satisfy at least the essential requirements of the European Directive on Medical Devices, taking into account the work of CEN, CENELEC and ISO Technical Committees. Currently, there are 87 published standards from this technical committee.
The European Committee for Standardization (CEN) is a public standards organization that brings together the national standardization bodies of 34 European countries. CEN provides a platform for developing European Standards (ENs) and other technical documents in relation to various products, materials, services, and processes, supporting the European Single Market.
A Technical Committee (TC) in CEN is a group of experts responsible for developing international standards in a specific technical area. TCs are composed of national member body delegates and work through consensus to create standards that meet global industry needs. Each TC may have subcommittees (SCs) and working groups (WGs) for specialized topics.