CEN/CLC/TC 3 - Quality management and corresponding general aspects for medical devices
The objective of the joint Technical Committee is to contribute to, and where necessary draft, suitable standards for "Quality management and corresponding general aspects for medical devices" that are applicable internationally and relevant to the essential requirements of EU Directives. The joint Technical Committee closely cooperates with ISO/TC 210 'Quality management and corresponding general aspects for medical devices' in the development of standards and revisions. The objective of the joint Technical Committee is to contribute to a further global harmonization of standards in close co-operation with ISO/TC 210. In principle the standards are drafted by ISO/TC 210 under the Vienna agreement with ISO-lead, including the joint work programme with IEC/SC 62. The joint Technical Committee will liaise with other Technical Committees - to achieve a coherent set of horizontal and product standards; - to minimize the necessity for additional European requirements; - to advise on aspects concerning quality management and risk management to ensure an optimal use of EN ISO 13485 and EN ISO 14971.
Quality management and corresponding general aspects for medical devices
The objective of the joint Technical Committee is to contribute to, and where necessary draft, suitable standards for "Quality management and corresponding general aspects for medical devices" that are applicable internationally and relevant to the essential requirements of EU Directives. The joint Technical Committee closely cooperates with ISO/TC 210 'Quality management and corresponding general aspects for medical devices' in the development of standards and revisions. The objective of the joint Technical Committee is to contribute to a further global harmonization of standards in close co-operation with ISO/TC 210. In principle the standards are drafted by ISO/TC 210 under the Vienna agreement with ISO-lead, including the joint work programme with IEC/SC 62. The joint Technical Committee will liaise with other Technical Committees - to achieve a coherent set of horizontal and product standards; - to minimize the necessity for additional European requirements; - to advise on aspects concerning quality management and risk management to ensure an optimal use of EN ISO 13485 and EN ISO 14971.
General Information
Frequently Asked Questions
CEN/CLC/TC 3 is a Technical Committee within CLC. It is named "Quality management and corresponding general aspects for medical devices" and is responsible for: The objective of the joint Technical Committee is to contribute to, and where necessary draft, suitable standards for "Quality management and corresponding general aspects for medical devices" that are applicable internationally and relevant to the essential requirements of EU Directives. The joint Technical Committee closely cooperates with ISO/TC 210 'Quality management and corresponding general aspects for medical devices' in the development of standards and revisions. The objective of the joint Technical Committee is to contribute to a further global harmonization of standards in close co-operation with ISO/TC 210. In principle the standards are drafted by ISO/TC 210 under the Vienna agreement with ISO-lead, including the joint work programme with IEC/SC 62. The joint Technical Committee will liaise with other Technical Committees - to achieve a coherent set of horizontal and product standards; - to minimize the necessity for additional European requirements; - to advise on aspects concerning quality management and risk management to ensure an optimal use of EN ISO 13485 and EN ISO 14971. This committee has published 66 standards.
CEN/CLC/TC 3 develops CLC standards in the area of S21 - LABORATORY MEDICINE, CLINICAL PATHOLOGY AND BIOSAFETY. The scope of work includes: The objective of the joint Technical Committee is to contribute to, and where necessary draft, suitable standards for "Quality management and corresponding general aspects for medical devices" that are applicable internationally and relevant to the essential requirements of EU Directives. The joint Technical Committee closely cooperates with ISO/TC 210 'Quality management and corresponding general aspects for medical devices' in the development of standards and revisions. The objective of the joint Technical Committee is to contribute to a further global harmonization of standards in close co-operation with ISO/TC 210. In principle the standards are drafted by ISO/TC 210 under the Vienna agreement with ISO-lead, including the joint work programme with IEC/SC 62. The joint Technical Committee will liaise with other Technical Committees - to achieve a coherent set of horizontal and product standards; - to minimize the necessity for additional European requirements; - to advise on aspects concerning quality management and risk management to ensure an optimal use of EN ISO 13485 and EN ISO 14971. Currently, there are 66 published standards from this technical committee.
CLC is a standardization organization that develops and publishes standards to support industry, commerce, and regulatory requirements.
A Technical Committee (TC) in CLC 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.