European and International Standardization
In health care standardization is primarily subject to the European and international level with a focus on its uniformity worldwide. This cooperation is supported by the Vienna Agreement and the Frankfurt Agreement.
DIN as well as DKE (German Commission for Electrical, Electronic & Information Technologies in DIN and VDE) both play an important role while holding secretariats of technical committees or working groups at the European Committees for Standardization (CEN or CENELEC), the International Organization for Standardization (ISO) and the International Electrotechnical Organization (IEC).
See also European (CEN, CENELEC) and International (ISO, IEC) Technical Committees in health care.
Technical Committees in the domain of health care at CEN and CENELEC
The following link will lead you to committees and the contact person of technical committees held by a DIN secretariat
Committees | Title | Secretariat (organisation,country) |
“Dentistry” | DIN, Germany | |
“Sterilizers and associated equipment for processing of medical devices” | DIN, Germany | |
“In vitro Diagnostic medical devices” | DIN, Germany | |
„Ophthalmic optics“ | DIN, Germany | |
CEN/TC 204 | „Sterilization of medical devices“ | BSI, Great Britain |
„Non-Active Medical Devices“ | DIN, Germany | |
“Biological and clinical evaluation of medical devices” | DIN, Germany | |
CEN/TC 215 | „Respiratory and anaesthetic equipment“ | BSI, Great Britain |
CEN/TC 216 | „Chemical disinfectants and antiseptics“ | AFNOR, France |
„Rescue systems“ | DIN, Germany | |
„Non-active surgical implants“ | DIN, Germany | |
CEN/TC 293 | “Assistive products for persons with disability” | SIS, Sweden |
CEN/TC 362 | “Healthcare services - Quality management system” | SIS, Sweden |
CEN/TC 450 | “Patient involvement in person-centred care” | SIS, Sweden |
CEN/CLC/JTC 3 | “Quality management and corresponding general aspects for medical devices“ | NEN, Netherlands |
“CEN/CENELEC Joint Working Group on Active Implantable Medical Devices” | DKE, Germany |
Technical Committees in the domain of health care at ISO and IEC
Note: Subcommittees (SC) were included in the overview if the secretariat is held by DIN or DKE.
The following link will lead you to committees and the contact person of technical committees and their subcommittees held by a DIN secretariat
Committees and Subcommittees | Title | Secretariat (organisation, country) |
“Transfusion, infusion and injection, and blood processing equipment for medical and pharmaceutical use” | DIN, Germany | |
ISO/TC 84 | “Devices for administration of medicinal products” | DS, Denmarkk |
ISO/TC 106 | “Dentristry” | SCC, Canada |
ISO/TC 121 | “Anaesthetic and respiratory equipment” | ANSI, USA |
“Breathing attachments and anaesthetic machines” | DIN, Germany | |
“Implants for surgery” | DIN, Germany | |
“Materials” | DIN, Germany | |
“Prosthetics and orthotics” | DIN, Germany | |
“Surgical instruments” | DIN, Germany | |
„Optics and photonics“ | DIN, Germany | |
“Microscopes and endoscopes” | DIN, Germany | |
“Ophthalmic optics and instruments” | DIN, Germany | |
ISO/TC 173 | “Assistive products” | SIS, Sweden |
“Biological and clinical evaluation of medical devices” | DIN, Germany | |
“Tissue product safety” | DIN, Germany | |
ISO/TC 198 | “Sterilization of health care products” | Secretariat: ANSI, USA |
ISO/TC 210 | “Quality management and corresponding general aspects for medical devices” | Secretariat: ANSI, USA |
ISO/TC 215 | “Health informatics” | Secretariat: ANSI, USA |
ISO/TC 249 | “Traditional chinese medicine” | Secretariat: SAC, China |
„Biotechnology“ | Secretariat: DIN, Germany | |
ISO/TC 304 | „Healthcare organzation management“ | Secretariat: ANSI, USA |
“Electrical equipment in medical practice” | Secretariat: DKE, Germany | |
“Diagnostic imaging equipment” | Secretariat: DKE, Germany | |
“Equipment for radiotherapy, nuclear medicine and radiation dosimetrie” | Secretariat: DKE, Germany |
