CTN 111 - Surgical and medical devices

FENIN - FEDERACIÓN ESPAÑOLA DE EMPRESAS DE TECNOLOGÍA SANITARIA

Standardization of: - Transfusion, infusion, and injection equipment and accessories for medical use, in their aspects of terms and definitions, general characteristics, test methods and function suitability as well as standardization of containers and primary and secondary packaging (such as elastomeric and metallic closures); - Surgical instruments and medical equipment in their aspects of terms and definitions, general characteristics, test methods and function suitability; - Sterilization: Characteristics, validation and control methods of sterilizers and sterilization processes; - Content, safety requirements and test methods for first aid kits; - Sterile and disposable medical devices, concerning terminology, general characteristics, test methods and appropriate performance Excluding: - Anaesthetic and respiratory equipment; - Aspects concerning safety of the electrical and electronic equipment; - Aspects related to quality of the materials which are within the scope of other technical committees.

SC 1 Terminology

SC 2 Disposable material

SC 3 Sistemas de gestión

SC 7 Sterilization

SC 9 Equipment for emergency services

SC 11 Surgical instruments

SC 13 Infusion, injection and transfusion equipments and devices

SC 14 Antiseptics and disinfectants

SC 15 Mechanical contraceptives

GT 1 Sistemas cerrados

ISO/TC 76  Transfusion, infusion and injection, and blood processing equipment for medical and pharmaceutical use

ISO/TC 84  Devices for administration of medicinal products and catheters

ISO/TC 157  Non-systemic contraceptives and STI barrier prophylactics

ISO/TC 170  Surgical instruments

ISO/TC 194  Biological and clinical evaluation of medical devices

ISO/TC 198  Sterilization of health care products

ISO/TC 210  Quality management and corresponding general aspects for products with a health purpose including medical devices

CEN/CLC/JTC 3  Quality management and corresponding general aspects for medical devices

CEN/CLC/SAG Healthcare Standards  Healthcare Standards

CEN/ABHS  Advisory Board for Health Standards

CEN/SS S02  Transfusion equipment

CEN/SS S03  Syringes

CEN/SS S99  Health, environment and medical equipment - Undetermined

CEN/TC 102  Sterilizers and associated equipment for processing of medical devices

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 216  Chemical disinfectants and antiseptics

CEN/TC 239  Rescue systems

* Some activities of this TC correspond to other AEN/CTN.