Quality management and corresponding general aspects for medical devices

• Connectors for citrate-based anticoagulant solution reservoirs for apheresis, N476
• Information supplied by the manufacturer of medical devices, EN 1041:2008/A1
• Medical devices - Part 1: Application of usability engineering to medical devices, IEC 62366
• Medical devices - Quality management - Medical device nomenclature data structure, ISO 15225
• Medical device - Software life cycle processes, ISO/IEC 62304:2012
• Medical devices - Application of usability engineering to medical devices - Amendment 1, IEC 62366:2007/DAmd1
• Guidance on the application of ISO 14971, ISO/TR 24971
• Connectors for enteral feed/solution reservoirs, ISO 18250
• Medical devices - Quality management systems - Requirements for regulatory purposes, EN ISO 13485
• Medical devices - Selection and use of standards in support of recognized essential principles of safety and performance of medical devices (Revision of ISO/TR 16142:2006), ISO 16142
• Medical devices - Quality management systems - Requirements for regulatory purposes, ISO 13485
• Medical device software - Part 2: Validation of software for regulated processes, ISO/TR 80000-2
• Small-bore connectors for liquids and gases in healthcare applications - Part 7: Connectors with 6% (Luer) taper for intravascular or hypodermic applications, ISO 80369-7
• Guidance on the application of ISO 14971, ISO/TR 16947
• Small bore connectors for liquids and gases in healthcare applications - Part 3: Connectors for enteral applications, ISO/IEC 80369-3
• Small-bore connectors for liquids and gases in healthcare applications - Part 5: Connectors for limb cuff inflation applications, ISO/IEC 80369-5
• Small-bore connectors for liquids and gases in healthcare applications - Part 6: Connectors for neuraxial applications, ISO 80369-6
• Small bore connectors for liquids and gases in healthcare applications - Part 2: Connectors for breathing systems and driving gases applications, ISO 80369-2

• SIS/TK 355/AG 1 ·

• AGA AB, LIDINGÖ
• AMO Uppsala AB, UPPSALA
• Ascom (Sweden) AB, GÖTEBORG
• Covidien Sverige AB, SOLNA
• Dentsply IH AB, Mölndal
• Etteplan Industry AB, Stockholm
• Gantus AB, MALMÖ
• GE Healthcare Bio-Sciences AB, UPPSALA
• Getinge Sterilization AB, GETINGE
• Läkemedelsverket, UPPSALA
• Maquet Critical Care AB, SOLNA
• Medos AB, LINKÖPING
• Mindray Medical Sweden AB, SUNDBYBERG
• Mölnlycke Health Care AB, GÖTEBORG
• Nobel Biocare AB, GÖTEBORG
• Permobil AB, TIMRÅ
• Preventia AB, BJÄRRED
• Q-Med A Galderma Division, UPPSALA
• Sveriges Kommuner och Landsting, STOCKHOLM
• Symbioteq Kvalitet AB, NACKA STRAND
• Synergus AB, DANDERYD
• Universitetssjukhuset Örebro, ÖREBRO

• CEN/CLC/TC 3, Quality management and corresponding general aspects for medical devices
• CEN/CLC/TC 3/WG 1, Information supplied by the manufacture of medical device
• CEN/CLC/TC 3/WG 2, Small bore connectors
• CEN/CLC/TC 3/WG 3, Traceability
• ISO/TC 210, Quality management and corresponding general aspects for medical devices
• ISO/TC 210/JWG 1, Joint ISO/TC 210-IEC/SC 62A WG : Application of risk management to medical devices
• ISO/TC 210/JWG 2, Joint ISO/TC 210-IEC/SC 62A WG : Medical device software
• ISO/TC 210/JWG 3, Joint ISO/TC 210-IEC/SC 62A WG : Medical device usability
• ISO/TC 210/JWG 4, Joint ISO/TC 210-IEC/SC 62D: Small bore connectors
• ISO/TC 210/WG 1, Application of quality systems to medical devices
• ISO/TC 210/WG 2, General aspects stemming from the application of quality principles to medical devices
• ISO/TC 210/WG 3, Symbols and nomenclature for medical devices

The work is directed and funded by the organizations that participate in the committee. The fee charged reflects the mode and scope of the project, and number of participants.