QUALITY SYSTEMS. MEDICAL DEVICES. PARTICULAR REQUIREMENTS FOR THE APPLICATION OF EN ISO 9003
€60.00
Nomenclature - Specification for a nomenclature system for medical devices for the purpose of regulatory data exchange. (ISO 15225:2000)
€69.00
Quality systems - Medical devices - Particular requirements for the application of EN ISO 9001. (ISO 13485:1996)
Graphical symbols for use in the labelling of medical devices.
€26.00
Medical electrical equipment -- Part 1-2: General requirements for safety - Collateral standard: Electromagnetic compatibility - Requirements and tests.
€133.00
Air, water and difficult terrain ambulances. Part 2: Operational and technical requirements for the continuity of patient care.
€74.00
Medical devices - Quality management systems - Requirements for regulatory purposes (ISO 13485:2003)
€0.00
Medical devices - Quality management systems - Guidance on the application of ISO 13485:2003 (ISO/TR 14969:2004)
€131.00
Medical electrical equipment -- Part 1-2: General requirements for safety - Collateral standard: Electromagnetic compatibility - Requirements and tests (IEC 60601-1-2:2001/A1:2004)
€71.00
Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral standard: Electromagnetic compatibility - Requirements and tests
€140.00
Symbols for use in the labelling of medical devices
€81.00
Medical vehicles and their equipment - Air ambulances - Part 2: Operational and technical requirements of air ambulances.
€79.00
Medical supply units (ISO 11197:2004)
€98.00
Biological evaluation of medical devices - Part 11: Tests for systemic toxicity (ISO 10993-11:2006)