Medical electrical equipment—Part 2-4: Particular requirements for the basic safety and essential performance of cardiac defibrillators, including Amendment 1
€1,014.00
Biological evaluation of medical devices—Part 3: Tests for genotoxicity, carcinogenicity, and reproductive toxicity
€268.00
Medical electrical equipment—Part 2-47: Particular requirements for the basic safety and essential performance of ambulatory electrocardiographic systems
€488.00
Biological evaluation of medical devices—Part 4: Selection of tests for interactions with blood
Medical electrical equipment—Part 2-50: Particular requirements for the basic safety and essential performance of infant phototherapy equipment
€282.00
Biological evaluation of medical devices—Part 5: Tests for in vitro cytotoxicity
€230.00
Medical device software—Software life cycle processes
€1,476.00
Biological evaluation of medical devices—Part 6: Tests for local effects after implantation
Application of risk management for IT Networks incorporating medical devices—Part 1: Roles, responsibilities and activities.
€379.00
Biological evaluation of medical devices—Part 7: Ethylene oxide sterilization residuals
€292.00
Medical electrical equipment—Part 2-58: Particular requirements for basic safety and essential performance of lens removal and vitrectomy devices for ophthalmic surgery
€178.00
Biological evaluation of medical devices—Part 9: Framework for identification and quantification of potential degradation products
€144.00
Amendment 1 to Medical Electrical Equipment Part 2-58
Application of risk management for IT-networks incorporating medical devices—Part 2-1: Step by step risk management of medical IT-networks; Practical applications and examples.
Application of risk management for IT-networks incorporating medical devices—Part 2-2: Guidance for the disclosure and communication of medical device security needs, risks and controls
