Medical Device Software—Part 3: Process reference model of medical device software life cycle processes (IEC 62304)
€269.00
Assessment of the safety of magnetic resonance imaging for patients with an active implantable medical device
€333.00
Biological evaluation of medical devices—Guidance on the conduct of biological evaluation within a risk management process
€178.00
Guidance for the use of medical equipment maintenance strategies and procedures
€144.00
Medical devices—Post-market surveillance for manufacturers
€251.00
Medical equipment management—Vocabulary used in medical equipment programs
€126.00
Guidance for uncertainty analysis regarding the application of ISO/TS 10974
Transcutaneous electrical nerve stimulators
Medical devices utilizing animal tissues and their derivatives—Part 4: Principles for elimination and/or inactivation of transmissible spongiform encephalopathy (TSE) agents and validation assays for those processes
Cardiovascular implants and artificial organs—Checklist for preoperative extracorporeal circulation equipment setup
€221.00
Medical devices—Guidance on the application of ISO 14971
€311.00
Reprocessing of hemodialyzers
€268.00
Medical device software—Part 2: Validation of software for medical device quality systems
Guide to the development and inclusion of aspects of safety in International Standards for medical devices
€213.00
Medical Devices and Medical Systems—Essential safety and performance requirements for equipment comprising the patient-centric integrated clinical environment (ICE)—Part 1: General requirements and conceptual model
