Active implantable medical devices— Requirements and test protocols for safety of patients with pacemakers and ICDs exposed to magnetic resonance imaging
€311.00
Ultrapure dialysis fluid for hemodialysis and related therapies
€251.00
Quality Management System (QMS) Recommendations on the Application of the U.S. FDA—s CGMP Final Rule on Combination Products
€178.00
Safety and effectiveness of health IT software and systems—Part 1: Fundamental concepts, principles, and requirements
Medical devices and medical systems—Essential safety and performance requirements for equipment comprising the patient-centric integrated clinical environment (ICE): Part 2-1: Particular requirements for forensic data logging
Standard for Risk Concerns for Interoperable Medical Products
€268.00
Standard for Interoperable Item Development Life Cycle
Standard for Interoperable Item Integration Life Cycle
€221.00
Standard for Medical Device Interoperability
Medical Electrical Equipment—Part 1-8: General requirements for basic safety and essential performance—Collateral standard: General requirements, tests and guidance for alarm systems in medical electrical equipment and medical electrical systems, Amend. 2
€430.00
Medical electrical equipment—Part 1-12: General requirements—Collateral standard: Requirements for medical electrical equipment and medical electrical systems intended for use in emergency medical services environment—Amendment 1
€126.00
Medical electrical equipment—Part 1: General requirements for basic safety and essential performance, Amendment 2
Guidance on the Application of ISO 14971 to Artificial Intelligence and Machine Learning
Medical electrical equipment—Part 1-11: General requirements for basic safety and essential performance—Collateral Standard: Requirements for medical electrical equipment and medical electrical systems used in the home healthcare environment, Amendment 1
Medical electrical equipment—Part 1-2: General requirements for basic safety and essential performance—Collateral standard: Electromagnetic disturbances—Requirements and tests, Amendment 1
€334.00
