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

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 (IEC 60601-1-11:2015, MOD)

Human factors engineering for processing medical devices

Management of loaned critical and semi-critical medical devices that require sterilization or high-level disinfection

Human factors engineering - Guidance for contextual inquiry

Water testing methodologies

Post-market surveillance of use error management

Environmental Monitoring For Terminally Sterilized Healthcare Products

Guidance for the development, validation and routine control of an ethylene oxide sterilization process utilizing flexible bag systems for the sterilization of medical devices

Guidance on electromagnetic compatibility of medical devices in healthcare facilities