Guidance on radiation validation and routine maintenance for single-use systems used for pharmaceutical and biopharmaceutical manufacturing
€144.00
Aseptic processing of health care products—Part 1: General requirements
€311.00
Packaging for terminally sterilized medical devices—Part 1: Requirements for materials, sterile barrier systems and packaging systems Amendment 1: Application of risk management
€178.00
Packaging for terminally sterilized medical devices—Part 2: Validation requirements for forming, sealing and assembly processes Amendment 1: Application of risk management
Standard for a medical equipment management program
€251.00
Alternate equipment management (AEM) program in healthcare delivery organizations (HDOs)
€221.00
Healthcare technology management (HTM) educational programs
Compatibility of materials subject to sterilization
External transport of reusable medical devices for processing
Human factors engineering—Design of medical devices
€706.00
Best practices for designing accessible at-home diagnostic test kits
Selection and use of protective apparel and surgical drapes in health care facilities
Guide for process characterization and control in radiation sterilization of medical devices
A compendium of processes, materials, test methods, and acceptance criteria for cleaning reusable medical devices
Process challenge devices/test packs for use in health care facilities