General requirements for Luer activated valves (LAVs) incorporated into medical devices for intravascular applications
Document status: Active
Active implantable medical devices - Electromagnetic compatibility - EMC test protocols for implantable cardiac pacemakers and implantable cardioverter defibrillators
Document status: Active
Cardiovascular implants and artificial organs - Extracorporeal blood circuit for hemodialyzers, hemodiafilters and hemofilters
Document status: Active
Amendment 2 to Washer-disinfectors, Part 1: General requirements, terms and definitions and tests
Document status: Active
Sterilization of health care products-Radiation-Part 4: Guidance on process control
Document status: Active
Sterilization of Health Care Products - Radiation Sterilization - Substantiation of 25 kGy as a Sterilization Dose for Small or Infrequent Production Batches
Document status: [ Withdrawn ]
Sterilization of Health Care Products - Radiation Sterilization - Substantiation of 25 kGy as a Sterilization Dose for Small or Infrequent Production Batches - Amendment 1
Document status: Active
Sterilization of health care products - Radiation sterilization - Selection of a sterilization dose for a single production batch
Document status: Active
Medical devices- Guidance on the selection of standards in support of recognized essential principles of safety and performance of medical devices
Document status: Active
Guidance for ANSI/AAMI/ISO 11607, Packaging for Terminally Sterilized Medical Devices
Document status: Active
