Sterilization of health care products-Radiation-Guidance on sterilization of biologics and tissue-based products.
Document status: Active
Medical device safety assurance case report guidance
Document status: Active
Guidance on selecting a microbial challenge and inoculation sites for sterilization validation of medical devices
Document status: Active
Apnea Monitoring by Means of Thoracic Impedance Pneumography
Document status: [ Withdrawn ]
Sterilization of health care products - Radiation - Guidance on dose setting utilizing a Modified Method 2
Document status: Active
Sterilization of health care products - Radiation - Guidance on dose setting utilizing a Modified Method 2
Document status: Active
Active implantable medical devices - Guidance for designation of left ventricle and implantable cardioverter defibrillator lead connectors and pulse generator connector cavities for implantable pacemakers and implantable cardioverter defibrillators
Document status: Active
Evaluation of particulates associated with vascular medical devices
Document status: Active
Evaluation of particulate associated with vascular medical devices
Document status: Active
Ultrapure dialysate for hemodialysis and related therapies
Document status: Active
