Chemical Sterilants and Sterilization Methods - A Guide to Selection and Use
Document status: Active
Microbiological Methods for Gamma Irradiation Sterilization of Medical Devices
Document status: Active
End-to-end microbiological quality and sterility assurance
Document status: Active
U.S. FDA 21 CFR mapping to the applicable regulatory requirement references in ISO 13485:2016 Quality Management Systems
Document status: Active
Guidance on transferring health care products between radiation sterilization sources
Document status: Active
Risk management guidance for combination products
Document status: Active
Microbiological methods—Understanding and use of product bioburden data
Document status: Active
Selection and use of protective apparel and surgical drapes in health care facilities
Document status: Active
Sterilization of health care products - Vocabulary
Document status: Active
Designing, testing and labeling reusable medical devices for reprocessing in health care facilities: A guide for medical device manufacturers
Document status: Active
