Medical devices - Hierarchal coding structure for adverse events - Part 1: Event type codes
Document status: Active
Medical devices - Hierarchal coding structure for adverse events - Part 1: Event type codes, Amendment 1
Document status: Active
Medical devices - Hierarchal coding structure for adverse events - Part 1: Event type codes
Document status: Active
Medical devices -Hierarchical coding structure for adverse events - Part 2: Evaluation codes
Document status: Active
Medical devices - Coding structure for adverse event type and cause
Document status: Active
Medical devices - Post-market surveillance for manufacturers
Document status: Active
Sterilization of health care products—Guidance on the requirements for the validation and routine processing of ethylene oxide sterilization processes using parametric release
Document status: Active
Guidance for uncertainty analysis regarding the application of ISO/TS 10974
Document status: Active
Medical devices utilizing animal tissues and their derivatives - Part 4: Principles for elimination and/or inactivation of transmissible spongiform encephalopathy (TSE) agents and validation assays for those processes
Document status: Active
Sterilization of health care products—Microbiological methods—Guidance on conducting bioburden determinations and tests of sterility for biologics and tissue-based products
Document status: Active
