Free Standards PDF Download

ANSI AAMI ISO 13485:2016 pdf download - Medical devices - Quality management systems - Requirements for regulatory purposes 1 Scope This International Standard specifies requirements for a quality management system where an organization needs to demonstrate its...

ANSI AAMI ISO 13022:2012 pdf download - Medical products containing viable human cells - Application of risk management and requirements for processing practices 1 Scope This International Standard specifies requirements and guidance for processing practices and managing...

ANSI AAMI ISO 11658:2012 pdf download - Cardiovascular implants and extracorporeal systems - Blood/tissue contact surface modifications for extracorporeal perfusion systems 1 Scope This International Standard specifies requirements for the physical, biological and performance testing of biocompatible...

ANSI AAMI ISO 11135:2014 pdf download - Sterilization of health care products - Ethylene oxide - Requirements for development, validation and routine control of a sterilization process for medical devices 5.1 General The purpose of this activity...

ANSI AAMI ISO 11134:1993 pdf download - Sterilization of health care products - Requirements for validation and routine control Industrial moist heat sterilization A maintenance scheme should be developed from the schedules provided by the sterilizer manufacturer,...