Sterilization & Validation Standards

The purpose of regulations and best practices for sterilization and decontamination processes is to create operating procedures that ensure safety of the staff and the medical device. Regulatory bodies stipulate standards on personal protective gear (gloves and face masks), work environment, sterilization equipment utilization, and maintenance for autoclaves, dry ovens, and Gamma ray Irradiators.

ISO Standards and Compliance

One of the most prominent standard-setting organizations for the medical device industry is the International Organization for Standardization (ISO).

ISO is the world’s largest developer and publisher of International Standards. Numerous ISO standards provide the guidelines for the various processes within the medical device industry. Of these, the major standard that all medical device companies must be familiar with and adhere to is ISO 13485:2003.

ISO 13485:2003, Medical devices – Quality management systems – Requirements for regulatory purposes, is based on quality management system requirements currently contained in medical device regulations around the world, as well as those appropriate requirements contained in ISO 9001:2000. It covers the quality management requirements for organizations involved in design and development, production, installation and servicing of medical devices and the design, development, and provision of related services. While ISO 13485 is a stand-alone standard, it is based on ISO 9001.

Companies looking to sterilize and validate medical devices need to be familiar with:

• ISO 13485:2003 Requirements for Quality Management System of Medical Device companies
• ISO 25424:2009 Low temperature steam and formaldehyde method
• ISO 11135-1:2007 Ethylene Oxide method
• ISO 17665:2024 Moist Heat/Steam Sterilization method
• ISO 15882:2008 Guidance on Chemical indicators during Sterilization
• ISO 11137-1:2006 Radiation/Gamma Ray method