ISO Standards

The purpose of regulations and best practices for Sterilization/Decontamination 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 (Autoclaves, Dry ovens and Gamma ray Irradiators) and much more. One of the more critical and prominent standard setting organizations for the medical device industry is ISO.

ISO stands for “International Organization for Standardization” and 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.

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