1. ISO 9001:2015 3 Quality management systems — Requirements
2. ISO 10012 Measurement management systems — Requirements for measurement processes and measuring equipment
3. ISO 11607-1:2006 Packaging for terminally sterilized medical devices — Part 1: Requirements for materials sterile barrier systems and packaging systems
4. ISO 11607-2 Packaging for terminally sterilized medical devices — Part 2: Validation requirements for forming sealing and assembly processes
5. ISO 14644 (all parts) Cleanrooms and associated controlled environments