Imagine a medical device arriving at the hospital, ready for use, with the critical guarantee of sterility. This is where ISO 11607-1:2019, published by the International Organization for Standardization (ISO), comes in. It sets the essential requirements for the materials, sterile barrier systems, and packaging systems used for terminally sterilized medical devices.
What does it do?
Why is it important?
ISO 11607-1:2019 forms the first part of a two-part standard. It lays the foundation for sterile medical device packaging, ensuring the materials and systems used can withstand the rigors of sterilization and protect the device throughout its journey. By adhering to this standard, medical device manufacturers contribute to patient safety and deliver products that meet the highest quality benchmarks.