BS EN ISO 11607-2:2020

What is BS EN ISO 11607‑2 about?  

BS EN ISO 11607‑2 is one of a series of documents for Packaging for terminally sterilized medical devices which outlines validation requirements for forming, sealing, and assembly processes. 

BS EN ISO 11607‑2 specifies requirements for the development and validation of processes for packaging medical devices that are terminally sterilized. These processes include forming, sealing, and assembly of preformed sterile barrier systems, sterile barrier systems, and packaging systems. 

Who is BS EN ISO 11607‑2 for? 

BS EN ISO 11607‑2 is applicable to the following: 

• Healthcare industry 
• Hospitals 
• Suppliers who package and sterilize medical devices  

Why should you use BS EN ISO 11607‑2? 

Packaging for terminally sterilized medical devices should be designed to ensure that the medical device can be sterilized and remain sterile under documented storage and transport conditions until the sterile barrier system is damaged or opened. Transfer of sterile contents from its sterile barrier system using conditions and procedures that minimize the risk of microbial contamination 

By adopting BS EN ISO 11607‑2 guidelines, manufacturers will get the idea about how medical devices delivered in a sterile state should have been manufactured, packed, and sterilized by appropriate, validated methods. 

What’s changed since the last update? 

BS EN ISO 11607‑2:2020 supersedes ISO 11607‑2:2006, which has been withdrawn, and BS EN ISO 11607‑2:2020 includes some technical changes, these includes- 

• Terms and definitions for “process variable”, “process parameter” and “monitoring of processes” have been added. 
• Various definitions have been aligned with the latest version of ISO 11139 
• The terminology of “critical” process parameters has been discontinued and the concept of a process the specification has been introduced to include all elements required to manufacture a product that consistently meets specifications