ISO 11607 - PACKAGING FOR TERMINALLY STERILIZED MEDICAL DEVICES
What is ISO 11607?
The process of developing and constructing a packaging system for terminally sterilized medical devices is a convoluted and pressing endeavor. The definitive nature of the medical device, the intended sterilization methods, the intended use, expiration date, transport, and storage all influence the packaging system design and choice of materials. The combination of the medical device and the packaging system should perform efficiently, safely, and adequately in the end-user’s hands.
ISO 11607-1 details the elemental attributes demanded of materials and pre-formed systems intended for use in packaging systems for terminally sterilized medical devices. It takes into consideration the vast array of potential materials, medical devices, packaging system designs, and sterilization methods.
ISO 11607-2 describes the validation requirements for forming, sealing and assembly processes. The development and validation of packaging processes are crucial to ensure that sterile barrier system integrity is maintained until opened by the users of sterile medical devices.
Benefits of ISO 11607 Certification
Who can be certified ISO 11607 Certification?
Disposable Syringes Needles
Document required for ISO 11607 Certification
The extent of Documented Information differs as per:
Role of Shamkris and Process of ISO 11607 Certification
Shamkris adopts a results-oriented approach to effective system implementation in the organization. A simple and practical method of system implementation helps organizations increase business efficiency and sustainability. Shamkris supports 100% documentation to obtain an accreditation body of success in addition to enhanced performance.
The implementation process is described below: