BS-EN-ISO-11607-2:2017 pdf free

BS-EN-ISO-11607-2:2017 pdf free.Packaging for terminally sterilized medical devices
This part of ISO 11607 specifies the requirements for 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.
This part of ISO 11607 is applicable to industry, to health care facilities, and wherever medical devices are packaged and sterilized.
This part of ISO 11607 does not cover all requirements for packaging medical devices that are manufactured aseptically. Additional requirements may also be necessary for drug/device combinations.
The following referenced documents are indispensable for the application of this document. For dated references, only the edition cited applies. For undated references, the latest edition of the referenced document (including any amendments) applies.
ISO 11607-1, Packaging for terminally sterilized medical devices – Part 1: Requirements for materials, sterile barrier systems and packaging systems
Process validation shall include, at a minimum, an installation qualification, an operational qualification, and a performance qualification in this order.
Process development, while not formally part of process validation, should be considered as an integral part of forming and sealing (see Annex A).
Validation of existing products may rely on data from previous installation and operation qualfcation. That data can be used for determination of the tolerances for critical parameters.
When similar preformed sterile barrier systems and sterile barrier system manufacturing processes are validated, a rationale for establishing similarities and identifying the worst case configuration shall be documented. As a minimum, the worst case configuration shall be validated to determine compliance with this part of ISO 11607.
The application of software systems, such as programmable logic controller, data collection, and inspection systems, shall be validated to ensure that they function as intended. Functional tests shall be performed to verify the correct functioning of the software and hardware, and especially the interfaces.
The system shall be checked (e.g. by entering correct and incorrect data, by simulating a loss of electrical power) to detect the availability, reliability, identity, accuracy and traceability of data or records.BS-EN-ISO-11607-2 pdf download.