Standard: AAMI 11607-2
PACKAGING FOR TERMINALLY STERILIZED MEDICAL DEVICES-PART 2: VALIDATION REQUIREMENTS FOR FORMING, SEALING, AND ASSEMBLY PROCESSES
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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.
|Organization:||Association for the Advancement of Medical Instrumentation|
|Document Number:||aami 11607-2|
|Most Recent Revision:||YES|
|Document #||Change Type||Update Date||Revision||Status|
|AAMI 11607-2||Change Type: A1||Revision: 06||Status: ACTV|
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