BS EN ISO 11607-2:2017 pdf free.Packaging for terminally sterilized medical devices.
1.Scope:This part of IS0 11607 specifies the requirements for development and validation of processes forpackaging medical devices that are terminally sterilized.These processes include forming, sealing,andassembly of preformed sterile barrier systems, sterile barrier systems and packaging systems.
This part of lSO 11607 is applicable to industry, to health care facilities, and wherever medical devicesare packaged and sterilized.
This part of lS0 11607 does not cover all requirements for packaging medical devices that aremanufactured aseptically. Additional requirements may also be necessary for drug/devicecombinations.
2.Normative references:The following referenced documents are indispensable for the application of this document. For datedreferences, only the edition cited applies. For undated references, the latest edition of the referenceddocument (including any amendments) applies.
IS0 11607-1，Packaging for terminally sterilized medical devices – Part 1: Requirements for materials,sterile barrier systems and packaging systems
3.Terms and definitions:For the purposes of this document, the following terms and definitions apply.
3.1.expiry date:indication of the date, by which the product should be used, expressed at least as the year and month.
3.2:installation qualification 1Q:process of obtaining and documenting evidence that equipment has been provided and installed inaccordance with its specification.[SOURCE: ISO/TS 11139:2006]
3.3.labelling:written, printed, electronic or graphic matter affixed to a medical device or its packaging system; oraccompanying a medical device
Note 1 to entry: Labelling is related to identification, technical description and use of the medical device butexcludes shipping documents.
3.4.operational qualification 0Q:process of obtainingand documentingevidence that installedequipment operates within predeterminedlimits when used in accordance with its operational procedures.[SOURCE: ISO/TS 11139:2006]
3.5.packaging system:combination of the sterile barrier system and protective packaging[SOURCE: ISO/TS 11139:2006]
3.6.performance qualification PQ:process of obtaining and documenting evidence that the equipment, as installed and operated inaccordance with operational procedures, consistently performs in accordance with predeterminedcriteria and thereby yields product meeting its specification [SOURCE: ISO/TS 11139:2006] BS EN ISO 11607 pdf download.