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.
DS/EN ISO 11607-2-2006由丹麦标准化协会 DK-DS 发布于 2006-06-28,并于 2006-06-28 实施。
DS/EN ISO 11607-2-2006在国际标准分类中归属于: 11.080.30 消毒封装。
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