Knowledge Gateway
Unlock your learning potential with industry insights and standards that matter. Share your email to begin.
Unlock your learning potential with industry insights and standards that matter. Share your email to begin.
Status : Withdrawn
Standard Type : Main
Document Year : 2006
Pages : 24
Edition : 1
Section Volume : Sterilization of health care products (ISO/TC 198.)
ISO 11607-1:2006 is applicable to industry, to health care facilities, and wherever medical devices are placed in sterile barrier systems and sterilized.
ISO 11607-1:2006 does not cover all requirements for sterile barrier systems and packaging systems for medical devices that are manufactured aseptically. Additional requirements might also be necessary for drug/device combinations.
ISO 11607-1:2006 does not describe a quality assurance system for control of all stages of manufacture.