This standard specifies the requirements and test methods for packaging materials, preformed sterile barrier systems, sterile barrier systems and packaging systems that are intended to maintain sterility of the terminally sterilized medical devices to the point of use.
Số hiệu tiêu chuẩn
DIN EN ISO 11607-1 Berichtigung 1
Tên tiêu chuẩn
Packaging for terminally sterilized medical devices - Part 1: Requirements for materials, sterile barrier systems and packaging systems (ISO 11607-1:2006); German version EN ISO 11607-1:2006, Corrigenda to DIN EN ISO 11607-1:2006-07
Ngày phát hành
2007-05-00
Từ khóa
Applications * Biocompatibility * Biological hazards * Closures * Compatibility * Conditioning * Covers * Density * Disposables * General conditions * Germs * Hygiene * Information * Inspection * Marking * Materials specification * Medical devices * Medical equipment * Medical products * Medical sciences * Medical technology * Methods * Packages * Packaging material * Packaging tests * Permability * Physical testing * Products * Public health * Quality * Quality assurance * Quality management * Rating tests * Reagents * Reuse * Safety * Safety requirements * Sampling methods * Sequence of operations * Specification * Specification (approval) * Stability * Sterile barrier systems * Sterility * Sterilization (birth control) * Sterilization (hygiene) * Sterilized goods * Sterilizers * Storage * Systems * Testing * Toxicity * Transport * Use * Validation * Visual inspection (testing) * Processes * Procedures * Bearings * Impermeability * Freedom from holes * Tightness * Implementation