Số hiệu tiêu chuẩn
prEN ISO 11607-1
Tên tiêu chuẩn
Packaging for terminally sterilized medical devices - Part 1: Requirements for materials, sterile barrier systems and packaging systems (ISO/DIS 11607-1:2004)
Ngày phát hành
2004-04-00
Tiêu chuẩn tương đương
DIN EN ISO 11607-1 (2004-07), IDT * NF S98-052-1, IDT * ISO/DIS 11607-1 (2004-04), IDT * OENORM EN ISO 11607-1 (2004-08-01), IDT
Từ khóa
Applications * Biocompatibility * Biological hazards * Closures * Compatibility * Conditioning * Covers * Definitions * 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 * Tests * Toxicity * Transport * Use * Validation * Visual inspection (testing) * Processes * Procedures * Bearings * Impermeability * Freedom from holes * Tightness * Implementation