Số hiệu tiêu chuẩn
EN ISO 11607-1
Tên tiêu chuẩn
Packaging for terminally sterilized medical devices - Part 1: Requirements for materials, sterile barrier systems and packaging systems (ISO 11607-1:2006)
Ngày phát hành
2009-06-00
Tiêu chuẩn tương đương
DIN EN ISO 11607-1 (2009-09), IDT * DIN EN ISO 11607-1 (2014-11), IDT * BS EN ISO 11607-1+A1 (2010-02-28), IDT * NF S98-052-1 (2009-08-01), IDT * ISO 11607-1 (2006-04), IDT * SN EN ISO 11607-1 (2009-10), IDT * OENORM EN ISO 11607-1 (2009-12-01), IDT * OENORM EN ISO 11607-1 (2014-11-15), IDT * OENORM EN ISO 11607-1 (2009-03-01), IDT * OENORM EN ISO 11607-1/A1 (2013-04-15), IDT * PN-EN ISO 11607-1 (2009-07-31), IDT * PN-EN ISO 11607-1 (2011-09-26), IDT * SS-EN ISO 11607-1 (2009-06-15), IDT * UNE-EN ISO 11607-1 (2009-10-14), IDT * TS EN ISO 11607-1 (2010-07-13), IDT * UNI EN ISO 11607-1:2009 (2009-08-26), IDT * UNI EN ISO 11607-1:2014 (2014-10-09), IDT * STN EN ISO 11607-1 (2009-12-01), IDT * CSN EN ISO 11607-1 (2010-01-01), IDT * DS/EN ISO 11607-1 (2009-08-30), IDT * NEN-EN-ISO 11607-1:2009 en (2009-07-01), IDT * SFS-EN ISO 11607-1:en (2009-10-30), IDT
Tiêu chuẩn liên quan
ISO 5636-5 (2003-06) * 93/42/EWG (1993-06-14)
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 * Toxicity * Transport * Use * Validation * Visual inspection (testing) * Processes * Procedures * Bearings * Impermeability * Freedom from holes * Tightness * Implementation