PD CEN ISO/TS 16775:2014 - Packaging for terminally sterilized medical devices. Guidance on the application of ISO 11607-1 and ISO 11607-2

PD CEN ISO/TS 16775:2014

Packaging for terminally sterilized medical devices. Guidance on the application of ISO 11607-1 and ISO 11607-2

Status : Current, Project Underway   Published : May 2014

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Standard NumberPD CEN ISO/TS 16775:2014
TitlePackaging for terminally sterilized medical devices. Guidance on the application of ISO 11607-1 and ISO 11607-2
StatusCurrent, Project Underway
Publication Date31 May 2014
Confirm Date05 March 2018
Normative References(Required to achieve compliance to this standard)No other standards are normatively referenced
Informative References(Provided for Information)ASTM F1140, ASTM F2250, ASTM F1886, ASTM F2203, EN 13429, ISO 15747, EN 13430, ASTM F1306, ASTM D3985, ISO/TS 17665-2, ASTM F2217, ASTM F2475, ASTM F2096, EN 13432, ISO 20857, EN 13427, ISO 11607-1:2006, ASTM D1938, ISO/ASTM 51649, ASTM D1894, ISO 11137-2, DIN 58953-8, ASTM F372, AAMI TIR29, ANSI/AAMI ST58, ASTM F2251, ASTM F2097, DIN 58953-6, IEC 60118-13:2004, ASTM D3078, DIN 58953-7, AAMI TIR17, ISO 14971, IEST-STD-CC1246D, ANSI/AAMI ST63, ISO 14708-2, DIN 58921, 94/62/EC, ASTM F904, ASTM D1709, ASTM D1003, ASTM D3776, ASTM F1249, EN 868-8, ISO 11137-1, ASTM F88, 2002/96/EC, AAMI TIR16, ISO 2859-1, ASTM F17, ASTM F392, ISO/TS 11135-2, ISO/TS 11139:2006, ASTM D4321, 10/2011/EC, EN 868-2, 2002/95/EC, ASTM F2054, ASTM F1327, ASTM F1980, ISO 10993-1, ASTM D4754, ISO 1924-2, 93/42/EEC, ASTM D589, EN 13428, ISO 11135-1, ASTM F2252, ASTM F2825, ISO 534, EN 60118-13, ISO 10993-7, ISO 17665-1, ISO 11137-3:2017, EN 13431, ASTM F1929, AAMI TIR35, ISO 14708-1, AAMI TIR20, ASTM D882, ASTM D2457, ASTM D3420, ASTM D5264, 98/79/EC, AAMI TIR28, ISO 11607-2:2006, ANSI/ASQ Z1.4, EN 868-5, AAMI TIR33, ASTM F2029
International RelationshipsISO/TS 16775:2014,CEN ISO/TS 16775 (ISO/TS 16775
DescriptorsPerformance, Packages, Wrapping, Sealing processes, Compatibility, Verification, Design, Medical equipment, Packaging materials, Quality, Performance testing, Seals, Quality assurance systems, Test methods, Packaging processes, Sterile equipment, Medical instruments, Acceptance (approval), Sterilization (hygiene), Packaging
ICS11.080.30
Title in FrenchEmballages des dispositifs médicaux stérilisés au stade terminal. Lignes directrices relatives à l'application de l'ISO 11607-1 et l'ISO 11607-2
Title in GermanVerpackungen für in der Endanwendung sterilisierte Medizinprodukte. Leitfaden für die Anwendung von ISO 11607-1 und ISO 11607-2
CommitteeCH/198
ISBN978 0 580 74178 4
PublisherBSI
FormatA4
DeliveryYes
Pages126
File Size2.303 MB
Price£314.00


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