BS EN ISO 11607-2:2020 - TC - Tracked Changes. Packaging for terminally sterilized medical devices. Validation requirements for forming, sealing and assembly processes

BS EN ISO 11607-2:2020 - TC

Tracked Changes. Packaging for terminally sterilized medical devices. Validation requirements for forming, sealing and assembly processes

Status : Current   Published : November 2020

Format
PDF






Standard NumberBS EN ISO 11607-2:2020 - TC
TitleTracked Changes. Packaging for terminally sterilized medical devices. Validation requirements for forming, sealing and assembly processes
StatusCurrent
Publication Date12 November 2020
Normative References(Required to achieve compliance to this standard)ISO 11607-1:2018
Informative References(Provided for Information)ANSI/AAMI ST65, DIN 58953-9, ISO/TS 16775, ISO 2859-1, DIN 58953-7, DIN 58953-8, ISO 14971, EN 13795-1, ISO 186, ANSI/AAMI ST77, EN 868-8, ISO 9001, ANSI/AAMI ST90, ISO 13485:2016, ISO 11139:2018
DescriptorsPackages, Wrapping, Packaging, Sealing processes, Sterilization (hygiene), Verification, Performance, Seals, Medical instruments, Quality, Medical equipment, Sterile equipment, Acceptance (approval), Performance testing, Packaging materials, Packaging processes, Quality assurance systems
ICS11.080.30
CommitteeCH/198
ISBN978 0 539 14723 0
PublisherBSI
FormatA4
DeliveryYes
File Size0 KB
Price£262.00


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