BS EN 556-2:2015 - TC - Tracked Changes. Sterilization of medical devices. Requirements for medical devices to be designated 'STERILE'. Requirements for aseptically processed medical devices

BS EN 556-2:2015 - TC

Tracked Changes. Sterilization of medical devices. Requirements for medical devices to be designated 'STERILE'. Requirements for aseptically processed medical devices

Status : Current, Under review   Published : February 2020

Format
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Standard NumberBS EN 556-2:2015 - TC
TitleTracked Changes. Sterilization of medical devices. Requirements for medical devices to be designated 'STERILE'. Requirements for aseptically processed medical devices
StatusCurrent, Under review
Publication Date24 February 2020
Normative References(Required to achieve compliance to this standard)ISO 17665-1:2006, ISO 14160:2011, ISO 14937:2009, ISO 11135:2014, EN ISO 13485:2012, EN ISO 11137-1:2015, EN ISO 11135:2014, EN ISO 14160:2011, ISO 20857:2010, ISO 13408-5:2006, EN ISO 13408-5:2011, EN ISO 17665-1:2006, EN ISO 14937:2009, ISO 13408-2:2003, EN ISO 25424:2011, ISO 13485:2003, ISO 25424:2009, EN ISO 20857:2013, EN ISO 13408-2:2011, SO 11137-1:2006/Amd 1:2013
Informative References(Provided for Information)98/79/EC, ISO 17664:2017, 93/42/EEC, ISO 13408-1:2008/Amd 1:2013, ISO/TS 11139:2006, EN ISO 15223-1, EN ISO 13408-1:2015, ISO 13408-7:2012, EN 556-1:2001, FprEN ISO 13408-6, EN ISO 11737-2:2020, BS EN ISO 11737-2:2020, ISO 13408-4, ISO 14971, EN ISO 14971, EN ISO 11137-3, EN ISO 9001, ISO/TS 17665-2, ISO 9001, EN ISO 11737-1, ISO 11137-2, EN ISO 13408-3, EN ISO 13408-4, ISO 13408-3, ISO 11737-2, CEN ISO/TS 17665-2, EN ISO 11137-2, EN ISO 17664, ISO 15223-1, ISO 13408-6, 90/385/EEC, 90/385/EEC, ISO 11137-3:2017, ISO 11737-1:2018, 93/42/EEC
DescriptorsContaminants, Sterilization (hygiene), Particulate materials, Environment (working), Controlled-atmosphere rooms, Medical instruments, Contamination, Sterile equipment, Quality control, Medical equipment, Microorganisms
ICS11.080.01
CommitteeCH/198
ISBN978-0-539-08335-4
PublisherBSI
FormatA4
DeliveryYes
Pages43
File Size2.364 MB
Price£188.00


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