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

BS EN 556-2:2015

Sterilization of medical devices. Requirements for medical devices to be designated "STERILE". Requirements for aseptically processed medical devices

Status : Current, Under review   Published : September 2015
Conformity to regulation : Designated

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This European Standard specifies the requirements for an aseptically processed medical device to be designated 'STERILE'. NOTE For the purpose of the EU Directive(s) for medical devices (see Bibliography), designating that a medical device is 'STERILE' is permissible when a validated manufacturing and sterilization process has been applied. Requirements for validation and routine control of aseptic processes are specified in EN ISO 13408 1. Specific requirements for the aseptic processing of solid medical devices and combination products are specified in ISO 13408 7.




Standard NumberBS EN 556-2:2015
TitleSterilization of medical devices. Requirements for medical devices to be designated "STERILE". Requirements for aseptically processed medical devices
StatusCurrent, Under review
Publication Date30 September 2015
Conformity to regulationDesignated
Normative References(Required to achieve compliance to this standard)EN ISO 13408-2:2011, ISO 14937:2009, EN ISO 13485:2012, EN ISO 14937:2009, EN ISO 14160:2011, ISO 14160:2011, ISO 11135:2014, EN ISO 11135:2014, SO 11137-1:2006/Amd 1:2013, ISO 13408-5:2006, EN ISO 11137-1:2015, EN ISO 20857:2013, EN ISO 25424:2011, ISO 13408-2:2003, ISO 25424:2009, EN ISO 17665-1:2006, EN ISO 13408-5:2011, ISO 20857:2010, ISO 17665-1:2006, ISO 13485:2003
Informative References(Provided for Information)ISO 17664:2017, EN ISO 13408-4, EN ISO 11137-2, EN ISO 13408-6, EN ISO 9001, ISO 13408-4, CEN ISO/TS 17665-2, ISO 13408-7:2012, ISO 9001, 90/385/EEC, EN ISO 11737-1, ISO 13408-3, 93/42/EEC, 98/79/EC, ISO/TS 17665-2, EN ISO 11737-2, EN ISO 11137-3, EN ISO 17664, EN ISO 15223-1, ISO 13408-6, ISO 13408-1:2008/Amd 1:2013, EN ISO 13408-1:2015, EN ISO 13408-3, ISO 15223-1, ISO/TS 11139:2006, EN ISO 14971, ISO 14971, ISO 11137-2, EN 556-1:2001, ISO 11137-3:2017, ISO 11737-1:2018, ISO 11737-2:2019, BS EN ISO 11737-2:2020
ReplacesBS EN 556-2:2003
International RelationshipsEN 556-2:2015
Draft Superseded By14/30273161 DC
DescriptorsEnvironment (working), Sterile equipment, Controlled-atmosphere rooms, Contamination, Medical equipment, Sterilization (hygiene), Medical instruments, Microorganisms, Quality control, Contaminants, Particulate materials
ICS11.080.01
Title in FrenchStérilisation des dispositifs médicaux. Exigences relatives aux dispositifs médicaux en vue d'obtenir l'étiquetage "STÉRILE". Exigences pour les dispositifs médicaux soumis à un traitement aseptique
Title in GermanSterilisation von Medizinprodukten. Anforderungen an Medizinprodukte, die als "STERIL" gekennzeichnet werden. Anforderungen an aseptisch hergestellte Medizinprodukte
CommitteeCH/198
ISBN978 0 580 80961 3
PublisherBSI
FormatA4
DeliveryYes
Pages20
File Size0.9932 MB
Price£134.00


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