BS EN 556-2:2003 - Sterilization of medical devices. Requirements for medical devices to be designated "STERILE". Requirements for aseptically processed medical devices

BS EN 556-2:2003

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

Status : Revised, Withdrawn   Published : January 2004 Replaced By : BS EN 556-2:2015

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Standard NumberBS EN 556-2:2003
TitleSterilization of medical devices. Requirements for medical devices to be designated "STERILE". Requirements for aseptically processed medical devices
StatusRevised, Withdrawn
Publication Date14 January 2004
Withdrawn Date30 September 2015
Normative References(Required to achieve compliance to this standard)EN 550, EN 552, EN 554, EN ISO 13485, ISO 13485:2003
Informative References(Provided for Information)90/385/EEC, 93/42/EEC, 98/79/EC, EN 556-1, EN 980, prEN 13824, EN ISO 9001:2000, ISO 9001:2000, EN ISO 13488, ISO 13488:1996, EN ISO 14160:1998, ISO 14160:1998, EN ISO 14937:2000, ISO 14937:2000, EN ISO 14971, ISO 14971:2000, European Pharmacopoeia 4, EN ISO 9002, EN 46002:1996
Replaced ByBS EN 556-2:2015
International RelationshipsEN 556-2:2003
Draft Superseded By02/560165 DC
DescriptorsMedical equipment, Medical instruments, Sterile equipment, Sterilization (hygiene), Quality control, Controlled-atmosphere rooms, Environment (working), Microorganisms, Particulate materials, Contaminants, Contamination
ICS11.080.01
Title in FrenchSterilisation des dispositifs medicaux. Exigences relatives aux dispositifs medicaux en vue d'obtenir l'etiquetage "STERILE". Exigences pour les dispositifs medicaux prepares aseptiquement
Title in GermanSterilisation von Medizinprodukten. Anforderungen an Medizinprodukte, die als STERIL gekennzeichnet werden. Anforderungen an aseptisch hergestellte Medizinprodukte
CommitteeCH/198
ISBN0 580 43213 0
PublisherBSI
FormatA4
DeliveryNo
Pages12
File Size266.6 KB
Price£110.00


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