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   Published : September 2015

Format
PDF

Format
HARDCOPY



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
Publication Date30 September 2015
Normative References(Required to achieve compliance to this standard)EN ISO 11135:2014, ISO 11135:2014, EN ISO 11137-1:2015, SO 11137-1:2006/Amd 1:2013, EN ISO 13408-2:2011, ISO 13408-2:2003, EN ISO 13408-5:2011, ISO 13408-5:2006, EN ISO 13485:2012, ISO 13485:2003, EN ISO 14160:2011, ISO 14160:2011, EN ISO 14937:2009, ISO 14937:2009, EN ISO 17665-1:2006, ISO 17665-1:2006, EN ISO 20857:2013, ISO 20857:2010, EN ISO 25424:2011, ISO 25424:2009
Informative References(Provided for Information)EN 556-1:2001, EN ISO 9001, ISO 9001, EN ISO 11137-2, ISO 11137-2, EN ISO 11137-3, ISO 11137-3, EN ISO 11737-1, ISO 11737-1, EN ISO 11737-2, ISO 11737-2, EN ISO 13408-1:2015, ISO 13408-1:2008/Amd 1:2013, EN ISO 13408-3, ISO 13408-3, EN ISO 13408-4, ISO 13408-4, EN ISO 13408-6, ISO 13408-6, EN ISO 14971, ISO 14971, EN ISO 15223-1, ISO 15223-1, EN ISO 17664, ISO 17664, ISO 13408-7:2012, ISO/TS 11139:2006, CEN ISO/TS 17665-2, ISO/TS 17665-2, 90/385/EEC, 93/42/EEC, 98/79/EC
ReplacesBS EN 556-2:2003
International RelationshipsEN 556-2:2015
Draft Superseded By14/30273161 DC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 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 Size1.014 MB
Price£130.00


 Your basket
Your basket is empty

Multi-user access to over 3,500 medical device standards, regulations, expert commentaries and other documents


Worldwide Standards
We can source any standard from anywhere in the world


Develop a PAS

Develop a fast-track standardization document in 9-12 months


Tracked Changes

Understand the changes made to a standard with our new Tracked Changes version


Customers who bought this product also bought

  • BS EN 1041:2008+A1:2013
    Information supplied by the manufacturer of medical devices
  • BS EN 556-1:2001
    Sterilization of medical devices. Requirements for medical devices to be designated "STERILE" Requirements for terminally sterilized medical devices
  • BS EN ISO 13408-1:2015
    Aseptic processing of health care products General requirements
  • BS EN ISO 14644-1:2015
    Cleanrooms and associated controlled environments Classification of air cleanliness by particle concentration