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 556-1:2001

Sterilization of medical devices. Requirements for medical devices to be designated "STERILE". Requirements for terminally sterilized medical devices

Status : Current   Published : December 2001

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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 556-1 is the standard that specifies the requirements for a terminally sterilized medical device to be designated “STERILE”.

Part 2 of BS EN 556 specifies the requirements for an aseptically processed medical device to be designated “STERILE”.

Designation of a medical device as “STERILE” is only permissible when a validated sterilization process has been applied.

Also available for sterilization of 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




Standard NumberBS EN 556-1:2001
TitleSterilization of medical devices. Requirements for medical devices to be designated "STERILE". Requirements for terminally sterilized medical devices
StatusCurrent
Publication Date11 December 2001
Normative References(Required to achieve compliance to this standard)EN ISO 13485:2000, EN ISO 9001, EN ISO 13488:2000, ISO 13485:1996, ISO 13488:1996
Informative References(Provided for Information)EN ISO 9001:1994, ISO 9001, EN ISO 9002:1994, ISO 9002:1994, EN 550, EN 552, EN 554, EN 980, EN ISO 14971:2000, ISO 14971:2000, EN ISO 14160:1998, EN ISO 14937:2000, ISO 14937:2000, 90/385/EC, 93/42/EC, 98/79/EC
ReplacesBS EN 556:1995
International RelationshipsEN 556-1:2001
Amended ByAMD 16728
AMD 16728 is a Corrigendum.
Draft Superseded By99/565209 DC
DescriptorsMedical equipment, Medical instruments, Sterile equipment, Sterilization (hygiene), Quality assurance, Quality control, Marking, Microorganisms
ICS11.080.01
Title in FrenchSterilisation des dispositifs medicaux. Exigences relatives aux dispositifs medicaux en vue d'obtenir l'etiquetage STERILE. Exigences relatives aux dispositifs medicaux sterilises au stade terminal
Title in GermanSterilisation von Medizinprodukten. Anforderungen an Medizinprodukte, die als STERIL gekennzeichnet werden. Anforderungen an Medizinprodukte, die in der Endpackung sterilisiert wurden
CommitteeCH/198
ISBN0 580 38311 3
PublisherBSI
FormatA4
DeliveryYes
Pages12
File Size443.5 KB
Price£110.00


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