BS EN 554:1994 - Sterilization of medical devices. Validation and routine control of sterilization by moist heat – BSI British Standards

BS EN 554:1994

Sterilization of medical devices. Validation and routine control of sterilization by moist heat

Status : Superseded, Withdrawn   Published : October 1994 Replaced By : BS EN ISO 17665-1:2006

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This European Standard specifies requirements for the process development, validation, process control and monitoring of the sterilization of medical devices using moist heat. This method is based on the monitoring of the physical factors that cause the product to become sterile and presupposes that prior to validation the sterilizer and its installation conform to an appropriate specification.

This European Standard does not describe a quality assurance system for the control of all stages of manufacture.

This European Standard does not address the routine testing of samples (sterility testing) or the use of biological indicators, except in a limited number of special applications, as these practices are of limited value in moist heat sterilization. In such special applications, they should be regarded as additional to the measurement of physical parameters.




Standard NumberBS EN 554:1994
TitleSterilization of medical devices. Validation and routine control of sterilization by moist heat
StatusSuperseded, Withdrawn
Publication Date15 October 1994
Confirm Date01 March 2005
Withdrawn Date29 September 2006
Normative References(Required to achieve compliance to this standard)No other standards are normatively referenced
Informative References(Provided for Information)No other standards are informatively referenced
Replaced ByBS EN ISO 17665-1:2006
International RelationshipsEN 554:1994
Draft Superseded By91/57780 DC
DescriptorsMedical equipment, Sterilization (hygiene), Steam, Verification, Quality control, Quality assurance, Certification (approval), Installation, Performance, Maintenance, Personnel, Medical instruments
ICS11.080.01
Title in FrenchStérilisation de dispositifs médicaux. Validation et contrôle routine pour la stérilisation à la vapeur d'eau
Title in GermanSterilisation von Medizin produkten. Validierung und Routineueberwachung fuer die Sterilisation mit feuchter Hitze
CommitteeCH/198
ISBN0 580 23203 4
PublisherBSI
FormatA4
DeliveryNo
Pages22
File Size397.1 KB
Price£130.00


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