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    The safety of donor skin preserved with glycerol - Evaluating the Euro Skin Bank preservation procedures of human donor skin against the prEN 12442 standard

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    Authors
    Geertsma RE
    Wassenaar C
    Series/Report no.
    RIVM Rapport 605148008
    Type
    Report
    Language
    en
    
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    Title
    The safety of donor skin preserved with glycerol - Evaluating the Euro Skin Bank preservation procedures of human donor skin against the prEN 12442 standard
    Translated Title
    De veiligheid van donorhuid gepreserveerd met glycerol - Een evaluatie van de preservatieprocedures voor humane donorhuid van de Euro Skin Bank aan de hand van de prEN 12442 norm
    Publiekssamenvatting
    The procedures for preservation of human donor skin with glycerol, as applied by the Euro Skin Bank (ESB), were evaluated against the prEN 12442 standard: animal tissues and their derivatives used in the manufacture of medical devices. The focus chosen for this review is on risks related to the transmission of diseases. Product-related hazards were identified. Subsequently, the associated risks and the ESB measures to reduce these risks were discussed. The acceptability of the residual risks was also evaluated by comparing the risk-reducing measures with the prEN 12442, EN 1441, EN 1174 and ISO 14160 standards. Conclusions drawn indicate that ESB procedures as they now stand do not meet all the requirements of these standards. Nonconformities were used to formulate a validation plan containing considerations and suggestions on process definition and control, as well as an assessment of bacteriological and virological inactivation and/or elimination. The implementation of this plan should lead to full conformance with the standards.
    De procedures voor de preservatie van humane donorhuid zoals die worden toegepast door de Euro Skin Bank (ESB) zijn geevalueerd met behulp van de Europese standaard prEN 12442: "Dierlijke weefsels en daarvan afgeleide producten die voor de vervaardiging van medische hulpmiddelen worden gebruikt". Dit overzicht heeft zich gericht op de risico's betreffende de overdracht van ziekte. Eerst werden productgerelateerde gevaren geidentificeerd en vervolgens werden de hieraan verbonden risico's en de beheersmaatregelen hiervoor van de ESB besproken. Verder werd geevalueerd of de overblijvende risico's accepteerbaar zijn door de risicoverlagende maatregelen te vergelijken met de eisen in de volgende standaarden: prEN 12442, EN 1441, EN 1174 en ISO 14160. De conclusies geven aan dat de ESB-procedures op dit moment niet aan alle eisen van deze standaarden voldoen. Met behulp van de geconstateerde tekortkomingen is vervolgens een validatieplan opgesteld, dat overwegingen en suggesties ten aanzien van proces-definitie en -beheersing en de beoordeling van bacteriologische en virologische inactivatie en/of eliminatie bevat. Implementatie van dit plan zou ertoe moeten leiden dat de procedures volledig aan de standaarden gaan voldoen.
    Publisher
    Rijksinstituut voor Volksgezondheid en Milieu RIVM
    URI
    http://hdl.handle.net/10029/9565
    Collections
    RIVM official reports

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