Résumé
Establishes requirements and guidance. Particular attention is drawn to the need for specific testing for safety, quality and efficacy, possibly exceeding the general requirements, which may be necessary for a specific product. Attention is drawn to the existence in some countries of regulations laying down safety requirements for handling ethylene oxide and for premises in which it is used as well as of regulations laying down limits for the level of ethylene oxide residues within medical devices and products.
Informations générales
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État actuel: AnnuléeDate de publication: 1994-01Stade: Annulation de la Norme internationale [95.99]
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Edition: 1Nombre de pages: 26
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Comité technique :ISO/TC 198ICS :11.080.01
- RSS mises à jour
Cycle de vie
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Actuellement
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00
Préliminaire
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10
Proposition
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20
Préparation
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30
Comité
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40
Enquête
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50
Approbation
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60
Publication
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90
Examen
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95
Annulation
Rectificatifs techniques
Corrigent l’édition en vigueur; gratuits; non inclus dans le texte de la norme en vigueur.AnnuléeISO 11135:1994/Cor 1:1994
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00
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Révisée par
AnnuléeISO 11135-1:2007
AnnuléeISO/TS 11135-2:2008