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Specifies requirements for the development, validation and routine control of a moist heat sterilization process for medical devices

La présente partie de l'ISO 19905 fournit un commentaire sur certains articles de l'ISO 19905-1, y compris des informations générales, des documents d'appui et des méthodes de calcul supplémentaires ou alternatives, le cas...

ISO 11137-1 describes the requirements for ensuring that the activities associated with the process of radiation sterilization are performed properly. Amendment 2 to included revisions to 4.3.4 and 11.2.

1.1 Éléments inclus 1.1.1 La présente partie de l'ISO 17665 spécifie les exigences relatives au développement, à la validation et au contrôle de routine du procédé de stérilisation des dispositifs médicaux à la chaleur humide...

1.1 This part of ISO 11137 specifies requirements for the development, validation and routine control of a radiation sterilization process for medical devices. NOTE Although the scope of this part of ISO 11137 is limited to...

This document defines physical characteristics and test methods for cards with devices, including but not limited to, power supplying devices, displays, sensors, microphones, loudspeakers, buttons or keypads. This document...

1.1 This part of ISO 11137 specifies requirements for the development, validation and routine control of a radiation sterilization process for medical devices. NOTE Although the scope of this part of ISO 11137 is limited to...

1.1 Inclusions 1.1.1 This International Standard specifies general requirements for the characterization of a sterilizing agent and for the development, validation and routine monitoring and control of a sterilization process...

1.1 This part of ISO 11137 specifies requirements for the development, validation and routine control of a radiation sterilization process for medical devices. NOTE Although the scope of this part of ISO 11137 is limited to...

Le présent document spécifie les exigences et les lignes directrices pour l’évaluation spécifique au site d’unités mobiles flottantes à utiliser dans les industries du pétrole et du gaz naturel. Elle traite de la phase...

Le présent document spécifie les principes régissant la gestion de l'intégrité structurelle (SIM) des structures en mer soumises à des types d'actions connus ou prévisibles. Il spécifie des exigences et fournit des...

1. Scope This clause of Part 1 is replaced as follows: 1.1 This standard applies to automatic electrical pressure sensing controls with a minimum gauge pressure rating of -60 kPa and a maximum gauge pressure rating of 4,2 MPa...