DANSK DS/EN 16602-70-53 PDF

This Standard describes a test protocol to determine the compatibility of materials, components, parts, and assemblies with sterilization processes. It is dedicated to test on non-flight hardware only. Any additional requirements that can be imposed by the potential use of test samples as flight hardware are not covered in this document (e.g. handling requirements). This Standard covers the following: - Identification of critical test parameters to establish functional integrity of the hardware. - Typical test protocols. - Acceptance criteria. Statements about compatibility of materials and components with sterilization processes in this document are made in general terms only. Other factors for determination of whether a material or component is suitable for a particular mission system application include: - The potential number of sterilization cycles to which the material/component will be subjected in their live cycle. - The additional stresses on materials/components introduced when they have become part of a larger unit/equipment/system undergoing sterilization. - Compatibility of sterilization processes at e.g. materials level. This compatibility does not automatically guarantee that it will perform to its requirements in an assembly. The final application and possible interactions at higher assembly level are important considerations for qualification. - Qualification of hardware achieved by specific sterilization parameters. They cannot be necessarily extrapolated to other sterilization parameters, not even within the same sterilization process. - The drift in performance that can be induced by sterilization processes . This drift can cause equipments to fail to meet their specified performance requirements, even though each individual element/component remains within spec. An example of this is where 'Select-on-test' components are used to operate a component over a critically narrow range its full performance. To assess ultimately the suitability/co ...