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ČSN EN 16602-70-53 (310510)
Space product assurance - Materials and hardware compatibility tests for sterilization processes
Automatically translated name:
Securing space products - Tests compatibility of materials and components used for sterilization processes (ISO direct use as CSN ).
STANDARD published on 1.9.2015
The information about the standard:
Designation standards: ČSN EN 16602-70-53
Classification mark: 310510
Catalog number: 97751
Publication date standards: 1.9.2015
SKU: NS-614085
The number of pages: 56
Approximate weight : 168 g (0.37 lbs)
Country: Czech technical standard
Category: Technical standards ČSN
The category - similar standards:
Annotation of standard text ČSN EN 16602-70-53 (310510):
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/compatibility of a material or component for an application requires a full consideration of the impact of sterilization processes to which it is subjected during its whole life. This includes sterilization processes it undergoes from the time it is a standalone component/material right through to when it experiences final sterilization as part of the complete system. This standard may be tailored for the specific characteristic and constrains of a space project in conformance with ECSS-S-ST-00
Preview of the standard ČSN EN 16602-70-53 (310510)
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