DIN EN 16602-70-53 Space product assurance - Materials and hardware compatibility tests for sterilization processes
Данный раздел/документ содержится в продуктах:
- Техэксперт: Машиностроительный комплекс
- Картотека зарубежных и международных стандартов
- CEN EN 16602-70-29 Space product assurance - Determination of offgassing products from materials and assembled articles to be used in a manned space vehicle crew compartment
- 49
- CEN EN 16602-70-29 Space product assurance - Determination of offgassing products from materials and assembled articles to be used in a manned space vehicle crew compartment
- 49.140
- CEN EN 16602-70-29 Space product assurance - Determination of offgassing products from materials and assembled articles to be used in a manned space vehicle crew compartment
- DIN EN 16602-20-07 Space produce assurance - Quality and safety assurance for space test centres
- DIN EN 16602-20-07 Space produce assurance - Quality and safety assurance for space test centres
- DIN EN 16602-20-07 Space produce assurance - Quality and safety assurance for space test centres
- DIN EN 16602-20-08 Space product assurance - Storage, handling and transportation of spacecraft hardware
- DIN EN 16602-70 Space product assurance - Materials, mechanical parts and processes
- DIN EN 16602-70-71 Space product assurance - Materials, processes and their data selection
- DIN EN 16602-70-10 Space product assurance - Qualification of printed circuit boards
- CEN EN 16602-20 Space product assurance - Quality assurance
- Картотека зарубежных и международных стандартов
Deutsches Institut fur Normung e. V.
Space product assurance - Materials and hardware compatibility tests for sterilization processes
N EN 16602-70-53
Annotation
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.
