• EN 16602-70-53:2015

    Current The latest, up-to-date edition.

    Space product assurance - Materials and hardware compatibility tests for sterilization processes

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    Published date:  28-01-2015

    Publisher:  Comite Europeen de Normalisation

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    Table of Contents - (Show below) - (Hide below)

    Foreword
    Introduction
    1 Scope
    2 Normative references
    3 Terms, definitions and abbreviated terms
    4 Principles
    5 Requirements
    Annex A (normative) - Request for sterilization compatibility
            test - DRD
    Annex B (normative) - Sterilization compatibility test specifications
            and procedures (Work Proposal) - DRD
    Annex C (normative) - Sterilization compatibility test report - DRD
    Annex D (informative) - Technology risks of sterilization
    Bibliography

    Abstract - (Show below) - (Hide below)

    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 oftest 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 toits 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.

    General Product Information - (Show below) - (Hide below)

    Committee CEN/CLC/JTC 5
    Document Type Standard
    Publisher Comite Europeen de Normalisation
    Status Current

    Standards Referenced By This Book - (Show below) - (Hide below)

    BS EN 16602-70-55:2015 Space product assurance. Microbiological examination of flight hardware and cleanrooms
    BS EN 16602-70-56:2015 Space product assurance. Vapour Phase Bioburden Reduction for Flight Hardware
    I.S. EN 16602-70-01:2014 SPACE PRODUCT ASSURANCE - CLEANLINESS AND CONTAMINATION CONTROL
    I.S. EN 16602-70-57:2015 SPACE PRODUCT ASSURANCE - DRY HEAT BIOBURDEN REDUCTION FOR FLIGHT HARDWARE
    I.S. EN 16602-70-55:2015 SPACE PRODUCT ASSURANCE - MICROBIOLOGICAL EXAMINATION OF FLIGHT HARDWARE AND CLEANROOMS
    EN 16602-70-55:2015 Space product assurance - Microbiological examination of flight hardware and cleanrooms
    BS EN 16602-70-57:2015 Space product assurance. Dry Heat Bioburden Reduction for Flight Hardware
    BS EN 16602-70-01:2014 Space product assurance. Cleanliness and contamination control
    EN 16602-70-57:2015 Space product assurance - Dry Heat Bioburden Reduction for Flight Hardware
    EN 16602-70-56:2015 Space product assurance - Vapour Phase Bioburden Reduction for Flight Hardware
    EN 16602-70-01:2014 Space product assurance - Cleanliness and contamination control
    I.S. EN 16602-70-56:2015 SPACE PRODUCT ASSURANCE - VAPOUR PHASE BIOBURDEN REDUCTION FOR FLIGHT HARDWARE

    Standards Referencing This Book - (Show below) - (Hide below)

    EN 16602-70-55:2015 Space product assurance - Microbiological examination of flight hardware and cleanrooms
    EN 16602-70-10:2015 Space product assurance - Qualification of printed circuit boards
    EN 16603-20-08:2014 Space engineering - Part 20-08: Photovoltaic assemblies and components
    EN 16602-60-05:2014 Space product assurance - Generic procurement requirements for hybrids
    EN 16603-32-11:2014 Space engineering - Modal survey assessment
    EN 16602-70-57:2015 Space product assurance - Dry Heat Bioburden Reduction for Flight Hardware
    EN 16601-00-01:2015 Space systems - Glossary of terms
    EN 16602-10-09:2014 Space product assurance - Nonconformance control system
    EN 16602-20-07:2016 Space product assurance - Quality and safety assurance for space test centres
    EN 16602-20:2014 Space product assurance - Quality assurance
    EN 16602-70-56:2015 Space product assurance - Vapour Phase Bioburden Reduction for Flight Hardware
    EN 16602-60:2015 Space product assurance - Electrical, electronic and electromechanical (EEE) components
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