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

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

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What is BS EN 16602-70-53- Materials and hardware compatibility tests for sterilization processes about?  

BS EN 16602-70-53 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 BS EN 16602-70-53. 

BS EN 16602-70-53 covers the following: 

  • Identification of critical test parameters to establish functional integrity of the hardware 
  • Typical test protocols 
  • Acceptance criteria 

Statements about the compatibility of materials and components with sterilization processes in BS EN 16602-70-53 are made in general terms only. 

Who is BS EN 16602-70-53- Materials and hardware compatibility tests for sterilization processes for? 

BS EN 16602-70-53 on materials and hardware compatibility tests for sterilization processes is useful for: 

  • Spacecraft and space products manufacturers           
  • Aerospace products manufacturers     
  • Testing agencies involved in the inspection of spacecraft and aerospace products           
  • Quality control personnel for spacecraft products        
  • Aeronautical engineers   
  • Space researchers 

Why should you use BS EN 16602-70-53- Materials and hardware compatibility tests for sterilization processes? 

A properly formulated and executed test program for all hardware elements that have to undergo sterilization is essential to guarantee their nominal performance and to prevent any immediate or long-term detrimental effects. 

The objective of BS EN 16602-70-53 is to ensure a successful mission by the definition of a test protocol and acceptance criteria for the determination of hardware compatibility with sterilization processes. 

BS EN 16602-70-53 has been developed to cover specifically space systems and has therefore precedence over any EN covering the same scope but with a wider domain of applicability (e.g.: aerospace). BS EN 16602-70-53 is tailored for the specific characteristic and constrains of a space project in conformance with ECSS-S-ST-00.