BS EN ISO 25424:2011

1   Scope

 1.1   Inclusions 
 
   
     1.1.1    This European Standard  specifies  requirements for the development,  validation  and routine control of a Low Temperature Steam and Formaldehyde (LTSF)  sterilization  process for  medical devices . 
   
     
       NOTE  Although the scope of this standard is limited to  medical devices , it  specifies  requirements and provides guidance that may be applicable to other  products  and equipment. 
   
 
 
   
     1.1.2    This European Standard is intended to be applied by process developers, manufacturers of  sterilization  equipment, manufacturers of  medical devices  to be sterilized and the organizations with responsibility for sterilizing  medical devices . (See EN ISO 14937:2000, Table E.1) 
 
 
   
     1.1.3    This European Standard covers  sterilization  processes which use a mixture of low temperature steam and formaldehyde as  sterilant , and which are working below ambient pressure only.