Sterilization of medical devices. Requirements for medical devices to be designated "STERILE" - Requirements for aseptically processed medical devices
Sterilization of medical devices. Requirements for medical devices to be designated "STERILE" - Requirements for aseptically processed medical devices
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Sterilization of medical devices. Requirements for medical devices to be designated "STERILE" - Requirements for aseptically processed medical devices

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What is BS EN 556-2 – Aseptically processed medical devices about?  

BS EN 556-2 is an international standard that focuses on requirements for aseptically processed medical devices. BS EN 556-2 specifies the requirements for an aseptically processed medical device to be designated 'STERILE'. 

Who is BS EN 556-2 - Aseptically processed medical devices for? 

BS EN 556-2 on requirements for aseptically processed medical devices is useful for: 

  • Doctors   
  • Testing laboratories/test personnel of medical devices 
  • Healthcare facilities  
  • Medical laboratories  

Why should you use BS EN 556-2 - Aseptically processed medical devices?  

Medical devices designated 'STERILE' are prepared using appropriate and validated methods. Whenever possible, sterile medical devices are terminally sterilized using a properly validated and controlled sterilization process. When a medical device is intended to be sterile but cannot be terminally sterilized, aseptic processing is the method of manufacture. BS EN 556-2 covers instrument, apparatus, implement, machine, appliance, implant, in vitro reagent or calibrator, software, material or other similar or related article, intended by the manufacturer to be used. 

BS EN 556-2 assist you:  

  • Diagnosis, prevention, monitoring, treatment or alleviation of disease 
  • Diagnosis, monitoring, treatment, alleviation of or compensation for an injury 
  • Investigation, replacement, modification or support of the anatomy or a physiological process 
  • Supporting or sustaining life 
  • Control of conception 
  • Providing information for medical purposes using in vitro examination of specimens derived from the human body 

What’s changed since the last update?  

BS EN 556-2:2015 supersedes BS EN 556-2:2003. BS EN 556-2:2015 includes some technical changes concerning BS EN 556-2:2003. These include: 

  • Normative references have been updated 
  • Terms and definitions have been aligned with ISO/TS 11139 and EN ISO 13408-1 
  • Requirements on validation and routine control have been revised 
  • Table 1 and Table 2 on acceptance limits and actions for the occurrence of non-sterile units in process simulations in initial performance qualification and periodic requalification, respectively, have been added 
  • Editorial revision according to the CEN Internal Regulations