BS EN 285:2015+A1:2021

What is BS EN 285-Large steam sterilizers about?  

BS EN 285 details best practices for ensuring safe and low-cost sterilization method. 

BS EN 285 specifies requirements and the relevant tests for large steam sterilizers primarily used in health care for the sterilization of medical devices and their accessories contained in one or more sterilization modules. 

BS EN 285 applies to steam sterilizers designed to accommodate at least one sterilization module or having a chamber volume of at least 60 l. 

Note: BS EN 285 does not specify requirements for large steam sterilizers intended to use, contain, or be exposed to flammable substances or substances which could cause combustion. BS EN 285 does not specify requirements for equipment intended to process biological waste or human tissues. 

Note: BS EN 285 does not describe a quality management system for the control of all stages of the manufacture of the sterilizer. 

Note: Attention is drawn to the standards for quality management systems e.g., EN ISO 13485. 

Who is BS EN 285- Large steam sterilizers for? 

BS EN 285 on large steam sterilizers is applicable to:  

• Testing laboratories that include sterilizers in their service  
• Medical device manufacturers and installers that include sterilizers in their service  
• Personnel responsible for the maintenance of sterilizers in hospitals and laboratories  
• Personnel responsible for sterilization quality control  

Why should you use BS EN 285- Large steam sterilizers? 

The purpose of sterilization is to deactivate microbiological contaminants and transform non-sterile products into sterile ones.  

BS EN 285 on large steam sterilizers provides you with test procedures and acceptance criteria to confirm whether the sterilizer is safe for use.  

Complying with BS EN 285 can increase the confidence of end-users that a large steam sterilizer is safe and fit for its purpose. Also, following BS EN 285 guidelines lets you improve the efficiency of the entire process - manufacture, installation, testing, maintenance, and assurance. 

In addition, you can strengthen your risk management systems along the supply chain - from manufacturer to end-users.  

BS EN 285 features up-to-date and improved requirements in the latest version. 

Overall, BS EN 285 can assist you in destroying all germs on the surface of an object or in a fluid in order to avoid disease transmission from that item's usage. 

What’s changed since the last update?  

BS EN 285:2015+A1:2021 supersedes BS EN 285:2006+A2:2009 which is withdrawn. BS EN 285:2015+A1:2021 includes some technical changes with respect to BS EN 285:2006+A2:2009. These include: 

• Normative references have been updated and corrected in the normative text 
• Note to entry was added to 3.17 and 3.27 
• 6.2 was adopted 
• Subclause 6.4.4.2 was added 
• Note was added to 8.1.3 and 15.1 
• Annex ZA’s relationship with the General Safety and Performance Requirements of Regulation (EU) 2017/745 including Tables ZA.1, ZA.2, and ZA.3 was added