BS 2646-1:2021

What is BS 2646-1 - Autoclaves for sterilization about? 

BS 2646-1 discusses about Autoclaves for sterilization in laboratories. BS 2646-1  specifies requirements for the design, construction, safety and performance 
of autoclaves for operation with saturated steam and for operation under vacuum (subject to external pressure).   

BS 2646-1 deals with laboratory autoclaves for the sterilization of goods and material which could be infected with organisms, the sterilization of growth media, or other materials required for the operation of a laboratory. 

Note 1: BS 2646-1 does not apply to sterilizers or disinfectors used for pharmaceutical production or medical purposes directly concerned with patient care. 

Note 2: BS 2646-1 does not apply to autoclaves utilizing a fired pressure vessel 

Who is BS 2646-1 - Autoclaves for sterilization for?  

BS 2646-1 on Design, construction, safety, and performance s of autoclaves applies to: 

• Design engineers 
• Autoclave manufacturers 
• Validation engineers 
• Purchasers of laboratory autoclaves 
• Service providers 
• SRegulatory authorities 

Why should you use BS 2646-1 - Autoclaves for sterilization?  

Steam sterilizers are important for healthcare facilities and other industries to kill harmful bacteria, viruses, fungi, and spores on items that are placed inside a pressure vessel. So, the autoclave needs to be made safe so that the process to reduce the microbial content of contaminated material so that it can be handled and disposed of without causing an infection hazard. 

BS 2646-1 provides requirements for safety, and performance of autoclaves for the manufacturer as they need to conform the requirements relating to autoclave pressure vessels of the law and regulations of the country.  

BS 2646-1 provides requirements for the autoclave design and construction that will help the manufacturer to issue a certificate of compliance/declaration of conformity to certify that the vessel has been designed, constructed and tested under a quality system in accordance with its construction code.    

What’s changed since the last update?  

BS 2646-1:2021 supersedes BS 26461:1993 and BS 26465:1993, which are withdrawn. 

In comparison with the previous edition, the following technical modifications have been made: 

The biggest change in BS 2646-1:2021 is the merging of BS 2646-1:1993 and BS 2646-5:1993 which brings together into one standard both performance requirements and the tests to prove performance. In addition, the 2021 standard: 

• Aligns with the European Machinery Directive 2006/42/EC and BS EN 61010-1 series of safety standards. 
• Incorporates the requirements of BS IEC 61010-2-120:2016, Safety requirements for electrical equipment for measurement, control, and laboratory use 
• Aligns its pressure vessel requirements with the Pressure Equipment Directive and future UK conformity assessment routes 
• Simplifies the tests required to demonstrate adequate performance and Allows type testing to reduce the amount of works testing of every   autoclave 
• Updates the requirements for test instrumentation in accordance with technology developments over the last 28 years also the references are updated