It’s fair to say that the British Standard specifying laboratory autoclaves was overdue for a revision, having been reviewed regularly but not changed since 1993. This blog post discusses the big changes that have now taken place.
BS 2646-1:2021 Autoclaves for sterilization in laboratories. Part 1: Specification for design, construction, safety and performance specifies requirements for the design, construction, safety and performance of autoclaves. It covers the type used in laboratories for sterilizing goods, growth media and other materials required for laboratory operation. It doesn’t apply to sterilizers or disinfectors used for pharmaceutical production or medical purposes concerned with patient care – these types of autoclave have their own standards. Lastly, what distinguishes BS 2646-1 is the exceptionally long time during which the standard was regularly considered for revision, but not revised. There are a couple of reasons why this happened.
Reason number one is simply because the core technology used by autoclaves did not change. But also, reason two is that over the years, higher priority was given to the standards that cover the types of autoclave that perform medical devices sterilization. These are directly involved in patient care and so attract more attention. Hence BS EN 285 on large steam sterilizers was last fully revised in 2015; and BS EN 13060 for small steam sterilizers was last amended in 2018. In comparison, BS 2646 has flown under the radar. Happily though, and with lots of help from the industry trade body, GAMBICA, that period of neglect is now at an end and the standard has undergone a comprehensive and radical revision.
Performance and testing requirements
The headline news is that the revision has merged both BS 2646-1:1993 and BS 2646-5:1993. As a result, both those standards have now been superseded by BS 2646-1:2021. The merge was done because the same users need both documents to see the performance requirements and then to verify them, using the tests that were formerly in Part 5. For ease of use it made sense to collocate these two sets of requirements in one place.
In addition, naturally a lot of regulatory and other changes have taken place since 1993 and these are reflected in the revision. Therefore the updated document now aligns with the European machinery directive and with the BS EN 61010-1 series of standards on the safety of electrical equipment used in laboratories.
The revision alsoincorporates requirements from BS IEC 61010-2-120:2016 on the safety of the machinery aspects of equipment, and aligns with the pressure vessel requirements in the Pressure Equipment Directive. With an eye to the post-Brexit future, it makes provision for future UK conformity assessment routes.
The 2021 standard also reflects the developments in test instrumentation that have happened since the standard was last published. And it now allows for type testing, meaning that every autoclave no longer has to undergo works testing. Finally, changes have been made that simplify some tests. Together these changes will lighten the testing burden on autoclave manufacturers.
The intended users of the standard are design engineers, autoclave manufacturers, validation engineers, purchasers of laboratory autoclaves, laboratory managers and microbiologists. As well, because laboratory autoclaves operate under pressure and can be dangerous, the standard will also be used by health and safety professionals in laboratory-oriented sectors including manufacturing, life sciences and healthcare, and scientific laboratories undertaking work on organisms categorized as Hazard Groups 1, 2 and 3.
All these users will now benefit from a streamlined and up-to-date standard that will help them to design, produce, procure and operate laboratory autoclaves that will be safe and fit for purpose for many years to come.