What is BS 2646-1:2021 about?
There are several different types of autoclave or sterilizer, with each type designed for specific uses. BS 2646-1:2021 deals with autoclaves for use in laboratories and sets out how these should be manufactured and tested.
Who is BS 2646-1:2021 for?
- Design engineers
- Autoclave manufacturers
- Validation engineers
- Purchasers of laboratory autoclaves
- Laboratory managers and microbiologists
- Health and safety professionals in all laboratory-oriented sectors, including manufacturing, life sciences and healthcare, and scientific laboratories undertaking work on organisms categorized as Hazard Groups 1, 2 and 3
Why should you use BS 2646-1:2021?
This British Standard specifies requirements for the design, construction, safety and performance of autoclaves for operation with saturated steam and under vacuum subject to external pressure.
It covers laboratory autoclaves for sterilizing goods and materials that could be infected with organisms, and for the sterilization of growth media or of other materials required for the operation of a laboratory.
Users will adopt the standard because they want to design, produce, procure and operate laboratory autoclaves that meet UK requirements, are safe and perform adequately. The standard will also help users to operate more efficiently, increase trust in their products and better manage their risks.
NOTE: BS 2646-1:2021 does not apply to sterilizers or disinfectors used for pharmaceutical production or medical purposes directly concerned with patient care. These are covered by BS EN 285 or BS EN 13060 and BS 3970-2. Nor does it apply to autoclaves utilizing a fired pressure vessel.
What’s new about BS 2646-1:2021?
This is a major revision. 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:
a) Aligns with the European Machinery Directive 2006/42/EC
b) Aligns with the BS EN 61010-1 series of safety standards
c) Incorporates the requirements of BS IEC 61010-2-120:2016, Safety requirements for electrical equipment for measurement, control, and laboratory use — Part 2-120: Particular safety requirements for machinery aspects of equipment
d) Aligns its pressure vessel requirements with the Pressure Equipment Directive and future UK conformity assessment routes
e) Simplifies the tests required to demonstrate adequate performance
f) Allows type testing to reduce the amount of works testing of every autoclave
g) Updates the requirements for test instrumentation in accordance with technology developments over the last 28 years
h) Updates references