What is BS EN 13060- Small steam sterilizers about?
BS EN 13060 discusses small steam sterilizers. BS EN 13060 is an international standard that provides requirements and test methods for small steam sterilizers.
BS EN 13060 layouts performance requirements and test methods for small steam sterilizers and sterilization cycles. Small steam sterilizers are used for medical purposes or for materials that are likely to meet blood or body fluids. BS EN 13060 supports you in meeting acceptable performance and personal hygiene for small steam sterilizers.
BS EN 13060 applies to automatically control small steam sterilizers that generate steam using electrical heaters or use steam that is generated by a system external to the sterilizer.
BS EN 13060 also applies to small steam sterilizers used primarily for the sterilization of medical devices with a chamber volume of less than 60 l and unable to accommodate a sterilization module (300 mm × 300 mm × 600 mm).
Note 1: BS EN 13060 does not apply to small steam sterilizers that are used to sterilize liquids or pharmaceutical products.
Note 2: BS EN 13060 does not specify safety requirements related to risks associated with the zone in which the sterilizer is used (e.g., flammable gases).
Note 3: BS EN 13060+A1 does not specify requirements for the validation and routine control of
sterilization by moist heat.
Note 4: BS EN 13060+A1 does not specify requirements for other sterilization processes that also employ moist heat as part of the process (i.e., formaldehyde, ethylene oxide).
Who is BS EN 13060- Small steam sterilizers for?
BS EN 13060on small steam sterilizers is useful for:
- Small steam sterilizer manufacturers
- Operators for steam sterilizer
- Hospital and non-hospital environments where a small steam sterilizer is used.
- Test centers for steam sterilizers
- Regulatory authorities
Why should you use BS EN 13060- Small steam sterilizers?
Small steam sterilizers are widely used for medical purposes, e.g., in general, medical practice, dentistry, podiatry, facilities for personal hygiene and beauty care, and veterinary practice. They are also used for materials and equipment which are likely to meet blood or bodily fluids.
The specific nature of such sterilization loads used within these fields of application call for different performance requirements for the sterilization cycles and hence different corresponding test methods.
BS EN 13060 assists you with general technical requirements, performance requirements, safety, risk control, usability, test equipment, and a test program for small steam sterilizers.
BS EN 13060 encourages you to conduct proper assessments and in standardizing the performance of small steam sterilizers.
In Addition, also ensures the health and safety of users.
What’s changed since the last update?
BS EN 13060:2014+A1:2018 supersedes EN 13060:2014, which has been withdrawn. BS EN 13060:2014+A1:2018 has made some amendments compared to the previous edition EN 13060:2014. These include:
- The scope of the standard has been revised to define small and large sterilizers on the chamber volume
- Normative references, terms, and definitions have been updated
- In Clause 4 various sub-clauses and relevant requirements have been added
- Sub-clause 4.8 has been divided into two subsections
- Requirements in 5.3 on Attainment of the sterilization conditions have been revised