BS EN 13060:2004+A2:2010 Small steam sterilizers
BS EN 13060 us a European Standard specifies the performance requirements and test methods for small steam sterilizers and sterilization cycles which are used for medical purposes or for materials that are likely to come into contact with blood or body fluids.
BS EN 13060 applies to automatically controlled 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 applies to small steam sterilizers used primarily for the sterilization of medical devices and unable to accommodate a sterilization module (300 mm × 300 mm × 600 mm) and with a chamber volume not exceeding 60 litres.
BS EN 13060 does not apply to small steam sterilizers that are used to sterilize liquids or pharmaceutical products.
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).
BS EN 13060 does not specify requirements for the validation and routine control of sterilization by moist heat.
Contents of BS EN 13060:
Foreword
Introduction
1 Scope
2 Normative references
3 Terms and definitions
4 General technical requirements
5 Performance requirements
6 Safety
7 Categories of tests
8 Test equipment
9 Test programme
10 Test methods
Annex A (informative) Clarification of the definition of hollow space A and hollow space B (see 3.19 and 3.20)
Annex B (informative) Process evaluation system
Annex C (informative) Suggested maximum limits of contaminants in and specification for water for steam sterilization
Annex D (informative) Example of a table to be supplied with pre-purchase documentation and with the instructions for use
Annex E (informative) Load support systems
Annex F (informative) Rationale for the tests
Annex ZA (informative) Relationship between this European Standard and the Essential
Requirements of EU Directive 93/42 EEC on medical devices
Bibliography