EN 13060:2014

Foreword
Introduction
1 Scope
2 Normative references
3 Terms and definitions
4 General technical requirements
5 Performance requirements
6 Safety, risk control and usability
7 Categories of tests
8 Test equipment
9 Test programme
10 Test methods
Annex A (informative) - Clarification of the definition of
        narrow lumens and simple hollow items
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 G (informative) - Example of a process challenge
        device for narrow lumen
Annex ZA (informative) - Relationship between this
         European Standard and the Essential
         Requirements of EU Directive 93/42 EEC on
         medical devices
Bibliography

This 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.This European Standard 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.This European Standard 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).The requirements concerning the quality management and risk management are addressed by other standards (e.g. EN ISO 13485, EN ISO 14971).This European Standard does not apply to small steam sterilizers that are used to sterilize liquids or pharmaceutical products.This European Standard does not specify safety requirements related to risks associated with the zone in which the sterilizer is used (e.g. flammable gases).This European Standard does not specify requirements for the validation and routine control of sterilization by moist heat.NOTERequirements for the validation and routine control of sterilization by moist heat are given in EN ISO 17665 1.This European Standard does not specify requirements for other sterilization processes that also employ moist heat as part of the process (i.e. formaldehyde, ethylene oxide).