DIN EN 13060:2010

Small steam sterilizers; German version EN 13060:2004+A2:2010 (Foreign Standard)

This standard specifies the performance requirements and test methods for small steam sterilizers and sterilization cycles which are used for medical purposes or for materials which are likely to come into contact with blood or body fluids. This standard applies to small steam sterilizers used primarily for the sterilization of medical devices and unable to accommodate a sterilization module (300 mm x 300 mm x 600 mm) and with a chamber volume not exceeding 60 l.*With the new edition of DIN EN 13060 the 2010 technical amendment, which basically includes the update and addition of terms and additional notes about the validity of specified performance requirements for prior decontamination programme processes and for the handling of indicators used in the PCD, has been incorporated into the European Standard. The new edition also contains the revised Annex ZA which takes into account the relevant essential requirements of EC Directive 2007/47/EC of the European Parliament and of the Council of 5 September 2007 amending Directives 90/385/EEC of the Council on the approximation of the laws of the Member States relating to active implantable medical devices and 93/42/EC of the Council concerning medical devices and Directive 98/8/EC concerning the placing of biocidal products on the market. EN 13060 is currently under revision. The revision is performed by European Working Group CEN/TC 102/WG 5 "Small sterilizers", in collaboration with German experts. The standard has been prepared by CEN/TC 102 "Sterilizers for medical purposes", the secretariat of which is held by DIN. The responsible German Working Committee is NA 063-04-01 AA "Dampf-Sterilisatoren" ("Steam sterilizers") of NAMed.