Overview

The revision of DIN EN 14180 primarily implemented the amendments of the relevant requirements of EC Directive 2007/47/EC of the European Parliament and of the Council of 5 September 2007 amending Council Directive 90/385/EEC on the approximation of the laws of the Member States relating to active implantable medical devices, Council Directive 93/42/EEC concerning medical devices and Directive 98/8/EC concerning the placing of biocidal products on the market. Low temperature steam and formaldehyde sterilizers (LTSF) are primarily used for the sterilization of heat labile medical devices in health care facilities. LTSF sterilizers operate automatically using pre-set cycles. The standard contains specifications on the sterilizer chamber, on design and construction, on indicating, measuring, operating and recording devices, process control and performance of LTSF sterilizers. The test methods and test equipment given in the standard can also be used for validation and routine control of LTSF sterilization processes. The normative part of the standard is supplemented by informative annexes on formaldehyde residues on medical devices and on environmental aspects. The relationship between this European Standard and the Essential Requirements of EU Directive 93/42/EEC on medical devices is shown in an informative annex. The standard has been prepared by CEN/TC 102 "Sterilizers for medical purposes", the secretariat of which is held by DIN. The responsible German committee is Working Committee NA 063-04-02 AA "Niedertemperatur-Sterilisatoren" ("Low temperature sterilizers") at NAMed.

Document: references other documents

Document: referenced in other documents

Responsible national committee

NA 176-03-04 AA - Low temperature sterilizers  

Responsible european committee

CEN/TC 102/WG 6 - Low temperature sterilizers