Dear Customer

Our Customer Service will be available again as of 2 January 2025

Please note that new registrations and requests to be processed manually will only be processed from this point onwards.

You can of course place orders and receive downloads online at any time.

We wish you happy holidays, a peaceful time and a healthy New Year!

Your DIN Media

Standards Worldwide
Standards Worldwide
Phone +49 30 58885700-07

Standard [CURRENT]

DIN EN 14180:2014-09

Sterilizers for medical purposes - Low temperature steam and formaldehyde sterilizers - Requirements and testing; German version EN 14180:2014

German title
Sterilisatoren für medizinische Zwecke - Niedertemperatur-Dampf-Formaldehyd-Sterilisatoren - Anforderungen und Prüfung; Deutsche Fassung EN 14180:2014
Publication date
2014-09
Original language
German
Pages
69

from 158.40 EUR VAT included

from 148.04 EUR VAT excluded

Format and language options

PDF download
  • 158.40 EUR

  • 197.80 EUR

Shipment (3-5 working days)
  • 191.30 EUR

  • 239.20 EUR

Monitor with the Standards Ticker

This option is only available after login.
Easily subscribe: Save time and money now!

You can also subscribe to this document - together with other important standards in your industry. This makes your work easier and pays for itself after a short time.

Sparschwein_data
Subscription advantages
Sparschwein Vorteil 1_data

Important standards for your industry, regularly updated

Sparschwein Vorteil 2_data

Much cheaper than buying individually

Sparschwein Vorteil 3_data

Useful functions: Filters, version comparison and more

Publication date
2014-09
Original language
German
Pages
69
DOI
https://dx.doi.org/10.31030/2076202

Quick delivery via download or delivery service

Buy securely with a credit card or pay upon receipt of invoice

All transactions are encrypted

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.

Content
ICS
11.080.10
DOI
https://dx.doi.org/10.31030/2076202
Replacement amendments

This document replaces DIN EN 14180:2010-01 .

Cooperation at DIN

Also available in
Loading recommended items...
Loading recommended items...
Loading recommended items...
Loading recommended items...