SIST EN 14180:2003

SLOVENSKI STANDARD
01-november-2003
Sterilizatorji za uporabo v medicini – Sterilizatorji s paro nizke temperature in s
formaldehidom – Zahteve in preskušanje
Sterilizers for medical purposes - Low temperature steam and formaldehyde sterilizers -
Requirements and testing
Sterilisatoren für medizinische Zwecke - Niedertemperatur-Dampf-Formaldehyd-
Sterilisatoren - Anforderungen und Prüfung
Stérilisateurs a usage médical - Stérilisateurs a la vapeur et au formaldéhyde a basse
température - Exigences et essais
Ta slovenski standard je istoveten z: EN 14180:2003
ICS:
11.080.10 Sterilizacijska oprema Sterilizing equipment
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

EUROPEAN STANDARD
EN 14180
NORME EUROPÉENNE
EUROPÄISCHE NORM
July 2003
ICS 11.080.10
English version
Sterilizers for medical purposes - Low temperature steam and
formaldehyde sterilizers - Requirements and testing
Stérilisateurs à usage médical - Stérilisateurs à la vapeur et Sterilisatoren für medizinische Zwecke - Niedertemperatur-
au formaldéhyde à basse température - Exigences et Dampf-Formaldehyd-Sterilisatoren - Anforderungen und
essais Prüfung
This European Standard was approved by CEN on 16 May 2003.
CEN members are bound to comply with the CEN/CENELEC Internal Regulations which stipulate the conditions for giving this European
Standard the status of a national standard without any alteration. Up-to-date lists and bibliographical references concerning such national
standards may be obtained on application to the Management Centre or to any CEN member.
This European Standard exists in three official versions (English, French, German). A version in any other language made by translation
under the responsibility of a CEN member into its own language and notified to the Management Centre has the same status as the official
versions.
CEN members are the national standards bodies of Austria, Belgium, Czech Republic, Denmark, Finland, France, Germany, Greece,
Hungary, Iceland, Ireland, Italy, Luxembourg, Malta, Netherlands, Norway, Portugal, Slovakia, Spain, Sweden, Switzerland and United
Kingdom.
EUROPEAN COMMITTEE FOR STANDARDIZATION
COMITÉ EUROPÉEN DE NORMALISATION
EUROPÄISCHES KOMITEE FÜR NORMUNG
Management Centre: rue de Stassart, 36  B-1050 Brussels
© 2003 CEN All rights of exploitation in any form and by any means reserved Ref. No. EN 14180:2003 E
worldwide for CEN national Members.

Contents
page
Foreword.3
Introduction .4
1 Scope .4
2 Normative references .4
3 Terms and definitions.5
4 Technical requirements.10
4.1 Sterilizer chamber.10
4.2 Design and construction.12
4.3 Indicating, measuring, operating and recording devices.14
5 Process control.19
5.1 General.19
5.2 Sterilization cycle and automatic control.19
5.3 Override of automatic control.21
5.4 Fault.21
6 Performance requirements .22
6.1 Sterilizing performance .22
6.2 Desorption efficacy.23
6.3 Drying.23
7 Sound power .23
8 Marking and labelling .24
9 Information to be supplied by the manufacturer.24
10 Service and local environment.26
10.1 General.26
10.2 Electricity.26
10.3 Sterilant.26
10.4 Steam .27
10.5 Water .27
10.6 Compressed air.27
10.7 Drainage and discharges .27
10.8 Ventilation and environment.28
Annex A (normative) Test methods .29
Annex B (normative) Sterilizer classification and testing .34
Annex C (normative) Test equipment .37
Annex D (normative) Determination of formaldehyde residuals in a filter indicator.40
Annex E (informative) Formaldehyde residues on medical devices.43
Annex F (informative) Environmental aspects .45
Annex ZA (informative) Clauses of this European Standard addressing essential requirements or
other provisions of EU Directives .48
Bibliography .49
Foreword
This document (EN 14180:2003) has been prepared by Technical Committee CEN /TC 102, "Sterilizers for medical
purposes", the secretariat of which is held by DIN.
This European Standard shall be given the status of a national standard, either by publication of an identical text or
by endorsement, at the latest by January 2004, and conflicting national standards shall be withdrawn at the latest
by January 2004.
This document has been prepared under a mandate given to CEN by the European Commission and the European
Free Trade Association, and supports essential requirements of EU Directive(s).
For relationship with EU Directive(s), see informative annex ZA which is an integral part of this document.
Annexes A, B, C and D are normative and form part of this European Standard.
Annexes E, F and ZA are for information only.
According to the CEN/CENELEC Internal Regulations, the national standards organizations of the following
countries are bound to implement this European Standard: Austria, Belgium, Czech Republic, Denmark, Finland,
France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Luxembourg, Malta, Netherlands, Norway, Portugal,
Slovakia, Spain, Sweden, Switzerland and the United Kingdom.
Introduction
This European Standard specifies minimum requirements and test methods for sterilizers working below ambient
atmospheric pressure performing a low temperature steam and formaldehyde (LTSF) process.
LTSF sterilizers are primarily used for the sterilization of medical devices in health care facilities, but may also be
used during the commercial production of medical devices.
LTSF processes are specified by physical parameters and verified using physical, chemical and microbiological
means. The sterilizers operate automatically using pre-set cycles.
The test methods and test equipment given may also be applicable to validation and routine control.
Validation and routine control of sterilization processes are essential to ensure their efficacy. This standard does
not cover validation and routine control of a LTSF process. General criteria for validation and routine control of a
sterilization process, also applicable to LTSF sterilization processes, are given in EN ISO 14937.
At the present state of knowledge, LTSF sterilizers should not be assumed to deliver processes effectively
inactivating the causative agents of spongiform encephalopathies such as scrapie, Bovine Spongiform
Encephalophaty and Creutzfeld-Jakob Disease. Specific recommendations have been produced in particular
countries for the processing of materials potentially contaminated with these agents. (See also
EN ISO 14937:2000, 1.6 Note 2).
Planning and design of products applying to this standard should consider not only technical issues but also the
environmental impact from the product during its life-cycle. Environmental aspects are addressed in annex F of this
standard.
NOTE Risk analysis methods, e. g. in EN ISO 14971, pay attention to environmental aspects.
Specifications on operator safety are addressed in EN 61010–1, EN 61010–2–042 and are not repeated in this
standard. EN 60204–1 may also give valuable guidelines.
1 Scope
This European Standard specifies requirements and tests for LTSF sterilizers, which use a mixture of low
temperature steam and formaldehyde as sterilizing agent, and which are working below ambient pressure only.
These sterilizers are primarily used for the sterilization of heat labile medical devices in health care facilities.
This European Standard specifies minimum requirements:
for the performance and design of sterilizers to ensure that the process is capable of sterilizing medical
devices;
for the equipment and controls of these sterilizers necessary for the validation and routine control of the
sterilization processes.
2 Normative references
This European Standard incorporates by dated or undated reference, provisions from other publications. These
normative references are cited at the appropriate places in the text and the publications are listed hereafter. For
dated references, subsequent amendments to or revisions of any of these publications apply to this European
Standard only when incorporated in it by amendment or revision. For undated references the latest edition of the
publication referred to applies (including amendments).
EN 866–1, Biological systems for testing sterilizers and sterilization processes — Part 1: General requirements.
EN 866–5, Biological systems for testing sterilizers and sterilization processes — Part 5: Particular systems for use
in low temperature steam and formaldehyde sterilizers.
EN 867–5, Non-biological systems for use in sterilizers — Part 5: Specification for indicator systems and process
challenge devices for use in performance testing for small sterilizers Type B and Type S.
EN 868–5, Packaging materials and systems for medical devices which are to be sterilized — Parts 5: Heat and
self-sealable pouches and reels of paper and plastic film construction — Requirements and test methods.
EN 60584–2, Thermocouples — Part 2: Tolerances (IEC 60584–2:1982 + A1:1989).
EN 60751, Industrial platinum resistance thermometer sensors (IEC 60751:1983 + A1:1986).
EN 61010–1, Safety requirements for electrical equipment for measurement, control and laboratory use — Part 1:
General requirements (IEC 61010-1:2001).
EN 61010–2–042:1997, Safety requirements for electrical equipment for measurement, control and laboratory
use — Part 2–042: Particular requirements for autoclaves and sterilizers using toxic gas for the treatment of
medical materials, and for laboratory processes (IEC 61010–2–042:1997).
EN 61326:1997, Electrical equipment for measurement, control and laboratory use — EMC requirements
(IEC 61326:1997).
EN ISO 3746, Acoustics — Determination of sound power levels of noise sources using sound pressure — Surve
...