SIST EN 14180:2003/kprA2:2009

Sterilizers for medical purposes - Low temperature steam and formaldehyde sterilizers - Requirements and testing

2008-11-04 SJ: WI approved by BT + derogation from 4 year rule for amendments: BT C 64/2008.

Sterilisatoren für medizinische Zwecke - Niedertemperatur-Dampf-Formaldehyd-Sterilisatoren - Anforderungen und Prüfung

Stérilisateurs à usage médical - Stérilisateurs à la vapeur et au formaldéhyde à basse température - Exigences et essais

Sterilizatorji za uporabo v medicini - Sterilizatorji s paro nizke temperature in s formaldehidom - Zahteve in preskušanje

General Information

• Status: Not Published
• Public Enquiry End Date: 30-Apr-2009
• ICS: 11.080.10 - Sterilizing equipment
• Technical Committee: VAZ - Healthcare
• Current Stage: 98 - Abandoned project (Adopted Project)
• Start Date: 29-Jul-2011
• Due Date: 03-Aug-2011
• Completion Date: 29-Jul-2011
• Directive: 2007/47/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
• Directive: 93/42/EEC - Council Directive 93/42/EEC of 14 June 1993 concerning medical devices
• Mandate: M/023 - Standardization mandate to CEN/CENELEC concerning the development of European standards relating to medical devices
• Ref Project: EN 14180:2003/prA2 - Sterilizers for medical purposes - Low temperature steam and formaldehyde sterilizers - Requirements and testing

Relations

• Amends: SIST EN 14180:2003 - Sterilizers for medical purposes - Low temperature steam and formaldehyde sterilizers - Requirements and testing
• Effective Date: 01-Apr-2009
• Consolidated By: SIST EN 14180:2003+A2:2009 - Sterilizers for medical purposes - Low temperature steam and formaldehyde sterilizers - Requirements and testing
• Effective Date: 18-Jan-2023
• Consolidated By: SIST EN 14180:2003+A2:2009 - Sterilizers for medical purposes - Low temperature steam and formaldehyde sterilizers - Requirements and testing
• Effective Date: 19-Jan-2023
• Consolidated By: SIST EN 14180:2003+A2:2009 - Sterilizers for medical purposes - Low temperature steam and formaldehyde sterilizers - Requirements and testing
• Effective Date: 01-Nov-2009

Standards Content (Sample)

SLOVENSKI STANDARD
SIST EN 14180:2003/kprA2:2009
01-april-2009
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 à usage médical - Stérilisateurs à la vapeur et au formaldéhyde à basse
température - Exigences et essais
Ta slovenski standard je istoveten z: EN 14180:2003/prA2
ICS:
11.080.10 Sterilizacijska oprema Sterilizing equipment
SIST EN 14180:2003/kprA2:2009 en,fr,de
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

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SIST EN 14180:2003/kprA2:2009

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SIST EN 14180:2003/kprA2:2009
EUROPEAN STANDARD
FINAL DRAFT
EN 14180:2003
NORME EUROPÉENNE
EUROPÄISCHE NORM
prA2
February 2009
ICS

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 draft amendment is submitted to CEN members for unique acceptance procedure. It has been drawn up by the Technical Committee
CEN/TC 102.
This draft amendment A2, if approved, will modify the European Standard EN 14180:2003. If this draft becomes an amendment, CEN
members are bound to comply with the CEN/CENELEC Internal Regulations which stipulate the conditions for inclusion of this amendment
into the relevant national standard without any alteration.
This draft amendment was established by CEN 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 CEN Management Centre has the same
status as the official versions.
CEN members are the national standards bodies of Austria, Belgium, Bulgaria, Cyprus, Czech Republic, Denmark, Estonia, Finland,
France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal,
Romania, Slovakia, Slovenia, Spain, Sweden, Switzerland and United Kingdom.
Warning : This document is not a European Standard. It is distributed for review and comments. It is subject to change without notice and
shall not be referred to as a European Standard.
EUROPEAN COMMITTEE FOR STANDARDIZATION
COMITÉ EUROPÉEN DE NORMALISATION
EUROPÄISCHES KOMITEE FÜR NORMUNG
Management Centre: rue de Stassart, 36  B-1050 Brussels
© 2009 CEN All rights of exploitation in any form and by any means reserved Ref. No. EN 14180:2003/prA2:2009: E
worldwide for CEN national Members.

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SIST EN 14180:2003/kprA2:2009
EN 14180:2003/prA2:2009 (E)
Contents Page
Foreword .3
1 Modification to the Introduction .4
2 Modification to Clause 2 .4
3 Modification to Clause 3 .4
4 Modification to 4.2.4.1 .5
5 Modification to 4.2.4.2 .5
6 Modification to 4.2.6.2 .5
7 Modification to 4.3.8.1 .5
8 Modification to 5.2.5 .5
9 Modification to 5.3.1 .5
10 Modification to 5.4.2 .6
11 Modification of 5.4.3 .6
12 Modification to 5.4.5 .6
13 Modification to 6.2 .6
14 Modification to 8.3 .6
15 Modification to Clause 9.1 m) .6
16 Modification to 9.2 a) list item 10) .7
17 Modification to 9.2 i) .7
18 Modification to 10.7 .7
19 Modification to 10.8 .7
20 Modification to A.3.3.6 .7
21 Modification to B.3.3 .7
22 Modification to B.3.4 .7
23 Modification to B.3.5 .8
24 Modification to C.7 .8
25 Modifications to Bibliography .8

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SIST EN 14180:2003/kprA2:2009
EN 14180:2003/prA2:2009 (E)
Foreword
This document (EN 14180:2003/prA2:2009) has been prepared by Technical Committee CEN/TC 102
“Sterilizers for medical purposes”, the secretariat of which is held by DIN.
This document is currently submitted to the Unique Acceptance Procedure.
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 EC Directive(s).
For relationship with EC Directive(s), see informative Annex ZA, which is an integral part of this document.
3

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SIST EN 14180:2003/kprA2:2009
EN 14180:2003/prA2:2009 (E)
1 Modification to the Introduction
th th
Replace the 5 and 6 paragraphs with the following:
"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. Criteria for validation and routine control of
LTSF sterilization processes are given in EN 15424.
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 15424:2007 1.2.1)."
Replace "EN 61010–2–042" in last paragraph with "EN 61010–2–040
...