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SIST

SIST EN 14180:2003/kprA1:2009

(Amendment)

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

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

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
09-Mar-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
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/prA1 - Sterilizers for medical purposes - Low temperature steam and formaldehyde sterilizers - Requirements and testing

Relations

Consolidated By
SIST EN 14180:2003+A1:2009 - Sterilizers for medical purposes - Low temperature steam and formaldehyde sterilizers - Requirements and testing
Effective Date
18-Jan-2023
Amends
SIST EN 14180:2003 - Sterilizers for medical purposes - Low temperature steam and formaldehyde sterilizers - Requirements and testing
Effective Date
01-Mar-2009
Consolidated By
SIST EN 14180:2003+A1:2009 - Sterilizers for medical purposes - Low temperature steam and formaldehyde sterilizers - Requirements and testing
Effective Date
19-Jan-2023
Consolidated By
SIST EN 14180:2003+A1:2009 - Sterilizers for medical purposes - Low temperature steam and formaldehyde sterilizers - Requirements and testing
Effective Date
01-Oct-2009

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Standards Content (Sample)

SLOVENSKI STANDARD
SIST EN 14180:2003/kprA1:2009
01-marec-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/prA1
ICS:
11.080.10 Sterilizacijska oprema Sterilizing equipment
SIST EN 14180:2003/kprA1:2009 en
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

---------------------- Page: 1 ----------------------

SIST EN 14180:2003/kprA1:2009

---------------------- Page: 2 ----------------------

SIST EN 14180:2003/kprA1:2009
EUROPEAN STANDARD
FINAL DRAFT
EN 14180:2003
NORME EUROPÉENNE
EUROPÄISCHE NORM
prA1
December 2008
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 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 A1, 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
© 2008 CEN All rights of exploitation in any form and by any means reserved Ref. No. EN 14180:2003/prA1:2008: E
worldwide for CEN national Members.

---------------------- Page: 3 ----------------------

SIST EN 14180:2003/kprA1:2009
EN 14180:2003/prA1:2008 (E)
Contents Page
Foreword .3
1 Modifications to Annex ZA .4

2

---------------------- Page: 4 ----------------------

SIST EN 14180:2003/kprA1:2009
EN 14180:2003/prA1:2008 (E)
Foreword
This document (EN 14180:2003/prA1:2008) 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

---------------------- Page: 5 ----------------------

SIST EN 14180:2003/kprA1:2009
EN 14180:2003/prA1:2008 (E)
1 Modifications to Annex ZA
Delete the title of Annex ZA and substitute the following:
"Relationship between this European Standard and the Essential Requirements of EU Directive
93/42/EEC"
Delete the first four paragraphs and substitute the following:
"This European Standard has been prepared under a mandate given to CEN
...

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