EN 14180:2003/prA2

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
• ICS: 11.080.10 - Sterilizing equipment
• Technical Committee: CEN/TC 102 - Sterilizers for medical purposes
• Drafting Committee: CEN/TC 102/WG 6 - Gas sterilizers
• Current Stage: 5060 - Closure of Vote - Formal Approval
• Start Date: 12-May-2009
• Due Date: 09-May-2010
• Completion Date: 12-May-2009
• 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: SIST EN 14180:2003/kprA2:2009 - Sterilizers for medical purposes - Low temperature steam and formaldehyde sterilizers - Requirements and testing

Relations

• Merged Into: EN 14180:2003+A2:2009 - Sterilizers for medical purposes - Low temperature steam and formaldehyde sterilizers - Requirements and testing
• Effective Date: 30-May-2009
• Amends: EN 14180:2003 - Sterilizers for medical purposes - Low temperature steam and formaldehyde sterilizers - Requirements and testing
• Effective Date: 22-Dec-2008

Overview

EN 14180:2003/prA2 is a CEN draft amendment to the European standard EN 14180:2003, titled Sterilizers for medical purposes - Low temperature steam and formaldehyde sterilizers - Requirements and testing. The prA2 text (2009) updates normative references, safety and EMC requirements, test limits and normative cross-references. It clarifies that validation and routine control are not covered by this document and directs users to EN 15424 for process validation and routine control of LTSF (low temperature steam and formaldehyde) sterilization processes.

Key topics and technical requirements

• Scope and status: Amendment prA2 modifies clauses throughout EN 14180:2003; the draft was circulated for unique acceptance (2009).
• Safety standards updated: Replaces references to EN 61010-2-042 with EN 61010-2-040 (electrical safety requirements for sterilizers and washer-disinfectors) and updates notes on installation, maintenance and markings to align with EN 61010-2-040.
• Electromagnetic compatibility (EMC): Sterilizers must comply with EN 61326; devices used in medical areas or near sensitive equipment are regarded as Class B and immunity requirements follow EN 61326:2006 Table 2.
• Biological indicators and testing: Biological indicators are defined and references moved to EN ISO 11138‑1 (general) and EN ISO 11138‑5 (LTSF biological indicators). Culture methods reference EN 11138‑1.
• Formaldehyde residues: Desorption-stage limits when tested per A.3.5 - mean ≤ 200 µg per test piece; single-piece limit raised to 400 µg (replacing earlier 250 µg limit). A note explains observed variance in residue measurements.
• Production, IQ/OQ guidance: Production test series (Table B.1) recommended for conformity. Installation/operational/maintenance qualification guidance is referenced to EN 15424 rather than being normatively included.

Applications and who uses it

• Medical device manufacturers of LTSF sterilizers and OEMs updating product design, safety labeling and EMC compliance.
• Hospital and clinical engineering teams evaluating sterilizer conformity and safety features prior to purchase or commissioning.
• Certification bodies and test laboratories performing type-testing, production testing and conformity assessments of low temperature steam and formaldehyde sterilizers.
• Regulatory and quality managers integrating normative cross-references (EN 15424, EN 61010‑2‑040, EN ISO 11138‑5) into sterilization protocols and technical documentation.

Related standards (normative & guidance)

• EN 15424 - Development, validation and routine control for LTSF processes
• EN 61010-2-040 - Safety requirements for sterilizers and washer-disinfectors
• EN 61326 - EMC for electrical equipment
• EN ISO 11138-1 / EN ISO 11138-5 - Biological indicators for sterilization
• EN ISO 11140-1 - Chemical indicators (bibliography replacement)

Keywords: EN 14180, low temperature steam and formaldehyde sterilizers, LTSF, sterilizer requirements and testing, EN 15424, EN 61010-2-040, EN ISO 11138-5, formaldehyde residues.

Standards Content (Sample)

SLOVENSKI STANDARD
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
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

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.

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

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.
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
...