oSIST prEN 14180:2023

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

1.1   This document 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.
1.2   This document specifies minimum requirements:
-   for the performance and design of sterilizers intended to deliver an LTSF-process capable of sterilizing medical devices;
-   for the equipment and controls of these sterilizers needed for operation, control and monitoring of the sterilization processes, and which can be used for validation of the sterilization process.
1.3   This document specifies further test equipment and test procedures used to verify conformance of the equipment design and performance specified by this document.
1.4   This document does not specify requirements and tests for decontamination systems for use in rooms, enclosures, or environmental spaces.

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

1.1   Dieses Dokument legt Anforderungen und Prüfverfahren für NTDF Sterilisatoren fest, in denen als Sterilisiermittel ein Gemisch von Niedertemperatur-Dampf und Formaldehyd angewendet wird und die nur unterhalb des Umgebungsdruckes arbeiten.
Diese Sterilisatoren werden in erster Linie in medizinischen Einrichtungen zur Sterilisation hitzeempfindlicher Medizinprodukte verwendet.
1.2   Dieses Dokument legt Mindestanforderungen zu folgenden Punkten fest:
-   für die Leistung und Konstruktion von Sterilisatoren, um ein NTDF Verfahren bereitzustellen, das in der Lage ist, Medizinprodukte zu sterilisieren;
-   an die Ausrüstung und Bedienelemente dieser Sterilisatoren, die für den Betrieb, die Steuerung und Überwachung der Sterilisationsverfahren erforderlich sind, und welche bei der Validierung der Sterilisationsverfahren angewendet werden können.
1.3   Dieses Dokument legt weitere Prüfgeräte und Prüfverfahren fest, um die Konformität der Ausrüstungs¬konstruktion und der nach diesem Dokument festgelegten Leistung zu verifizieren.
1.4   Dieses Dokument legt keine Anforderungen an und Prüfungen für Dekontaminationssysteme zur Verwendung in Räumen, umschlossenen Räumen oder umgebenden Räumen fest.

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

1.1   Le présent document spécifie les exigences et les essais relatifs aux stérilisateurs à la vapeur et au formaldéhyde à basse température, utilisant comme agent stérilisant un mélange à basse température de vapeur d’eau et de formaldéhyde et fonctionnant uniquement à une pression inférieure à la pression atmosphérique.
Ces stérilisateurs sont utilisés en priorité pour stériliser les dispositifs médicaux thermolabiles dans les centres de soins.
1.2   Le présent document spécifie les exigences minimales :
-   de performance et de conception des stérilisateurs destinés à assurer un procédé LTSF capable de stériliser des dispositifs médicaux ;
-   pour les équipements et commandes de ces stérilisateurs nécessaires au fonctionnement, au pilotage et à la surveillance des procédés de stérilisation et qui peuvent être utilisés pour la validation du procédé de stérilisation.
1.3   Le présent document spécifie l’appareillage d’essai et des modes opératoires d’essai supplémentaires utilisés pour vérifier la conformité de la conception et des performances de l’équipement spécifiées par le présent document.
1.4   Le présent document ne spécifie pas d’exigences ni d’essais concernant les systèmes de décontamination destinés à être utilisés dans des salles, des enceintes ou des espaces environnementaux.

Sterilizatorji za uporabo v medicini - Sterilizatorji s paro z nizko temperaturo in s formaldehidom - Zahteve in preskušanje

General Information

• Status: Not Published
• Public Enquiry End Date: 28-Jun-2023
• ICS: 11.080.10 - Sterilizing equipment
• Technical Committee: VAZ - Healthcare
• Current Stage: 4020 - Public enquire (PE) (Adopted Project)
• Start Date: 14-Apr-2023
• Due Date: 01-Sep-2023
• Completion Date: 05-Jul-2023
• Directive: 2017/745 - Regulation (EU) 2017/745 of the European Parliament and of the Council of 5 April 2017 on medical devices, amending Directive 2001/83/EC, Regulation (EC) No 178/2002 and Regulation (EC) No 1223/2009 and repealing Council Directives 90/385/EEC and 93/42/EEC
• Mandate: M/575 - Medical devices in support of Regulation (EU) 2017/745 and in vitro diagnostic medical devices in support of Regulation (EU) 2017/746
• Ref Project: prEN 14180 - Sterilizers for medical purposes - Low temperature steam and formaldehyde sterilizers - Requirements and testing

Relations

• Replaces: SIST EN 14180:2014 - Sterilizers for medical purposes - Low temperature steam and formaldehyde sterilizers - Requirements and testing
• Effective Date: 02-Mar-2022

Standards Content (Sample)

SLOVENSKI STANDARD
oSIST prEN 14180:2023
01-junij-2023
Nadomešča:
SIST EN 14180:2014
Sterilizatorji za uporabo v medicini - Sterilizatorji s paro z nizko temperaturo 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: prEN 14180
ICS:
11.080.10 Sterilizacijska oprema Sterilizing equipment
oSIST prEN 14180:2023 en,fr,de
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

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oSIST prEN 14180:2023

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oSIST prEN 14180:2023


DRAFT
EUROPEAN STANDARD
prEN 14180
NORME EUROPÉENNE

EUROPÄISCHE NORM

April 2023
ICS 11.080.10 Will supersede EN 14180:2014
English Version

Sterilizers for medical purposes - Low temperature steam
and formaldehyde sterilizers - Requirements and testing
Stérilisateurs à usage médical - Stérilisateurs à la Sterilisatoren für medizinische Zwecke -
vapeur et au formaldéhyde à basse température - Niedertemperatur-Dampf-Formaldehyd-Sterilisatoren
Exigences et essais - Anforderungen und Prüfung
This draft European Standard is submitted to CEN members for enquiry. It has been drawn up by the Technical Committee
CEN/TC 102.

If this draft becomes a European Standard, 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.

This draft European Standard 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-CENELEC
Management Centre has the same status as the official versions.

CEN members are the national standards bodies of Austria, Belgium, Bulgaria, Croatia, Cyprus, Czech Republic, Denmark, Estonia,
Finland, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway,
Poland, Portugal, Republic of North Macedonia, Romania, Serbia, Slovakia, Slovenia, Spain, Sweden, Switzerland, Türkiye and
United Kingdom.

Recipients of this draft are invited to submit, with their comments, notification of any relevant patent rights of which they are
aware and to provide supporting documentation.

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

CEN-CENELEC Management Centre: Rue de la Science 23, B-1040 Brussels
© 2023 CEN All rights of exploitation in any form and by any means reserved Ref. No. prEN 14180:2023 E
worldwide for CEN national Members.

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oSIST prEN 14180:2023
prEN 14180:2023 (E)
Contents Page
European foreword . 6
Introduction . 7
1 Scope . 8
2 Normative references . 8
3 Terms and definitions . 9
4 General. 20
4.1 Sterilizer type definition . 20
4.2 Equipment development . 21
4.3 Calibration . 22
5 Equipment design and construction . 22
5.1 Safety and security . 22
5.1.1 General. 22
5.1.2 Protective measures . 23
5.1.3 Risk control and usability . 24
5.2 Sterilizer chamber . 25
5.2.1 Materials . 25
5.2.2 Dimensions. 25
5.2.3 Doors and interlocks of the sterilizer chamber . 26
5.2.4 Temperature control and insulating the sterilizer chamber . 27
5.2.5 Test connections . 27
5.3 Further functional components . 29
5.3.1 Pipework and fittings . 29
5.3.2 Evacuation system . 29
5.3.3 Aeration system . 29
5.3.4 Framework and panelling . 29
5.4 Vibration . 30
5.5 Ancillary equipment and components . 30
5.6 Transport . 30
5.7 User interfaces . 31
6 Indicating, monitoring, controlling, and recording devices . 32
6.1 General. 32
6.1.1 Pre-set programme . 32
6.1.2 Automatic controller . 32
6.2 Automatic control . 32
6.3 Control and monitoring system . 34
6.4 Failures . 36
6.4.1 General. 36
6.4.2 Faults . 36
6.4.3 Power failure . 37
6.4.4 Other failures . 37
6.5 Instrumentation . 38
6.5.1 General. 38
6.5.2 Temperature measuring devices . 38
6.5.3 Pressure measuring devices . 39
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6.5.4 Time measuring devices . 41
6.5.5 Sterilizing agent control and measuring devices . 41
6.6 Indicating devices . 41
6.6.1 General . 41
6.6.2 Cycle parameter indicating devices . 42
6.6.3 Cycle parameter indications . 43
6.6.4 Status indicators and indications . 44
6.6.5 Operating cycle counter . 45
6.7 Recording systems . 45
6.7.1 General . 45
6.7.2 Records . 46
6.7.3 Analogue presentation of records . 47
6.7.4 Digital records . 48
6.7.5 Data format for applied sterilant amount . 48
6.8 Operating cycle . 48
6.8.1 General . 48
6.8.2 Leak test . 48
6.8.3 Sterilization cycles . 49
7 Services and local environment . 51
7.1 General . 51
7.2 Sterilizing agent and sterilant . 52
7.3 Electrical supply . 52
7.4 Water . 53
7.4.1 Water used for sterilizer operation . 53
7.4.2 Feed water . 53
7.5 Steam . 53
7.6 Vacuum . 53
7.7 Drainage and discharges . 53
7.8 Lighting . 53
7.9 Compressed air . 54
7.10 Air and inert gases. 54
7.11 Ventilation and environment . 54
8 Emissions . 54
8.1 Electromagnetic emissions . 54
8.2 Noise . 55
8.3 Exhaust emissions . 55
8.4 Heat emissions . 56
9 Test instrumentation . 56
10 Performance assessment . 56
10.1 General . 56
10.2 Attainment of conditions . 57
10.2.1 Physical conditions . 57
10.2.2 Sterilant and sterilizing agent . 58
10.2.3 Microbiological performance . 58
10.3 Desorption efficacy . 59
10.4 Load dryness . 59
10.5 Pressure change . 59
11 Information to be supplied . 59
11.1 General . 59
11.2 Information to be available prior to purchase . 60
11.3 Information prior to installation . 61
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11.4 Marking and labelling . 61
11.5 Instructions for use . 62
11.6 Further information to be provided . 63
12 Packaging . 64
Annex A (normative) Test methods. 65
A.1 General. 65
A.2 Test loads . 65
A.3 Test procedures . 67
Annex B (normative) Sterilizer testing . 73
B.1 General. 73
B.2 Test concept . 73
Annex C (normative) Test equipment . 76
C.1 Pressure instrumentation . 76
C.2 Temperature sensors . 76
C.3 Temperature recording instrument . 76
C.4 Pressure recording instrument . 77
C.5 Penetration type test device (PTTD) . 78
C.6 Residues challenge device . 78
C.7 Biological indicators and systems . 79
C.8 Sterile barrier systems . 79
Annex D (normative) Determination of formaldehyde residuals in a filter indicator . 80
D.1 Procedure for sample preparation . 80
D.2 Analysis of formaldehyde contents in filter indicator . 80
Annex E (informative) Application of Formaldehyde in LTSF-processes . 83
E.1 Formaldehyde concentrations, physico-chemical conditions during a cycle . 83
E.2 Formaldehyde residuals on medical devices . 85
Annex F (informative) Illustrations of the interrelationship between control and recording. 88
F.1 Introduction . 88
F.2 Illustration 1 . 88
F.3 Illustration 2 . 90
F.4 Illustration 3 . 91
Annex G (normative) Alternative Protective measures . 94
Annex H (informative) Environmental aspects . 96
H.1 Environmental aspects regarding the life cycle of LTSF sterilizers . 96
H.2 Formaldehyde (brief description) . 96
H.3 Environmental impact . 96
Annex I (normative) Technical information and documentation . 98
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Annex ZA (informative) Relationship between this European Standard and the General Safety and
Performance Requirements of Regulation (EU) 2017/745 aimed to be covered . 100
Bibliography . 117

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oSIST prEN 14180:2023
prEN 14180:2023 (E)
European foreword
This document (prEN 14180:2023) has been prepared by Technical Committee CEN/TC 102 “Sterilizers
and associated equipment for processing of medical devices”, the secretariat of which is held by DIN.
This document is currently submitted to the CEN Enquiry.
This document will supersede EN 14180:2014.
This document has been prepared under a Standardization Request given to CEN by the European
Commission and the European Free Trade Association, and supports essential requirements of EU
Directive(s) / Regulation(s).
For relationship with EU Directive(s) / Regulation(s), see informative Annex ZA, which is an integral part
of this document.
In comparison with the previous edition, the following technical modifications have been made:
— structure of the main text has been adapted to the structure of ISO/TS 22421:2021 and harmonized
with the current revisions of EN 17180 and EN 1422 in 2022;
— references have been updated, including Table H.1 on Environmental Aspects, and the bibliography;
— some definitions of terms have been added, most definitions have been adapted with reference to
EN ISO 11139:2018;
— a separate clause ‘Protective measures’ has been implemented for referencing to individual clauses
of EN IEC 61010-2-040:2021;
— a new Annex G ‘Alternative protective measures’ has been added;
— requirements on the control and monitoring system have been merged into a new clause and
informative illustrations have been provided in a new Annex F;
— an informative new Annex E ‘Application of Formaldehyde in LTSF-processes.’ has been added to
explain in some detail the physico-chemical specifics during operation of the sterilizer;
— the specifications provide as a new option a specific cycle for simple items and a ‘simple items test
load’ to allow (shorter) cycles for load configurations providing a lower challenge to the sterilization
process regarding sterilizing agent penetration, desorption and total mass of the load;
— a new Annex I ‘Technical information and documentation’ has been added to consider Annex II of the
European Medical Device Regulation (MDR);
— a new Annex ZA has been added to show the relationship between this European Standard and
applicable European Directives and European Regulations.
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oSIST prEN 14180:2023
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Introduction
This document provides minimum requirements and test methods for sterilizers working below ambient
atmospheric pressure performing a low temperature steam and formaldehyde (LTSF) process.
LTSF sterilizers typically use a mixture of steam and formaldehyde at thermodynamic equilibrium
conditions. Sterilization occurs in the condensate layer at the surface of the items to be sterilized.
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 [12]. 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
document 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 ISO 25424.
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
Encephalopathy and Creutzfeldt-Jakob Disease. Specific recommendations have been produced in
particular countries for the processing of materials potentially contaminated with these agents. See also
EN ISO 25424:2019, 1.2.1.
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 H of this document.
General safety requirements for sterilizers are specified by EN 61010-1, and EN IEC 61010-2-040.
Further, EN 60204-1 can provide valuable options. They are referenced herein, but not repeated.
Occupational safety is not addressed in this document.
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oSIST prEN 14180:2023
prEN 14180:2023 (E)
1 Scope
1.1 This document 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 on
...