EN 14222:2021
(Main)Stainless steel steam boilers
Stainless steel steam boilers
This document specifies requirements for electrically heated steam boilers manufactured from stainless steel specifically dedicated for generating steam for sterilizers and disinfectors.
This document covers only steam boilers that are heated by immersion heaters and which have a maximum allowable pressure (PS) of not greater than 6 bar, a maximum volume (V) of 1 000 litres and a product of PS ∙ V not greater than 3 000 bar ∙ l.
Edelstahl-Dampfkessel
Dieses Dokument legt die Anforderungen an elektrisch beheizte Dampfkessel aus nichtrostenden Stählen (Edelstahl) fest, die zur Versorgung von Sterilisations und Desinfektionsanlagen dienen.
Dieses Dokument gilt nur für mit Eintauchheizelementen beheizte Dampfkessel mit einem maximal zulässigen Druck (PS) von nicht mehr als 6 bar, einem maximalen Volumen (V) von 1 000 l und einem Produkt PS · V von nicht mehr als 3 000 bar · l.
Chaudières à vapeur en acier inoxydable
Le présent document spécifie les exigences applicables aux chaudières à vapeur chauffées électriquement, fabriquées en acier inoxydable, spécifiquement destinées à la production de vapeur pour les stérilisateurs et les dispositifs de désinfection.
Seules les chaudières à vapeur qui sont chauffées par des dispositifs de chauffage immergés et qui ont une pression maximale admissible (PS) inférieure ou égale à 6 bar, un volume maximal (V) de 1 000 l et un produit PS ∙ V inférieur ou égal à 3 000 bar ∙ l, sont couvertes par le présent document.
Parni kotli iz nerjavnega jekla
General Information
Relations
Standards Content (Sample)
SLOVENSKI STANDARD
01-marec-2021
Nadomešča:
SIST EN 14222:2003
Parni kotli iz nerjavnega jekla
Stainless steel steam boilers
Edelstahl-Dampfkessel
Chaudières à vapeur en acier inoxydable
Ta slovenski standard je istoveten z: EN 14222:2021
ICS:
27.060.30 Grelniki vode in prenosniki Boilers and heat exchangers
toplote
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.
EN 14222
EUROPEAN STANDARD
NORME EUROPÉENNE
January 2021
EUROPÄISCHE NORM
ICS 27.060.30 Supersedes EN 14222:2003
English Version
Stainless steel steam boilers
Chaudières à vapeur en acier inoxydable Edelstahl-Dampfkessel
This European Standard was approved by CEN on 13 December 2020.
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 CEN-CENELEC 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 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, Turkey and
United Kingdom.
EUROPEAN COMMITTEE FOR STANDARDIZATION
COMITÉ EUROPÉEN DE NORMALISATION
EUROPÄISCHES KOMITEE FÜR NORMUNG
CEN-CENELEC Management Centre: Rue de la Science 23, B-1040 Brussels
© 2021 CEN All rights of exploitation in any form and by any means reserved Ref. No. EN 14222:2021 E
worldwide for CEN national Members.
Contents Page
European foreword . 3
Introduction . 5
1 Scope . 6
2 Normative references . 6
3 Terms and definitions . 7
4 Materials . 8
5 Design . 8
6 Manufacture . 8
7 Inspection and testing . 8
8 Marking . 9
9 Requirements for equipment . 9
9.1 General . 9
9.2 Safeguards against excessive pressure . 9
9.3 Materials for valves, fittings, flanges and bolting . 9
9.4 Limiting devices and safety circuits . 9
9.5 Steam boiler heat supply . 10
9.6 Water level indication . 10
9.7 Steam pressure indication . 11
9.8 Drain and blowdown devices . 12
9.9 Valves for connections . 12
9.9.1 Steam outlets . 12
9.9.2 Feed water connections and steam supply lines . 12
9.10 Feed water supply . 13
9.11 Feed water control . 13
9.12 Limiter . 13
9.12.1 Low water protection . 13
9.12.2 Pressure limitation . 13
10 Operation of steam boilers . 13
11 Small steam boilers . 13
Annex A (informative) Operation of steam boilers . 14
Annex B (informative) Guidance on the relationship between this European Standard and
the General Safety and Performance Requirements of Regulation (EU) 2017/745 on
medical devices . 15
Annex ZA (informative) Relationship between this European Standard and the essential
requirements of Directive 2014/68/EU on Pressure Equipment aimed to be covered
[OJEC L 189] . 19
Annex ZB (informative) Relationship between this European Standard and the essential
requirements of Directive 93/42/EEC on medical devices aimed to be covered [OJEC
L 169] . 20
Bibliography . 22
European foreword
This document (EN 14222:2021) 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 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 July 2021, and conflicting national standards shall be
withdrawn at the latest by July 2021.
Attention is drawn to the possibility that some of the elements of this document may be the subject of
patent rights. CEN shall not be held responsible for identifying any or all such patent rights.
This document supersedes EN 14222:2003.
This document has been prepared under mandates (M/071 and M/023) 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 Annexes ZA and ZB, which are an integral part of
this document.
Further to the updating both technically and editorially, the following changes compared to the
previous edition have been made:
— in the title “shell” has been changed to “steam” to read: "stainless steel steam boilers";
— Scope has been refined by replacing "allowable pressure (PS) of 6 bar" by "allowable pressure (PS)
of not greater than 6 bar";
— Introduction added;
— Normative references and Bibliography have been updated;
— alignment of terminology throughout the document;
— definition of “limiter” has been aligned with EN 12953-9 and new definition of "steam boiler" was
introduced;
— requirements on materials have been aligned with new edition of EN 13445-2;
— general requirements for equipment (see 9.1) have been revised, e.g. requirements on materials in
contact with steam added;
— requirements on limiting devices and safety circuits (see 9.4) have been fundamentally revised;
— requirements on steam boiler heat supply revised by adding cross-references to requirements of
EN 285:2015, or EN 13060:2014+A1:2018 (see 9.5);
— the option of the use of an safety temperature limiter instead of a water level limiter has been
addressed (see 9.6.3);
— requirements on steam pressure indication have been revised by adding reference to small steam
sterilizers (see 9.7.1);
— requirements on limiter regarding low water protection (see 9.12.1) have been fundamentally
revised;
— inclusion of informative Annex B on Guidance on the intended relationship between this European
Standard and the General Safety and Performance Requirements of Regulation (EU) 2017/745 on
medical devices aimed to be covered;
— update of Annex ZA on the Relationship between this European Standard and the essential
requirements of Directive 2014/68/EU on Pressure Equipment aimed to be covered [OJEC L 189];
— inclusion of Annex ZB on the Relationship between this European Standard and the essential
requirements of Directive 93/42/EEC on medical devices aimed to be covered [OJEC L 169].
According to the CEN-CENELEC Internal Regulations, the national standards organisations of the
following countries are bound to implement this European Standard: 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, Turkey and the
United Kingdom.
Introduction
EN 14222 is referred to normatively in EN 285:2015 ‘Sterilization – Steam sterilizers – Large sterilizers’
and can be applied to EN 13060:2014+A1:2018 ‘Small steam sterilizers’, two standards developed by
CEN/TC 102 ‘Sterilizers and associated equipment for processing of medical devices’.
During the systematic review of EN 14222:2003 in 2014, CEN/TC 102 identified and expressed that the
standard needed revising to bring it to the state of the art, and hence to enhance the requirements
contained in EN 285:2015 and EN 13060:2014+A1:2018.
This document refers to EN 12953, Shell boilers and EN 13445, Unfired pressure vessels.
1 Scope
This document specifies requirements for electrically heated steam boilers manufactured from stainless
steel specifically dedicated for generating steam for sterilizers and disinfectors.
This document covers only steam boilers that are heated by immersion heaters and which have a
maximum allowable pressure (PS) of not greater than 6 bar, a maximum volume (V) of 1 000 litres and
a product of PS ∙ V not greater than 3 000 bar ∙ l.
2 Normative references
The following documents are referred to in the text in such a way that some or all of their content
constitutes requirements of this document. For dated references, only the edition cited applies. For
undated references, the latest edition of the referenced document (including any amendments) applies.
1)
EN 285:2015 , Sterilisation — Steam sterilizers — Large sterilizers
EN 764-1:2015+A1:2016, Pressure equipment — Part 1: Vocabulary
EN 12953-1:2012, Shell boilers — Part 1: General
EN 12953-5:2020, Shell boilers — Part 5: Inspection during construction, documentation and marking of
pressure parts of the boiler
EN 12953-6:2011, Shell boilers — Part 6: Requirements for equipment for the boiler
EN 12953-8:2001, Shell boilers — Part 8: Requirements for safeguards against excessive pressure
EN 12953-9:2007, Shell boilers — Part 9: Requirements for limiting devices of the boiler and accessories
EN 13060:2014+A1:2018, Small steam sterilizers
2)
EN 13445-2:2014 , Unfired pressure vessels — Part 2: Materials
2)
EN 13445-3:2014 , Unfired pressure vessels — Part 3: Design
2)
EN 13445-4:2014 , Unfired pressure vessels — Part 4: Fabrication
2)
EN 13445-5:2014 , Unfired pressure vessels — Part 5: Inspection and testing
EN 14597:2012, Temperature control devices and temperature limiters for heat generating systems
EN 60204-1:2018, Safety of machinery — Electrical equipment of machines — Part 1: General
requirements (I
...
SLOVENSKI STANDARD
oSIST prEN 14222:2019
01-julij-2019
Mnogovodni kotli iz nerjavnega jekla
Stainless steel shell boilers
Edelstahl-Großwasserraumkessel
Chaudières à tubes de fumée en acier inoxydable
Ta slovenski standard je istoveten z: prEN 14222
ICS:
27.060.30 Grelniki vode in prenosniki Boilers and heat exchangers
toplote
oSIST prEN 14222:2019 en,fr,de
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.
oSIST prEN 14222:2019
oSIST prEN 14222:2019
DRAFT
EUROPEAN STANDARD
prEN 14222
NORME EUROPÉENNE
EUROPÄISCHE NORM
April 2019
ICS 27.060.30 Will supersede EN 14222:2003
English Version
Stainless steel shell boilers
Chaudières à tubes de fumée en acier inoxydable Edelstahl-Großwasserraumkessel
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, Former Yugoslav Republic of Macedonia, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania,
Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Romania, Serbia, Slovakia, Slovenia, Spain, Sweden, Switzerland,
Turkey 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
© 2019 CEN All rights of exploitation in any form and by any means reserved Ref. No. prEN 14222:2019 E
worldwide for CEN national Members.
oSIST prEN 14222:2019
prEN 14222:2019 (E)
Contents Page
European foreword . 3
Introduction . 4
1 Scope . 5
2 Normative references . 5
3 Terms and definitions . 5
4 Materials . 6
5 Design . 6
6 Manufacture . 6
7 Inspection and testing . 6
8 Marking . 6
9 Requirements for equipment . 6
9.1 General . 6
9.2 Safeguards against excessive pressure . 7
9.3 Materials for valves, fittings, flanges and bolting . 7
9.4 Limiting devices and safety circuits . 7
9.5 Boiler heat supply . 7
9.6 Water level indication . 7
9.7 Steam pressure indication . 8
9.8 Drain and blowdown devices . 9
9.9 Valves for connections . 9
9.9.1 Steam outlets . 9
9.9.2 Feed connections . 9
9.10 Feed water supply . 10
9.11 Feed water control . 10
9.12 Limiting devices . 10
9.12.1 Low water protection . 10
9.12.2 Pressure limitation . 10
10 Operational aspects of steam boilers . 10
11 Small steam boilers . 10
Annex A (informative) Operational aspects of steam boilers . 11
Annex ZA (informative) Relationship between this European Standard and the essential
requirements of Directive 2014/68/EU on Pressure Equipment aimed to be covered
[OJEC L 189] . 12
Annex ZB (informative) Relationship between this European Standard and the essential
requirements of Directive 93/42/EEC on medical devices aimed to be covered [1993
OJEC L 169] . 13
Annex ZC (informative) Relationship between this European Standard and the General
Safety and Performance Requirements of Regulation (EU) 2017/745 aimed to be
covered. 15
Bibliography . 19
oSIST prEN 14222:2019
prEN 14222:2019 (E)
European foreword
This document (prEN 14222:2019) 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 14222:2003.
This document has been prepared under a mandate (M/071 and M/023) 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 Annexes ZA, ZB and ZC which are integral parts of
this document.
oSIST prEN 14222:2019
prEN 14222:2019 (E)
Introduction
In 2016 CEN/TC 102 “Sterilizers and associated equipment for processing of medical devices” adopted
EN 14222 from CEN/TC 269 “Shell and water-tube boilers” into its work programme. The main reason
was the need for CEN/TC 102 to revise EN 14222:2003, as e.g. EN 285 and EN 13060 refer to it and
comments submitted by CEN/TC 102 during systematic review in 2014 could not be reviewed by CEN.
EN 14222 is to a large extent referred to normatively in EN 285:2015 ‘Sterilization – Steam sterilizers –
Large sterilizers’ and EN 13060:2014+A1:2018 ‘Small steam sterilizers’, two standards developed by
CEN/TC 102 ‘Sterilizers for medical purposes’.
During the systematic review of EN 14222:2003 in 2014, CEN/TC 102 identified and expressed that the
standard needed revising to bring it to the state of the art, and hence to enhance the requirements
contained in EN 285:2015 and EN 13060:2014+A1:2018.
However, due to a lack of relevant expertise able to engage in a revision process for EN 14222:2003,
CEN/TC 269 could not take the CEN/TC 102 comments into account but recognized that a revision
would be necessary.
It is essential that the revised standard supports listing of those sterilizer standards of CEN/TC 102 (e.g.
EN 285, EN 13060) in the European Journal, which are referencing normatively to EN 14222.
The standard covers electrically heated shell boilers specifically dedicated for generating steam for
sterilizers and disinfectors.
This European Standard refers to EN 12953, Shell boilers and EN 13445, Unfired pressure vessels.
oSIST prEN 14222:2019
prEN 14222:2019 (E)
1 Scope
This document specifies requirements for electrically heated shell boilers manufactured from stainless
steel specifically dedicated for generating steam for sterilizers and disinfectors.
This document covers only boilers that are heated by immersion heaters and which have a maximum
allowable pressure (PS) of not greater than 6 bar, a maximum volume (V) of 1 000 litres and a product
of PS ∙ V not greater than 3 000 bar ∙ l.
2 Normative references
The following documents are referred to in the text in such a way that some or all of their content
constitutes requirements of this document. For dated references, only the edition cited applies. For
undated references, the latest edition of the referenced document (including any amendments) applies.
EN 285:2015, Sterilization — Steam sterilizers — Large sterilizers
EN 12953-1:2012, Shell boilers — Part 1: General
EN 12953-5:2002, Shell boilers — Part 5: Inspection during construction, documentation and marking of
pressure parts of the boiler
EN 12953-6:2011, Shell Boilers — Part 6: Requirements for equipment for the boiler
EN 12953-8:2001, Shell boilers — Part 8: Requirements for safeguards against excessive pressure
EN 12953-9:2007, Shell boilers — Part 9: Requirements for limiting devices of the boiler and accessories
EN 13060:2014+A1:2018, Small steam sterilizers
EN 13445-2:2014, Unfired pressure vessels — Part 2: Materials
EN 13445-3:2014, Unfired pressure vessels — Part 3: Design
EN 13445-4:2014, Unfired pressure vessels — Part 4: Fabrication
EN 13445-5:2014, Unfired pressure vessels — Part 5: Inspection and testing
EN 14597:2012, Temperature control devices and temperature limiters for heat generating systems
EN 60204-1:2018, Safety of machinery — Electrical equipment of machines — Part 1: General
requirements (IEC 60204-1:2016, modified)
EN 61010-1:2010, Safety requirements for electrical equipment for measurement, control, and laboratory
use — Part 1: General requirements (IEC 61010-1:2010, modified)
EN 61010-2-040:2015, Safety requirements for electrical equipment for measurement, control, and
laboratory use — Part 2-040 Particular requirements for sterilizers and washer-disinfectors used to treat
medical materials (IEC 61010-2-040:2015)
3 Terms and definitions
For the purposes of this document, the terms and definitions given in EN 12953-1:2012,
EN 12953-6:2011 and the following apply.
oSIST prEN 14222:2019
prEN 14222:2019 (E)
ISO and IEC maintain terminological databases for use in standardization at the following addresses:
— IEC Electropedia: available at http://www.electropedia.org/
— ISO Online browsing platform: available at http://www.iso.org/obp
3.1
control
regulation of variables within specified limits
Note 1 to entry: Fro example water level, pressure, temperature.
[SOURCE: EN ISO 11139:2018, 3.63 – modified: Note 1 to entry added.]
3.2
limiter
device that, on reaching a fixed value (e.g. pressure, temperature, flow, water level) is used to interrupt
and lock-out the heating energy supply and lock-out requires manual unlocking before restart
3.3
lock-out
isolation of energy supply which requires a manual intervention to reinstate
3.4
functional check
testing of the safety device to ensure it performs its intended function
4 Materials
Each steam boiler shall be manufactured from austentic steel and/or austentic ferritic stainless steel
(duplex) in accordance with EN 13445-2:2014.
5 Design
Each steam boiler shall be designed in accordance with EN 13445-3:20
...
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