SIST EN 14222:2021
(Main)Stainless steel steam boilers
Stainless steel steam boilers
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.
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 tubes de fumée chauffées électriquement, fabriquées en acier inoxydable, spécifiquement destinées à la production de vapeur pour les stérilisateurs et les dispositifs de désinfection.
Seules les chaudières 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
SIST EN 14222:2021
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
SIST EN 14222:2021 en,fr,de
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.
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SIST EN 14222:2021
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SIST EN 14222:2021
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.
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SIST EN 14222:2021
EN 14222:2021 (E)
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
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SIST EN 14222:2021
EN 14222:2021 (E)
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);
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SIST EN 14222:2021
EN 14222:2021 (E)
— 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.
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SIST EN 14222:2021
EN 14222:2021 (E)
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.
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SIST EN 14222:2021
EN 14222:2021 (E)
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 (IEC 60204-1:2016, modified)
3)
EN 61010-1:2010 , Safety requirements for electrical equipment for measurement, control, and
laboratory use — Part 1: General requirements (IEC 61010-1:2010)
1) This document is being amended by EN 285:2015/FprA1:2020.
2) Including all amendments.
3) This document is impacted by amendment EN 61010-1:2010/A1:2019 and corrigendum
EN 61010-1:2010/A1:2019/AC:2019-04.
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EN 14222:2021 (E)
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)
4)
EN 62061:2005 , Safety of machinery — Functional safety of safety-related electrical, electronic and
programmable electronic control systems (IEC 62061:2005)
EN ISO 11139:2018, Sterilization of health care products — Vocabulary of terms used in sterilization and
related equipment and process standards (ISO 11139:2018)
EN ISO 13849-1:2015, Safety of machinery — Safety-related parts of control systems — Part 1: General
principles for design (ISO 13849-1:2015)
EN ISO 13849-2:2012, Safety of machinery — Safety-related parts of control systems — Part 2: Validation
(ISO 13849-2:2012)
3 Terms and definitions
For the purposes of this document, the terms and definitions of the pressure equipment directive (PED),
and terms and definitions given in EN 764-1:2015+A1:2016, EN 12953-1:2012 and EN 12953-6:2011,
and the following apply.
In case of conflicts with terms defined in EN ISO 11139:2018, the terms from the PED have priority.
ISO and IEC maintain terminological databases for use in standardization at the following addresses:
— ISO Online browsing platform: available at https://www.iso.org/obp
— IEC Electropedia: available at http://www.electropedia.org/
3.1
control
regulation of variables within specified limits
Note 1 to entry: For example, water level, pressure, temperature.
[SOURCE: EN ISO 11139:2018, 3.63 — modified: Note 1 to entry added.]
3.2
limiter
limiting device that, on reaching a fixed value is used to interrupt and lock-out the heating energy
supply
Note 1 to entry: Limiting device comprises
— a measuring or detection function
— an activation function or correction, or shutdown, or shutdown and lock out, and which is used to carry out
safety related functions as defined in the PED, on its own or as part of safety (protective) system (e.g.
sensors, limiters) (see also Figure 1). If this is achieved by multi channel systems, then all items or limiters for
safety purposes are included with safety (protective) system.
4) This document is impacted by amendments EN 62061:2005/A1:2013 and EN 62061:2005/A2:2015.
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EN 14222:2021 (E)
Figure 1 — Protective devices and safety accessory according to Directive 2014/68/EU (PED)
Note 2 to entry: Fixed value can e.g. be specified pressure, temperature, flow, water level.
[SOURCE: EN 12953-9:2007, 3.1 — modified, Note 2 to entry added to move examples “(e.g. pressure,
temperature, flow, water level)” from the definition into a note and cited Directive has been updated in
the Figure title from "Directive 97/23/EC" to "Directive 2014/68/EU".]
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
3.5
steam boiler
device to supply steam for external use comprising a vessel under pressure containing water to
generate the steam by applying heat energy
4 Materials
Each steam boiler shall be manufactured from austenitic steel and/or austenitic ferritic stainless steel
(duplex) in accordance with EN 13445-2:2014.
5 Design
Each steam boiler shall be designed in accordance with EN 13445-3:2014.
6 Manufacture
Each steam boiler shall be manufactured in accordance with EN 13445-4:2014.
7 Inspection and testing
Each steam boiler shall be inspected, tested and documented in accordance with EN 13445-5:2014.
8
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EN 14222:2021 (E)
8 Marking
The requirements for marking shall be in accordance with EN 12953-5:2020.
9 Requirements for equipment
9.1 General
9.1.1 The requirements for electrically heated stainless steel steam boilers are given in
EN 60204-1:2018. The requirements regarding shell boilers are derived from EN 12953-1:2012,
EN 12953-5:2020, EN 12953-6:2011, EN 12953-8:2001 and EN 12953-9:2007 and modified by the
following clauses.
9.1.2 Materials in contact with steam shall:
a) resist attack from steam and condensate;
b) not cause deterioration of the quality of the steam;
c) not release any substances known to be toxic in such quantities that could create a health or
environmental hazard.
NOTE For further requirements on material, see EN 285:2015, 4.2.
9.2 Safeguards against excessive pressure
Each steam boiler shall be equipped with safeguards against excessive pressure in accordance with
EN 12953-8:2001. In a deviation from EN 12953-8:2001 the minimum inside diameter of the safety
valve seat may be reduced to 8 mm.
9.3 Materials for valves, fittings, flanges and bolting
Steel materials for valves, fittings, flanges and bolting shall be in accordance with EN 13445-2:2014.
9.4 Limiting devices and safety circuits
9.4.1 Limiters shall be designed in accordance with EN 12953-9:2007. In addition to the
requirements of EN 12953-9:2007, 5.4.2, level electrode inclinations between 45° and 90° from the
vertical shall be allowed provided that functional capability and equivalent safety level examinations
have proven successful.
The electrical safety circuits shall be in accordance with EN 60204-1:2018. If the steam boiler is a part
of a sterilizer complying with EN 285:2015 or EN 13060:2014+A1:2018, electrical safety circuits may
be analogous to the sterilizer in accordance to EN 61010-1:2010 and EN 61010-2-040:2015.
9.4.2 Software used for limiting devices, the boiler heat supply system and any further safety function
and component shall be developed, verified and validated according to the respective requirements
given by EN 285:2015 and EN 13060:2014+A1:2018, respectively (see EN 285:2015, 7.3 and
EN 13060:2014+A1:2018, 4.5.4). Respective requirements from EN 12953-6:2011 or EN 12953-9:2007
may be applied alternatively.
9.4.3 Based on a hazard analysis, for limiting devices, the boiler heat supply system and any further
safety function and component appropriate safety performance levels shall be established according to
EN 62061:2005 and/or EN ISO 13849-1:2015 and EN ISO 13849-2:2012 (see EN 60204-1:2018, 9.4.1).
Respective requirements from EN 12953-6:2011 or EN 12953-9:2007 may be applied alternatively.
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9.4.4 Functional checking of all limiters shall be possible at any time during operation or by a
separate test, e.g. by simulation, where appropriate.
9.4.5 If a limiter responds, the steam boiler shall automatically go to a safe condition and a signal shall
be given to indicate steam boiler malfunction.
9.4.6 After manual resetting of a limiter lock-out, the steam boiler shall be put back into operation by
manual intervention only.
9.5 Steam boiler heat supply
9.5.1 The operating pressure of each steam boiler shall be controlled automatically by regulating the
heating energy input. If the steam boiler is a part of a sterilizer complying with EN 285:2015 or
EN 13060:2014+A1:2018, control of the steam boiler may be executed by the sterilizer's control
equipment as specified in EN 285:2015, Clause 7, or EN 13060:2014+A1:2018, 4.5.
9.5.2 Automatic start-up of the steam boiler and the system is permitted provided that equipment is
installed to ensure that start-up is conducted safely. Automatic restarting after normal shut-down shall
not be considered a start-up.
9.5.3 A high temperature alarm device for shutting off the heating energy supply shall be provided
and adjusted accordingly. The alarm temperature shall be determined.
9.5.4 The electrical supply circuits and the safety of the control equipment shall conform to
EN 60204-1:2018. If the steam boiler is a part of a sterilizer complying with EN 285:2015 or
EN 13060:2014+A1:2018, the electrical supply circuits and the safety of the control equipment may be
analogous to the sterilizer in accordance with EN 61010-1:2010 and EN 61010-2-040:2015.
9.6 Water level indication
9.6.1 Each steam boiler shall have at least one independent means (independent from other
equipment) of indicating the water level, which shall be a water level gauge of transparent material
directly connected to the steam boiler.
9.6.2 The water level gauge(s) shall be mounted so that the water level is visible through the
transparent material at the lowest alarm level, i.e. at the lowest permissible water level (LWL), which
shall be marked. The specified maximum permissible water level shall also be visible. The water level
gauge shall be capable of showing a measurement of "15 mm below LWL".
9.6.3 If the steam generator is equipped with a safety water level limiter (see 9.12.1) then the lowest
permissible water level (LWL) of the boiler (see Figure 2), which shall be permanently and legibly
marked on the steam boiler shell and identified by the letters "LWL", shall be at least 30 mm above the
uppermost surface of the immersion heaters "UHS". If the steam boiler is equipped with a safety
temperature limiter instead of a water level limiter (see 9.12.1), the lowest permissible water level
(LWL) shall be marked at the switch point of the safety temperature limiter.
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EN 14222:2021 (E)
Key
1 controlled water level
2 lowest permissible water level (LWL)
3 uppermost surface of the immersion heaters (UHS)
Figure 2 — Water level indication
9.6.4 Pipes and fittings connecting a water level gauge to a steam boiler shall be as short as possible
and constructed so that no undrained pocket is formed between the steam boiler and the water level
gauge. There shall be no outlet therefrom except for regulators, steam pressure gauges and drains or
other similar component, which does not permit the escape of a significant amount of steam.
Pipes connecting a water level gauge to the steam boiler shall not be less than 8 mm bore. Where a
chamber of a safety control or alarm device is fitted to the water level gauge or its piping, the
connecting pipes between the steam boiler and the water level gauge shall have a bore not less than
15 mm.
9.6.5 Where the water level gauge is a part of the steam boiler, the requirements of 9.6.4 shall not
apply.
9.7 Steam pressure indication
9.7.1 Each steam boiler shall have a steam pressure gauge in accordance with EN 285:2015, 6.2, or
EN 13060:2014+A1:2018, 4.4.2.4, for small steam sterilizers connected to the steam space either
directly or through the water level gauge column or its steam connection.
9.7.2 The steam pressure gauge shall be connected via a water seal to keep the gauge protected from
excessive temperature within the range of operating conditions. The pipe shall be of sufficient size and
shall have provision for blowing through, if possible. Alternatively, the pressure line shall be fitted with
an isolating membrane close to the steam boiler. The pressure line between the membrane and the
gauge shall contain a non-compressible fluid.
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EN 14222:2021 (E)
9.7.3 Steam pressure gauge connections shall be made suitable for the design pressure of the steam
boiler.
9.7.4 Steam pressure gauges shall be graduated to indicate the pressure in bars. The maximum
allowable pressure shall be indicated by a fixed and readily visible red mark on the steam pressure
gauge.
In addition, the operating pressure and the safety valve set pressure may also be indicated.
9.7.5 Each steam boiler shall be provided with a valve connection for the special purpose of
connecting a test gauge when the steam boiler is in service so that the accuracy of the steam boiler
steam gauge can be ascertained.
9.8 Drain and blowdown devices
9.8.1 Each steam boiler shall be fitted with drain valves placed at, or as near as practicable to, the
lowest point of the steam boiler.
Drain valves may be used for blowdown purposes.
9.8.2 Where drain valves from two or more steam boilers are connected to a common discharge, two
valves shall be fitted to each drain, one being of a non-return type to prevent the contents of one steam
boiler passing to another. As an alternative to the non-return valves, a safety shut-down device, or stop
valve system, enabling only one valve to be open at a time, shall be allowed.
9.8.3 Taper-plug valves where fitted, shall be of the bolted cover type with separately packed glands.
9.8.4 Where drain valves are not self-closing or capable of being locked in the closed position, a
further shut-off device, safety shut-down device, or stop valve shall be installed in the line.
Having the drain valve enclosed by a cabinet or an inspection door is included in the term "being locked
in a closed position".
9.9 Valves for connections
9.9.1 Steam outlets
The stop valve connecting the steam boiler to the steam pipe shall be attached directly to the steam
boiler or shall be as near to it as practicable. The valve should preferably be of a type, which positively
indicates whether it is open or closed. Where more than one steam boiler is connected to a common
header or steam manifold, the steam connections for each steam boiler shall be provided with two stop
valves, shut-down devices, or some similar safety method shall be provided.
It is preferable that the valve nearest the steam boiler be a non-return type.
9.9.2 Feed water connections and steam supply lines
Each feed water connection to an individual steam boiler, and each steam supply line from the steam
boiler to the sterilizer shall be provided with a non-return valve and a separate stop valve near the
steam boiler.
If the stop valve and non-return valve are not connected directly to each other, it shall be possible to
relieve the pressure in the interconnecting piping.
The feed line and internal pipe connection to the steam boiler shall be so arranged that in case of
leakage in the feed line, the steam boiler cannot empty itself to a level below the uppermost surface of
the immersion heaters.
12
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...
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.
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oSIST prEN 14222:2019
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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.
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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
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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.
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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.
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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.
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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 13445-3:2014.
6 Manufacture
Each steam boiler shall be manufactured in accordance with EN 13445-4:2014.
7 Inspection and testing
Each steam boiler shall be inspected, tested and documented in accordance with EN 13445-5:2014.
8 Marking
The requirements for marking shall be in accordance with EN 12953-5:2002.
9 Requirements for equipment
9.1 General
The following requirements for equipment for electrically heated stainless steel shell boilers are
worked out on the basis of EN 12953-6:2011.
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9.2 Safeguards against excessive pressure
Each steam boiler shall be equipped with safeguards against excessive pressure in accordance with
EN 12953-8:2001. In a deviation from EN 12953-8:2001 the minimum inside diameter of the safety
valve seat could be reduced to 8 mm.
9.3 Materials for valves, fittings, flanges and bolting
Steel materials for valves, fittings, flanges and bolting shall be in accordance with EN 13445-2:2014.
9.4 Limiting devices and safety circuits
9.4.1 Limiters shall be designed in addition to EN 12953-9:2007. In accordance with
EN 12953-9:2007, 5.4.2 level electrode inclinations between 45° and 90° from the vertical shall be
allowed provided that functional capability examinations have proven successful.
The electrical safety circuits shall be in accordance with EN 60204-1:2018. If the steam boiler is a part
of a sterilizer complying with EN 285 or EN 13060, electrical safety circuits may be analogous to the
sterilizer in accordance to EN 61010-1:2010 and EN 61010-2-040:2015.
9.4.2 Functional checking of all limiters shall be possible at any time during operation or by a
separate test, e.g. by simulation, where appropriate.
9.4.3 If a limiter responds, the boiler shall automatically go to a safe condition and a signal shall be
given to indicate boiler malfunction.
9.4.4 After manual resetting of a limiter lock-out, the boiler shall be put back into operation by
manual intervention only.
9.5 Boiler heat supply
9.5.1 The pressure of each boiler shall be controlled automatically by regulating the heating energy
input. If the steam boiler is a part of a sterilizer complying with EN 285:2015 or EN
13060:2014+A1:2018, control of the steam boiler may be executed by the sterilizer's control equipment
as specified in EN 285:2015, Clause 7, or EN 13060:2014+A1:2018, 4.5.
9.5.2 Automatic start-up of the boiler and the system is permitted provided that equipment is
installed to ensure that start-up is conducted safely. Automatic restarting after normal shut-down shall
not be considered a start-up.
9.5.3 A high temperature alarm device for shutting off the heating energy supply shall be provided.
The alarm temperature shall be determined by the manufacturer.
9.5.4 The electrical supply circuits and the safety of the control equipment shall conform to
EN 60204-1:2018. If the steam boiler is a part of a sterilizer complying with EN 285:2015 or EN
13060:2014+A1:2018, the electrical supply circuits and the safety of the control equipment may be
analogous to the sterilizer in accordance to EN 61010-1:2010 and EN 61010-2-040:2015.
9.6 Water level indication
9.6.1 Each steam boiler shall have at least one independent means (independent from other
equipment) of indicating the water level, which shall be a gauge of transparent material directly
connected to the boiler shell.
9.6.2 The gauge(s) shall be mounted so that the water level is visible through the transparent
material at the lowest alarm level, i.e. at the lowest permissible water level (LWL), which shall be
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marked. The maximum permissible water level, which shall be specified by the boiler manufacturer,
shall be visible. The gauge shall be capable of showing a measurement of "15 mm below LWL".
9.6.3 If the steam generator is equipped with a safety water level limiter (see 9.12.1) then the lowest
permissible water level (LWL) of the boiler (see Figure 1), which shall be permanently and legibly
marked on the boiler shell and identified by the letters "LWL", shall be at least 30 mm above the
uppermost surface of the immersion heaters "HHS". If the steam boiler is equipped with a safety
temperature limiter instead of a water level limiter (see 9.12.1), the lowest permissible water level
(LWL) shall be marked at the switch point of the safety temperature limiter.
Key
1 controlled water level
2 lowest permissible water level (LWL)
3 uppermost surface of the immersion heaters (HHS)
Figure 1 — Water level indication
9.6.4 Pipes and fittings connecting a water level gauge to a boiler shall be as short as possible and
constructed so that no undrained pocket is formed between the boiler and the gauge. There shall be no
outlet therefrom except for regulators, steam pressure gauges and drains or other similar apparatus,
which does not permit the escape of a significant amount of steam.
Pipes connecting a water level gauge to the boiler shall not be less than 8 mm bore. Where a chamber of
a safety control or alarm device is fitted to the water gauge or its piping, the connecting pipes between
the boiler and the water level gauge shall have a bore not less than 15 mm.
9.6.5 Where the water level gauge is a part of the boiler shell, the requirements of 9.6.4 shall not
apply.
9.7 Steam pressure indication
9.7.1 Each boiler shall have a steam pressure gauge in accordance with EN 285:2015, 6.2, or EN
13060:2014+A1:2018, 4.4.2.4, for small steam sterilizers connected to the steam space either directly
or through the water level gauge column or its steam connection.
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9.7.2 The steam pressure gauge shall be connected to a siphon or similar device of sufficient capacity
to keep the gauge tube filled with water. The pipe shall be of sufficient size and shall have provision for
blowing through if possible. Alternatively, the pressure line shall be fitted with an isolating membrane
close to the boiler. The pressure line between the membrane and the gauge shall contain a non-
compressible fluid.
9.7.3 Steam pressure gauge connections shall be made suitable for the design working pressure of the
boiler.
9.7.4 Pressure gauges shall be graduated to indicate the pressure in bars. The maximum allowable
pressure shall be indicated by a fixed and readily visible red mark on the pressure gauge.
NOTE In addition, the operating pressure and the safety valve set pressure can also be indicated.
9.7.5 Eac
...
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