EN 14222:2021

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 (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.
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.
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 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.
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 E
...