SIST EN 14222:2021+A1:2025

SLOVENSKI STANDARD
01-november-2025
Parni kotli iz nerjavnega jekla (vključno z dopolnilom A1)
Stainless steel steam boilers
Edelstahl-Dampfkessel
Chaudières à vapeur en acier inoxydable
Ta slovenski standard je istoveten z: EN 14222:2021+A1:2025
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 14222:2021+A1
EUROPEAN STANDARD
NORME EUROPÉENNE
September 2025
EUROPÄISCHE NORM
ICS 27.060.30 Supersedes EN 14222:2021
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 and includes Amendment 1 approved by CEN on 16 April
2025.
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, Türkiye 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
© 2025 CEN All rights of exploitation in any form and by any means reserved Ref. No. EN 14222:2021+A1:2025 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 ZA !(informative) Relationship between this European Standard the General Safety
and Performance Requirements of Regulation (EU) 2017/745 aimed to be covered . 16
Annex ZB (informative) Relationship between this European Standard and the essential
requirements of Directive 2014/68/EU on Pressure Equipment aimed to be
covered" . 19
Bibliography . 20
European foreword
This document (EN 14222:2021+A1:2025) 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 March 2026, and conflicting national standards shall
be withdrawn at the latest by March 2026.
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 14222:2021".
This document includes Amendment 1 approved by CEN on 16 April 2025.
The start and finish of text introduced or altered by amendment is indicated in the text by tags !".
!This document has been prepared under a standardization request addressed to CEN by the
European Commission. The Standing Committee of the EFTA States subsequently approves these
requests for its Member States.
For the relationship with EU Legislation, see informative Annex ZA, and Annex ZB, which are integral
parts 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+A1:2021, 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;
— !removal 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 the General Safety and
Performance Requirements of Regulation (EU) 2017/745 aimed to be covered;
— update of Annex ZB on the Relationship between this European Standard and the essential
requirements of Directive 2014/68/EU on Pressure Equipment aimed to be covered".
!Any feedback and questions on this document should be directed to the users’ national standards
body. A complete listing of these bodies can be found on the CEN website."
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, Türkiye and the
United Kingdom.
Introduction
EN 14222 is referred to normatively in !EN 285:2015+A1:2021", 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+A1:2021" 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.
!EN 285:2015+A1:2021, Sterilization — 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 12953-6:2024, Shell boilers — Part 6: Requirements for equipment for the boiler"
1)
!EN 12953-8:2001, Shell boilers — Part 8: Requirements for safeguards against excessive
pressure"
!EN 12953-9:2024, Shell boilers — Part 9: Requirements for limiting devices of the boiler and
accessories "
EN 13060:2014+A1:2018, Small steam sterilizers
!EN 13445-2:2021+A1:2023, Unfired pressure vessels — Part 2: Materials"
!EN 13445-3:2021, Unfired pressure vessels — Part 3: Design"
!EN 13445-4:2021+A1:2023, Unfired pressure vessels — Part 4: Fabrication"
!EN 13445-5:2021+A1:2024, Unfired pressure vessels — Part 5: Inspection and testing"
EN 14597:2012, Temperature control devices and temperature limiters for heat generating systems
2)
!EN 60204-1:2018, Safety of machinery — Electrical equipment of machines — Part 1: General
requirements (IEC 60204-1:2016)"
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 impacted by corrigendum EN 12953-8:2001/AC:2002.
2)
This document is impacted by amendment EN 60204-1:2018/A1:2025.
!EN IEC 61010-2-040:2021, 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 61010-2-040:2020)"
4)
!EN IEC 62061:2021, Safety of machinery — Functional safety of safety-related control systems
(IEC 62061:2021)"
5)
!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 13849-1:2023, Safety of machinery — Safety-related parts of control systems — Part 1:
General principles for design (ISO 13849-1:2023)"
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-
6:2024", 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 terminology databases for use in standardization at the following addresses:
— ISO Online browsing platform: available at https://www.iso.org/obp
— IEC Electropedia: available at https://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,

3)
This document is impacted by amendment EN 61010-1:2010/A1:2019 and corrigendum
EN 61010-1:2010/A1:2019/AC:2019-04.
4)
This document is impacted by amendment EN IEC 62061:2021/A1:2024.
5)
This document is impacted by amendment EN ISO 11139:2018/A1:2024.
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.

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 13445-2:2021+A1:2023".
5 Design
Each steam boiler shall be designed in accordance with !EN 13445-3:2021".
6 Manufacture
Each steam boiler shall be manufactured in accordance with !EN 13445-4:2021+A1:2023".
7 Inspection and testing
Each steam boiler shall be inspected, tested and documented in accordance with !EN 13445-
5:2021+A1:2024".
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 12953-6:2024", EN 12953-8:2001 and !EN 12953-9:2024" 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+A1:2021", 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-
2:2021+A1:2023".
9.4 Limiting devices and safety circuits
9.4.1 Limiters shall be designed in accordance with !EN 12953-9:2024". In addition to the
requirements of !EN 12953-9:2024", 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+A1:2021" or EN 13060:2014+A1:2018, electrical
safety circuits may be analogous to the sterilizer in accordance to EN 61010-1:2010 and
!EN IEC 61010-2-040:2021".
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+A1:2021" and EN 13060:2014+A1:2018, respectively (see
!EN 285:2015+A1:2021", 7.3 and EN 13060:2014+A1:2018, 4.5.4). Respective requirements from
!EN 12953-6:2024" or !EN 12953-9:2024" 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 IEC 62061:2021" and/or!EN ISO 13849-1:2023" and EN ISO 13849-2:2012 (see
EN 60204-1:2018, 9.4.1). Respective requirements from !EN 12953-6:2024" or !EN 12953-
...