oSIST prEN ISO 19253:2026

SLOVENSKI STANDARD
01-marec-2026
Sterilizacija izdelkov za zdravstveno nego - Vlažna toplota - Zahteve za
sterilizatorje, ki se uporabljajo za končno sterilizacijo vodnih tekočin v zaprtih
posodah (ISO/DIS 19253:2026)
Sterilization of health care products - Moist heat - Requirements for sterilizers used for
the terminal sterilization of aqueous liquid in sealed containers (ISO/DIS 19253:2026)
Sterilisation von Produkten für die Gesundheitsfürsorge - Anwendung von ISO/TS 22421
auf die Anforderungen an Sterilisatoren, die für die Endsterilisation von Produkten für die
Gesundheitsfürsorge verwendet werden, die wässrige Flüssigkeiten in verschlossenen
Behältern enthalten (ISO/DIS 19253:2026)
Stérilisation des produits de santé - Chaleur humide - Exigences relatives aux
stérilisateurs utilisés pour la stérilisation terminale des liquides aqueux dans des
récipients hermétiques (ISO/DIS 19253:2026)
Ta slovenski standard je istoveten z: prEN ISO 19253
ICS:
11.080.10 Sterilizacijska oprema Sterilizing equipment
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

DRAFT
International
Standard
ISO/DIS 19253
ISO/TC 198
Sterilization of health care
Secretariat: ANSI
products — Moist heat —
Voting begins on:
Requirements for sterilizers used
2026-01-30
for the terminal sterilization of
Voting terminates on:
aqueous liquid in sealed containers
2026-04-24
ICS: 11.080.10
THIS DOCUMENT IS A DRAFT CIRCULATED
FOR COMMENTS AND APPROVAL. IT
IS THEREFORE SUBJECT TO CHANGE
AND MAY NOT BE REFERRED TO AS AN
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Reference number
ISO/DIS 19253:2026(en)
DRAFT
ISO/DIS 19253:2026(en)
International
Standard
ISO/DIS 19253
ISO/TC 198
Sterilization of health care
Secretariat: ANSI
products — Moist heat —
Voting begins on:
Requirements for sterilizers used
for the terminal sterilization of
Voting terminates on:
aqueous liquid in sealed containers
ICS: 11.080.10
THIS DOCUMENT IS A DRAFT CIRCULATED
FOR COMMENTS AND APPROVAL. IT
IS THEREFORE SUBJECT TO CHANGE
AND MAY NOT BE REFERRED TO AS AN
INTERNATIONAL STANDARD UNTIL
PUBLISHED AS SUCH.
This document is circulated as received from the committee secretariat.
IN ADDITION TO THEIR EVALUATION AS
BEING ACCEPTABLE FOR INDUSTRIAL,
© ISO 2026
TECHNOLOGICAL, COMMERCIAL AND
USER PURPOSES, DRAFT INTERNATIONAL
All rights reserved. Unless otherwise specified, or required in the context of its implementation, no part of this publication may
STANDARDS MAY ON OCCASION HAVE TO
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Published in Switzerland Reference number
ISO/DIS 19253:2026(en)
ii
ISO/DIS 19253:2026(en)
Contents Page
Foreword .v
Introduction .vi
1 Scope . 1
2 Normative references . 2
3 Terms and definitions . 3
4 General . 7
4.1 Product definition .7
4.2 Equipment development .8
4.3 Calibration .8
5 Equipment design and construction . 9
5.1 Safety and security .9
5.1.1 General .9
5.1.2 Over pressure protection devices (OPPD) .9
5.1.3 Over temperature protection devices .10
5.1.4 Door release safety system .10
5.1.5 Chamber empty protection system. .11
5.2 Chamber .11
5.2.1 General .11
5.2.2 Dimensions .11
5.2.3 Design of water dispersion systems within the chamber . 12
5.2.4 Doors . 12
5.2.5 Chamber integrity . 15
5.2.6 Pressure vessels .16
5.2.7 Uniformity of conditions .16
5.2.8 Ancillary equipment and components .17
5.3 Materials .19
5.4 Interlocks . 20
5.5 Test connections. 20
5.6 Vibration .21
5.7 User interfaces .21
6 Indicating, monitoring, controlling and recording .23
6.1 General . 23
6.2 Automatic control . 23
6.3 Control and monitoring system.24
6.4 Failure. 26
6.4.1 General . 26
6.4.2 Fault .27
6.4.3 Power failure . . 28
6.4.4 Other failures . 28
6.5 Instrumentation . 28
6.6 Indicating devices .32
6.7 Recorders . 33
7 Service and local environment .34
7.1 General . 34
7.2 Sterilizing agent and sterilant . 35
7.3 Electrical supply . 35
7.4 Water . 35
7.5 Steam . 36
7.6 Vacuum .37
7.7 Drains .37
7.8 Lighting .37
7.9 Compressed air .37

iii
ISO/DIS 19253:2026(en)
7.10 Air and inert gases . 38
7.11 Ventilation . 38
8 Emissions .38
8.1 Electromagnetic emissions . 38
8.2 Noise . 38
8.3 Exhaust emissions . 39
8.4 Heat emissions . 39
9 Test instrumentation .40
10 Performance and assessment .40
10.1 General . 40
10.2 Chamber integrity . 40
10.3 Attainment of conditions - Thermometric .41
10.4 Microbiological performance . 44
10.5 Pressure change . 44
11 Information to be supplied .44
11.1 General . 44
11.2 Information to be available prior to purchase .45
11.3 Post delivery information to be provided . 46
11.4 Marking .47
11.5 Label .47
11.6 Instructions for use .47
11.7 Technical description. 48
Annex A (informative) Background to the development of ISO 19253 .51
Annex B (informative) Illustrations of the interrelationship between control and recording .53
Annex C (normative) Methods for the determination of the dimensions of the sterilizer chamber
and the usable chamber space .58
Annex D (informative) Examples of contained product sterilization processes and an
explanation of the stages and terminology associated with such processes .62
Annex E (informative) Verification of the sterilizer’s F value accumulation system (if fitted) .67
Annex F (normative) Test methods and reference loads for contained product sterilizers .71
Annex G (informative) Suggestions for information which can be supplied by the purchaser of
the sterilizer .86
Annex H (normative) Test instrumentation .88
Annex I (informative) Test methods for determining steam quality .94
Annex J (informative) An exemplar thermometric approach to Performance Qualification when
validating a contained product sterilization process according to ISO 17665:2024 .96
Annex K (informative) Potential hazards associated with the sterilization of aqueous fluids in
sealed rigid containers.98
Annex L (informative) Methods for locating heat penetration temperature sensors into aqueous
liquids in sealed containers .100
Bibliography .109

iv
ISO/DIS 19253:2026(en)
Foreword
ISO (the International Organization for Standardization) is a worldwide federation of national standards
bodies (ISO member bodies). The work of preparing International Standards is normally carried out through
ISO technical committees. Each member body interested in a subject for which a technical committee
has been established has the right to be represented on that committee. International organizations,
governmental and non-governmental, in liaison with ISO, also take part in the work. ISO collaborates closely
with the International Electrotechnical Commission (IEC) on all matters of electrotechnical standardization.
The procedures used to develop this document and those intended for its further maintenance are described
in the ISO/IEC Directives, Part 1. In particular, the different approval criteria needed for the different types
of ISO documents should be noted. This document was drafted in accordance with the editorial rules of the
ISO/IEC Directives, Part 2 (see www.iso.org/directives).
ISO draws attention to the possibility that the implementation of this document may involve the use of (a)
patent(s). ISO takes no position concerning the evidence, validity or applicability of any claimed patent
rights in respect thereof. As of the date of publication of this document, ISO had not received notice of (a)
patent(s) which may be required to implement this document. However, implementers are cautioned that
this may not represent the latest information, which may be obtained from the patent database available at
www.iso.org/patents. ISO shall not be held responsible for identifying any or all such patent rights.
Any trade name used in this document is information given for the convenience of users and does not
constitute an endorsement.
For an explanation of the voluntary nature of standards, the meaning of ISO specific terms and expressions
related to conformity assessment, as well as information about ISO's adherence to the World Trade
Organization (WTO) principles in the Technical Barriers to Trade (TBT), see www.iso.org/iso/foreword.html.
This document was prepared by Technical Committee ISO/TC 198, Sterilization of health care products in
collaboration with the European Committee for Standardization (CEN) Technical Committee CEN/TC 102,
Sterilizers and associated equipment for processing of medical devices, in accordance with the Agreement on
technical cooperation between ISO and CEN (Vienna Agreement).
A list of all parts in the ISO 19253 series can be found on the ISO website.
Any feedback or questions on this document should be directed to the user’s national standards body. A
complete listing of these bodies can be found at www.iso.org/members.html.

v
ISO/DIS 19253:2026(en)
Introduction
Sterilizers designed to deliver moist heat sterilization processes are capable of reliable and effective
inactivation of microbiological contaminants to provide sterile medical products. Validated moist heat
sterilization processes can be utilized to sterilize porous loads or contained medical products (see
ISO 17665). However, the moist heat sterilization processes and sterilizers used to deliver these processes
can differ significantly for these two product types.
While saturated steam is used to sterilize porous load medical products, the heating medium (moist heat)
used for contained products can consist of saturated steam, non-saturated steam, a mixture of steam and
air or an inert gas, a mixture of steam and a pressurized water spray or water immersion. Saturated steam
sterilization processes employ the use of a passive or active air removal stage followed by sterilization with
saturated steam that directly contacts the product providing the required energy for heating and moisture
for effective microbial inactivation. Conversely, sterilization of contained fluid products can be accomplished
with energy from a heating medium containing steam or heated water that is transferred through the sealed
product container materials with the sterilizing agent, moist heat, being generated from the heated aqueous
formulation. Additionally, an overpressure ballasting, non-condensing gas such as air or nitrogen is often
required to protect the integrity of the container closure system for contained products. Due to these and
other sterilization process differences, this standard was developed to address the specific requirements for
contained product sterilizers. This document is based on the content, format and structure of ISO/TS 22421
and provides specific requirements for the sterilizer used for the sterilization of medical products presented
as aqueous formulations in sealed containers. The requirements for saturated steam sterilizers used for
porous loads of medical products are covered in other standards such as EN 285.
Sterilizers conforming to the requirements of this document:
— can be used in a health care facility or in an industrial setting for sterilizing contained products such as
pharmaceuticals, veterinary products or other aqueous sterile products in sealed containers;
— can be used to sterilize contained medical products including aqueous liquids, gels, a solution of a solute
in water, a colloidal dispersion, a suspension of a solid substrate in water, or an oil in water emulsion;
— can be used to process sealed containers which can be rigid (e.g. glass ampoules, vials or bottles), semi-
rigid (e.g. polypropylene bottles or syringes), or flexible intravenous infusion bags (e.g. polyvinyl chloride
bags);
— can be designed to provide a sterilization cycle in which:
— the load is heated to a specified temperature and held for a specified time, then cooled;
— the load is exposed to specified parameters for the heating period, exposure period (i.e. time at
a specified temperature or an accumulated F value), and a cooling period to meet physical
microbiological lethality values i.e. a specified F value and F requirements to support the
0 BIOLOGICAL
required sterility assurance level (SAL) for the medical products;
NOTE For information about F see ISO 17665.
BIOLOGICAL
— are designed for batch production but not for processes in which the product continually passes through
a processing environment;
— can be designed so that the load remains static throughout the sterilization process or can provide a
means of agitating the load by, for example, shaking or rotating, to enable the container contents to be
mixed;
— can be of any usable chamber space.
Some sterilizers are designed to process vented containers which are those which are not sealed but rather
allow free gaseous exchange in order to avoid pressure build up inside the container. Whilst sterilizers
conforming to this document are designed for the terminal sterilization of sealed containers a process can
be implemented in such a sterilizer to process vented containers.

vi
ISO/DIS 19253:2026(en)
The delivery of a validated and accurately controlled sterilization process is enabled by the use of sterilizing
equipment that is designed, constructed, installed and qualified to deliver the sterilization process safely
and reproducibly. Use of a sterilizer meeting the requirements of this standard and conformance with
ISO 17665 for the development, validation and routine control of sterilization processes ensures the delivery
of a reliable, reproducible, and accurately controlled sterilization process that can provide the required
-6
Sterility Assurance Level (e.g. ≤1 x 10 ) for contained medical products.
The tests described in this standard are reference tests intended for use in demonstrating conformity with
the specified performance requirements. They can be used in type tests, works tests, in validation and re-
validation tests, or in periodic and routine tests carried out by the user.
Sterilizers conforming to this document can be designed to perform separate contained product sterilization
cycles and saturated steam sterilization cycles for porous products. In such cases, the requirements specified
in this document and a standard which includes sterilizers for saturated steam sterilization processes (e.g.
EN 285) should be considered.
This document does not specify requirements for equipment for inactivating the causative agents of
spongiform encephalopathies such as scrapie, bovine spongiform encephalopathy and Creutzfeldt-Jakob
disease.
NOTE Specific regulations have been produced in particular countries for the processing of materials potentially
contaminated with these agents. See also ISO 22442-1, ISO 22442-2 and ISO 22442-3.
Background to the development of this document is provided in Annex A.

vii
DRAFT International Standard ISO/DIS 19253:2026(en)
Sterilization of health care products — Moist heat —
Requirements for sterilizers used for the terminal
sterilization of aqueous liquid in sealed containers
1 Scope
This document specifies the requirements and tests for moist heat sterilizers intended to be used for
the terminal sterilization of batch produced health care products presented as aqueous liquid in sealed
containers.
The aqueous liquid which the sterilizer is designed to process can be:
a) liquid water or solutions in which a solute is dissolved;
b) suspensions in which solid particles are suspended in an aqueous solvent;
c) oil in water emulsions in which oil droplets are suspended in an aqueous solvent.
The container which the sterilizer is designed to process can be rigid, semi rigid, or flexible and constructed
from, for example, glass or polymeric materials.
The sterilizer is designed to operate with a moist heat heating medium introduced into or created within the
chamber, which can consist of:
1. saturated steam;
2. non-saturated steam;
3. a mixture of steam and pressurized water spray; or
4. water immersion.
An over pressurising non-condensable gas such as air or nitrogen introduced into the chamber can be used
to prevent container deformation or bursting and protect the integrity of the container closure system for
steam-air mixtures, heated water as a spray or water immersion processes.
This document applies to sterilizers designed to allow the load to remain static throughout the sterilization
cycle and sterilizers that have a means by which the load is mechanically agitated by, for example, shaking
or rotation.
The sterilizer can be used in a health care facility or an industrial setting.
The reference loads described in this document are representative of a small load of low thermal capacity
and a large load of high thermal capacity which can be used for establishing the basic performance of the
sterilizer. The performance of the sterilizer when processing production loads will be established during
validation using specified loads. Requirements for the development, validation and routine control of moist
heat sterilization processes is described in ISO 17665.
This document is intended for sterilizers which are designed to process a defined load of product and not for
those which are designed to sterilize a continuous flow of product through a processing environment.
Sterilizers conforming with this document can also be used for the sterilization of veterinary products.
Sterilizers conforming with this document can also be used for the sterilization of a contained product
enclosed within a sterile barrier system conforming to the ISO 11607 series.

ISO/DIS 19253:2026(en)
This document is not intended to be retrospectively applied to pre-existing sterilizer equipment.
NOTE 1 The sterilizing agent, moist heat, is produced within the contained product by use of a heating medium.
NOTE 2 Sterilizers using saturated steam for sterilizing the surfaces of medical devices are covered by other
standards, e.g. EN 285, EN 13060, ANSI/AAMI ST8, ANSI/AAMI ST55, JIS T 7322 and JIS T 7324. Some moist heat /
steam sterilizers can be designed to provide both saturated steam sterilization processes and contained fluid
sterilization processes.
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.
ISO 228-1:2000, Pipe threads where pressure-tight joints are not made on the threads — Part 1: Dimensions,
tolerances and designation
ISO 3746:2010, Acoustics — Determination of sound power levels and sound energy levels of noise sources using
sound pressure — Survey method using an enveloping measurement surface over a reflecting plane
ISO 4126-1:2013+A2:2019, Safety devices for protection against excessive pressure — Part 1: Safety valves
ISO 8362-1, Injection containers and accessories — Part 1: Injection vials made of glass tubing
ISO 8362-2, Injection containers and accessories — Part 2: Closures for injection vials
ISO 8362-3, Injection containers and accessories — Part 3: Aluminium caps for injection vials
ISO 8536-1, Infusion equipment for medical use — Part 1: Infusion glass bottles
ISO 8573-1, Compressed air — Part 1: Contaminants and purity classes
ISO 11138-3, Sterilization of health care products — Biological indicators — Part 3: Biological indicators for
moist heat sterilization processes
ISO 13408-2:2018, Aseptic processing of health care products — Part 2: Sterilizing filtration
ISO 17665:2024, Sterilization of health care products — Moist heat — Requirements for the development,
validation and routine control of a sterilization process for medical devices
ISO 20417, Medical devices — Information to be supplied by the manufacturer
IEC 60204-1:2016+A1:2021, Safety of machinery — Electrical equipment of machines — Part 1: General
requirements
IEC 60584-1:2013, Thermocouples EMF specifications and tolerances
IEC 60751:2022, Industrial platinum resistance thermometers and platinum temperature sensors
IEC 61010-1:2010+A1:2019, Safety requirements for electrical equipment for measurement, control, and
laboratory use — Part 1: General requirements
IEC 61010-2-040:2020, 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 61326-1:2020, Electrical equipment for measurement, control and laboratory use — EMC requirements —
Part 1: General requirements
IEC 62828-1, Reference conditions and procedures for testing industrial and process measurement transmitters
— Part 1: General procedures for all types of transmitters

ISO/DIS 19253:2026(en)
3 Terms and definitions
For the purposes of this document, the terms and definitions given in ISO 17665:2024 and ISO/TS 22421 and
the following apply.
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
access device
means by which entry to restricted parts of equipment is controlled
Note 1 to entry: This can be by dedicated key, code, or tool.
Note 2 to entry: There is likely to be more than one access device all of which can be different depending on function.
Note 3 to entry: The equipment can be software in which case the access device can be a code.
[SOURCE: ISO 11139:2018, 3.4, modified — The term “achieved” has been replaced by “controlled” and Notes
2 and 3 to entry were added.]
3.2
aqueous liquid
liquid water or solutions in which liquid water is the solvent into which a solute is dissolved, is the fluid in
which solids are suspended or is the aqueous phase of an oil in water emulsion in which oil droplets are
emulsified.
EXAMPLE Water for injection, normal saline solution, sterile intravenous suspension, total parenteral nutrition
emulsions.
3.3
contained product sterilization
validated process where indirect contact of a moist heat heating medium on
the external surfaces of contained product is used to create moist heat internally to achieve the specified
requirements for sterility within the contained product
Note 1 to entry: Often referred to as “aqueous liquid sterilization.”
[SOURCE: ISO 11139:2018/Amd 1:2024, 3.332, modified — The term “moist heat” added has been added to
the definition and “aqueous” has been added to Note 1 to entry.]
3.4
cooling medium
fluid used during an operating cycle to remove thermal energy from a load of contained product
Note 1 to entry: The cooling medium can be a flow of cooled air, a cooled water spray or a body of cooled water in
which product is immersed.
3.5
cooling period
time elapsed after the exposure period when the load of contained product is cooled to a specified
temperature
Note 1 to entry: The specified temperature is chosen so as not to create a thermal hazard when the load is removed
from the chamber.
3.6
double-ended
having separate doors for loading and unloading in separate areas

ISO/DIS 19253:2026(en)
Note 1 to entry: In some settings a sterilizer can be double-ended without being loaded and unloaded in separate
areas.
[SOURCE: ISO 11139:2018, 3.92, modified — Note 1 to entry added.]
3.7
equilibration time
period between the attainment of defined sterilization process parameters at the reference measurement
point and the attainment of the specified sterilization process parameters at all points within the load
Note 1 to entry: For the purposes of this document the process parameter to which this definition refers is temperature.
Note 2 to entry: For the purposes of this document the equilibration time only relates to those contained product
sterilization processes which employ an operating cycle which heats the load to a specified sterilization temperature,
holds it at that temperature for a specified time and then cools it.
[SOURCE: ISO 11139:2018, 3.105, modified — Notes to entry added.]
3.8
exposure period
time elapsed during the sterilization cycle when specified temperature(s) are
maintained within defined ranges determined to be necessary to achieve the specified microbial lethality to
support the required Sterility Assurance Level for the load of contained product
3.9
F value
measure of microbiological lethality delivered by a moist heat sterilization process expressed in terms of
the equivalent time, in minutes, at a temperature of 121,1 °C with reference to microorganisms with a z
value of 10 °C
[SOURCE: ISO 11139:2018, 3.113.1, modified — 10 K was replaced by °C (by convention, z value is expressed
in °C).]
3.10
heating medium
fluid used during an operating cycle to transfer thermal energy to a load of contained product
Note 1 to entry: The heating medium can be saturated steam, steam-air mixtures, a heated water spray or a body of
heated water in which product is immersed.
3.11
heating period
time elapsed from the introduction of the heating medium into the chamber to the attainment of a specified
temperature(s) within the chamber or contained product within the load
Note 1 to entry: the specified temperature can be a defined sterilization temperature or a temperature when the
automatic controller begins to accumulate F values.
3.12
holding time
period for which the temperatures at the reference measurement point and at all
points within the load are continuously within the sterilization temperature band
Note 1 to entry: For the purposes of this document in addition to the load other fluids within the chamber are included
in the definition e.g. cooling fluid, ballasting gas.
Note 2 to entry: For the purposes of this document the holding time only relates to those contained product sterilization
processes which employ an operating cycle which heats the load to a specified sterilization temperature, holds it at
that temperature for a specified time and then cools it.
[SOURCE: ISO 11139:2018/Amd 1:2024, 3.133.1, modified — Notes to entry added.]

ISO/DIS 19253:2026(en)
3.13
load surrogate device
container filled with liquid into which a heat penetration probe is inserted providing temperature data
to the automatic controller allowing control and monitoring of the sterilization cycle and calculation of F
values
3.14
locked, door
condition in which the (a) chamber door is closed, that the securing mechanisms are in place, that the door
is firmly sealed against the mating surface and that the door interlocks are activated and indicate to the
automatic controller that the operating cycle can commence
3.15
maximum allowable working pressure
MAWP
maximum pressure to which a component is designed to be subjected to and which is the basis for
determining the strength of the component under consideration
Note 1 to entry: The component can be the chamber.
[SOURCE: ISO 13985:2006, 3.10]
3.16
maximum permissi
...