oSIST prEN ISO 14159:2026

SLOVENSKI STANDARD
01-september-2026
Varnost strojev - Splošne higienske zahteve za načrtovanje (ISO/DIS 14159:2026)
Safety of machinery - General requirements for hygienic design (ISO/DIS 14159:2026)
Sicherheit von Maschinen - Hygieneanforderungen an die Gestaltung von Maschinen
(ISO/DIS 14159:2026)
Sécurité des machines - Exigences générales relatives à l'hygiène lors de la conception
(ISO/DIS 14159:2026)
Ta slovenski standard je istoveten z: prEN ISO 14159
ICS:
13.110 Varnost strojev Safety of machinery
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

DRAFT
International
Standard
ISO/DIS 14159
ISO/TC 199
Safety of machinery — General
Secretariat: DIN
requirements for hygienic design
Voting begins on:
Sécurité des machines — Exigences générales relatives à l'hygiène
2026-07-09
lors de la conception
Voting terminates on:
ICS: 13.110 2026-10-01
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 has not been edited by the ISO Central Secretariat.
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Reference number
ISO/DIS 14159:2026(en)
DRAFT
ISO/DIS 14159:2026(en)
International
Standard
ISO/DIS 14159
ISO/TC 199
Safety of machinery — General
Secretariat: DIN
requirements for hygienic design
Voting begins on:
Sécurité des machines — Exigences générales relatives à l'hygiène
lors de la conception
Voting terminates on:
ICS: 13.110
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 has not been edited by the ISO Central 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
ISO/CEN PARALLEL PROCESSING
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BE CONSIDERED IN THE LIGHT OF THEIR
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Published in Switzerland Reference number
ISO/DIS 14159:2026(en)
ii
ISO/DIS 14159:2026(en)
Contents Page
Foreword .iv
Introduction .v
1 Scope . 1
2 Normative references . 1
3 Terms and definitions . 1
4 List of significant hazards . 5
5 Hygiene requirements and hygiene measures . 6
5.1 General .6
5.2 Risk assessment strategy .6
5.2.1 Basic strategy for selecting hygiene measures .6
5.2.2 Elements of risk assessment .6
5.2.3 Hygiene risk assessment (see Figure 1, Item 27) .7
5.2.4 Hygiene risk reduction process . . 12
6 Hygiene Risk Reduction .15
7 Verification of hygiene measures and test methods . 19
8 Instruction handbook, Maintenance and Cleaning .20
8.1 General . 20
8.1.1 Installation . 20
8.1.2 Instruction for use . 20
8.2 Maintenance and Cleaning . 20
8.2.1 Maintenance . 20
8.2.2 Cleaning . 20
Annex A (informative) Examples of potential risks and possible solutions .21
Annex B (informative) Examples of hygiene hazards .37
Annex ZA (informative) Relationship between this European Standard and the essential
requirements of Regulation (EU) 2023/1230 aimed to be covered .42
Bibliography .44

iii
ISO/DIS 14159:2026(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/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 199 Safety of machinery.
This second edition cancels and replaces the first edition ISO 14159:2002-04-01 Safety of machinery –
Hygiene requirements for the design of machinery, which has been technically revised.
The main changes are as follows:
— References, terms and definitions were updated
— New clause 5 “Hygiene requirements and hygiene measures”
— Clause 6 “Hygiene Risk reduction” was structured in product-, splash- and non-product area
— Informative Annexes A, C were deleted and replaced by
Annex A Examples of potential risks and possible solution
Annex B Examples of hygiene hazard
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.

iv
ISO/DIS 14159:2026(en)
Introduction
This International Standard is one of a series of standards relating to the safety of machinery
(ISO 12100:2010). It is a Type B standard and as such very general.
This document does not deal with the hygiene-related risks to operators arising from the use of the
machinery.
Hygiene risks are associated with the ability of a machine to prevent product contamination and to be freed
from product debris and microorganisms that can compromise the health and safety of persons or domestic
animals.
This standard considers machinery and their associated equipment and can be used to provide guidance
to the manufacturers of machines, associated equipment and other equipment where hygiene risks to the
consumer of the products can occur. Type C standard applicable to specific machines types can implement or
modify the requirement of this standard. Furthermore, detailed B standards with requirements for specific
sectors of machinery - depending on identified hazards - can be deduced on basis of this general Type B
standard.
It is applicable to all machines and associated equipment in applications where hygiene risks to the consumer
of the product can occur (e.g.: food, feed,beverages, pharmaceuticals, biotechnological products, cosmetics).
Other standards, for example machinery specific Type C standards, may be required to provide guidance
for specific types of equipment and/or for specific industry sectors. Furthermore, detailed B standards with
requirements for specific sectors of machinery - depending on identified hazards - can be deduced on basis
of this general Type B standard.
When no design or safeguarding options are within the state of the art to adequately control both hygiene
and safety risks, then one of the risks, or both, would have to be dealt with by residual safeguards, including
instructions to the user. The assessment of the respective safety and hygiene risks shall indicate their
relative significance, and the highest level of protection (i.e. safeguarding) shall be implemented to deal with
the severest risk, and residual safeguards shall be used for the lesser risk. This standard deals in particular
with hygiene risks but also considers the possible conflict between safety and hygiene measures.
The technical solutions given in this International Standard permit both objectives to be met for those
significant and common risks identified as justifying common requirements specified in this International
Standard.
v
DRAFT International Standard ISO/DIS 14159:2026(en)
Safety of machinery — General requirements for hygienic
design
1 Scope
This International Standard specifies general requirements for the hygienic design of machinery and
associated equipment as well as instructions for use. It applies to all types of machines and associated
equipment used in applications where hygiene risks to the consumer of the product can occur.
This International Standard does not cover requirements relative to the egress of microbiological agents
from the machine.
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 12100:2010, Safety of machinery — General principles for design — Risk assessment and risk reduction
Reduction
ISO 21920:2022, Geometrical product specifications (GPS) – Surface texture: Profile- Part 2: Terms, definitions
and surface texture parameters
ISO 20607:2019, Safety of machinery — Instruction handbook — General drafting principles
For the purposes of this document, the following terms and definitions apply.
ISO and IEC maintain terminology databases for use in standardization at the following addresses:
3 Terms and definitions
For the purposes of this document, the following terms and definitions 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
associated equipment
all equipment associated with a machine, not defined as machinery (3.13), that is essential to the functioning
of the machine for it to hygienically process a product (e.g. fittings, piping, tubing)
3.2
bond
joining of materials with an adhesive

ISO/DIS 14159:2026(en)
3.3
cleaning in place
cleaning (3.4) of a machine or an equipment of a machine without dismantling parts
Note 1 to entry: for example, providing circulation of flowing chemical solutions, cleaning liquid and water rinses onto
and over surfaces.
3.4
cleaning
removal of soil (see 3.33)
3.5
cleanable
designed and constructed so that soil can be removed
3.6
consumer
end user of the product (including domestic animals)
3.7
corrosion resistant material
material having the property to maintain its original surface characteristics for its intended life time when
exposed to the conditions encountered in the environment of intended use, including exposed contact with
product, cleaning, disinfection, pasteurization or sterilization conditions
3.8
crevice
sharp, cleft-like, irregular opening of small depth which adversely affects cleanability
3.9
dead space
space wherein a product, cleaning or disinfecting agents, or soils can be trapped, retained, or not completely
removed during the operation of cleaning
3.10
disinfection
inactivation of pathogens and a wide range of other unwanted micro-organisms to an tolerable level
3.11
hygiene
taking of all measures during product handling, preparation and processing to ensure its suitability for use
by humans or domestic animals
3.12
joint
junction of two or more pieces of material
3.13
machinery
assembly, fitted with or intended to be fitted with a drive system consisting of linked parts or components,
at least one of which moves, and which are joined together for a specific application
Note 1 to entry: The term “machinery” also covers an assembly of machines which, in order to achieve the same end,
are arranged and controlled so that they function as an integral whole.
[SOURCE: ISO 12100:2010, 3.1]
3.14
manual cleaning
cleaning by manual means when the machinery is open, or partially or totally disassembled

ISO/DIS 14159:2026(en)
3.15
micro-organism (relevant)
bacteria, fungi, yeasts, molds, spores and viruses that are able to contaminate, multiply or survive in the
product and are able to be harmful or adversely affect product quality
3.16
non-toxic materials
materials which, under the intended conditions of their use, will not cause the product to be harmful to
humans or domestic animals
3.17
non-absorbent materials
materials which, under the intended conditions of their use, do not retain substances with which they come
into contact, so as to have no adverse effect on the hygiene of the product
3.18
pasteurization
process that inactivates all relevant micro-organisms except some microbial spores
3.19
pasteurizable
〈equipment〉 designed to be capable of being pasteurized
3.20
pest
mammals, birds, reptiles, vermin and insects which can adversely influence the product
3.21
practical test
set of procedures and parameters used to determine an evaluation
3.22
product
any substance intended to be applied or taken into humans or domestic animals (e.g.by ingestion, injection,
topical application, insertion)
3.23
product area
machine and machine components surface which are exposed to the product or from which product or other
materials can drain, drip, diffuse or be drawn into the product or product container
3.24
splash area
area composed of surfaces on which part of the product can splash or flow along under intended conditions
of use and does not return into the product
Note 1 to entry: Once product comes into contact with the splash area, it is no longer a product within the meaning of
3.22. It is then no longer used as a product and is therefore considered as soil.
3.25
non-product area
any area other than product area or splash area
Note 1 to entry: Soil that comes into contact with the non-product area during the cleaning phase (rinsing) has no
influence on the classification of this area

ISO/DIS 14159:2026(en)
3.26
easily cleanable
designed and constructed to be cleanable by a simple cleaning method, where necessary after removing
easily dismountable parts
Note 1 to entry: Simple cleaning methods could be, e.g. vacuum cleaning, cleaning in place (CIP) or cleaning after
dismantling parts without the need of tools (e.g. spanner) for dismantling.
[SOURCE: EN 1672-2:2020, 3.6.2]
3.27
readily accessible
location which can be reached by an operator from the floor, a platform or other permanent work area
3.28
readily removable
designed to be separated from the machine without tools or with the use of simple hand tools
Note 1 to entry: Simple hand tools are for example a screwdriver, wrench, mallet, or readily available dedicated tool(s)
normally used by operating and cleaning personnel.
3.29
seal
closure of an aperture so as to effectively prevent the entry or passage of unwanted matter
3.30
self-draining
combination of design, construction, installation and surface finish so as to prevent the retention of liquid
except for normal surface wetting
3.31
sensors
devices or instrumentation attached to machinery for process monitoring/control
3.32
smooth
condition of a surface which satisfies hygienic requirements and is without surface defects (e.g. crevices)
capable or retaining soil
3.33
soil
any unwanted matter
3.34
sterilization
a process aimed at removing or killing all forms of micro-organisms, including bacterial spores
3.35
sterilizability
〈equipment〉 designed to be capable of being sterilized
3.36
wet cleaning
cleaning with the liquid solvent
3.37
dry cleaning
solvent free cleaning
ISO/DIS 14159:2026(en)
3.38
verification
application of methods, procedures, test and other evaluations, in addition to monitoring to determine
compliance
3.39
hygienic integrity
probability of a hygiene-related system satisfactorily performing the required hygiene functions under all
the specified conditions within a specified period of time.
4 List of significant hazards
The significant hazards can arise from:
a) microbiological causes, e.g.:
1) pathogens (from e.g. opportunistic pathogens like salmonella, Enterobacter, coliform bacteria)
2) microbiological toxins (from e.g. Bacillus cereus, Staphylococcus aureus) and biogenic amines of
pathogens
3) microorganism
4) other biological causes, e.g.:
— mono- and multicellular vermin (e.g. toxoplasma, tapeworm);
— unconventional transmissible agents
b) Chemical causes, e.g.:
— cleaning and disinfection agents
— lubricants
— veterinary drugs
— agricultural pesticides
— contaminants, e.g. allergens, dioxins, polychlorinated biphenyl (PCB), mycotoxins, heavy metals
— substances released by materials
c) Physical causes, e.g.:
— foreign bodies (e.g. bone fragments, metal parts and broken glass)
— contaminants and radiation arising from raw material, machinery or other sources
Malfunction of machinery or malfunction of equipment e.g.:
— Interruption of the flow of modifying or protective gases
— Malfunction of filters
— Interruption of the flow of sterilized air
— Malfunction of pasteurizing or sterilizing system
— Malfunction of the cleaning system
can have an impact on hygiene causing hazardous situations.
Note 1 to entry further information of significant hazards is available in Annex B

ISO/DIS 14159:2026(en)
5 Hygiene requirements and hygiene measures
5.1 General
Either hygiene requirements or risk reduction measures or both shall be implemented
5.2 Risk assessment strategy
The risk assessment strategy for selecting hygiene measures is applicable to the product area, splash area
and non-product areas.
NOTE For more information see EN 1672-2:2020 or ISO TR 14121-2:2013 / ANSI document ANSI B11.0 2023
5.2.1 Basic strategy for selecting hygiene measures
The basic strategy for selecting hygiene measures for the design of machinery and equipment shall be
consistent with ISO 12100:2010. This includes the following:
— identification of the process for which the machine is intended
— hazards associated with the product(s) produced (see clause 4)
— hygiene risk assessment associated with each hazard identified (see clause 5.2.3)
— hygiene risk reduction which can eliminate hazards or reduce risks associated with these hazards (see
clause 6)
— identification of any other hazards (either safety or hygienic) which can be introduced by methods used
to reduce the risk associated with the hazard under analysis
— means of verification of the effectiveness of the hazard elimination or the risk reduction method (see
clause 7)
— description of residual risks and any additional precautions necessary in the information for use where
applicable (see clauses 7 and 8)
Applying measures to reduce hygiene risks, such as improving visibility, can sometimes raise safety risks.
The iterative hygiene risk reduction procedure is schematically represented in Figure 1.
5.2.2 Elements of risk assessment
When undertaking the elements of the risk assessment, the following parameters are presented as guidance
to the range and type of factors that shall be considered for the machine and its associated equipment.
The intended use of the machine: Will the machine be used for one specific purpose only, for which the
hazards are readily identifiable, or could the machine be used for a wide range of products in various
industrial sectors (e.g. a pump)?
The product type to be processed by the machine: Will the product be already contaminated (e.g. a raw
material) or will it be “preserved” or aseptic?
The degree of further processing: Will the product processed by the machinery subsequently undergo a
further process which functions as a hazard elimination step (e.g. a heat treatment) or is the process for
which the machine is intended the final process?
Specific application of the product:
1. Is the product to be used by the consumer immediately after processing or is there a product shelf-life in
which the severity of the hazard could increase (e.g. relevant microbial growth)?

ISO/DIS 14159:2026(en)
2. Will the product be used by a specific consumer group to whom the hazard may present a more serious
risk (e.g.: a baby, elderly or infirm person)?
The degree of cleaning, disinfection, pasteurization, sterilization and/or inspection: Is the machine to be
cleaned, disinfected, pasteurized, sterilized and/or inspected after every use, routinely during the day,
every day, or every week, etc.?
The use of the machine: Is the machine likely to be well maintained or used infrequently. Is it designed for
high or continuous use or is misuse foreseeable?
Figure 1 — Schematic iterative hygiene risk reduction procedure
5.2.3 Hygiene risk assessment (see Figure 1, Item 27)
Hygiene risk assessment comprises

ISO/DIS 14159:2026(en)
— A Hygiene risk analysis
— B Hygiene risk estimation
— C Hygiene risk evaluation
(A)  Hygiene risk analysis (see Figure 1, Item 26)
Hygiene risk analysis, comprising:
(1) determination of the limits of the machinery (2) product safety hazard identification
Hygiene risk analysis provides information required for the hygiene risk evaluation which in turn allows
judgments to be made about whether or not risk reduction is required.
The risk assessment shall start with the determination of the limits of the machinery, considering all the
phases of the machinery life
After determination of the limits of the product processing machine, the most important step in the hygiene
risk assessment is the identification of each hazards that can lead to unsafe product. The identification of
the product safety hazard by the manufacturer shall take into account the significant hazards defined in
Clause 4.
The objective of the product hazard identification is to create a list of all the hazards to hygiene that arise
from contact with product processing machines and/or their processing steps. Unidentified hazards can
lead to unsafe products which can cause health harm of its consumers.
Only when a hazard (incl. hazardous situations and/or hazardous events) has been identified, it is possible
to take action to eliminate them or to reduce resulting associated risks.
For the identification of product safety hazards the following factors described in “Product safety hazard
identification” shall be considered.
After product safety hazard identification, hygiene risk estimation shall be carried out for each hazard and/
or hazardous situation.
The elements of risk given in: Severity of health harm, Probability of occurrence of health harm, Existing
possibilities to avoid or limit health harm as well as aspects to be considered given in: Consumers Combination
of hazards, Human factors, Tools for hygiene risk estimation shall be taken into account.
Product safety hazards can lead to unsafe product, and its consumption can lead to health harm.
The hygiene risk associated with a particular hazard depends on the following elements:
— the severity of health harm
— the probability of occurrence of health harm, which is a function of
— the occurrence of a hazardous event
— the technical and human possibilities to avoid or limit the health harm.
NOTE 1 The exposure of an operator to the "hygienic" hazard is not considered according to the scope of this
standard.
NOTE 2 Possibilities to avoid or limit health harm are measures such as washing, peeling, cooking, baking, before
consuming (this is not applicable to ready-to-eat product) considered in Hygiene risk estimation.
(1)  Determination of the limits of the machine (see Figure 1, Item 2)
a)  Use limits
Use limits shall include the intended use and the reasonably foreseeable misuse, failure or malfunction.

ISO/DIS 14159:2026(en)
One machine can be used for one specific purpose only (single product type), for which hazards are readily
identifiable. Another machine can be used for a wide range of product products (more than one product
type) under various conditions.
In connection with hygienic aspects, the following issues shall be considered:
— the different operating modes (e.g. product processing, cleaning, maintenance)
— the type of operators
— professional and/or non-professional
— the anticipated foreseeable users’ level of training, experience or ability (e.g. operators, cleaning
personnel, maintenance personnel)
b)  Space limits
The following aspects of space limits shall be considered:
— the range of movements of the machine and of all its parts (e.g. access to maintenance openings)
— space requirements for operators interacting with the machine during operation, cleaning and
maintenance.
NOTE 1 Space requirements can include necessary space for e.g. cleaning, removing parts.
c)  Time limits
The following aspects of time limits shall be considered:
— the life limit of the machinery and/or of some of its components (parts that can wear, seals etc.), taking
into account its intended use and reasonably foreseeable misuse
— recommended maintenance intervals
— recommended cleaning intervals
d)  Other limits
Examples of other limits:
— state of product, properties of the input material(s) to be processed and the output material(s) and
product sensitivity (e.g. perishable or non-perishable product)
— stage of processing levels
— variations in local, national or international properties of product, products and ingredients
— consumption group (healthy, vulnerable group, i.e. elderly or infant, allergic persons etc.)
— open or closed process
— cleaning procedures (e.g. dry or wet cleaning)
— the level of cleanliness required and
environmental – the recommended minimum and maximum temperatures, whether the machine can be
operated indoors or outdoors, in dry or wet atmosphere, in direct sunlight, tolerance to dust and humidity
etc.
(2) Product safety hazard identification (see Figure 1, Item 3)
a)  Phases of life cycle of the machine

ISO/DIS 14159:2026(en)
Causes for hazards that can lead to unsafe products during the following phases of the machine life cycle
shall be identified:
— assembly and installation
— start-up
— operation
— cleaning and, where required, disinfection and therefore necessary dismantling
— maintenance
— temporarily disabling
b)  Hygiene risk associated with the product
The hygiene risk associated with the product depends on many factors that shall be identified and
determined, e.g.:
— type or types of products to be processed (e.g. perishable or non-perishable)
— status of product (e.g. raw material, partly processed, ready-to-eat product)
— other properties of the product (e.g. pH, dry, wet, glutinous)
NOTE 1 The type and condition of product can change depending on the processing stage.
c)  Process
The factors to be considered from the process as well as the processing method for the products, which can
influence the hazards, shall be determined, e.g.:
— open or closed process
— intended use (single product type, more than one product type – simultaneously or consecutively)
— stage of processing (upstream process stage, last process stage), all processes (e.g. cooking, baking,
pasteurizing) to be performed by the product processing machine as well as their effects on the product
— the product processing machine functions (e.g. washing, cutting, mixing) to be performed with it
The different areas of equipment shall be taken into account (see 3.23, 3.24, 3.25). Proper classification of
the areas is of crucial importance.
d) Other hygiene hazards
In addition, reasonably, foreseeable hygiene hazards not directly related to the product, its processing and
the machine function shall be identified, e.g.:
— human interaction during the whole life cycle of the machine such as:
— tasks to be performed by operators (e.g. manual feeding and handling, manual intervention)
— stopping the machine in case of emergency
— recovery of operation from jam or blockage
— maintenance works
— cleaning and, where required, disinfection methods (dry or wet)

ISO/DIS 14159:2026(en)
— possible states of the product processing machine:
— the machine does not perform the intended function, including unwanted variation of properties of
the processed product
— wear or failure of one or more of the machine component parts
— external disturbances (e.g. loss of one or more required energy supplies), design error or deficiency
(e.g. unsuitable surface finish of material)
— unwanted surrounding conditions (e.g. uncooled environment, UV-radiation)
B  Hygiene risk estimation (see Figure 1, Item 4)
(1)  Severity of health harm
The severity of health harm caused by the hazard can be estimated by taking into account the following:
— the severity of health harm, e.g.:
— low (slight), medium (serious), high (death)
— the extent of health harm to e.g.:
— one consumer
— a group of consumers
— any consumer
(2)  Probability of occurrence of health harm
a)  Occurrence of health harm
Factors to be considered when estimating the probability of occurrence of health harm from unsafe product
include among others:
— experience based on Good Manufacturing Practice
— market surveillance
— consideration of exposed consumers (see also Consumers)
— medical data (e.g. occurrence of infections or allergies) as far as known or available.
b)  Existing possibilities to avoid or limit health harm
Before consuming, existing possibilities to avoid or limit health harm are measures such as washing, peeling,
cooking, baking.
NOTE This is not applicable to ready-to-eat product.
Consumers: Hygiene risk estimation shall take into account the following groups of consumers of product,
e.g.:
— healthy
— health-burdened (e.g. allergies, intolerance)
— sick (e.g. hospitalized patients)
— part of a health risk group, e.g. younger (infants) or elderly people or people with immune system
deficiencies
Combination of hazards: The effects of combinations of product safety hazards shall be considered.

ISO/DIS 14159:2026(en)
Human factors: Human factors can affect hygiene risks and shall be taken into account in the hygiene risk
estimation, including, e.g.:
— the interaction of operator(s) with the machinery (e.g. cross contamination, foreign bodies)
— the capacity of operator to be aware of hygiene risks in a given situation depending on their training,
experience and ability (e.g. countermeasures, production stop)
— Training, experience and ability can affect risk. Nevertheless, none of these factors shall be used as
a substitute for the removal of a hazard, risk reduction by hygienic design or technical measures,
wherever these risk reduction measures can be practically implemented.
Tools for hygiene risk estimation: For the risk assessment, one of the many risk assessment tools should
be selected and used
Note 1 For additional information ISO/TR 14121-2:2013, Clause 6
C  Hygiene risk evaluation (see Figure 1, Item 5)
After hygiene risk estimation, hygiene risk evaluation shall be carried out to determine if hygiene risk
reduction is required or whether product safety has been achieved by reducing risks to a tolerable level.
The objective of the hygiene risk assessment is to decide which hazard to product safety, if any, requires
further risk reduction.
Care should be taken that simple and effective measures for reducing relatively low risks are not overlooked
due to an exclusive focus on the highest risks.
Question: “Has the hygiene risk been adequately reduced?” (see Figure 1, Item 6)
If an existing hygiene risk is not tolerable, it has to be reduced. The risk reduction measure shall be
determined using the subsequent multi-step procedure.
5.2.4 Hygiene risk reduction process
5.2.4.1 General
All risk reduction measures shall be applied in the following sequence:
Hygiene risk reduction by (see Figure 1, Item 28)
— A Hazard removal and/or Hygienic design
— B Technical measures
— C Cleaning and/or disinfection measures and/or
Hygiene risk reduction by additional measures and
— D Other elements of the iterative hygiene risk reduction process
A removal of the hygiene hazard or hygiene risk reduction by hygienic design
Question: “Can the hygiene hazard be removed?” (see Figure 1, Item 7)
The first step in the hygiene risk reduction process is to consider if the hygiene hazard can be eliminated.
NOTE 1: If the hazard is eliminated, no corresponding hygiene risk is present.
Question: “Can the hygiene risk be reduced by hygienic design?” (see Figure 1, Item 8)

ISO/DIS 14159:2026(en)
The second step in the hygiene risk reduction process is the elimination of the hygiene risk by hygienic
design.
For this purpose, it shall be considered whether the requirements laid down in subclauses of 5.3 in the
various areas can be fulfilled. If not, check if the hygiene risk can be reduced by other technical measures
with an effect on hygiene.
NOTE 1: Hygienic design is understood as material requirements as well as the constructive design as
described in this document (see Figure 1, Note 1).
Implement hazard removal or hygienic design measures (see Figure 1, Item 9).
Question: “Is the intended hygiene risk reduction achieved?” (see Figure 1, Item 10)
Hygienic risk is eliminated or tolerable.
If the residual hygiene risk is not tolerable, check whether it can be eliminated or reduced to an tolerable
level by technical measures (see Figure, Item 11).
B  Hygiene risk reduction by technical measures
Question: “Can the hygiene risk be reduced by technical measures?” (see Figure 1, Item 11)
If hygienic risks cannot be eliminated or reduced to an tolerable level by hygienic design, consider tech-
nical measures. Cleaning and disinfection measures are not considered to be technical measures.
Hygiene risk reduction by technical measures (see Figure 1, Item 12)
Implement selected technical measures.
NOTE 1: Temperature setting, reducing humidity, sorting out contaminated products are examples of
technical measures.
Question: “Is the intended hygiene risk reduction achieved?” (see Figure 1, Item 13)
Clarify the question whether the technical measures minimize the hygiene risk so that the existing re-
sidual hygienic risk is eliminated or tolerable.
If the residual hygiene risk is not tolerable, check whether it can be eliminated or reduced to a tolerable
level by cleaning and/or disinfection.
C.1  Hygiene risk reduction by cleaning and / or disinfection measures
Question: “Can the hygiene risk be reduced by cleaning/disinfection?” (see Figure 1, Item 15)
If hygiene hazards cannot be eliminated by hygienic design or technical measures or reduced to a toler-
able level, check whether this can be achieved by appropriate cleaning and where required disinfection
measures.
EXAMPLE Intermediate cleaning and intermediate disinfection of knives, using special cleaning utensils.
NOTE 1:These measures can be automated or involve the user of the machine.
Hygiene reduction by cleaning and or disinfection (see Figure 1, Item 16)
Apply cleaning/disinfection measures to reduce the hygiene risk.
NOTE 1: Provide space for disassembly and disassembly instruction if required (see Figure 1).
Question: “Is the intended hygiene risk reduction achieved?” (see Figure 1, Item 17)

ISO/DIS 14159:2026(en)
Evaluate the question whether the cleaning and/or disinfection measures minimize the hygiene risk so
that the existing residual hygienic risk is eliminated or tolerable.
If the residual hygiene risk is not tolerable, check whether it can be eliminated or reduced to a tolerable
level by additional measures.
Provide information for use (see Figure 1, Item 21)
Describe in the user information all necessary cleaning/disinfection measures and/or additional measures
leading to the elimination or reduction of the residual risk to a tolerable level.
C.2  Hygiene risk reduction by additional measures
Question: “Can the hygiene risk be reduced by additional measures?” (see Figure 1, Item 18)
If hygiene hazards cannot be eliminated or be reduced to a tolerable level by hygienic design or technical
measures, or cleaning/disinfection measures, check whether this can be achieved by additional measures
(e.g. requirements for personnel hygiene, specific training).
NOTE 1: Such additional measures are always implemented by the operator of the machine.
Hygiene reduction by additional measures (see Figure 1, Item 19)
Apply additional measures to further reduce the hygiene risk.
Information on these additional measures shall be given in
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