SIST EN ISO 14159:2004

SLOVENSKI STANDARD
SIST EN ISO 14159:2004
01-september-2004
9DUQRVWVWURMHY+LJLHQVNH]DKWHYH]DQDþUWRYDQMHVWURMHY,62
Safety of machinery - Hygiene requirements for the design of machinery (ISO
14159:2002)
Sicherheit von Maschinen - Hygieneanforderungen an die Gestaltung von Maschinen
(ISO 14159:2002)
Sécurité des machines - Prescriptions relatives a l'hygiene de la conception des
machines (ISO 14159:2002)
Ta slovenski standard je istoveten z: EN ISO 14159:2004
ICS:
13.110 Varnost strojev Safety of machinery
SIST EN ISO 14159:2004 en
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

---------------------- Page: 1 ----------------------

EUROPEAN STANDARD
EN ISO 14159
NORME EUROPÉENNE
EUROPÄISCHE NORM
February 2004
ICS 13.110
English version
Safety of machinery - Hygiene requirements for the design of
machinery (ISO 14159:2002)
Sécurité des machines - Prescriptions relatives à l'hygiène Sicherheit von Maschinen - Hygieneanforderungen an die
de la conception des machines (ISO 14159:2002) Gestaltung von Maschinen (ISO 14159:2002)
This European Standard was approved by CEN on 2 January 2004.
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 Central Secretariat 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 Central Secretariat has the same status as the official
versions.
CEN members are the national standards bodies of Austria, Belgium, Cyprus, Czech Republic, Denmark, Estonia, Finland, France,
Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Slovakia,
Slovenia, Spain, Sweden, Switzerland and United Kingdom.
EUROPEAN COMMITTEE FOR STANDARDIZATION
COMITÉ EUROPÉEN DE NORMALISATION
EUROPÄISCHES KOMITEE FÜR NORMUNG
Management Centre: rue de Stassart, 36  B-1050 Brussels
© 2004 CEN All rights of exploitation in any form and by any means reserved Ref. No. EN ISO 14159:2004: E
worldwide for CEN national Members.

---------------------- Page: 2 ----------------------

EN ISO 14159:2004 (E)
Foreword
The text of ISO 14159:2002 has been prepared by Technical Committee ISO/TC 199 "Safety of machinery” of the
International Organization for Standardization (ISO) and has been taken over as EN ISO 14159:2004 by Technical
Committee CEN/TC 114 "Safety of machinery", 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 August 2004, and conflicting national standards shall be withdrawn at the latest by
August 2004.
This document has been prepared under a mandate 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 Annex ZB, which is an integral part of this document.
According to the CEN/CENELEC Internal Regulations, the national standards organizations of the following
countries are bound to implement this European Standard: Austria, Belgium, Cyprus, Czech Republic, Denmark,
Estonia, Finland, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta,
Netherlands, Norway, Poland, Portugal, Slovakia, Slovenia, Spain, Sweden, Switzerland and United Kingdom.
Endorsement notice
The text of ISO 14159:2002 has been approved by CEN as EN ISO 14159:2004 without any modifications.
NOTE Normative references to International Standards are listed in annex ZA (normative).
2

---------------------- Page: 3 ----------------------

EN ISO 14159:2004 (E)
Annex ZA
(normative)
Normative references to international publications with their relevant
European publications
This European Standard incorporates by dated or undated reference, provisions from other publications. These
normative references are cited at the appropriate places in the text and the publications are listed hereafter. For
dated references, subsequent amendments to or revisions of any of these publications apply to this European
Standard only when incorporated in it by amendment or revision. For undated references the latest edition of the
publication referred to applies.
Publication Year Title EN Year
ISO 4287 1997 Geometrical product specifications (GPS) - EN ISO 4287 1998
Surface texture: Profile method - Terms,
definitions and surface texture parameters
3

---------------------- Page: 4 ----------------------

EN ISO 14159:2004 (E)
Annex ZB
(informative)
Relationship of this European Standard with EU Directives
This document has been prepared under a mandate given to CEN by the European Commission and the European
Free Trade Association and supports essential requirements of EU Directive(s)
Machinery Directive 98/37/EC, amended by Directive 98/79/EC
Compliance with this document provides one means of conforming with the specific essential requirements of the
Directive concerned and associated EFTA regulations.
WARNING — Other requirements and other EU Directives may be applicable to the product(s) falling within the
scope of this document.
4

---------------------- Page: 5 ----------------------

INTERNATIONAL ISO
STANDARD 14159
First edition
2002-04-01


Safety of machinery — Hygiene
requirements for the design of machinery
Sécurité des machines — Prescriptions relatives à l'hygiène lors de la
conception des machines





Reference number
ISO 14159:2002(E)
©
 ISO 2002

---------------------- Page: 6 ----------------------

ISO 14159:2002(E)
PDF disclaimer
This PDF file may contain embedded typefaces. In accordance with Adobe's licensing policy, this file may be printed or viewed but shall not
be edited unless the typefaces which are embedded are licensed to and installed on the computer performing the editing. In downloading this
file, parties accept therein the responsibility of not infringing Adobe's licensing policy. The ISO Central Secretariat accepts no liability in this
area.
Adobe is a trademark of Adobe Systems Incorporated.
Details of the software products used to create this PDF file can be found in the General Info relative to the file; the PDF-creation parameters
were optimized for printing. Every care has been taken to ensure that the file is suitable for use by ISO member bodies. In the unlikely event
that a problem relating to it is found, please inform the Central Secretariat at the address given below.


©  ISO 2002
All rights reserved. Unless otherwise specified, no part of this publication may be reproduced or utilized in any form or by any means, electronic
or mechanical, including photocopying and microfilm, without permission in writing from either ISO at the address below or ISO's member body
in the country of the requester.
ISO copyright office
Case postale 56 • CH-1211 Geneva 20
Tel. + 41 22 749 01 11
Fax + 41 22 749 09 47
E-mail copyright@iso.ch
Web www.iso.ch
Printed in Switzerland

ii © ISO 2002 – All rights reserved

---------------------- Page: 7 ----------------------

ISO 14159:2002(E)
Contents Page
Foreword.iv
Introduction.v
1 Scope .1
2 Normative references.1
3 Terms and definitions .1
4 Hazards.4
5 Hygiene requirements and/or measures.4
5.1 Strategy for selecting hygiene measures .4
5.2 Hygienic design .7
6 Verification of hygiene measures and test methods .11
7 Instruction handbook, maintenance and cleaning.11
7.1 Instruction handbook.11
7.2 Maintenance and cleaning.11
8 Additional information (limitations of use) .12
Annex A (informative) Categorization of machinery and associated equipment for intended use.13
Annex B (informative) Examples of good and bad hygienic design features.14
Annex C (informative) Relationship between International Standards referenced in clause 2 and
corresponding European Standards .29
Bibliography.30

© ISO 2002 – All rights reserved iii

---------------------- Page: 8 ----------------------

ISO 14159:2002(E)
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.
International Standards are drafted in accordance with the rules given in the ISO/IEC Directives, Part 3.
The main task of technical committees is to prepare International Standards. Draft International Standards adopted
by the technical committees are circulated to the member bodies for voting. Publication as an International
Standard requires approval by at least 75 % of the member bodies casting a vote.
Attention is drawn to the possibility that some of the elements of this International Standard may be the subject of
patent rights. ISO shall not be held responsible for identifying any or all such patent rights.
ISO 14159 was prepared by Technical Committee ISO/TC 199, Safety of machinery.
Annexes A to C are for information only.
iv © ISO 2002 – All rights reserved

---------------------- Page: 9 ----------------------

ISO 14159:2002(E)
Introduction
This International Standard is one of a series of standards relating to the safety of machinery (ISO 12100 series). It
differs from other safety standards, however, in that it is concerned with the associated hygiene risks of the
machinery to the consumer of the product being processed, not to the operator of the machine.
Hygiene risks are very different from other safety risks. They are more associated with the ability of machines to be
freed from product debris and micro-organisms, and thus preventing product contamination, rather than from the
dangers of moving parts or electrical hazards to the operator. For this reason, and whilst this International Standard
considers machines and their associated equipment, it can be used to provide guidance to the manufacturers of all
equipment types where hygiene risks to the consumer of products to be processed by such equipment could occur.
This International Standard is a Type B standard (see ISO 12100) and as such is very general. 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, pharmaceuticals, biotechnology, cosmetics). Other standards, such as for example machinery specific
Type C standards (see Bibliography), may be required to provide guidance for specific types of equipment and/or
for specific industry sectors.
Historically, there have been cases where safety criteria have been addressed in machinery design without taking
into account the implications linked to hygienic risks (and vice versa). In almost all cases, at least one of the
different methods of design, safeguarding or residual safeguards can be chosen which will meet both safety and
hygiene essential requirements and adequately control both risks. The option chosen shall satisfy both hygiene and
safety risks, even if it may not be the most obvious option to have been adopted had the risk only been to safety or
to hygiene.
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.
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.
© ISO 2002 – All rights reserved v

---------------------- Page: 10 ----------------------

INTERNATIONAL STANDARD ISO 14159:2002(E)

Safety of machinery — Hygiene requirements for the design of
machinery
1 Scope
This International Standard specifies hygiene requirements of machines and provides information for the intended
use to be provided by the manufacturer. 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 uncontrolled egress of microbiological
agents from the machine.
2 Normative references
The following normative documents contain provisions which, through reference in this text, constitute provisions of
this International Standard. For dated references, subsequent amendments to, or revisions of, any of these
publications do not apply. However, parties to agreements based on this International Standard are encouraged to
investigate the possibility of applying the most recent editions of the normative documents indicated below. For
undated references, the latest edition of the normative document referred to applies. Members of ISO and IEC
maintain registers of currently valid International Standards.
ISO 4287:1997, Geometrical Product Specifications (GP ) — Surface texture: Profile method — Terms, definitions
and surface texture parameters
1)
ISO 12100-1:— , Safety of machinery — Basic concepts and general principles for design — Part 1: Basic
terminology and methodology
2)
ISO 12100-2:— , Safety of machinery — Basic concepts and general principles for design — Part 2: Technical
principles
3 Terms and definitions
For the purposes of this International Standard, the following terms and definitions apply.
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

1) To be published. (Revision of ISO/TR 12100-1:1992)
2) To be published. (Revision of ISO/TR 12100-2:1992)
© ISO 2002 – All rights reserved 1

---------------------- Page: 11 ----------------------

ISO 14159:2002(E)
3.3
cleaning in place
cleaning (3.4) of equipment by impingement or circulation of flowing chemical solutions, cleaning liquids and water
rinses into, onto and over surfaces in equipment or systems without dismantling and designed for the purpose
3.4
cleaning
removal of soil (see 3.31)
3.5
cleanable
〈equipment〉 designed to be freed from soil
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
process applied to a clean surface which is capable of reducing the numbers of vegetative micro-organisms, but
not necessarily their spores, to a level considered safe for product production
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 of linked parts or components, at least one of which moves, with appropriate machine actuators, control
and power circuits, joined together for a specific application, in particular for the processing, treatment, moving or
packaging of a material
NOTE The term machinery also covers an assembly of machines.
[ISO 12100-1:—, 3.1]
3.14
manual cleaning
cleaning by manual means when the machinery is open, or partially or totally disassembled
2 © ISO 2002 – All rights reserved

---------------------- Page: 12 ----------------------

ISO 14159:2002(E)
3.15
micro-organism (relevant)
bacteria, fungi, yeasts, moulds, 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-absorbant 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 affect 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
documented 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 contact surface
machinery surfaces which are exposed to the product and from which the product or other materials can drain, drip,
diffuse or be drawn into (self-returned) the product or product container
3.24
non-product contact surface
all other exposed machinery surfaces including, where applicable, the splash area (3.32)
3.25
readily accessible
location which can be reached by an employee from the floor, a platform or other permanent work area
3.26
readily removable
designed to be separated from the machine with or without the use of simple hand tools
3.27
seal
closure of an aperture so as to effectively prevent the entry or passage of unwanted matter
© ISO 2002 – All rights reserved 3

---------------------- Page: 13 ----------------------

ISO 14159:2002(E)
3.28
self-draining
combination of design, construction, installation and surface finish so as to prevent the retention of liquid except for
normal surface wetting
3.29
sensors
devices or instrumentation attached to machinery for process monitoring/control
3.30
smooth
condition of a surface which satisfies hygienic requirements and is without surface defects (e.g. crevices) capable
or retaining soil
3.31
soil
any unwanted matter
3.32
splash area
area composed of surfaces where product may come into contact and does not return to the product
3.33
sterilization
process that inactivates all micro-organisms and relevant microbial spores
3.34
sterilizability
〈equipment〉 designed to be capable of being sterilized
4 Hazards
The hazards that can be associated with product handling, preparation and processing can arise from:
 biological causes such as pathogens, spoilage micro-organisms or toxins (e.g. ingress or retention of bacteria,
spores, viruses, yeasts/moulds);
 chemical causes including those from cleaning and disinfection substances (e.g. lubricants, cleaning fluids,
allergens);
 physical causes such as foreign materials arising from raw materials, equipment or other sources (e.g.
allergens, pests, metals, materials used in the construction of the machine/equipment).
5 Hygiene requirements and/or measures
5.1 Strategy for selecting hygiene measures
5.1.1 General
The risk assessment strategy for selecting hygiene measures is applicable to both product and non-product contact
areas.
4 © ISO 2002 – All rights reserved

---------------------- Page: 14 ----------------------

ISO 14159:2002(E)
5.1.2 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 12100-1:—, clause 5. This includes the following:
 identification of the process for which the machine is intended;
 hazards associated with the product(s) produced (see clause 4);
 risk assessment associated with each hazard identified (see 5.1.3);
 design methods/measures which can eliminate hazards or reduce risks associated with these hazards (see
5.2);
 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 6);
 description of residual risks and any additional precautions necessary in the information for use where
applicable (see clauses 7 and 8).
This process is schematically represented in Figure 1. After this process has been undertaken for all hazards
identified, it may be applicable to define the item of machinery according to one of the hygiene levels described in
annex A in order to help clarify the intended use.
5.1.3 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.
a) 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 many industries
(e.g. a pump)?
b) 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?
c) 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?
d) 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)?
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)?
e) 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.?
f) 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?
© ISO 2002 – All rights reserved 5

---------------------- Page: 15 ----------------------

ISO 14159:2002(E)

Figure 1 — Schematic risk assessment procedure
6 © ISO 2002 – All rights reserved

---------------------- Page: 16 ----------------------

ISO 14159:2002(E)
5.2 Hygienic design
5.2.1 Materials of construction
5.2.1.1 General
Materials shall be suitable for their intended use.
Surfaces of materials and coatings shall be durable, cleanable and, if necessary, capable of being disinfected,
without breaks, resistant to cracking, chipping, flaking, erosion, corrosion and abrasion and prevent penetration of
unwanted matter under intended use.
5.2.1.2 Product contact surfaces
In addition to the general requirements (see 5.2.1.1), materials used for product contact surfaces shall:
 be corrosion resistant to both product and cleaning/disinfection materials;
 be non-toxic;
 not contaminate or otherwise have any adverse effect on the product;
 be non-absorbent (except where technically or functionally unavoidable);
 be temperature resistant to processing and heat treatments where necessary (e.g. freezing, pasteurization,
sterilization).
5.2.1.3 Metals
Product contact surfaces shall be:
 of stainless steel of a type appropriate for the application; or
 other metals (including solder) suitable for the conditions of intended use.
Product contact surfaces may be modified by surface treatment or coating(s).
5.2.1.4 Non-metals
Elastomers (e.g. rubber and rubber-like materials) and other polymers (e.g. plastic materials) may be used in
product contact applications and shall conform with the appropriate requirements for the application.
Elastomers and other polymers having product contact surfaces shall be of such composition as to retain their
surface and conformational characteristics when exposed to the conditions encountered in the environment of
intended use and in cleaning, disinfection, pasteurization or sterilization.
Adhesives and the bonds created by their use shall be compatible with the surfaces, products and
cleaning/disinfectant materials in which they are in contact. All bonds shall be continuous and mechanically sound
so that the adhesives do not separate from the base materials to which they are bonded.
Where materials having certain inherent functional purposes are required for specific applications, product contact
surfaces may be made of these materials (i.e. carbon, glass, ceramic materials).
Product contact surfaces may be modified by surface treatment or coating(s).
© ISO 2002 – All rights reserved 7

---------------------- Page: 17 ----------------------

ISO 14159:2002(E)
5.2.1.5 Non-product contact surfaces
In addition to the general requirements (see 5.2.1.1), materials used for non-product contact surfaces (including
splash areas), under the conditions of intended use, shall:
 be of corrosion-resistant material or material that is treated (e.g. coating, painting) so as to be corrosion
resistant to both product and cleaning/disinfection materials. When coated, the coating shall adhere;
 be non-absorbent (except where technically or functionally unavoidable);
 not contaminate or otherwise have any adverse effect on the product.
Parts removable for cleaning having both product contact and non-product contact surfaces shall be designed to
ensure that hygiene risks are eliminated.
5.2.2 Design and fabrication of product contact surfaces
5.2.2.1 Surface texture
Surfaces shall be free of imperfections such as pits, folds, cracks and crevices. Technical requirements for surface
finish according to ISO 4287, shall be given in the specific standards, if appropriate.
5.2.2.2 Cleaning and inspection
Surfaces shall be cleanable. For machinery intended to be disassembled, the design shall ensure that relevant
areas are readily accessible for cleaning and inspection and the demountable parts shall be readily removable.
Alternatively, machinery may be designed to be cleaned in place. Some machinery cleaned in place may need to
be designed to allow ready access for inspection after cleaning.
5.2.2.3 Disinfection, pasteurization and sterilization
Machinery
...