EN ISO 14159:2004
(Main)Safety of machinery - Hygiene requirements for the design of machinery (ISO 14159:2002)
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)
Diese Internationale Norm legt Hygieneanforderungen für die Gestaltung von Maschinen fest und enthält Informationen zur vom Hersteller der Maschine bestimmte, vorgesehene Verwendung. Diese Norm gilt für alle Arten von Maschinen und die zugehörigen Ausrüstungen, bei deren Verwendung Hygienerisiken für den Konsumenten des Produkts entstehen können.
Anforderungen an die unkontrollierte Freisetzung mikrobiologischer Arbeitsstoffe durch die Maschine werden durch diese Internationale Norm nicht erfasst.
Sécurité des machines - Prescriptions relatives à l'hygiène de la conception des machines (ISO 14159:2002)
Varnost strojev - Higienske zahteve za načrtovanje strojev (ISO 14159:2002)
General Information
Relations
Standards Content (Sample)
SLOVENSKI STANDARD
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
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.
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.
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).
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
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.
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
ISO 14159:2002(E)
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ii © ISO 2002 – All rights reserved
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 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
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.
INTERNATIONAL STANDARD ISO 14159:2002(E)
Safety of machinery — Hygiene requirements for the design o
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