National foreword

This British Standard is the UK implementation of EN ISO 14159:2008. It is identical to ISO 14159:2002. It supersedes BS EN ISO 14159:2004 which is withdrawn.

The UK participation in its preparation was entrusted to Technical Committee MCE/3, Safeguarding of machinery.

A list of organizations represented on this committee can be obtained on request to its secretary.

This publication does not purport to include all the necessary provisions of a contract. Users are responsible for its correct application.

Compliance with a British Standard cannot confer immunity from legal obligations.

This British Standard was published under the authority of the Standards Policy and Strategy Committee on 30 June 2009.

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 14159:2008 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of an identical text or by endorsement, at the latest by October 2008, and conflicting national standards shall be withdrawn at the latest by October 2008.

Attention is drawn to the possibility that some of the elements of this document may be the subject of patent rights. CEN [and/or CENELEC] shall not be held responsible for identifying any or all such patent rights.

This document supersedes EN ISO 14159:2004.

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 EC Directives.

For relationship with EC Directives, see informative Annex ZA and ZB which are 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, Bulgaria, Cyprus, Czech Republic, Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden, Switzerland and the United Kingdom.

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.

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.

Endorsement notice

The text of ISO 14159:2002 has been approved by CEN as a EN ISO 14159:2008 without any modification.

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

3 Terms and definitions

4 Hazards

5 Hygiene requirements and/or measures

5.1 Strategy for selecting hygiene measures

5.2 Hygienic design

6 Verification of hygiene measures and test methods

7 Instruction handbook, maintenance and cleaning

7.1 Instruction handbook

7.2 Maintenance and cleaning

8 Additional information (limitations of use)

Bibliography

BS EN ISO 14159:2008

Safety of machinery. Hygiene requirements for the design of machinery

Current, Under Review

Published:

30 Jun 2009