EN ISO 11161: Basic Requirements for Integrated Manufacturing Systems

EN ISO 11161, which is the standard for assemblies of machinery, and goes on to outline its
contents and describe its relationship to the Machinery Directive 2006/42/EC and other
machinery safety standards.

The European Machinery Directive, throughout its various revisions, has always recognized
'assemblies' of machines but, in its latest version 2006/42/EC, which came into force w.e.f
29th December 2009, clearly specifies the essential health and safety requirements for such
assemblies. These assemblies must be considered to be whole new machines and must
therefore be CE marked. Supporting guidance has recently been published as standard:-
“EN ISO 1161:2007+A1:2010 Safety of machinery. Integrated manufacturing systems. Basic
requirements “

An Integrated Manufacturing Systems (IMS) is an assembly of machines that together perform a

specific manufacturing function - for example, bottling lines, canning lines, cartoning lines,
packaging lines, component assembly systems, palletizing systems, de-palletizing systems, etc.
These may comprise new, partly completed and/or used machines arranged and controlled to
function as an 'integral whole.' Often it is the end user that takes on the task of integrating the
various machines to create the complete line. Because integrated assemblies of machines must
be considered to be a whole new and different machine rather than just individual machines
combined, it is, therefore, the integrator that must bear the burden of assessing and ensuring
compliance of the final construction and declare its compliance as an 'integral whole' by CE
marking it in accordance with the Machinery Directive 2006/42/EC.

Harmonised standards

In support of the essential health and safety requirements of the European Machinery
Directive, guidance for assemblies of machinery is provided in the standard EN ISO
11161:2007+A1:2010 Safety of machinery. Integrated manufacturing systems. Basic
requirements.

This Standard specifies the safety requirements for Integrated Manufacturing Systems that
incorporate two or more interconnected machines and gives requirements and
recommendations for their specification, assessment, safe design, safeguarding, co-ordination
and information for use..

EN ISO 11161 presents a strategy for the integrator to develop the IMS specification, setting out
the functional requirements and determining the foreseeable tasks and need for access and
intervention. From this the integrator must identify the hazards and risks and, working in close
co-operation with the user and the suppliers of the component machines and associated
equipment, undertake a risk assessment from which a strategy for reducing the risks may be
established.

Among the many operational features required of an IMS, and described in the standard, is that
of segregated Task Zones, enabling areas of the IMS to be isolated to allow intervention tasks -
 EN ISO 11161: Basic Requirements for Integrated Manufacturing Systems

such as jam clearing, setting and inspections - to take place safely while other portions of the
IMS continue to function normally in automatic operation.

While EN ISO 11161 spells out the general requirements and principles of guarding, protective
measures and controls associated with IMSs, it is supported by three new standards that make
a significant contribution the design and safety of machinery and Integrated Manufacturing
Systems:

• EN ISO 13857:2008 - Safety of machinery. Safety distances to prevent hazard zones

being reached by upper and lower limbs
• EN ISO 13855:2010 Safety of machinery - Positioning of safeguards with respect to the
approach speeds of parts of the human body
• EN ISO 13849-1:2008 Safety of machinery. Safety-related parts of control systems.
General principles for design

These three, in support of EN ISO 11161 and all included within the harmonized Safety of
machinery series, provides the detailed guidance that is vital for the design and co-ordination of
guarding, protective devices and safety-related control systems for machine assemblies and
Integrated Manufacturing Systems.