Risk Analysis and Assessment
Performance Level Calculation

The Micro Style staff can offer a complete or partial professional support to customers in all stages of the CE Marking process:

 

risk analysis;
 

application of harmonized standards;
 

technical construction file
 

calculation of the performance level for safety related parts of control system (SSP/CS)
 

noise tests
 

informative support

Risk analysis and assessment

A proper risk assessment associated with the installation, use and maintenance of a machine/plant represents the first and most important step for the design and construction of “safe machines“. Micro Style has developed a methodology for analyzing the possible dangers and assessing the risks arising, based on the application of the Harmonized Standards in force (EN ISO 12100, ISO TR 14121-2, EN ISO 13849-1, EN 62061) which rationalizes and simplifies the drafting of the Probation Document required by Directive 2006/42/EC and which must be included in the Technical Construction File of the machine/plant. The method used (hybrid method according to ISO TR 14121-2) is recognized and approved by the main Notified Bodies and Market Supervisory Bodies at the international level.


Application of harmonized standards

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The Machine Directive 2006/42/EC and the Guide to the application of the Directive refer to various Harmonized European Standards (over 800) classified as:

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Type A standards (valid for all machines) e.g. EN 12100 - Safety of machinery - General principles of design - Risk assessment and risk reduction;
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Type B standards (valid for certain aspects of all machines) e.g. EN 60204-1 - Electrical equipment of the machines;
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Type C standards (valid for specific machine categories) e.g.:

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EN 11111 for textile machines;
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EN 12417 (EN 16090) for numerically controlled machining centers;
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EN 23125 for numerically controlled lathes;
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EN ISO 16092-1 for presses;
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etc;
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The rigorous application of the standards (in particular the Type C standards) in force by the Manufacturer automatically assures the “Presumption of Conformity with the Directive“.
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The continuous evolution of the standards, however, makes it complicated for the Manufacturer to always have the certainty that the applied standards are still valid.
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Micro Stylekeeps its Customers constantly informed about the evolution of the relevant standards through information notes sent directly or published in the news area of the Website www.microstyle.it.


Technical construction file

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In case of dispute by a Market Supervisory Body or in case of accident occurring during the installation, use or maintenance of a machine, the Technical Construction File is the main evidence for the Manufacturer, provided it succeeds to demonstrate in great detail all the Essential Health and Safety Requirements applicable to the machine in question, among those listed in Annex I of the Machinery Directive, which have been observed, implemented and verified during the design and construction phases of the machine.

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The Micro Style support in the development of the Technical File is therefore focused on the arguments that demonstrate how each applicable EHSR was actually satisfied, indicating the appropriate references to the paragraphs and the specific clauses of the various Harmonized Standards adopted.

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Obviously the Micro Style support also includes other fundamental activities such as:

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Verification of formal correctness of Declarations of Conformity or Incorporation of external acquisition groups/components, integrated in the machine or in the Manufacturer's plant. Often this aspect is neglected with consequent implicit “concourse of guilt“, in the case of formally incorrect or untruthful declarations.

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Verification of conformity of the machine/plant with the requirements of Electrical Safety (EN 60204-1 standard) and Electromagnetic Compatibility (2014/30/EU Directive).
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The possible implications of PED (Pressure Equipment) and/or ATEX (areas at risk of explosion).

Calculation of the Performance Level of the safety functions

The EN ISO 13849-1:2015 harmonized standard prescribes a complex set of rules and methodologies for the selection and design of control systems related to safety:

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emergency circuits
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interlocking circuits for movable guards
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immaterial barriers
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prevention of unexpected startups
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etc.

Compared to the previous standard (EN 954-1) which only prescribed a quantitative assessment of the solutions to be adopted (Category of components used), the new standard (EN 13849-1) requires both a quantitative assessment (category) and a qualitative assessment (Performance Level) for the various safety functions. The complexity of the calculations and of the mathematical formulas to be applied for the choice of the appropriate Performance Level have led some Manufacturers (e.g. Siemens, Pilz) to develop proprietary software to facilitate such calculations. At the same time, the German organization IFA (equivalent INAIL in Italy) has developed an application software (free downloadable from Internet) called SISTEMA (Safety Integrity Software Tool for Evaluation of Machinery Application).

This software has quickly established itself as a “De facto” standard for a number of reasons:

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credibility and “Super Partes” role of the IFA organization
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availability of a rich library of safety components with the relative parameters of reliability made available by almost all the suppliers of safety components
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professional and complete reports provided by the program that demonstrate compliance with the required safety requirements (Performance Level)


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