The basis of the EN13849 Assessment and Validation Service is to meet the requirements specified in EN13849-1 and EN13849-2 and to then produce, and provide, the relevant Validation Reports to verify that CE Compliance for the Machine(s) Safety Related Control System has been achieved.

The Validation Report and supporting Documentation will be forwarded to the Client such that these Documents can then be incorporated into the Technical Construction File (TCF) applicable to the relevant Machine.

To complete the Validation Project, several pieces of Machine information must first be gathered for inspection and processing by our Validation Team. Some of our clients will have this information to hand; some will require encouragement, assistance and guidance to obtain the relevant information. Whichever type of client you are, please be assured that we at Laicon Inc pride ourselves in our commitment, experience, patience and determination to make this process as pleasant (and ‘painless’) as possible.

To help you to better understand what Machine information is required for the Validation Project to progress, please review the “Information Requirement List” below. Please note that this is an indicative list and that there may therefore be additional information requested of you from our Validation Team (dependent upon your Machine Type/Application). To complete the Validation Project for your Machine, the Validation Team will need the following items as a minimum.

EN13849-2 Validation – Information Requirement List

1	All EN13849-1 Risk Assessments pertaining to the Hazards identified on the Machine and identifying the PLr for the SRP/CS.Note – See EN13849-1 Assessment information Section below, for further details on how to conduct the actual EN13849-1 Assessments.
2	All Electrical, Hydraulic, Pneumatic Drawings and Schematics.
3	All Mechanical Drawings for the Machine.
4	Machine Instruction Manual.
5	Photographs of the Machine, photographs of the Machine Hazards (as per the EN13849-1 Assessments), photographs of the Safety Components in situ on the Machine, photographs of the Guarding, photographs of the Hydraulic and/or Pneumatic Safety Components etc. Basically, Photographs of anything that helps our Validation Team to understand the Machine Type, relevant and typical Hazards and the safety measures taken to prevent injury.
6	A Block Diagram of the Machine Safety Related Control System (SRCS) layout Drawings to include any/all E-Stops, Contact/Non-Contact Interlocks, Trapped Key Interlocks, Light Curtains, Safety Relays, Safety Output Contactors, Air Dump Valves, Hydraulic In-Line Fuses etc. Client to identify how many Safety Components there are and it may also be necessary to provide more than one Diagram if Safety Components are on separate Circuits.
7	Technical Data Sheets for all Safety Components used. The Safety Component Manufacturers Tech Data Sheets should contain relevant information pertaining to the Mean Time To Dangerous Failure (MTTFd) or B10d value of the component. This Component information, along with the SRCS configuration and relevant Diagnostic Coverage, is utilized during the Validation process.
8	Technical Data Sheets for Motors, Servos, Manifolds, Valves, Sensors, Solenoids, Dump Valves, Temperature monitoring devices etc.
9	Confirmation of Frequency of use for the Machine i.e. How many Hours in a Day do you anticipate the Machine to be operating (e.g. 1-Shift system = 8 hours a day, or a 2 Shift system =16 Hours a day?), how many days in the week do you anticipate the Machine to be used (e.g. Mon to Fri = 5 Days, or maybe it will be used continually = 7 Days a week?) and how many weeks in the Year (e.g. Shut down for National Holidays, therefore Machine could be operating for 40 Weeks a Year?). Note – This is not an exact science as Machine usage may vary, dependent on whom/where the Machine User is. However, as Manufacturer/Supplier of the Machine, it is feasible to expect you to have a fairly accurate understanding of how the Machine is to be used (or how often it was designed to be used).
10	Confirmation of Frequency of use for the Safety Related Control System(SRCS) i.e. How many times do you anticipate that a demand will be made upon the SRCS? How often will the Operator have to go through an Interlocked Guard to conduct a Product Change, or break a Light Curtain to clear a Product Jam, or enter the Machine for Maintenance/Cleaning etc? Note – Again, this is not an exact science as it may vary dependent on whom/where the Machine User is. However, as Manufacturer/Supplier of the Machine, it is feasible to expect you to have a fairly accurate understanding of how often the Machine User will access the Machine through the various access points on the Machine e.g. Through an interlocked door, or light curtain etc.

EN13849 Assessment and Validation Services

EN13849-1 Assessments

To enable Laicon Inc to validate your Safety Related Control System (SRCS) and Parts of your SRCS (SRP/CS), our Validation Team will require your EN13849-1 Assessments.

What is an EN13849-1 Assessment?

EN13849-1….. is the first part of the EN13849 Series and explains, in detail, the process for identifying the Performance Level required (PLr) for the Machine under Assessment. It is of note that the Hazards generated by the Machine, the exposure to those Hazards and the likelihood of avoiding those Hazards, will effectively determine the required Performance Levels for that Machine. It is also of note that it is possible to have different Performance Level requirements (PLr) for different ‘parts’ of your Machine (Or complex Assembly).

Note – Performance Level is determined by identifying (a) The Severity of Injury, defined as S1 or S2, (b) The Frequency and/or time of Exposure, defined as F1 or F2 and (c) The Probability of Avoidance, defined as P1 or P2 – See EN13849-1 Annex A, Section A.2.1, A.2.2 & A.2.3 for further guidance on definitions of S1/S2, F1/F2 & P1/P2.

For Example (1) – You may have a Shearing Hazard on your Machine that is protected by an Interlocked Hinged Guard. The Hazard may be sufficient to cause a Serious Injury (S2); it may also be located on a section of Machine that is frequently accessed by the Operator/Maintainer (F2). It may be that if the Machine was to ‘start-up’ whilst a person was exposed to this Hazard, that they would have enough space, and time, to avoid the Hazard (P1). By using these factors in accordance with EN13849-1 (Annex A, Figure A.1), the Safety Related Parts of the Control System (SRP/CS) controlling that particular Interlocked Hinged Guard would need to achieve a Performance Level D, because S2 + F2 + P1 = PLd.

FYI: In comparison to an EN954 Assessment, a PLc system would be very similar in configuration to an EN954 Control Category 3 system i.e. Dual Channel with Redundancy.

For Example (2) – If on this same Machine you also had a Pneumatic System, but the Hazard generated from the Pneumatic System was a minimal Injury (S1) and the Operator was rarely exposed to this Hazard (F1) and it would be possible to avoid the Hazard if for example the Machine was to be unintentionally started (P1); by using these factors, in accordance with EN13849-1 (Annex A, Figure A.1), the SRP/CS controlling the e.g. Pneumatic Dump Valve, need only achieve Performance Level A, because S1 + F1 + P1 = PLa.

FYI: In comparison to an EN954 Assessment, a PLa system would be very similar in configuration to an EN954 Control Category 1 system i.e. Single Channel, no Redundancy or monitoring.

As can be seen from the above two examples, it is feasible that a Machine can have different Performance Levels for different parts of the Machines SRP/CS. This can have an overall effect on Unit cost for the Machine as instead of deciding that the whole SRPCS must meet the requirements of a PLc system (e.g. Dual Channel, high rated MTTFd Safety Components, medium to high Diagnostic Coverage etc), the Manufacturer can now utilize cheaper Safety Components (Low MTTFd) and a less complex SRP/CS configuration.

For further information and explanation relating to the required SRCS configuration, please see Table 7 of EN13849-1.

To determine the required Performance Levels for any Machine, the Manufacturer must firstly identify each of the Hazards pertaining to his Machine e.g. Nip Point, Shear Hazard, Thermal Hazard, Crushing Hazard etc (Note – A list of generic Hazards can be found in EN12100 (2010) Annex B).

An EN13849-1 Assessment must then be calculated for each Hazard associated with the Machine, which can be determined after referencing/utilizing Figure A1 in Annex A of EN13849-1. It may help to know that when determining if your answer is S1 or S2, F1 or F2, P1 or P2, you can also reference EN13849-1 Annex A, Section A.2.1., A.2.2. and A.2.3. (These Sections offer further guidance and description of S1/S2, F1/F2, P1/P2).

By completing the above and then providing Laicon Inc with all of your Machine EN13849-1 Assessments (along with applicable matrix charts, as per Annex B of EN13849-1), we are then able to move on to the next stage of Validation.

IMPORTANT NOTE – Laicon Inc can conduct the EN13849-1 Assessments on your behalf, but this would require an on-site visit to inspect the Machine, identify the associated Machine Hazards and identify each of the relevant EN13849-1 Assessment Performance Levels required (PLr) for the Machine. Whilst on-site, our Engineers would also be able to verify and collect other Machine information needed for the Validation process (as identified by the Information Requirement List above).

What is a Typical Cost for an EN13849-1 Assessment Project?

Depending on the clients location in the USA and the physical size/complexity of the Machine under Assessment, a typical cost for Laicon Inc to conduct the EN13849-1 Validation at the clients facility (which would include 1 Day for travel, 1 Day On-site to collate the information and inspect the Machine and Expenses), the cost would be around $4,000 Total.

What is a Typical Cost for an EN13849-2 Validation Project?

Depending on the physical size/complexity of the Machine being validated, a typical cost for Laicon Inc to Validate a Machine to EN13849-2 (at least 3 Days) and provide the documentation to support compliance (at least 1 Day) would be around $3,000 Total.

Laicon uses the SISTEMA software system to validate your safety related control system, which is available for download from the DGUV website

Should you require further information pertaining to EN13849 (or EN62061), or if you are interested in discussing the methodology of the Validation Services for these EN Standards, please contact Laicon Inc at [email protected] or [email protected] or contact myself directly at[email protected].

For further information on our other services, please call us on 407-926-6185. Thank You.