Summary of Machinery Directive Satisfaction - DEN-S-NET-xx

Document Creation

L. van Noort

Person responsible for Technical File

Authorized Representative*:

*An Authorized Representative is required for CE marking directives/regulations when the Manufacturer is located outside of the EU, or for UKCA marking when the manufacturer is located outside of the UK.

N/A

Product Description:

Denali Safe NET

Part Number:

DEN-S-NET-xx

Scope*:

*i.e. the Regulation, Directive or Voluntary Certificate that is satisfied

Machinery Directive 2006/42/EC

EN 61800-5-2:2007 & EN 61800-5-2:2017

Adjustable speed electrical power drive system - Part 5-2: Safety requirements - Functional

EN ISO 13849-1:2023

Safety of machinery - Safety-related parts of control systems - Part 1: General principles for design

EN 61508 Parts 1-7: 2010

Functional safety of electrical/electronic/programmable electronics safety related systems - Parts 1-7

The manufacturer or his authorized representative must ensure that a risk assessment is carried out in order to determine the health and safety requirements which apply to the machinery. The machinery must then be designed and constructed taking into account the result of the risk assessment.

N

Since product is meant for integration, it is impossible to assess risk without knowing the final application. Instead, a specific safety integrity level and performance level are chosen and product is designed to meet these levels.

1.1.2. (a)

Machinery must be so designed and constructed so that it is fitted for its function, and can be operated, adjusted and maintained without putting persons at risk when these operations are carried out under the conditions foreseen but also taking into account any reasonable foreseeable misuse thereof.

Y

Product meets requirements of PLe and SIL3 and is certified to these levels [2]

1.1.2. (b)

In selecting the most appropriate methods, the manufacturer or his authorized representative must apply the following principles, in the order given:

• Eliminate or reduce risks as far as possible

• Take the necessary protective measures in relation to risks that cannot be eliminated

• Inform users of the residual risks due to any shortcomings of the protective measures adopted

N

Since product is meant for integration, it is impossible to assess risk without knowing the final application. Instead, a specific safety integrity level and performance level are chosen and product is designed to meet these levels.

1.1.2. (c)

When designed and constructing machinery and when drafting the instructions, the manufacturer or his authorized representative must envisage not only the intended use of the machinery but also any reasonable foreseeable misuse thereof.

Machinery must be designed and constructed in such a way as to prevent the abnormal use if such use would engender a risk.

Y

See information contained in product manuals [4]

1.1.2. (d)

Machinery must be designed and constructed to take account of the constraints to which the operator is subject as a result of the necessary or foreseeable use of personal protective equipment.

N

Product is machinery component

1.1.2. (e)

Machinery must be supplied with all the special equipment and accessories essential to enable it to be adjusted, maintained and used safely.

N

Product is machinery component

1.1.3.

The materials used to construct machinery or products used or created during its use must not endanger persons' safety or health. In particular where fluids are used, machinery must be designed and constructed to prevent risk due to filling, recovery or draining.

Y

Product meets requirements of PLe and SIL3 and is certified to these levels [2].

Product does not use or depend on fluids.

1.1.4.

Lighting

N

Product is machinery component and does require provision of lighting

1.1.5.

Machinery, or each component part thereof, must:

• be capable of being handled and transported safely,

• be packaged or designed so that it can be stored safely and without damage

Y

Product is packaged in Faraday cage ESD bag [ref], and situated in packaging as defined in [ref], foreseen of the appropriate Handle with Care logo [7], to ensure it can be transported and delivered safely and without damage.

1.1.6.

Ergonomics

N

Product is machinery component and does not require ergonomics considerations

1.1.7.

Operating positions

N

Product is machinery component and does not require operating positions considerations

1.1.8.

Seating

N

Product is machinery component and does not require seating considerations

1.2.1

Control systems must be designed and constructed in such a way as to prevent hazardous situations from arising. Above all, they must be designed and constructed in such a way that:

• they can withstand the intended operating stresses and external influences,

• a fault in the hardware or the software of the control system does not lead to a hazardous situation,

• errors in the control system logic do not lead to hazardous situations,

• reasonably foreseeable human error during operation does not lead to hazardous situation

Y

Product has been designed according to the standard 61508 parts 1-7 which requires that failure rates be determined, this has been fulfilled by performing a failure mode and effect analysis [12]. Operation stress testing is performed in the system verification stage. The product has been tested against external influences according to 61508-2 table A.16 which covers EMC [8, 13, 14] and environmental testing [15]. Fault mitigation actions have been verified by fault injection tests [16].

1.2.2.

Control devices

N

Product is machinery component and not considered a control device

1.2.3.

Starting

N

Product is machinery component

1.2.4.

Stopping

N

Product is machinery component

1.3.

Protection against mechanical hazards

N

Product does not have moving parts

1.4.

Required characteristics of guards and protective devices

N

Product is not, and does not include, guards or protective devices

1.5.1.

Where machinery has an electricity supply, it must be designed, constructed and equipped in such a way that all hazards of an electrical nature are or can be prevented.

Y

See Summary of Low Voltage Directive Satisfaction [9]

1.5.2.

Machinery must be designed and constructed to prevent or limit the build-up of potentially dangerous electrostatic charges and/or be fitted with a discharging system

1.5.3.

Energy supply other than electricity

N

Product does not operate on energy other than electricity

1.5.4.

Errors likely to be made when fitting or refitting certain parts which could be a source of risk must be made impossible by the design and construction of such parts or, failing this, by information given on the parts themselves and/or their housings.

N

Product does not contain parts for fitting/refitting

1.5.5.

Steps must be taken to eliminate any risk or injury arising from contact with or proximity to machinery parts or materials at high or very low temperatures

Y

Drives contain temperature sensors to manage maximum temperature, and user manual contains warning about hot surface [3-5]

1.5.6.

Machinery must be designed and constructed in such a way as to avoid any risk of fire or overheating posed by the machinery itself or by gases, liquids, dust, vapours or other substances produced or used by the machinery.

Y

Internal temperature sensor, sets drive into reset stage if internal temperature exceeds specified limits

1.5.7.

Machinery must be designed and constructed in such a way as to avoid any risk of explosion posed by the machinery itself or by gases, liquids, dust, vapours or other substances produced by the machinery.

Y

FMEA is performed considering dangerous and non-dangerous failure modes [12]. FMEA was performed on most complete configuration (EVE-XCR) as worst-case configuration. Drives are not meant for installation in explosive environments.

1.5.8.

Machinery must be designed and constructed in such a way that risk resulting from the emission of airborne noise are reduced to the lowest level, taking account of technical progress and the availability of means of reducing noise, in particular at source.

Y

Drive does not inherently produce sound.

1.5.9.

Machinery must be so designed and constructed in such a way that risk resulting from vibrations produced by machinery are reduced to the lowest level, taking account of technical progress and the availability of means of reducing vibration, in particular at source.

Y

Environmental test performed, covering shock and vibrations resistance [15].

1.5.10.

Undesirable radiation emissions from the machinery must be eliminated or be reduced to levels that do not have adverse effects on persons.

Y

See Summary of EMC Directive Satisfaction [8].

1.5.11.

Machinery must be designed and constructed in such a way that external radiation does not interfere with its operation.

Y

1.5.12.

Laser radiation

N

N/A

1.5.13.

Machinery must be designed and constructed in such a way that risk of inhalation, ingestion, contact with the skin, eyes and mucous membranes and penetration through the skin of hazardous materials and substances which it produced can be avoided.

Y

Drive does not produce hazardous substances and is compliant with ROHS Directive on the Reduction of the use of Hazardous Substances.

1.5.14.

Risk of being trapped in a machine

N

Product is machinery component.

1.5.15.

Risk of slipping, tripping or falling

N

Product is machinery component.

1.5.16.

Lightning

N

Product is machinery component.

1.6.

Maintenance

N

Product is machinery component.

1.7.1.

Information and warnings on the machinery should preferably be provided in the form of readily understandable symbols or pictograms. Any written or verbal information and warnings must be expressed in an official Community language or languages, which may be determined in accordance with the Treaty by the Member State in which the machinery is placed on the market and/or put into service and may be accompanied, on request, by versions in any other official Community language or languages understood by the operators.

Y

Installation manual requires the use of symbols and pictograms by the installer [3-5]

1.7.1.1.

The information needed to control machinery must be provided in a form that is unambiguous and easily understood. It must not be excessive to the extent of overloading the operator.

Y

The product in itself does not require continuous control and operation. Instructions for use and installation are found in the Product Manuals [3-5], written in a clear and unambiguous way.

1.7.1.2.

Warning devices

N

N/A

1.7.2.

When risks remain despite the inherent safe design measures, safeguarding and complementary protective measures adopted, the necessary warnings, including warning devices, must be provided.

Y

The product in itself does not require continuous control and operation. Instructions for safe use are found in the Safety Manuals [3-5], written in a clear and unambiguous way.

1.7.3.

All machinery must be marked visibly, legibly and indelibly with the following minimum particulars:

• The business name and full address of the manufacturer and, where applicable, his authorised representative

• designation of the machinery

• the CE marking

• designation of series or type

• serial number, if any

• the year of construction, that is the year in which the manufacturing process is completed.

It is prohibited to pre-date or post-date the machinery when affixing the CE marking.

Machinery designed and constructed for use in a potentially explosive atmosphere must be marked accordingly.

Machinery must also bear full information relevant to its type and essential for safe use. Such information is subject to the requirements set out in in section 1.7.1.

Where a machinery part must be handled during use with lifting equipment, its mass must be indicated legibly, indelibly and unambiguously.

Y

Labeling includes CE marking, Serial Number, and a link to the website as well as a QR code to access all additional [10].

Product is not intended for use in an explosive atmosphere.

1.7.4.

All machinery must be accompanied by instructions in the official Community language or languages of the Member State in which it is placed on the market and/or put into service.

The instructions accompanying the machinery must be either ‘Original instructions' or 'Translation of the original instructions’, in which case the translation must be accompanied by the original instructions.

By way of exception, the maintenance instructions intended for use by specialised personnel mandated by the manufacturer or his authorised representative may be supplied in only one Community language which the specialised personnel understand.

The instructions must be drafted in accordance with the principles set out below.

Y

User manuals are supplied in English [4].

Not currently using “Original instructions” language

No maintenance requirements apply

1.7.4.1.

• The instructions must be drafted in one or more of the official Community languages. The words ‘Original instructions’ must appear on the language version(s) verified by the manufacturer or his authorised representative.

• Where no ‘Original instructions' exist in the official language(s) of the country where the machinery is to be used, a translation into that/those language(s) must be provided by the manufacturer or his authorised representative or by the person bringing the machinery into the language area in question. The translations must bear the words 'Translation of the original instructions’.

• The contents of the instructions must cover not only the intended use of the machinery but also take into account any reasonably foreseeable misuse thereof.

• In the case of machinery intended for use by non-professional operators, the wording and layout of the instructions for use must take into account the level of general education and acumen that can reasonably be expected from such operators.

Y

See information contained in user manuals [4].

1.7.4.2.

Each instruction manual must contain, where applicable, at least the following information:

• the business name and full address of the manufacturer and of his authorized representative;

• the designation of the machinery as marked on the machinery itself, except for the serial number;

• the EC declaration of conformity, or a document setting out the contents of the EC declaration of conformity, showing the particulars of the machinery, not necessarily including the serial number and the signature;

• a general description of the machinery;

• the drawings, diagrams, descriptions and explanations necessary for the use, maintenance and repair of the machinery and for checking its correct functioning;

• a description of the workstation(s) likely to be occupied by operators;

• a description of the intended use of the machinery;

• warnings concerning ways in which the machinery must not be used that experience has shown might occur;

• assembly, installation and connection instructions, including drawings, diagrams and the means of attachment and the designation of the chassis or installation on which the machinery is to be mounted;

• instructions relating to installation and assembly for reducing noise or vibration;

• instructions for the putting into service and use of the machinery and, if necessary, instructions for the training of operators;

• information about the residual risks that remain despite the inherent safe design measures, safeguarding and complementary protective measures adopted;

• instructions on the protective measures to be taken by the user, including, where appropriate, the personal protective equipment to be provided;

• the essential characteristics of tools which may be fitted to the machinery;

• the conditions in which the machinery meets the requirements of stability during use, transportation, assembly, dismantling when out of service, testing or foreseeable breakdowns;

• instructions with a view to ensuring that transport, handling and storage operations can be made safely, giving the mass of the machinery and of its various parts where these are regularly to be transported separately;

• the operating method to be followed in the event of accident or breakdown; if a blockage is likely to occur, the operating method to be followed so as to enable the equipment to be safely unblocked;

• the description of the adjustment and maintenance operations that should be carried out by the user and the preventive maintenance measures that should be observed;

• instructions designed to enable adjustment and maintenance to be carried out safely, including the protective measures that should be taken during these operations;

• the specifications of the spare parts to be used, when these affect the health and safety of operators;

• the following information on airborne noise emissions:

  • the A-weighted emission sound pressure level at workstations, where this exceeds 70 dB(A); where this level does not exceed 70 dB(A), this fact must be indicated,

  • the peak C-weighted instantaneous sounds pressure value at workstations, where this exceeds 63 Pa (130 dB in relation to 20 microPa)

  • the A-weighted sound power level emitted by the machinery, where the A-weighted emission sound pressure level at workstations exceeds 80 dB(A)

• where machinery is likely to emit non-ionising radiation which may cause harm to persons, in particular, persons with active or non-active implantable medical devices, information concerning the radiation emitted for the operator and exposed persons.

Y

See information contained in user manuals [4].

1.7.4.3.

Sales literature describing the machinery must not contradict the instructions as regards health and safety aspects. Sales literature describing the performance characteristics of machinery must contain the same information on emissions as is contained in the instructions

Y

Periodic reviews of sales literature by compliance team, as called out in Standard Operating Procedure on NPI/NSI/FRA Compliance [11].

Supplementary Essential Health and Safety Requirements for Certain Categories of Machinery

N

Product does not fall under any of the highlighted machinery categories.

Supplementary Essential Health and Safety Requirements to Offset Hazards due to the Mobility of Machinery

N

Product is meant for installation and not independently designed as (self) mobile device.

Supplementary Essential Health and Safety Requirements to Offset Hazards due to Lifting Operations

N

Product is not independently responsible for lifting operations.

Supplementary Essential Health and Safety Requirements for Machinery Intended for Underground Work

N

Product is not independently responsible for underground work.

Loading Control for Machinery moved by Power other than Human Strength

N

Product is not designed for loading control.

[1]

Machinery Directive 2006/42/EC

Directive - 2006/42 - EN - Machinery Directive - EUR-Lex

[2]

EC Type-Certification

Summit Safety Series EC Type Certificate

[4]

User Manuals EVS-S-NET

Denali Safe NET - Product Manual - Denali Safe NET - Novanta Motion - Confluence

[6]

Website

Servo Drives from INGENIA: Application focused motor control solutions

[7]

Shipping label Information

Shipping Label information - Quality - Drives - Novanta Motion - Confluence

[8]

Summary of EMC Directive Satisfaction

Summary of EMC Directive Satisfaction - DEN-S-NET-xx - Denali Safe NET - Novanta Motion - Confluence

[9]

Summary of Low Voltage Directive Satisfaction

[10]

Product marking EVS-S-NET

Product Marking DEN-S-NET-XX - Denali Safe NET - Novanta Motion - Confluence

[11]

Product Compliance SOP

QAP-000XX NPI_NSI_FRA Regulatory Compliance Procedure.docx (Document currently in draft)

[12]

Failure Mode and Effects Analysis (FMEA) EVS-S-NET

FMEA DEN-S-NET

[13]

EN IEC 61800-3:2018 EMC Test Report

Lab test results - Phase 2 - Denali Safe NET - Novanta Motion - Confluence

[14]

EN IEC 61800-5-2:2017 EMC Test Report

Lab test results - Phase 2 - Denali Safe NET - Novanta Motion - Confluence

[15]

Environmental test report

Lab Test Results - Denali Safe NET - Novanta Motion - Confluence