• CE Marking and the Impact of Hardware Design Changes on CE Marked Electrical Equipment

    Hello everyone, this is my first posting, and I hope I'm not going to be judged as teaching grandmother how to suck eggs, but CE marking is a subject which captured my attention as a design engineer in the 90's when I ended up running a manufacturing facility in Lancashire before I made the decision to set up a test lab for independently evaluating electrical and electronic products that were similar to what we were manufacturing at that time. As a family business starting from scratch, we're now UKAS accredited thanks largely to my son and wife, and our company Cranage EMC & Safety in N. Shropshire has grown beyond expectation, but we haven't lost our roots.

    Hopefully, the following notes I have made, directed at industrial and scientific electrical and electronic equipment will help to address someone's concerns about when to CE mark and the potential impact of subsequently making hardware design changes on equipment that has already been CE marked.

    The process of CE marking electrical equipment usually involves having to deal the EMC Directive, electromagnetic emissions and immunity, and the Low Voltage Directive, which is really a little bit about electrical safety but a lot about product safety in its widest sense.

    Impact assessment of hardware design changes on EMC

    Electromagnetic interference (EMI) affects electronic equipment through conduction and radiation and so the performance standards used for verifying electromagnetic compatibility (EMC) include tests on the enclosure and tests on the cabling.

    Critical design factors for EMC involve the use of semiconductors, printed circuit boards, switched mode power supplies, enclosures, internal wiring, cable screening and segregation, grounding and bonding, and filtering components. Significant changes made to any of the foregoing on an item of equipment that had been proven to meet EMC requirements could put previous CE marking at risk and would require either a Notified Body to examine the technical design as part of a conformity assessment procedure, or for the manufacturer to have the equipment fully or partially retested for EMC.

    Mitigation of EMI could only be achieved by careful design and once successful EMC compliance had been achieved, the company’s procedures and work instructions should demonstrate ‘due diligence’ by keeping records of design, assembly instructions and drawings for all EMC critical parts.

    Impact assessment of hardware design changes on safety
    Product safety standards are applied to ensure that hazards to the operator and the surrounding area are reduced to a tolerable level under normal use, foreseeable misuse, abnormal and single fault conditions. Tests are carried out to check for protection against electric shock, burn, spread of fire, excessive temperature, effects of fluids and fluid pressure, mechanical hazards, radiation sources, and liberated gases which may give rise to explosion or implosion.

    A safety evaluation also includes the application of environmental stress such as temperature, humidity, mains supply voltage fluctuations and transients, dust, water and solid matter if present in the surrounding area.

    Critical design factors for safety involve the use of transformers, power supplies, printed circuit boards, internal wiring, cables, fuses, current or voltage limiters, insulating and conducting materials, earthing, enclosures, covers, handles, grips and lifting devices, sub-assemblies, accessible live parts, electrical and mechanical loads, heating or cooling devices, ventilation, controls and interlocks. Significant changes made to any of the foregoing on an item of equipment that had been proven to meet safety requirements could put previous CE marking at risk and would require either a technical design review or for the manufacturer to have the equipment retested for safety in the area of concern.

    Safety-critical components should always be chosen to carry approval marks from a trusted third party wherever possible and checked for their suitability for CE marking projects. However, functional safety should never be assumed and should always be verified in the end product as part of the testing procedure.

    Custom made parts and sub-assemblies that are deemed to have an impact on functional safety or that will have been supplied to the manufacturer without any supporting technical documentation or evidence of intrinsic safety shall be separately tested for its intended application. A suppliers Declaration of Conformity should not be relied on as providing evidence of suitability and so in the absence of vital data or a trusted third party report which confirms that the part or sub-assembly meets all the requirements for safety, it may be necessary to include cost and timescale contingencies for additional testing and CE marking.
    Testing and documentation assessment procedures for demonstrating electrical equipment safety are detailed in the appropriate product safety standard. Once compliance has been achieved, the company’s procedures and work instructions should demonstrate ‘due diligence’ by keeping records of design, assembly instructions, drawings, bills of materials, and regulatory approvals documentation for all safety critical parts.

    Thank you for taking the time to read this, I do hope it will help in some way, and if there's anything we can do to look after you, just ask.

    Keith
    Last edited by Keith Richens; 01-02-2019 at 05:55 PM. Reason: textual
    0
  • Hello everyone, this is my first posting, and I hope I'm not going to be judged as teaching grandmother how to suck eggs, but CE marking is a subject which captured my attention as a design engineer in the 90's when I ended up running a manufacturing facility in Lancashire before I made the decision to set up a test lab for independently evaluating electrical and electronic products that were similar to what we were manufacturing at that time. As a family business starting from scratch, we're now UKAS accredited thanks largely to my son and wife, and our company Cranage EMC & Safety in N. Shropshire has grown beyond expectation, but we haven't lost our roots.

    Hopefully, the following notes I have made, directed at industrial and scientific electrical and electronic equipment will help to address someone's concerns about when to CE mark and the potential impact of subsequently making hardware design changes on equipment that has already been CE marked.

    The process of CE marking electrical equipment usually involves having to deal the EMC Directive, electromagnetic emissions and immunity, and the Low Voltage Directive, which is really a little bit about electrical safety but a lot about product safety in its widest sense.

    Impact assessment of hardware design changes on EMC

    Electromagnetic interference (EMI) affects electronic equipment through conduction and radiation and so the performance standards used for verifying electromagnetic compatibility (EMC) include tests on the enclosure and tests on the cabling.

    Critical design factors for EMC involve the use of semiconductors, printed circuit boards, switched mode power supplies, enclosures, internal wiring, cable screening and segregation, grounding and bonding, and filtering components. Significant changes made to any of the foregoing on an item of equipment that had been proven to meet EMC requirements could put previous CE marking at risk and would require either a Notified Body to examine the technical design as part of a conformity assessment procedure, or for the manufacturer to have the equipment fully or partially retested for EMC.

    Mitigation of EMI could only be achieved by careful design and once successful EMC compliance had been achieved, the company’s procedures and work instructions should demonstrate ‘due diligence’ by keeping records of design, assembly instructions and drawings for all EMC critical parts.

    Impact assessment of hardware design changes on safety
    Product safety standards are applied to ensure that hazards to the operator and the surrounding area are reduced to a tolerable level under normal use, foreseeable misuse, abnormal and single fault conditions. Tests are carried out to check for protection against electric shock, burn, spread of fire, excessive temperature, effects of fluids and fluid pressure, mechanical hazards, radiation sources, and liberated gases which may give rise to explosion or implosion.

    A safety evaluation also includes the application of environmental stress such as temperature, humidity, mains supply voltage fluctuations and transients, dust, water and solid matter if present in the surrounding area.

    Critical design factors for safety involve the use of transformers, power supplies, printed circuit boards, internal wiring, cables, fuses, current or voltage limiters, insulating and conducting materials, earthing, enclosures, covers, handles, grips and lifting devices, sub-assemblies, accessible live parts, electrical and mechanical loads, heating or cooling devices, ventilation, controls and interlocks. Significant changes made to any of the foregoing on an item of equipment that had been proven to meet safety requirements could put previous CE marking at risk and would require either a technical design review or for the manufacturer to have the equipment retested for safety in the area of concern.

    Safety-critical components should always be chosen to carry approval marks from a trusted third party wherever possible and checked for their suitability for CE marking projects. However, functional safety should never be assumed and should always be verified in the end product as part of the testing procedure.

    Custom made parts and sub-assemblies that are deemed to have an impact on functional safety or that will have been supplied to the manufacturer without any supporting technical documentation or evidence of intrinsic safety shall be separately tested for its intended application. A suppliers Declaration of Conformity should not be relied on as providing evidence of suitability and so in the absence of vital data or a trusted third party report which confirms that the part or sub-assembly meets all the requirements for safety, it may be necessary to include cost and timescale contingencies for additional testing and CE marking.
    Testing and documentation assessment procedures for demonstrating electrical equipment safety are detailed in the appropriate product safety standard. Once compliance has been achieved, the company’s procedures and work instructions should demonstrate ‘due diligence’ by keeping records of design, assembly instructions, drawings, bills of materials, and regulatory approvals documentation for all safety critical parts.

    Thank you for taking the time to read this, I do hope it will help in some way, and if there's anything we can do to look after you, just ask.

    Keith
  • Thank you for posting @Keith Richen

    Extremely useful advice for other community members.

    Best regards,

    Daniel.

    Sent from my SM-G920F using EEF Network mobile app
    Community Manager
    Need help? Ask me your questions about the Community here
    0
  • Thank you for posting @Keith Richen

    Extremely useful advice for other community members.

    Best regards,

    Daniel.

    Sent from my SM-G920F using EEF Network mobile app
    Community Manager
    Need help? Ask me your questions about the Community here
  • Hey @Keith Richens not sure if you've seen this already but saw this article on the BBC about CE markings this morning and thought of you!

    https://www.bbc.co.uk/news/business-47096621

    The government has drawn up plans to replace the CE safety symbol on products in the event of a no-deal Brexit. The mark belongs to the European Union, so if Britain leaves the EU without a deal, goods will have to be stamped with a new symbol - UKCA.

    Would be interested to hear your thoughts on this?

    Amy

    Name:  HCE mark brexit.PNG
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    Community Manager
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  • Hey @Keith Richens not sure if you've seen this already but saw this article on the BBC about CE markings this morning and thought of you!

    https://www.bbc.co.uk/news/business-47096621

    The government has drawn up plans to replace the CE safety symbol on products in the event of a no-deal Brexit. The mark belongs to the European Union, so if Britain leaves the EU without a deal, goods will have to be stamped with a new symbol - UKCA.

    Would be interested to hear your thoughts on this?

    Amy

    Name:  HCE mark brexit.PNG
Views: 49
Size:  528.1 KB
    Community Manager
    Need help? Ask me your questions about the community here
  • Hi Amy, what a coincidence, was discussing the UKCA subject with my colleagues yesterday evening over a curry!

    In my opinion, just when industry needed ‘calm’, we get this half-baked announcement which on the face of it looks like another nail in the UK manufacturers coffin. However, country specific marking is a normal practice around the world and third countries cannot use the CE Mark for their own purposes.

    As a ConformityAssessment Body in regular contact with BEIS, our current understanding is that technical processes and DoC procedures are going to be exactly the same as those for CE Marking, so there should be no additional work for the manufacturer other than a new label and another self-declared certificate. The information we have at the moment is that not all products will be required to bear the UKCA Mark (if one is introduced?). To be honest, the UKCA mark was marketed to us as a new framework for UK Notified Bodies to operate under when the EU role in the UK is made redundant but the rules are lacking definition and we haven’t been notified of any changes that might affect Conformity Assessment such as ‘harmonised supply voltage’.
    Last edited by Keith Richens; 05-02-2019 at 02:13 PM. Reason: syntax errors
    2
  • Hi Amy, what a coincidence, was discussing the UKCA subject with my colleagues yesterday evening over a curry!

    In my opinion, just when industry needed ‘calm’, we get this half-baked announcement which on the face of it looks like another nail in the UK manufacturers coffin. However, country specific marking is a normal practice around the world and third countries cannot use the CE Mark for their own purposes.

    As a ConformityAssessment Body in regular contact with BEIS, our current understanding is that technical processes and DoC procedures are going to be exactly the same as those for CE Marking, so there should be no additional work for the manufacturer other than a new label and another self-declared certificate. The information we have at the moment is that not all products will be required to bear the UKCA Mark (if one is introduced?). To be honest, the UKCA mark was marketed to us as a new framework for UK Notified Bodies to operate under when the EU role in the UK is made redundant but the rules are lacking definition and we haven’t been notified of any changes that might affect Conformity Assessment such as ‘harmonised supply voltage’.
  • We are heavily involved in CE marking for our products and currently we are considering the options of maintaining the CE mark, which means us having an importer in the EU. Around 25% of our product is sold directly in the EU.
    I am not sure who in the world is going to recognise UKCA? This will take a long time to gain full acceptance.
    If anything we would consider this to be an 'and' not an 'or'. In a lot of cases we would not have a spare space for dual marking.
    2
  • We are heavily involved in CE marking for our products and currently we are considering the options of maintaining the CE mark, which means us having an importer in the EU. Around 25% of our product is sold directly in the EU.
    I am not sure who in the world is going to recognise UKCA? This will take a long time to gain full acceptance.
    If anything we would consider this to be an 'and' not an 'or'. In a lot of cases we would not have a spare space for dual marking.