Product compliance can become complicated quickly. Manufacturers may need to consider several directives, technical standards, safety requirements, and documentation requirements before equipment can enter its intended market.
Two terms that come up often during this process are directives and standards. They are closely connected, but they serve different purposes.
Directives establish the essential requirements that applicable products must meet. Standards provide technical guidance that can help manufacturers meet those requirements.
Understanding how the two work together can make the compliance process easier to navigate. It can also help manufacturers identify requirements earlier, make better design decisions, and avoid unnecessary problems later in a project.
What You Can Expect From The Video and Blog
- The difference between directives and technical standards
- How standards help manufacturers address essential requirements
- Why harmonized standards are important for CE compliance
- What happens when multiple requirements apply to the same equipment
- Why these requirements should be considered during equipment design
- How HTDS can help manufacturers navigate the compliance process
Directives Establish the Requirements, Standards Help Address Them
A European directive establishes essential requirements that certain products must meet.
Depending on the equipment, requirements may come from the Machinery Directive, Low Voltage Directive, EMC Directive, or a combination of applicable directives.
These directives establish what needs to be achieved. However, manufacturers still need to determine how those requirements will be addressed in the actual design and evaluation of their equipment.
This is where technical standards come into the process.
Standards provide more detailed technical requirements and guidance. They can cover specific areas such as:
- Electrical equipment of machines
- Low-voltage switchgear and controlgear assemblies
- Risk assessment and risk reduction
- Safety-related control systems
- Functional safety
- Electrical installations
In simple terms, directives establish the requirements, while standards can provide a technical path for addressing them.
Understanding that relationship is an important starting point for developing a compliance strategy.
Why Harmonized Standards Matter
Harmonized standards can give manufacturers an established way to address the essential requirements of European directives.
These standards are developed through the European standardization process. Many European electrotechnical standards are also based substantially on international IEC standards.
Using an applicable harmonized standard can provide a presumption of conformity with the corresponding essential requirements that the standard addresses.
This gives manufacturers a clearer technical framework to follow when evaluating their equipment.
Standards are generally voluntary. A manufacturer may choose another approach instead of using a harmonized standard. However, the manufacturer must still demonstrate that the applicable essential requirements have been fulfilled.
Because of this, manufacturers should look beyond simply asking:
“Which standard applies to my equipment?”
A better question is:
“Which requirements apply to my equipment, and how will we show that those requirements have been met?”
That approach puts the focus on the complete compliance process rather than simply checking off a standard.
What Happens When Multiple Directives and Standards Apply?
Industrial equipment does not always fall under one directive or one standard.
A single product may fall within the scope of several directives. When that happens, the applicable requirements from each directive need to be addressed.
The same can be true for technical standards.
One standard may address the electrical equipment of a machine. Another may cover the construction and verification of a low-voltage controlgear assembly. Additional standards may address risk assessment, functional safety, or safety-related control systems.
This is why selecting standards is not always as simple as finding one that matches the general type of equipment.
Manufacturers need to look at the equipment as a complete system.
That means considering:
- What the equipment does
- How it will be used
- Its electrical characteristics
- The hazards it presents
- Its safety functions
- The market where it will be placed
These factors help determine which directives and standards need to become part of the compliance strategy.
How Do IEC Standards Fit Into European Requirements?
For manufacturers working across different markets, it is also helpful to understand the relationship between international IEC standards and European standards.
Many European electrotechnical standards are closely connected to IEC standards.
For example, IEC 60204-1 addresses the electrical equipment of machines. The IEC 61439 series addresses low-voltage switchgear and controlgear assemblies. Related European standards are then used within the European conformity framework.
This relationship can provide a useful technical foundation for manufacturers developing equipment for international markets.
However, following an IEC standard does not automatically answer every compliance question.
Manufacturers still need to determine which directives, adopted standards, and other requirements apply in the market where the equipment will be used or sold.
Why Identifying Requirements Early Matters
Compliance is easier to manage when it is considered during the engineering process rather than after the equipment is complete.
When the applicable directives and standards are identified early, engineers can consider those requirements while developing:
- Electrical systems
- Control panels
- Protective measures
- Safety-related control functions
- Risk reduction measures
- Technical documentation
This can help the design team address compliance requirements as the equipment is being developed.
Waiting until the equipment is finished can make the process more difficult.
An evaluation may uncover areas where the existing design does not meet applicable requirements. Addressing those issues later can lead to additional engineering work, documentation, testing, or design changes.
Identifying the requirements earlier gives manufacturers more time to address potential issues before they become larger problems.
What Does This Mean for Your Equipment?
There is no single compliance checklist that works for every piece of industrial equipment.
The correct path depends on the equipment itself and where it is going.
Manufacturers need to consider questions such as:
- What does the equipment do?
- Where will it be placed on the market?
- What hazards are present?
- Which directives apply?
- Which standards address those hazards and requirements?
- What documentation is needed?
- How will conformity be demonstrated?
This also means that two pieces of equipment that appear similar may not follow exactly the same compliance path.
Differences in design, function, electrical characteristics, intended use, and destination can change which requirements need to be addressed.
A strong compliance strategy starts by understanding the equipment and then determining the requirements that apply to it.
How HTDS Helps Manufacturers Navigate the Requirements
Determining which standards and directives apply can become challenging, especially with complex industrial equipment.
HTDS helps manufacturers evaluate applicable requirements and develop a clearer path through the compliance process.
This can include evaluating equipment against applicable requirements, identifying potential nonconformities, supporting risk evaluation, and helping engineering teams understand what needs to be addressed.
When HTDS is involved during the design process, potential compliance issues can be identified before they become more difficult to correct.
HTDS can also support manufacturers when the equipment has already been designed. In that situation, the applicable requirements still need to be identified, the equipment needs to be evaluated, and any nonconformities need to be addressed.
In either case, the goal is the same: create a compliance process based on the actual equipment, its requirements, and its intended market rather than treating compliance as a checklist at the end of the project.
Summary
Key Takeaways
- Directives and standards serve different purposes. Directives establish essential requirements, while standards provide technical guidance that can help manufacturers address them.
- Harmonized standards can provide a clearer path to conformity. Applying the appropriate harmonized standards can provide a presumption of conformity with the corresponding essential requirements they address.
- Multiple requirements may apply. Industrial equipment may need to address several directives and technical standards.
- IEC and European standards are closely connected. International IEC standards can provide an important technical foundation, but manufacturers still need to evaluate the requirements of their intended market.
- Compliance should be considered early. Identifying requirements during design can help reduce late-stage corrective work.
- Every piece of equipment is different. Intended use, hazards, electrical characteristics, functions, and destination can all affect the compliance path.
Standards and directives work together to create the framework manufacturers use to evaluate safety, address risks, document conformity, and prepare equipment for its intended market.
Understanding that relationship early can make the entire process easier to manage and give engineering teams a clearer path toward compliance.
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What should you check out next? Understanding Harmonized Standards for CE Compliance, Understanding IEC 60204, How to Approach Product Compliance if your Equipment is Already Designed
