What Is an ATEX Technical File?
Technical documentation supporting ATEX conformity assessment and compliance for equipment intended for explosive atmospheres.
An ATEX Technical File is the common industry term for the technical documentation a manufacturer prepares to demonstrate that equipment or a protective system complies with the applicable requirements of the ATEX Equipment Directive, 2014/34/EU.
The documentation may include product descriptions, engineering drawings, risk assessments, calculations, standards applied, examination results, test reports, and other evidence relevant to conformity assessment.
The Technical File is not itself an ATEX certificate. It is the underlying technical evidence supporting the manufacturer's compliance obligations, the applicable conformity assessment procedure, and the EU Declaration of Conformity.
What Is an ATEX Technical File?
Directive 2014/34/EU uses the term technical documentation. The term ATEX Technical File is commonly used in industry to describe the collection of records that demonstrates how a product meets the applicable essential health and safety requirements.
Under the Directive, the manufacturer must prepare technical documentation and follow the relevant conformity assessment procedure. The documentation must make it possible to assess conformity and cover the product's design, manufacture, and operation to the extent relevant to that assessment.
There is no single universal document template that applies identically to every ATEX product. The documentation required depends on the product, its intended use, and the applicable conformity assessment route.
Why Is the ATEX Technical File Required?
An Ex marking or CE marking alone does not provide the complete technical evidence behind a product's conformity claim. The manufacturer must be able to demonstrate how the equipment meets the applicable requirements of Directive 2014/34/EU.
The technical documentation supports activities such as:
- Conformity assessment under the ATEX Equipment Directive
- Assessment by a Notified Body where the selected procedure requires it
- Preparation and support of the EU Declaration of Conformity
- Regulatory and market-surveillance review
- Assessment of relevant product modifications
The Technical File is therefore the technical evidence behind the compliance claim, not a substitute for the certificate or declaration itself.
Who Is Responsible for the Technical File?
The manufacturer is responsible for drawing up and maintaining the technical documentation required by Directive 2014/34/EU.
An authorised representative may perform specified tasks under a written mandate, but the Directive does not transfer the manufacturer's fundamental responsibility for drawing up the technical documentation to that representative.
Testing laboratories, suppliers, engineering consultants, and Notified Bodies may contribute reports or assessment records. However, the manufacturer remains responsible for ensuring that the required technical documentation is established and maintained.
When Must the Technical File Be Prepared?
The technical documentation must be established as part of the conformity process before the product is placed on the market.
The manufacturer must also ensure that series production remains in conformity with the Directive. Relevant changes to product design or characteristics, as well as changes to the standards or technical specifications used to support conformity, must be appropriately considered.
A product modification may therefore require updated documentation and, depending on the applicable conformity assessment procedure, additional assessment or approval.
How Long Must the Technical File Be Retained?
Under Article 6 of Directive 2014/34/EU, the manufacturer must keep the technical documentation and the EU Declaration of Conformity, or applicable attestation of conformity, for 10 years after the product has been placed on the market.
The documentation must be made available to the relevant national authorities when required. Manufacturers must also provide the information and documentation necessary to demonstrate conformity when requested by a competent authority.
What Does an ATEX Technical File Contain?
The exact contents depend on the equipment and conformity assessment procedure. Annex VIII, for example, describes the technical documentation requirements for Module A. Other conformity assessment modules have their own applicable requirements.
A technical documentation package may include the following:
| Document category | Purpose |
|---|---|
| Product description | Identifies the equipment, model, intended use, and relevant ratings. |
| Design and manufacturing drawings | Documents the construction and configuration of the product. |
| Electrical and mechanical design information | Explains relevant circuits, components, assemblies, and design features. |
| Risk assessment | Identifies relevant hazards and explains how they are addressed. |
| Calculations and engineering analysis | Provides technical justification where required. |
| Standards and technical specifications | Identifies the technical basis used to demonstrate conformity. |
| Examination and test reports | Records relevant test results and assessment evidence. |
| Certificates and assessment records | Documents applicable third-party conformity assessment. |
| Marking information | Supports product identification and the required Ex marking. |
| Instructions for use | Defines applicable installation, operation, maintenance, and safety requirements. |
This is a practical overview, not a mandatory checklist for every product. Only the documentation relevant to the product and applicable conformity assessment requirements should be assumed necessary.
Product Description and Engineering Drawings
The documentation should identify exactly which product is covered by the conformity assessment. Depending on the equipment, the product description may include its model designation, variants, intended use, operating conditions, ratings, and explosion protection concept.
Supporting design information may include:
- General arrangement and assembly drawings
- Mechanical detail drawings
- Electrical schematics and terminal layouts
- Component and circuit information
- Cable-entry arrangements
- Flamepath drawings for applicable flameproof equipment
The necessary level of detail depends on the product and what is needed to demonstrate conformity with the applicable requirements.
Risk Assessment and Ignition Hazards
The technical documentation must address the relevant risks in accordance with the applicable requirements and conformity assessment procedure.
For explosion-protected equipment, relevant technical considerations may include:
- Electrical ignition sources
- Hot surfaces and temperature limits
- Mechanical ignition sources
- Electrostatic effects
- Component failures and abnormal operating conditions
- Environmental conditions affecting protection
- Interactions between components or protective measures
The assessment should be appropriate to the equipment and its intended conditions of use. A generic risk assessment is not sufficient if it fails to address the product's actual hazards.
Design Calculations and Test Reports
Where needed to demonstrate conformity, the technical documentation includes calculations, engineering analysis, examinations, and test results relevant to the equipment.
Examples may include temperature-rise calculations, thermal analysis, mechanical strength assessments, electrical loading calculations, and verification of relevant clearances or creepage distances.
Test evidence depends on the protection concept and applicable standards. It may address impact resistance, ingress protection, dielectric strength, thermal endurance, explosion containment, or dust protection, where relevant.
Not every test applies to every product. The applicable standards and conformity assessment requirements determine the necessary evidence.
Which Standards Are Used?
The technical documentation identifies the harmonised standards applied, including the relevant parts and editions. If harmonised standards are not applied, the manufacturer must document the solutions adopted to meet the essential health and safety requirements and identify other relevant technical specifications used.
Depending on the equipment and protection concept, the technical basis may include standards from the IEC 60079 series, for example:
| Standard | Typical subject |
|---|---|
| IEC 60079-0 | General requirements for Ex equipment |
| IEC 60079-1 | Flameproof enclosure protection, Ex d |
| IEC 60079-7 | Increased safety protection, Ex e |
| IEC 60079-11 | Intrinsic safety protection, Ex i |
| IEC 60079-18 | Encapsulation protection, Ex m |
| IEC 60079-31 | Protection by enclosure for combustible dust, Ex t |
This list is illustrative. The standards selected must match the equipment's design, protection concept, and applicable conformity assessment requirements.
Where Does an ATEX Certificate Fit In?
An ATEX certificate is not the Technical File itself. Where a conformity assessment procedure requires a Notified Body, the relevant certificate or assessment records may form part of the manufacturer's technical documentation.
For example, under Module B, a Notified Body conducts EU-type examination and issues an EU-Type Examination Certificate when the applicable requirements are met. The manufacturer then uses the relevant assessment outcome within the applicable conformity assessment process.
Other procedures have different requirements. Some routes involve a Notified Body at particular stages, while Module A uses internal production control without a Notified Body performing that module's conformity assessment.
It is therefore incorrect to assume that every ATEX product follows an identical certification process or that the Technical File is simply a folder containing one certificate.
Equipment Marking and Instructions for Use
The technical documentation should support the product identification and marking applied to the equipment. For example, the marking II 2G Ex db IIC T4 Gb communicates defined information about the equipment group, category, protection concept, gas group, temperature class, and equipment protection level.
The supporting evidence must be consistent with the product's actual design and the applicable conformity assessment. The marking itself is not a substitute for the underlying technical documentation.
Instructions for use may also contain essential information for safe installation and operation, such as ambient temperature limits, cable-entry requirements, maintenance instructions, and any special conditions for safe use.
For additional guidance, see How to Read ATEX Markings.
Technical Documentation vs ATEX Certificate vs Declaration of Conformity
| Document | Function |
|---|---|
| Technical documentation | Provides the technical evidence supporting conformity. |
| ATEX certificate | Records a specific third-party assessment where required by the applicable procedure. |
| EU Declaration of Conformity | Is the manufacturer's formal declaration that the identified product complies with applicable EU legislation. |
These documents have different functions. The technical documentation supports the conformity claim, the certificate records a relevant assessment where applicable, and the Declaration of Conformity is the manufacturer's formal declaration.
Can a Customer Request the Complete Technical File?
The complete technical documentation is primarily a manufacturer's compliance record and is not normally supplied to every customer as part of a standard product documentation package.
Depending on the product and project requirements, customers commonly receive documents such as:
- EU Declaration of Conformity
- ATEX certificate, where applicable
- Product datasheet
- Installation and operating instructions
- Ex marking information
- Relevant supporting certificates
Competent national authorities can require the manufacturer to provide documentation necessary to demonstrate conformity. A customer requesting the complete Technical File should clarify the reason for the request and agree on the scope and access arrangements with the manufacturer.
Practical Document Checks for Engineers
Even when the complete Technical File is not available to the purchaser, engineers can review the documents supplied with the equipment and check for consistency.
- Confirm the exact product model and variant.
- Identify the applicable ATEX conformity assessment route.
- Check the certificate and Declaration of Conformity where applicable.
- Confirm that product identification and Ex marking are consistent across the documentation.
- Review applicable installation instructions and special conditions for safe use.
- Check whether relevant product modifications have been addressed.
- Confirm that the standards and technical specifications cited are appropriate to the product.
These checks are particularly useful during vendor document review and technical bid evaluation. They do not replace the manufacturer's conformity obligations or a required conformity assessment.
Common Misunderstandings About ATEX Technical Files
The Technical File Is an ATEX Certificate
No. A certificate is a separate document that records a relevant conformity assessment where applicable. The Technical File contains the broader technical evidence supporting conformity.
The Technical File Must Be a Single Standardized PDF
No. The Directive specifies documentation requirements, but the organization and format of the records can vary according to the product and conformity assessment procedure.
Every Customer Receives the Complete Technical File
No. The manufacturer normally retains the technical documentation. Customers typically receive the documents needed to demonstrate conformity and support safe use.
Every ATEX Product Requires the Same Notified Body Process
No. The applicable conformity assessment route depends on the product and the Directive's requirements. Not every product follows the same module or requires the same Notified Body involvement.
The Technical Documentation Never Changes
No. Relevant changes to product design, characteristics, standards, or technical specifications must be considered and documented as appropriate.
Frequently Asked Questions
What is an ATEX Technical File?
It is the common industry term for the technical documentation a manufacturer prepares to demonstrate conformity with Directive 2014/34/EU.
Who is responsible for the Technical File?
The manufacturer is responsible for establishing and maintaining the required technical documentation.
Does every ATEX product require technical documentation?
Products within the scope of Directive 2014/34/EU require the technical documentation applicable to their conformity assessment. The exact contents depend on the product and procedure.
Does the Technical File contain the ATEX certificate?
The relevant certificate or assessment records may be included in the manufacturer's technical documentation where applicable. However, a certificate is not the complete Technical File.
How long must the Technical File be retained?
Under Directive 2014/34/EU, the manufacturer must retain the technical documentation for 10 years after the product has been placed on the market.
Can a Notified Body review the Technical File?
Yes. Where the applicable conformity assessment procedure involves a Notified Body, relevant technical documentation is reviewed as part of that assessment.
What is the difference between the Technical File and the Declaration of Conformity?
The technical documentation provides the supporting technical evidence. The EU Declaration of Conformity is the manufacturer's formal declaration that the identified product complies with the applicable legislation.
Conclusion
An ATEX Technical File is the technical documentation supporting a manufacturer's demonstration of conformity with Directive 2014/34/EU. Depending on the product and conformity assessment route, it may contain descriptions, drawings, risk assessments, calculations, standards, test reports, and relevant certification records.
It should not be confused with an ATEX certificate or the EU Declaration of Conformity. For engineers and procurement teams, understanding this distinction helps ensure that the documents supplied for hazardous area equipment are relevant, consistent, and appropriate to the product's conformity assessment.
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