SIST EN ISO/IEC 80079-34:2020 PDF

Overview

EN ISO/IEC 80079-34:2020 (Explosive atmospheres - Part 34) specifies particular requirements and guidance for establishing and maintaining a quality management system (QMS) for the manufacture of Ex Products (equipment and protective systems intended for use in explosive atmospheres). Published by CEN and aligned with ISO/IEC 80079-34:2018, this European adoption is a full technical revision of the 2011 edition and is intended to be read in conjunction with ISO 9001:2015. The document sets minimum QMS requirements to ensure that production consistently delivers products that conform to design certificates and applicable regulatory requirements.

Key topics and requirements

• QMS scope for Ex Product manufacture: Defines the structure and information needed to demonstrate control of processes affecting safety-relevant characteristics of Ex equipment.
• Minimum documented procedures and records: Requirements for traceability, configuration control, nonconforming product handling and corrective actions consistent with ISO 9001 objectives.
• Production and verification activities: Controls and routine tests related to manufacturing, assembly and final acceptance (examples from the standard’s informative annexes include pressure tests, insulation resistance, functional tests and sealing checks).
• Supplier and material control: Selection, verification and documentation of safety‑relevant materials and components used in Ex Products.
• Audit and assessment: Internal and external audit requirements; guidance for Notified Bodies assessing quality systems under EU Directive 2014/34/EU (ATEX).
• Product-specific guidance (informative annexes): Examples and additional checks for product families such as fans, petrol dispensers, electrostatic spraying equipment and protective systems.

Practical applications

• Ensures manufactured Ex Products match the EU-type examination sample and maintain certificate conformity during serial production.
• Helps manufacturers implement a QMS tailored to explosion-protection requirements while remaining compatible with ISO 9001:2015.
• Supports documented procedures for routine testing, final inspection and release of Ex equipment to market.
• Facilitates compliance with Directive 2014/34/EU through harmonized references and annex guidance.

Who uses this standard

• Manufacturers of explosion-protected equipment and protective systems (Ex Products)
• Quality managers and production engineers implementing QMS for Ex manufacture
• Compliance and regulatory teams preparing technical files for EU market access
• Notified Bodies and auditors assessing quality systems under ATEX/2014/34/EU

Related standards

• ISO 9001:2015 - Quality management systems
• IEC 60079 series / EN IEC 60079-0 - General requirements for equipment in explosive atmospheres
• Product-specific harmonized standards (referenced in the standard’s annexes)

EN ISO/IEC 80079-34:2020 is an essential reference for organizations that need a compliant, auditable QMS focused on the safe manufacture of Ex Products for explosive atmospheres.