EN IEC 60335-2-120:2025/A11:2025

Overview

EN IEC 60335-2-120:2025/A11:2025 sets out the particular safety requirements for household and similar electrical appliances intended for the generation of directly inhalable aerosols. Published by CLC, this European amendment enhances the wider IEC 60335 series, focusing specifically on devices operating at not more than 250V for single-phase appliances, and also covering appliances supplied by direct current and batteries.

This standard is crucial for manufacturers, importers, and testing laboratories to ensure that aerosol-generating appliances are safe to use in domestic and similar environments. By following these harmonized safety requirements, stakeholders help protect end-users and support regulatory compliance in the European market.

Key Topics

• Scope of Application

  • Applies to both single-phase AC and DC/battery-operated appliances
  • Intended for equipment generating aerosols that are directly inhaled by users

• Safety Focus

  • Emphasizes protections against electrical, mechanical, and thermal hazards
  • Addresses unique risks associated with the inhalation of aerosols

• European Harmonization

  • Integrates specific amendments for coherence with EN IEC 60335-1:2023+A11:2023 (general safety) and EN IEC 60335-2-120:2025 (particular requirements)
  • Ensures compatibility with relevant European and international safety practices

• Documentation and Compliance

  • Outlines timelines for national implementation and withdrawal of conflicting standards
  • Notes on additional clauses and bibliographic references help maintain up-to-date technical alignment

Applications

EN IEC 60335-2-120:2025/A11:2025 applies to a diverse range of household and similar appliances, in both consumer and commercial settings, including:

• Healthcare and Wellness Devices

  • Nebulizers and inhalers for home respiratory therapy
  • Aromatherapy appliances designed to deliver inhalable substances

• Personal Care Products

  • Beauty and skin care devices emitting inhalable mists or aerosols

• Home Cleaning Technologies

  • Devices that produce aerosolized cleaning agents for domestic use

• Commercial and Retail Use

  • Appliances used in clinics, spas, or retail that are based on directly inhalable aerosol generation

Adhering to this standard helps manufacturers demonstrate due diligence in risk management and product safety, facilitating access to European markets and reassuring users about the reliability of inhalable aerosol appliances.

Related Standards

When implementing or referencing EN IEC 60335-2-120:2025/A11:2025, consider its relationship to the following standards for comprehensive compliance:

• EN IEC 60335-1:2023+A11:2023 - General safety requirements for household and similar electrical appliances
• EN IEC 60335-2-120:2025 - Particular requirements focused on directly inhalable aerosol appliances (core text)
• EN IEC 60335-2-98 - Safety of humidifiers intended for household use
• EN ISO 20714 - Aerosol generation and characterization standards
• EN ISO 20768 - Clinical performance evaluation of aerosol-generating devices

Utilizing these interconnected standards helps ensure a robust approach to domestic safety, product quality, and regulatory conformity for aerosol-generating devices across the European Union and internationally.