SIST EN IEC 60335-2-120:2025/A11:2025
(Amendment)Household and similar electrical appliances - Safety - Part 2-120: Particular requirements for the safety of appliances for the generation of directly inhalable aerosols
Household and similar electrical appliances - Safety - Part 2-120: Particular requirements for the safety of appliances for the generation of directly inhalable aerosols
This Standard deals with the safety of appliances for generation of directly inhalable aerosols, their rated voltage being not more than 250 V for single-phase appliances, and other appliances including direct current (DC) supplied appliances and battery-operated appliances.
Sicherheit elektrischer Geräte für den Hausgebrauch und ähnliche Zwecke - Teil 2-120: Spezielle Anforderungen an die Sicherheit von Systemen die direkt inhalierbare Aerosole generieren
Appareils électrodomestiques et analogues - Sécurité - Partie 2-120: Exigences particulières de sécurité des appareils destinés à produire des aérosols directement inhalables
Gospodinjski in podobni električni aparati - Varnost - 2-120. del: Posebne zahteve za naprave za proizvodnjo neposredno vdihljivih aerosolov - Dopolnilo A11
Ta standard obravnava varnost naprav za proizvodnjo neposredno vdihljivih aerosolov z nazivno napetostjo, ki ne presega 250 V za enofazne naprave, ter drugih naprav, vključno z napravami z enosmernim napajanjem in baterijskimi napravami.
General Information
Relations
Overview
The SIST EN IEC 60335-2-120:2025/A11:2025 standard, issued by CLC, establishes the particular safety requirements for household and similar electrical appliances designed to generate directly inhalable aerosols. It applies to appliances rated at a voltage not exceeding 250 V for single-phase devices, including those powered by direct current (DC) and battery-operated models. This amendment, A11, updates and supplements the previous 2025 edition of the standard, reflecting the latest safety practices and regulatory compliance for aerosol-generating appliances used in domestic environments.
Key Topics
The standard addresses critical aspects of appliance safety in the context of aerosol generation for inhalation, focusing on:
- Electrical safety of aerosol-generating devices within rated voltage limits.
- Specific safety measures tailored to appliances producing directly inhalable aerosols to prevent risks such as electrical shock, fire hazards, and mechanical failures.
- Design considerations for appliances supplied via alternating current (AC), direct current (DC), and batteries.
- Testing protocols and compliance criteria to ensure appliances consistently meet stringent household safety regulations.
- Clear definitions and technical requirements aligned with related IEC and ISO standards to maintain harmonization and interoperability.
- Updates to the standard's introduction and bibliography to incorporate recent normative references and directives.
Applications
EN IEC 60335-2-120:2025/A11 is essential for manufacturers, designers, and safety assessors involved with:
- Household aerosol generators, such as nebulizers, humidifiers, and other devices that emit aerosols intended for direct inhalation by users.
- Devices used in medical, therapeutic, or cosmetic applications requiring safe aerosol generation.
- Appliances intended for domestic and similar environments, ensuring compliance with European and international electrical safety norms.
- Improving consumer protection by minimizing risks associated with the use of electrically powered aerosol generation systems.
- Supporting compliance efforts for market access within the European Union and CENELEC member countries.
Related Standards
This amendment references and supplements key related standards, including:
- EN IEC 60335-1:2023+A11:2023 (Part 1) - General requirements for the safety of household and similar electrical appliances.
- EN IEC 60335-2-120:2025 (Part 2) - The base standard detailing particular requirements for aerosol-generating appliances.
- IEC 60335-2-98 - Safety of vaporizer appliances.
- ISO 20714 and ISO 20768 - Standards related to aerosol generation performance and testing, adopted as EN ISO standards within Europe.
Practical Value
Complying with EN IEC 60335-2-120:2025/A11 ensures:
- Enhanced consumer safety through clear, up-to-date safety requirements.
- Streamlined regulatory approval processes for aerosol-generating electrical appliances in European markets.
- Alignment with the latest technical and safety advancements, reducing liability and product recall risks.
- Support for innovation by providing a well-defined safety framework for new product development in aerosol technology.
By adhering to this updated European standard, manufacturers and stakeholders can confidently deliver safe, reliable, and compliant aerosol-generating appliances suitable for household use, accommodating a range of power sources including AC, DC, and battery operation.
Frequently Asked Questions
SIST EN IEC 60335-2-120:2025/A11:2025 is a amendment published by the Slovenian Institute for Standardization (SIST). Its full title is "Household and similar electrical appliances - Safety - Part 2-120: Particular requirements for the safety of appliances for the generation of directly inhalable aerosols". This standard covers: This Standard deals with the safety of appliances for generation of directly inhalable aerosols, their rated voltage being not more than 250 V for single-phase appliances, and other appliances including direct current (DC) supplied appliances and battery-operated appliances.
This Standard deals with the safety of appliances for generation of directly inhalable aerosols, their rated voltage being not more than 250 V for single-phase appliances, and other appliances including direct current (DC) supplied appliances and battery-operated appliances.
SIST EN IEC 60335-2-120:2025/A11:2025 is classified under the following ICS (International Classification for Standards) categories: 13.120 - Domestic safety; 97.180 - Miscellaneous domestic and commercial equipment. The ICS classification helps identify the subject area and facilitates finding related standards.
SIST EN IEC 60335-2-120:2025/A11:2025 has the following relationships with other standards: It is inter standard links to SIST EN IEC 60335-2-120:2025. Understanding these relationships helps ensure you are using the most current and applicable version of the standard.
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Standards Content (Sample)
SLOVENSKI STANDARD
01-september-2025
Gospodinjski in podobni električni aparati - Varnost - 2-120. del: Posebne zahteve
za naprave za proizvodnjo neposredno vdihljivih aerosolov - Dopolnilo A11
Household and similar electrical appliances - Safety - Part 2-120: Particular requirements
for the safety of appliances for the generation of directly inhalable aerosols
Sicherheit elektrischer Geräte für den Hausgebrauch und ähnliche Zwecke - Teil 2-120:
Spezielle Anforderungen an die Sicherheit von Systemen die direkt inhalierbare Aerosole
generieren
Appareils électrodomestiques et analogues - Sécurité - Partie 2-120: Exigences
particulières de sécurité des appareils destinés à produire des aérosols directement
inhalables
Ta slovenski standard je istoveten z: EN IEC 60335-2-120:2025/A11:2025
ICS:
13.120 Varnost na domu Domestic safety
97.180 Razna oprema za dom in Miscellaneous domestic and
trgovino commercial equipment
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.
EUROPEAN STANDARD EN IEC 60335-2-
120:2025/A11
NORME EUROPÉENNE
EUROPÄISCHE NORM
August 2025
ICS 13.120; 97.180
English Version
Household and similar electrical appliances - Safety - Part 2-120:
Particular requirements for the safety of appliances for the
generation of directly inhalable aerosols
Appareils électrodomestiques et analogues - Sécurité - To be completed
Partie 2-120: Exigences particulières de sécurité des
appareils destinés à produire des aérosols directement
inhalables
This amendment A11 modifies the European Standard EN IEC 60335-2-120:2025; it was approved by CENELEC on 2025-04-21.
CENELEC members are bound to comply with the CEN/CENELEC Internal Regulations which stipulate the conditions for giving this
amendment the status of a national standard without any alteration.
Up-to-date lists and bibliographical references concerning such national standards may be obtained on application to the CEN-CENELEC
Management Centre or to any CENELEC member.
This amendment exists in three official versions (English, French, German). A version in any other language made by translation under the
responsibility of a CENELEC member into its own language and notified to the CEN-CENELEC Management Centre has the same status as
the official versions.
CENELEC members are the national electrotechnical committees of Austria, Belgium, Bulgaria, Croatia, Cyprus, the Czech Republic,
Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, the
Netherlands, Norway, Poland, Portugal, Republic of North Macedo
...
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