SIST EN ISO 10079-1:2022/A1:2026

Medical suction equipment - Part 1: Electrically powered suction equipment - Amendment 1: Ingress of water (ISO 10079-1:2022/Amd 1:2026)

Medizinische Absauggeräte - Teil 1: Elektrisch betriebene Absauggeräte - Änderung 1: Wassereintritt (ISO 10079-1:2022/Amd 1:2026)

Appareils d'aspiration médicale - Partie 1: Appareils électriques d'aspiration - Amendement 1: Pénétration d'eau (ISO 10079-1:2022/Amd 1:2026)

Medicinska sukcijska (aspiracijska) oprema - 1. del: Električna sukcijska (aspiracijska) oprema - Dopolnilo A1: Vdor vode (ISO 10079-1:2022/Amd 1:2026)

General Information

• Status: Published
• Public Enquiry End Date: 26-Oct-2025
• Publication Date: 16-Apr-2026
• ICS: 11.040.10 - Anaesthetic, respiratory and reanimation equipment
• Technical Committee: VAZ - Healthcare
• Current Stage: 6060 - National Implementation/Publication (Adopted Project)
• Start Date: 09-Apr-2026
• Due Date: 14-Jun-2026
• Completion Date: 17-Apr-2026
• Ref Project: EN ISO 10079-1:2022/A1:2026 - Medical suction equipment - Part 1: Electrically powered suction equipment - Amendment 1: Ingress of water (ISO 10079-1:2022/Amd 1:2026)

Relations

• Referred By: SIST EN ISO 14823-1:2024 - Intelligent transport systems - Graphic data dictionary - Part 1: Specification (ISO 14823-1:2024)
• Effective Date: 28-Jan-2026
• Amends: SIST EN ISO 10079-1:2022 - Medical suction equipment - Part 1: Electrically powered suction equipment (ISO 10079-1:2022)
• Effective Date: 01-Jun-2026

Overview

SIST EN ISO 10079-1:2022/A1:2026 Medical suction equipment – Part 1: Electrically powered suction equipment – Amendment 1: Ingress of water is a vital amendment developed by CEN and ISO for the medical industry. This standard addresses the safety and functional requirements for electrically powered suction devices, with a specific focus on the resistance to ingress of water. It is a cornerstone reference for designing, manufacturing, and maintaining medical suction equipment used in clinical, home healthcare, and emergency environments. This amendment ensures protection from water and solid particles, ultimately supporting reliable medical device performance and patient safety.

Key Topics

• Ingress Protection Requirements: Specifies criteria that electrically powered suction equipment must fulfill to resist water and solid ingress under different usage scenarios.
• Normative References: Integrates key international safety standards such as IEC 60601-1 (general medical electrical equipment safety), IEC 60601-1-11 (home healthcare environments), IEC 60601-1-12 (emergency medical services), and IEC 60529 (IP ratings for ingress protection).
• Testing for Compliance: Outlines the use of standardized tests from IEC 60529 to verify equipment's protection against entry of water and solids.
• Use-Specific Criteria: Applies differentiated requirements depending on whether the suction equipment is for hospital, home healthcare, or emergency/transport use, aligned with associated IEC standards.

Applications

SIST EN ISO 10079-1:2022/A1:2026 is directly applicable to:

• Medical Device Manufacturers: Guiding compliance in the design and production of electrically powered suction devices (also known as aspirators).
• Clinical Engineering: Supporting maintenance teams in equipment selection, testing, and risk assessment in hospitals and emergency services.
• Home Healthcare Providers: Ensuring devices intended for non-clinical or layperson environments meet relevant ingress protection standards for safety.
• Regulatory and Quality Assurance Professionals: Assisting in the development of procedures for certification, audits, and ongoing compliance to international safety standards.

Adherence to this standard helps organizations:

• Minimize the risk of device failure caused by water or fluid ingress during medical procedures.
• Demonstrate conformity with national and European regulatory frameworks for medical suction equipment.
• Improve device reliability and patient outcomes by ensuring robust engineering against everyday hazards.

Related Standards

The following related standards are referenced or aligned for comprehensive compliance and implementation:

• IEC 60601-1
  Medical electrical equipment – Part 1: General requirements for basic safety and essential performance
• IEC 60529
  Degrees of protection provided by enclosures (IP Code)
• IEC 60601-1-11
  Requirements for medical electrical equipment used in the home healthcare environment
• IEC 60601-1-12
  Requirements for medical electrical equipment intended for emergency medical services
• ISO 10079-1:2022
  Medical suction equipment – Electrically powered suction equipment (base standard)

For further updates and guidance, device manufacturers and professionals should consult their national standards organizations and the official CEN and ISO documentation to stay informed of ongoing amendments and best practices in medical suction equipment safety.

By implementing the requirements of SIST EN ISO 10079-1:2022/A1:2026, the medical industry supports higher safety, quality, and trust in electrically powered suction devices across healthcare settings.

Standards Content (Sample)

SLOVENSKI STANDARD
01-junij-2026
Medicinska sukcijska (aspiracijska) oprema - 1. del: Električna sukcijska
(aspiracijska) oprema - Dopolnilo A1: Vdor vode (ISO 10079-1:2022/Amd 1:2026)
Medical suction equipment - Part 1: Electrically powered suction equipment -
Amendment 1: Ingress of water (ISO 10079-1:2022/Amd 1:2026)
Medizinische Absauggeräte - Teil 1: Elektrisch betriebene Absauggeräte - Änderung 1:
Wassereintritt (ISO 10079-1:2022/Amd 1:2026)
Appareils d'aspiration médicale - Partie 1: Appareils électriques d'aspiration -
Amendement 1: Pénétration d'eau (ISO 10079-1:2022/Amd 1:2026)
Ta slovenski standard je istoveten z: EN ISO 10079-1:2022/A1:2026
ICS:
11.040.10 Anestezijska, respiratorna in Anaesthetic, respiratory and
reanimacijska oprema reanimation equipment
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

EN ISO 10079-1:2022/A1
EUROPEAN STANDARD
NORME EUROPÉENNE
March 2026
EUROPÄISCHE NORM
ICS 11.040.10
English Version
Medical suction equipment - Part 1: Electrically powered
suction equipment - Amendment 1: Ingress of water (ISO
10079-1:2022/Amd 1:2026)
Appareils d'aspiration médicale - Partie 1: Appareils Medizinische Absauggeräte - Teil 1: Elektrisch
électriques d'aspiration - Amendement 1: Pénétration betriebene Absauggeräte - Änderung 1: Wassereintritt
d'eau (ISO 10079-1:2022/Amd 1:2026) (ISO 10079-1:2022/Amd 1:2026)
This amendment A1 modifies the European Standard EN ISO 10079-1:2022; it was approved by CEN on 28 November 2025.

CEN members are bound to comply with the CEN/CENELEC Internal Regulations which stipulate the conditions for inclusion of
this amendment into the relevant 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 CEN
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 CEN member into its own language and notified to the CEN-CENELEC Management Centre has the
same status as the official versions.

CEN members are the national standards bodies of Austria, Belgium, Bulgaria, Croatia, Cyprus, Czech Republic, Denmark, Estonia,
Finland, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway,
Poland, Portugal, Republic of North Macedonia, Romania, Serbia, Slovakia, Slovenia, Spain, Sweden, Switzerland, Türkiye and
United Kingdom.
EUROPEAN COMMITTEE FOR STANDARDIZATION
COMITÉ EUROPÉEN DE NORMALISATION

EUROPÄISCHES KOMITEE FÜR NORMUNG

CEN-CENELEC Management Centre: Rue de la Science 23, B-1040 Brussels
© 2026 CEN All rights of exploitation in any form and by any means reserved Ref. No. EN ISO 10079-1:2022/A1:2026 E
worldwide for CEN national Members.

Contents Page
European foreword . 3

European foreword
This document (EN ISO 10079-1:2022/A1:2026) has been prepared by Technical Committee
ISO/TC 121 "Anaesthetic and respiratory equipment" in collaboration with Technical Committee
CEN/TC 215 “Respiratory and anaesthetic equipment” the secretariat of which is held by BSI.
This Amendment to the European Standard EN ISO 10079-1:2022 shall be given the status of a national
standard, either by publication of an identical text or by endorsement, at the latest by September 2026,
and conflicting national standards shall be withdrawn at the latest by September 2026.
Attention is drawn to the possibility that some of the elements of this document may be the subject of
patent rights. CEN shall not be held responsible for identifying any or all such patent rights.
Any feedback and questions on this document should be directed to the users’ national standards
body/national committee. A complete listing of these bodies can be found on the CEN website.
According to the CEN-CENELEC Internal Regulations, the national standards organizations of the
following countries are bound to implement this European Standard: Austria, Belgium, Bulgaria,
Croatia, Cyprus, Czech Republic, Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Iceland,
Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Republic of
North Macedonia, Romania, Serbia, Slovakia, Slovenia, Spain, Sweden, Switzerland, Türkiye and the
United Kingdom.
Endorsement notice
The text of ISO 10079-1:2022/Amd 1:2026 has been approved by CEN as EN ISO 10079-
1:2022/A1:2026 without any modification.

International
Standard
ISO 10079-1
Fourth edition
Medical suction equipment —
2022-03
Part 1:
AMENDMENT 1
Electrically powered suction
2026-03
equipment
AMENDMENT 1: Ingress of water
Appareils d'aspiration médicale —
Partie 1: Appareils électriques d'aspiration
AMENDEMENT 1: Pénétration d'eau
Reference number
ISO 10079-1:202
...