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

The SIST EN ISO 10079-1:2022/oprA1:2025 amendment addresses the critical aspect of water ingress protection for electrically powered medical suction equipment. This draft amendment, due for publication in 2025, updates the existing standard ISO 10079-1:2022 by refining requirements to enhance the safety, reliability, and durability of suction devices used in diverse healthcare settings. Developed under the CEN framework and aligned with ISO technical committees, this document ensures suction equipment meets stringent resistance criteria against the ingress of solids and liquids-including water-thereby safeguarding patient safety and device functionality.

Key Topics

• Ingress of Water Protection:
  The amendment specifically updates protection requirements related to the ingress of liquids. It mandates that suction equipment must conform to internationally recognized testing methods to verify resistance to water penetration.

• Reference to IEC Standards:
  Compliance is gauged according to IEC 60529 tests, international benchmarks for degrees of protection provided by enclosures (IP codes). This includes IP2X for solid foreign objects and specific tests for water spillage as detailed in IEC 60601-1 and IEC 60601-1-11 standards.

• Use-Case Specific Requirements:
  Different standards apply depending on the operating environment:

  • Hospital settings rely on IEC 60601-1:2020 and IEC 60529:2013 guidelines for spillage and solid object ingress.
  • Home healthcare environments, which include patient or layperson use, adhere to IEC 60601-1-11:2020.
  • Field and transport uses by trained healthcare providers follow IEC 60601-1-12:2020 directives.

• Safety and Performance:
  The update supports enhanced basic safety and essential performance of electrically powered suction devices, maintaining compliance with medical electrical equipment requirements.

Applications

This amendment is crucial for manufacturers, healthcare providers, and regulatory bodies involved with electrically powered suction equipment:

• Medical Device Manufacturers:
  Guide product design to meet updated ingress protection standards, ensuring machinery can withstand exposure to water without compromising function.

• Healthcare Facilities:
  Support procurement decisions by selecting suction devices certified for effective water ingress protection, enhancing patient safety during surgical, emergency, and respiratory procedures.

• Home and Field Care Providers:
  Ensure equipment used by patients, caregivers, or trained professionals in various environments-from clinics to transport vehicles-is robust against liquids and solids penetration.

• Regulatory Compliance:
  Assist conformity assessments aligned with international electrical safety standards, facilitating market access and regulatory approvals globally.

Related Standards

• ISO 10079-1:2022 – Base standard for electrically powered suction equipment, defining performance and safety requirements.
• IEC 60529:2013 – Specifies the IP (Ingress Protection) ratings, detailing resistance to solids and liquids for enclosures of electrical equipment.
• IEC 60601-1:2005+AMD1:2012+AMD2:2020 – Fundamental safety and essential performance requirements for medical electrical equipment.
• IEC 60601-1-11:2015+A1:2020 – Collateral standard focusing on devices used in home healthcare environments, covering electrical safety and water ingress.
• IEC 60601-1-12:2020 – Additional requirements for medical electrical systems used in transport and field environments.

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By integrating this amendment, stakeholders in the medical suction equipment domain ensure devices remain safe and functional under real-world conditions involving exposure to water and solids. This fosters greater patient safety, supports compliance with global regulations, and underpins trust in electrically powered medical aspirators across healthcare settings worldwide.

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
...