SIST EN ISO 10079-1:2022/oprA1:2025

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.

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.