SIST EN ISO 80601-2-13:2022 PDF

Overview

EN ISO 80601-2-13:2022 - titled Medical electrical equipment - Particular requirements for basic safety and essential performance of an anaesthetic workstation - specifies safety and performance requirements for anaesthetic workstations used to administer inhalational anaesthesia while continuously attended by a professional operator. Published by CEN and aligned with ISO, this standard covers complete workstations and individual components (e.g., ventilators, gas delivery and scavenging systems, vapourisers, monitoring and alarm systems) and applies to accessories whose characteristics can affect workstation safety or performance. It excludes workstations intended for use with flammable anaesthetic agents (see Annex BB).

Key topics and requirements

• Scope and applicability: Requirements for complete anaesthetic workstations and specified components (anaesthetic gas delivery system, breathing system, AGSS, vapour delivery, ventilator, monitoring, alarms, protection devices).
• Basic safety & essential performance: Tests and criteria to ensure patient and operator safety during normal and fault conditions, including hazardous outputs and fault management.
• Component-specific requirements: Additional clauses for breathing systems, ventilators, scavenging (differentiating active vs non‑active AGSS), vapour delivery, pressure/flow characteristics and reservoir connections.
• Alarms, monitoring and usability: Requirements for alarm systems, clinical monitoring (exhaled volume, pressure-volume loops), marking and instructions for use to support safe operation.
• Electrical, mechanical & EMC protection: Electrical safety, mechanical hazard protection, electromagnetic compatibility (EMC) and marking for MRI suitability.
• Lifecycle and serviceability: Requirements added for expected service life, internal power sources, and behaviour on electrical/pneumatic power interruption.
• Documentation & clinical evaluation: Instructions for use, technical documentation, clinical evaluation guidance and guidance/rationale in informative annexes (Annex AA).
• Normative references: Interaction with general standard IEC/ISO 60601-1 for medical electrical equipment and other series parts (PEMS, usability, EMC).

Practical applications

• Ensures anaesthetic workstations meet internationally harmonized safety and performance criteria for operating theatres, ambulatory surgery and intensive care settings where inhalational anaesthesia is used.
• Guides design, testing and risk mitigation for manufacturers of anaesthetic machines, ventilators, vapourisers, scavenging systems and related accessories.
• Provides test labs and conformity assessment bodies with standardized test requirements for certification and regulatory compliance.

Who should use this standard

• Medical device manufacturers and designers (anaesthetic workstations and components)
• Clinical engineers, hospital procurement and biomedical maintenance teams
• Notified bodies, testing laboratories and regulatory compliance specialists
• Risk managers and usability engineers involved in perioperative equipment

Related standards

• IEC/ISO 60601-1 (general requirements for basic safety of medical electrical equipment)
• Other parts of the ISO/IEC 80601 series addressing ventilators, EMC, usability and home-care variants

Keywords: EN ISO 80601-2-13:2022, anaesthetic workstation, medical electrical equipment, anaesthetic ventilator, anaesthetic gas delivery, AGSS, safety standard, CEN, ISO.