ISO 80601-2-67-2020 PDF

Full title and description

ISO 80601-2-67:2020 — Medical electrical equipment — Part 2-67: Particular requirements for basic safety and essential performance of oxygen‑conserving equipment. This standard specifies safety and performance requirements, test methods, marking and documentation intended to ensure the safe use and predictable performance of active oxygen‑conserving devices and their accessories, primarily for home healthcare use but also applicable in clinical settings.

Abstract

ISO 80601-2-67:2020 applies to active oxygen‑conserving equipment (devices that deliver supplemental oxygen intermittently and synchronized with the patient’s inspiratory cycle) and to accessories whose characteristics can affect basic safety or essential performance. The document clarifies differences between conserving and continuous‑flow oxygen delivery, mandates standardized performance testing and labelling, and aligns particular requirements with the general medical electrical equipment safety standard (IEC 60601‑1) where applicable.

General information

• Status: Published.
• Publication date: October 2020 (Edition 2, published 2020-10-30).
• Publisher: ISO (International Organization for Standardization).
• ICS / categories: 11.040.10 — Anaesthetic, respiratory and reanimation equipment.
• Edition / version: Edition 2 (2020).
• Number of pages: 57 pages.

Key bibliographic and status details are listed on the official ISO/IEC publication records.

Scope

The standard is applicable to the basic safety and essential performance of oxygen‑conserving equipment and accessories intended to conserve supplemental oxygen by delivering gas intermittently and synchronized with the patient’s inspiratory cycle. It is intended chiefly for devices used in the home healthcare environment (typically by lay operators) but also applies when conserving equipment is used in professional healthcare facilities or incorporated with other equipment (for example, oxygen concentrators or pressure regulators). Non‑active devices (such as reservoir cannulas) are excluded. The standard requires clarification of device operation versus continuous‑flow oxygen, harmonized performance tests, and clear labelling and instructions to avoid misinterpretation of dose settings.

Key topics and requirements

• Particular requirements for basic safety and essential performance derived from IEC 60601‑1 (electrical, mechanical, thermal protection and hazard mitigation).
• Performance testing protocols for intermittent/synchronized delivery: trigger sensitivity, timing, delivered volume/flow and dose reproducibility under defined conditions.
• Labelling, identification and user documentation designed for lay operators and clinical users (marking, symbols, dose interpretation guidance).
• Requirements for compatibility and interaction with accessories and upstream equipment (oxygen concentrators, regulators, tubing) that may affect safety or performance.
• Risk management, fault detection and alarm/indicator requirements for unsafe states or delivery failures.
• Tests and tolerances for control accuracy, sensors, and output characteristics relevant to oxygen delivery performance.

These topics are addressed through normative clauses, specified test methods and informative annexes that provide guidance on marking and user information.

Typical use and users

Typical users include manufacturers and designers of oxygen‑conserving devices, test laboratories performing conformity assessment, regulatory bodies and notified/recognized bodies assessing medical devices, and clinical engineers or procurement teams specifying home oxygen therapy equipment. End users are primarily patients receiving home oxygen therapy and lay caregivers; clinical staff in hospitals and clinics may also use or service such equipment when conserving devices are part of a larger system. The standard supports safe design, performance verification and clear user instructions to reduce the risk of incorrect dosing or misuse.

Related standards

ISO 80601-2-67:2020 references and sits alongside related standards, including IEC 60601‑1 (general requirements for basic safety and essential performance of medical electrical equipment), earlier ISO 18779 (withdrawn/replaced), ISO 80601 series parts (for related respiratory and therapy equipment), ISO 5359 (low‑pressure hose assemblies), ISO 80369 (small‑bore connectors), and quality/medical device system standards such as ISO 13485 and applicable regional regulatory guidance. Manufacturers should consider both the general IEC/ISO 60601 requirements and device‑specific references when demonstrating conformity.

Keywords

oxygen‑conserving equipment; conserving device; intermittent oxygen delivery; synchronized inspiratory delivery; home oxygen therapy; essential performance; IEC 60601‑1; labelling; accessories; performance testing; trigger sensitivity; oxygen concentrator compatibility.

FAQ

Q: What is this standard?

A: ISO 80601-2-67:2020 is a particular standard in the ISO 80601/IEC 60601 family that specifies safety and performance requirements, tests and documentation for active oxygen‑conserving medical electrical equipment and relevant accessories.

Q: What does it cover?

A: It covers basic safety and essential performance for devices that conserve supplemental oxygen by delivering gas intermittently and synchronized with a patient’s inspiratory cycle, including performance test methods, labelling and requirements for interaction with accessories and upstream oxygen sources. Non‑active devices (e.g., reservoir cannulas) are excluded.

Q: Who typically uses it?

A: Device manufacturers, test and conformity assessment laboratories, regulatory bodies and notified bodies, clinical engineers, procurement specialists, and healthcare providers involved in home oxygen therapy; also useful for technical writers preparing user instructions and labelling.

Q: Is it current or superseded?

A: The 2020 edition (Edition 2) is the current published version and supersedes ISO 80601-2-67:2014. The standard is subject to periodic review by ISO (typically every five years); users should confirm any amendments or revisions with the official standards body before relying on the document for conformity assessment.

Q: Is it part of a series?

A: Yes — it is a "Part 2‑67" particular standard within the broader ISO 80601 / IEC 60601 family addressing medical electrical equipment; other parts of the series cover different types of medical electrical devices and their specific requirements.

Q: What are the key keywords?

A: Oxygen‑conserving equipment, intermittent oxygen delivery, synchronized delivery, home oxygen therapy, essential performance, safety, labelling, accessories, IEC 60601‑1.