ISO TR 21954:2018

Overview

ISO/TR 21954:2018 - Guidance on the selection of the appropriate means of ventilation based on the intended patient, use environment, and operator - is a technical report developed jointly by ISO and IEC technical committees. It helps clarify which ventilation- and resuscitation-related product standards are appropriate for specific patients, environments and operators. The report covers a spectrum of devices including gas- and operator-powered resuscitators, critical care ventilators, emergency medical services (EMS) ventilators, various home‑healthcare ventilators and sleep apnoea breathing therapy equipment.

Key topics and requirements

• Intended patient criteria: patient acuity, fragility, dependency on ventilation, and consequences of ventilation loss (what level of monitoring and safety is required).
• Intended use environment: comparisons of environmental characteristics for home healthcare, professional healthcare facilities and EMS settings, and how environment influences device selection.
• Intended operator: required operator training, expected frequency of clinical assessment and respiratory-related care.
• Device categories analyzed:
  • Gas-powered resuscitators (ISO 10651-5)
  • Operator-powered resuscitators (ISO 10651-4)
  • Critical care ventilators (ISO 80601‑2‑12)
  • EMS ventilators (ISO 80601‑2‑84; replacement for ISO 10651‑3)
  • Home‑healthcare ventilators (ISO 80601‑2‑72, -79, -80)
  • Sleep apnoea breathing therapy equipment (ISO 80601‑2‑70) - included to illustrate why it is not classed as an artificial ventilator
• Supporting annexes: rationale and guidance (Annex A), environmental comparison tables (Annex B), mapping of product standards to use environments (Annex C), and technical requirement comparisons (Annex F).

Practical applications

• Manufacturers: select appropriate product standards for design, risk management and labeling based on intended patient population, operator competence and environment.
• Regulators and authorities having jurisdiction: define suitable regulatory pathways and device classifications for procurement, compliance and market surveillance.
• Procurement and clinical teams: choose ventilatory devices matched to patient acuity and care setting (ICU, EMS, home care).
• Service providers and trainers: plan operator training and maintenance programs aligned to device class and environment.

Related standards (high relevance)

• ISO 80601‑2‑12, ISO 80601‑2‑72, ISO 80601‑2‑79, ISO 80601‑2‑80, ISO 80601‑2‑84
• ISO 10651‑4, ISO 10651‑5
• ISO 80601‑2‑70 (sleep apnoea breathing therapy equipment)
• IEC 60601 series (electrical medical equipment safety and harmonization notes)

ISO/TR 21954:2018 is a practical, standards‑oriented guide for aligning ventilator selection with clinical needs, environment constraints and operator capabilities - a valuable reference for product development, clinical procurement and regulatory decisions.