Overview
ISO 10651-5:2006 - "Lung ventilators for medical use - Particular requirements for basic safety and essential performance - Part 5: Gas-powered emergency resuscitators" specifies safety and performance requirements for portable, gas-powered emergency resuscitators intended for use by first responders. The standard covers devices intended for emergency field use that are continuously operator-attended and includes requirements for complete resuscitator sets. It expressly excludes electrically powered resuscitators.
Keywords: ISO 10651-5:2006, gas-powered emergency resuscitators, lung ventilators, resuscitator sets, first responders, basic safety, essential performance.
Key topics
ISO 10651-5 organizes requirements into practical, testable sections. Major topics include:
- Scope and definitions
- Clarifies intended use (first responders, field use), and key terminology (delivered volume, demand valve, resuscitator dead space).
- General requirements and risk management
- Safety goals, single-fault conditions and a requirement to apply ISO 14971 risk management.
- Constructional requirements
- Design and connector requirements for medical gas interfaces and breathing system components.
- Operational requirements
- Durability: resistance to environmental influences and typical use, size and mass, and gas supply considerations.
- Performance requirements
- Ventilatory requirements and measurable ventilation performance (delivered volume, minute volume, pressure limits).
- Identification, marking and documentation
- Clear labelling, accompanying documents, and user/maintenance information.
- Testing and annexes
- Normative and informative annexes include test methods, rationale, relationships to CPR guidelines and defined terminology.
Applications and who uses it
ISO 10651-5:2006 is relevant to:
- Manufacturers of gas-powered emergency resuscitators (design, verification, CE/market compliance).
- Regulatory bodies and procurement teams specifying equipment for EMS, fire services, disaster response, and public venues.
- Test laboratories and conformity assessors conducting performance and safety testing against the standard’s test methods.
- Training organizations and first responder programs to ensure supplied equipment meets expected performance and labeling.
- Biomedical engineers and clinical safety officers integrating resuscitator sets into emergency kits and protocols.
Practical value: ensures resuscitators deliver controlled ventilation reliably in field conditions, reduces safety hazards, and supports consistent procurement and testing criteria.
Related standards
Open preview (PDF)Lung ventilators for medical use — Particular requirements for basic safety and essential performance — Part 5: Gas-powered emergency resuscitators