ISO 10651-4:2023

Overview

ISO 10651-4:2023 - "Lung ventilators - Part 4: Particular requirements for user-powered resuscitators" defines safety, performance, testing and information requirements for user-powered resuscitators (e.g., self‑inflating and flow‑inflating bag resuscitators) intended to provide lung ventilation across all age groups. The second edition (2023) updates test conditions, environmental and lifetime requirements, manufacturer labelling, and adds biocompatibility and usability provisions. The standard also covers accessories and point‑of‑use packaging when their characteristics affect resuscitator safety.

Key topics and technical requirements

• Scope and exclusions: Applies to hand‑squeezed self‑inflating and flow‑inflating bag resuscitators and relevant accessories; excludes gas‑powered emergency resuscitators (see ISO 10651‑5), electrically powered resuscitators, and anaesthetic reservoir bags (ISO 5362).
• Performance and ventilatory requirements: Requirements and tests for delivered oxygen concentration, inspiratory/expiratory resistance, deadspace, and guaranteed tidal volumes (single‑hand and two‑hand operation), plus maximum pressure limits.
• Connectors and interfaces: Specifications for patient ports, expiratory ports, oxygen inlets, bag refill valves and pressure monitoring connections to ensure compatibility and safe coupling.
• Operational and environmental testing: Type tests, contamination (vomitus) performance, mechanical strength, immersion/transport conditions, storage, shelf‑life and expected lifetime.
• Accessories and labelling: Criteria for masks, PEEP valves, filters, metronomes, sensors and electronic feedback devices; harmonized marking and instruction requirements aligned with ISO 20417 and ISO 15223‑1.
• Processing, biocompatibility and usability: Reprocessing (cleaning/sterilization) guidance, biological safety of materials, and human factors/usability testing to reduce user error.
• Regulatory alignment: Addresses IMDRF essential principles and labelling (Annex D), ISO 16142‑1 safety/performance principles (Annex E), and EU MDR (EU) 2017/745 general requirements (Annex F).

Practical applications and who uses this standard

• Manufacturers and product designers: Use ISO 10651‑4:2023 to design, test and document compliant user‑powered resuscitators and accessories.
• Test laboratories and conformity assessors: Apply the standard’s test methods and uncertainty reporting for type approval and certification.
• Clinical engineers and procurement: Evaluate device performance, compatibility and lifecycle claims when selecting resuscitators for hospitals, EMS and disaster response.
• Regulators and notified bodies: Reference annexed alignment with IMDRF and EU MDR for conformity assessment and labeling reviews.
• Healthcare providers and trainers: Understand device limitations (oxygen delivery, resistance, deadspace) and safe operating conditions in emergency and transport settings.

Related standards and references

• ISO 10651‑5 (gas‑powered emergency resuscitators)
• ISO 5362 (anaesthetic reservoir bags)
• ISO 20417, ISO 15223‑1 (labelling and instructions)
• ISO 16142‑1 (safety and performance principles)
• EU Regulation (EU) 2017/745 (MDR) and IMDRF guidances

Keywords: ISO 10651-4:2023, user-powered resuscitators, lung ventilators, self-inflating bag, flow-inflating bag, ventilatory requirements, medical device standards, biocompatibility, usability, manufacturer labelling.