SIST EN ISO 10651-5:2021

Overview

EN ISO 10651-5:2021 (identical to ISO 10651-5:2006) defines the basic safety and essential performance requirements for gas-powered emergency resuscitators used with humans by first responders. The standard covers devices intended for emergency field use that are continuously operator-attended in normal operation and also specifies requirements for resuscitator sets. It is explicit that this part is not applicable to electrically-powered resuscitators.

Key Topics

• Scope and terminology: Defines terms and the intended use for gas-powered emergency resuscitators within the broader family of lung ventilators for medical use.
• Constructional requirements: Guidance on device construction including connectors, materials and compatibility with breathing system components.
• Operational requirements: Tests and acceptance criteria for real-world use - resistance to environmental influences, resistance to typical use, size and mass limits, and gas supply considerations.
• Performance requirements: Ventilatory requirements and ventilation performance expectations for delivering controlled ventilation during emergency resuscitation.
• Identification and documentation: Marking, labelling and manufacturer information required for safe operation and maintenance.
• Test methods and annexes: Normative and informative annexes provide test procedures, rationale, and links to cardiopulmonary resuscitation guidelines.

Practical Applications

• Procurement and specification of gas-powered emergency resuscitators for emergency medical services (EMS), fire and rescue teams, event medical coverage, and public-access emergency kits.
• Design and manufacturing compliance for medical device makers producing resuscitators and resuscitator sets (e.g., regulators, hoses, masks).
• Regulatory and conformity assessment activities, quality management, and risk management to demonstrate compliance with accepted safety and performance criteria.
• Training and clinical utility guidance for first responders and medical directors choosing devices for field resuscitation.

Who Uses This Standard

• Medical device manufacturers and R&D teams designing gas-powered resuscitators
• EMS and pre-hospital care procurement officers
• National standards bodies and conformity assessors
• Hospital and rescue service biomedical engineers and clinical leads
• First responder trainers and safety officers specifying equipment

Related Standards

Relevant cross-references and normative documents include other parts of the ISO 10651 series and supporting standards cited in EN ISO 10651-5:2021, such as:

• ISO 10651 (other parts: transport ventilators, operator-powered resuscitators)
• ISO 5356-1 / ISO 5356-2 (conical connectors)
• ISO 10524 series (pressure regulators)
• ISO 5367 (breathing tubes)
• ISO 14971 (risk management)
• ISO 15223 (symbols and labelling)
• ISO 11607, ISO 17664 and others listed in the standard

Keywords: EN ISO 10651-5:2021, ISO 10651-5:2006, gas-powered emergency resuscitators, lung ventilators, resuscitator sets, emergency field use, ventilatory performance.