BS EN ISO 10651-4:2009 Lung ventilators . Particular requirements for operator-powered resuscitators
BS EN ISO 10651-4 is the European standard that specifies requirements for operator-powered resuscitators intended for use with all age groups and which are portable and intended to provide lung ventilation to individuals whose breathing is inadequate. Operator-powered resuscitators for infants and children are designated according to body mass range and approximate age equivalent.
Electrically- and gas-powered resuscitators are not covered by BS EN ISO 10651-4.
Contents of BS EN ISO 10651-4 include:
- Foreword
- Scope
- Normative references
- Terms and definitions
- Connectors
- Operational requirements
- Ventilatory requirements
- Storage and operating conditions
- Requirements for resuscitator, or parts, supplied sterile
- Marking
- Information to be provided by the manufacturer in operating and maintenance instructions
- Test methods
- Rationale
- Bibliography
ISO 10651 consists of the following parts, under the general title Lung ventilators:
- Part 1: Requirements
- Part 2: Particular requirements for basic safety and essential performance. Home care ventilators for ventilator-dependent patients
- Part 3: Particular requirements for emergency and transport ventilators
- Part 4: Particular requirements for operator-powered resuscitators
- Part 5: Lung ventilators for medical use. Particular requirements for basic safety and essential performance. Gas-powered emergency resuscitators
- Part 6: Lung ventilators for medical use. Particular requirements for basic safety and essential performance. Home-care ventilatory support devices