BS EN ISO 10651-2:2009 Lung ventilators for medical use. Particular requirements for basic safety and essential performance. Home care ventilators for ventilator-dependent patients
BS EN ISO 10651-2 specifies requirements for lung ventilators intended for home applications for those patients who are dependent on ventilatory support. Such ventilators are considered life-supporting equipment, are frequently used in locations where driving power is not reliable, and are often supervised by non-healthcare personnel with different levels of training.
BS EN ISO 10651-2 does not apply to cuirass and “iron-lung” ventilators.
BS EN ISO 10651-2 does not apply to ventilators intended only to augment the ventilation of spontaneously breathing patients.
The requirements of this part of ISO 10651 which replace or modify the requirements of IEC 60601-1:1988 and its Amendments 1 (1991) and 2 (1995) are intended to take precedence over the corresponding general requirements
Contents of BS EN ISO 10651-2:
- Foreword
- Introduction
- Scope
- Normative references
- Terms and definitions
- General requirements and requirements for tests
- Classification
- Identification, marking and documents
- Power input
- Basic safety categories
- Removable protective means
- Environmental conditions
- General
- Requirements related to classification
- Limitation of voltage and/or energy
- Enclosures and protective covers
- Separation
- Protective earthing, functional earthing and potential equalization
- Continuous leakage currents and patient auxiliary currents
- Dielectric strength
- Mechanical strength
- Moving parts
- Surfaces, corners and edges
- Stability in normal use
- Expelled parts
- Vibration and noise
- Pneumatic and hydraulic power
- Suspended masses
- X-radiation
- Alpha, beta, gamma, neutron radiation and other particle radiation
- Microwave radiation
- Light radiation (including lasers
- Infra-red-radiation
- Ultraviolet radiation
- Acoustical energy (including ultrasonics
- Electromagnetic compatibility
- Locations and basic requirements
- Marking, accompanying documents
- Common requirements for category AP and category APG equipment
- Requirements and tests for category AP equipment, parts and components thereof
- Requirements and tests for category APG equipment, parts and components thereof
- Excessive temperatures
- Fire prevention
- Overflow, spillage, leakage, humidity, ingress of liquids, cleaning, sterilization, disinfection and
- compatibility
- Pressure vessels and parts subject to pressure
- Human errors
- Electrostatic charges
- Biocompatibility
- Interruption of the power supply
- Accuracy of operating data
- Protection against hazardous output
- Abnormal operation and fault conditions
- Environmental tests
- General
- Enclosures and covers
- Components and general assembly
- Mains parts, components and layout
- Protective earthing — Terminals and connections
- Construction and layout
- Alarm systems
- Indication and access
- Alarm condition logging
- Appendices of IEC 60601-1:1988
- Rationale
- Reference to the essential principles
- Bibliography