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 – BSI British Standards

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

Status : Superseded, Withdrawn   Published : July 2009 Replaced By : BS EN ISO 80601-2-72:2015

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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



Standard NumberBS EN ISO 10651-2:2009
TitleLung ventilators for medical use. Particular requirements for basic safety and essential performance. Home care ventilators for ventilator-dependent patients
StatusSuperseded, Withdrawn
Publication Date31 July 2009
Withdrawn Date30 September 2015
Normative References(Required to achieve compliance to this standard)ISO 32, ISO 4135, ISO 5356-1, ISO 5356-2, ISO 5359, ISO 5362, ISO 5367, ISO 7396-1, ISO 8185, ISO 8185/Technical Corrigendum 1:2001, ISO 9360-1, ISO 9360-2, ISO 9919, ISO 14937, ISO 14937/Technical Corrigendum 1:2003, ISO 14971, ISO 15001, ISO 15223:2000, ISO 21647, IEC 600
Informative References(Provided for Information)ISO 31, ISO 594-1, ISO 690, ISO 1000, ISO 8359, ISO 8835-5, ISO 9703-1, ISO 9703-2, ISO 9703-3, ISO 10241, ISO 10524-2, ISO 10524-3, ISO 11195, ISO 15002, ISO/TR 16142, ISO 18777, ISO 18779, ISO 23328-2, IEC 60027, IEC/TR 60513, IEC 60601-1-1, IEC 60601-1-4, IEC 60601-2-13, IEC
Replaced ByBS EN ISO 80601-2-72:2015
ReplacesBS EN ISO 10651-2:2004
International RelationshipsISO 10651-2:2004,EN ISO 10651-2:2009
DescriptorsRespirators, Breathing apparatus, Lungs, Medical breathing apparatus, Medical equipment, Artificial respiration, Electrical medical equipment, Domestic, Equipment safety, Safety measures, Performance, Performance testing
ICS11.040.10
Title in FrenchVentilateurs pulmonaires à usage médical. Exigences particulières pour la sécurité de base et les performances essentielles. Ventilateurs pour soins à domicile pour patients dépendants
Title in GermanBeatmungsgeräte für die medizinische Anwendung. Besondere Festlegungen für die grundlegende Sicherheit einschließlich der wesentlichen Leistungsmerkmale. Heimbeatmungsgeräte für vom Gerät abhängige Patienten
CommitteeCH/121/5
ISBN978 0 580 65524 1
PublisherBSI
FormatA4
DeliveryNo
Pages46
File Size887.7 KB
Price£240.00


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