BS EN ISO 10651-2:2009
Lung ventilators for medical use - Particular requirements for basic safety and essential performance - Part 2: Home care ventilators for ventilator-dependent patients (ISO 10651-2:2004)

Standard No.

BS EN ISO 10651-2:2009

Release Date

2009

Published By

British Standards Institution (BSI)

Status

Be replaced 2015-09

Replace By

BS EN ISO 80601-2-72:2015

Latest

BS EN ISO 80601-2-72:2015

Replace

BS EN ISO 10651-2:2004

Scope

IEC 60601-1:1988, Clause 1 applies, except as follows. Amendment: This part of ISO 10651 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. This part of ISO 10651 is not applicable to cuirass and “iron-lung” ventilators. This part of ISO 10651 is not applicable 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.

BS EN ISO 10651-2:2009 Referenced Document

• IEC 60079-4 Electrical apparatus for explosive gas atmospheres - Part 4: Method of test for ignition temperature; Amendment 1
• IEC 60601-1-2 Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral Standard: Electromagnetic disturbances - Requirements and tests*， 2024-04-19 Update
• IEC 60601-1-6 Medical electrical equipment - Part 1-6: General requirements for basic safety and essential performance - Collateral standard: Usability*， 2024-04-19 Update
• IEC 60601-1-8:2003 Medical electrical equipment - Part 1-8: General requirements for safety - Collateral standard: General requirements, tests and guidance for alarm systems in medical electrical equipment and medical electrical systems
• IEC 60601-1:1988 Medical electrical equipment; part 1: general requirements for safety
• ISO 14937 Sterilization of health care products - General requirements for characterization of a sterilizing agent and the development, validation and routine control of a sterilization process for medical devices*， 2009-10-01 Update
• ISO 14971 Medical devices - Application of risk management to medical devices*， 2019-12-01 Update
• ISO 15001 Anaesthetic and respiratory equipment - Compatibility with oxygen*， 2010-06-01 Update
• ISO 15223:2000 Medical devices - Symbols to be used with medical device labels, labelling and information to be supplied
• ISO 21647 Medical electrical equipment - Particular requirements for the basic safety and essential performance of respiratory gas monitors; Technical Corrigendum 1
• ISO 32 Gas cylinders for medical use; Marking for identification of content
• ISO 4135 Anaesthesiology — Vocabulary*， 2022-01-19 Update
• ISO 5356-1 Anaesthetic and respiratory equipment - Conical connectors - Part 1: Cones and sockets*， 2015-03-01 Update
• ISO 5356-2 Anaesthetic and respiratory equipment — Conical connectors — Part 2: Screw-threaded weight-bearing connectors AMENDMENT 1*， 2012-01-01 Update
• ISO 5359 Anaesthetic and respiratory equipment — Low-pressure hose assemblies for use with medical gases AMENDMENT 1*， 2014-01-01 Update
• ISO 5362 Anaesthetic reservoir bags
• ISO 5367 Anaesthetic and respiratory equipment — Breathing sets and connectors*， 2023-07-01 Update
• ISO 7396-1 Medical gas pipeline systems — Part 1: Pipeline systems for compressed medical gases and vacuum AMENDMENT 1*， 2016-01-01 Update
• ISO 8185 Respiratory tract humidifiers for medical use — Particular requirements for respiratory humidification systems
• ISO 9360-1 Anaesthetic and respiratory equipment - Heat and moisture exchangers (HMEs) for humidifying respired gases in humans - Part 1: HMEs for use with minimum tidal volumes of 250 ml
• ISO 9360-2 Anaesthetic and respiratory equipment - Heat and moisture exchangers (HMEs) for humidifying respired gases in humans - Part 2: HMEs for use with tracheostomized patients having minimum tidal volumes of 250 ml
• ISO 9919 Medical electrical equipment - Particular requirements for the basic safety and essential performance of pulse oximeter equipment for medical use

BS EN ISO 10651-2:2009 history

• 2015 BS EN ISO 80601-2-72:2015 Medical electrical equipment. Particular requirements for basic safety and essential performance of home healthcare environment ventilators for ventilator-dependent patients
• 2009 BS EN ISO 10651-2:2009 Lung ventilators for medical use - Particular requirements for basic safety and essential performance - Part 2: Home care ventilators for ventilator-dependent patients (ISO 10651-2:2004)
• 0000 BS EN ISO 10651-2:2004