ISO 10651-6:2004
Lung ventilators for medical use - Particular requirements for basic safety and essential performance - Part 6: Home-care ventilatory support devices

Standard No.

ISO 10651-6:2004

Release Date

2004

Published By

International Organization for Standardization (ISO)

Latest

ISO 10651-6:2004

Scope

IEC 60601-1:1988, Clause 1 applies, except as follows. Amendment: This part of ISO 10651 specifies the basic safety and essential performance requirements for home-care ventilatory support devices, intended mainly for use in home care but which could be used elsewhere (e.g. in healthcare facilities) for appropriate patients for whom the use of a home-care ventilator complying with ISO 10651-2 is not required. 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.

ISO 10651-6:2004 Referenced Document

• IEC 60079-4 Electrical apparatus for explosive gas atmospheres - Part 4: Method of test for ignition temperature; Amendment 1
• IEC 60601-1-2:2001 Medical electrical equipment - Part 1-2: General requirements for safety; Collateral standard: Electromagnetic compatibility; Requirements and tests
• IEC 60601-1-6 Medical electrical equipment - Part 1-6: General requirements for basic safety and essential performance - Collateral standard: Usability*， 2024-04-18 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 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 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*， 2006-06-01 Update
• 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 10651-6:2004 history

• 2004 ISO 10651-6:2004 Lung ventilators for medical use - Particular requirements for basic safety and essential performance - Part 6: Home-care ventilatory support devices