• There are no items in your cart

ISO 80601-2-69:2014

Withdrawn
Withdrawn

A Withdrawn Standard is one, which is removed from sale, and its unique number can no longer be used. The Standard can be withdrawn and not replaced, or it can be withdrawn and replaced by a Standard with a different number.

View Superseded by
withdrawn

A Withdrawn Standard is one, which is removed from sale, and its unique number can no longer be used. The Standard can be withdrawn and not replaced, or it can be withdrawn and replaced by a Standard with a different number.

Medical electrical equipment Part 2-69: Particular requirements for basic safety and essential performance of oxygen concentrator equipment
Available format(s)

Hardcopy , PDF , PDF 3 Users , PDF 5 Users , PDF 9 Users

Withdrawn date

11-10-2020

Language(s)

French, English

Published date

07-15-2014

ISO 80601-2-69:2014 specifies requirements for the basic safety and essential performance of an oxygen concentrator in combination with its accessories, hereafter referred to as ME equipment, intended to increase the oxygen concentration of gas intended to be delivered to a single patient. Such oxygen concentrators are typically intended for use in the home healthcare environment, including transit-operable use by a single patient in various environments including any private and public transportation as well as in commercial aircraft.

ISO 80601-2-69:2014 is applicable to a transit-operable and non-transit-operable oxygen concentrator. It is applicable to an oxygen concentrator integrated into or used with other medical devices, ME equipment or ME systems.

DevelopmentNote
Supersedes ISO/DIS 80601-2-69 and ISO 8359. (07/2014)
DocumentType
Standard
Pages
44
PublisherName
International Organization for Standardization
Status
Withdrawn
SupersededBy
Supersedes

17/30337954 DC : 0 BS ISO 19211 - ANAESTHETIC AND RESPIRATORY EQUIPMENT - FIRE-ACTIVATED OXYGEN SHUT-OFF DEVICES FOR USE DURING OXYGEN THERAPY
BS EN ISO 7396-1:2016 Medical gas pipeline systems Pipeline systems for compressed medical gases and vacuum
EN ISO 7396-1:2016 Medical gas pipeline systems - Part 1: Pipeline systems for compressed medical gases and vacuum (ISO 7396-1:2016)
15/30280904 DC : 0 BS ISO 18190 - ANAESTHETIC AND RESPIRATORY EQUIPMENT - GENERAL REQUIREMENTS FOR AIRWAYS AND RELATED EQUIPMENT
I.S. EN ISO 7396-1:2016 MEDICAL GAS PIPELINE SYSTEMS - PART 1: PIPELINE SYSTEMS FOR COMPRESSED MEDICAL GASES AND VACUUM (ISO 7396-1:2016)
16/30346835 DC : 0 BS ISO 20789 - ANAESTHETIC AND RESPIRATORY EQUIPMENT - PASSIVE HUMIDIFIERS
DIN EN ISO 7396-1:2016-09 MEDICAL GAS PIPELINE SYSTEMS - PART 1: PIPELINE SYSTEMS FOR COMPRESSED MEDICAL GASES AND VACUUM (ISO 7396-1:2016)
BS ISO 18190:2016 Anaesthetic and respiratory equipment. General requirements for airways and related equipment
UNE-EN ISO 7396-1:2016 Medical gas pipeline systems - Part 1: Pipeline systems for compressed medical gases and vacuum (ISO 7396-1:2016)
ISO 7396-1:2016 Medical gas pipeline systems — Part 1: Pipeline systems for compressed medical gases and vacuum
ISO 18190:2016 Anaesthetic and respiratory equipment — General requirements for airways and related equipment

ISO 7010:2011 Graphical symbols Safety colours and safety signs Registered safety signs
ISO 80601-2-67:2014 Medical electrical equipment Part 2-67: Particular requirements for basic safety and essential performance of oxygen-conserving equipment
ISO 3744:2010 Acoustics Determination of sound power levels and sound energy levels of noise sources using sound pressure Engineering methods for an essentially free field over a reflecting plane
EN 15986:2011 Symbol for use in the labelling of medical devices - Requirements for labelling of medical devices containing phthalates
IEC 60601-1:2005+AMD1:2012 CSV Medical electrical equipment - Part 1: General requirements for basic safety and essential performance
CFR 45(PTS1-199) : OCT 2017 PUBLIC WELFARE - SUBTITLE A - DEPARTMENT OF HEALTH AND HUMAN SERVICES - GENERAL ADMINISTRATION - SUBTITLE B - REGULATIONS RELATING TO PUBLIC WELFARE
IEC 60601-1-6:2010+AMD1:2013 CSV Medical electrical equipment - Part 1-6: General requirements for basic safety and essential performance - Collateral standard: Usability
ISO 14937:2009 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
ISO 8835-7:2011 Inhalational anaesthesia systems — Part 7: Anaesthetic systems for use in areas with limited logistical supplies of electricity and anaesthetic gases
ISO 10083:2006 Oxygen concentrator supply systems for use with medical gas pipeline systems
IEC 60601-1-8:2006+AMD1:2012 CSV Medical electrical equipment - Part 1-8: General requirements forbasic safety and essential performance - Collateral Standard: General requirements, tests and guidance for alarm systems inmedical electrical equipment and medical electrical systems
IEC 62366:2007+AMD1:2014 CSV Medical devices - Application of usability engineering to medical devices
IEC 60601-1-2:2014 Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral Standard: Electromagnetic disturbances - Requirements and tests
ISO 8185:2007 Respiratory tract humidifiers for medical use Particular requirements for respiratory humidification systems
ISO/TR 16142:2006 Medical devices Guidance on the selection of standards in support of recognized essential principles of safety and performance of medical devices
ISO 14159:2002 Safety of machinery — Hygiene requirements for the design of machinery
ISO 80369-1:2010 Small-bore connectors for liquids and gases in healthcare applications Part 1: General requirements
ISO 14971:2007 Medical devices Application of risk management to medical devices
ISO 7000:2014 Graphical symbols for use on equipment Registered symbols
ISO 4135:2001 Anaesthetic and respiratory equipment Vocabulary
ISO 10524-1:2006 Pressure regulators for use with medical gases Part 1: Pressure regulators and pressure regulators with flow-metering devices
ISO 15223-1:2016 Medical devices Symbols to be used with medical device labels, labelling and information to be supplied Part 1: General requirements
ISO 17664:2017 Processing of health care products Information to be provided by the medical device manufacturer for the processing of medical devices
ISO 7396-1:2016 Medical gas pipeline systems — Part 1: Pipeline systems for compressed medical gases and vacuum

View more information
US$73.00
Excluding Tax where applicable

Access your standards online with a subscription

Features

  • Simple online access to standards, technical information and regulations.

  • Critical updates of standards and customisable alerts and notifications.

  • Multi-user online standards collection: secure, flexible and cost effective.