DIN EN ISO 18777:2009
Transportable liquid oxygen systems for medical use - Particular requirements (ISO 18777:2005); English version of DIN EN ISO 18777:2009-07

Standard No.

DIN EN ISO 18777:2009

Release Date

2009

Published By

German Institute for Standardization

Status

Be replaced

Replace By

DIN EN ISO 18777:2009-07

Latest

DIN EN ISO 18777:2009-07

Replace

DIN EN ISO 18777:2005 DIN EN ISO 18777/A1:2008

Scope

IEC 60601-1:1988, Clause 1, applies except as follows: Amendments (add at end of 1.1): 1.1 This International Standard specifies requirements for the safety and essential performance of transportable liquid oxygen systems which are used as a supply source for oxygen therapy. These devices usually consist of a portable unit to be carried by or with the patient whilst in use and the vessel used to refill the portable unit. These devices are mostly used in home care applications and in health care facilities/institutions. These devices are often used without professional supervision. Liquid oxygen vessels used as a supply source for oxygen pipeline systems are excluded from this International Standard. The requirements of this International Standard which replace or modify the requirements of IEC 60601-1:1998 and its Amendments 1 (1991) and 2 (1995) are intended to take precedence over the corresponding general requirements. 1.4 Addition: NOTE Planning and design of products complying with this Intematinal Standard can have environmental impact during the product life cycle. Environmental aspects are addressed in Annex BB. Additional aspects of environmental impact are addressed in ISO 14971.

DIN EN ISO 18777:2009 Referenced Document

• EN 1041:1998 Information Supplied by the Manufacturer with Medical Devices
• EN 1251-1:2000 Cryogenic vessels - Transportable vacuum insulated vessels of not more than 1000 litres volume - Part 1: Fundamental requirements
• EN 1251-2:2000 Cryogenic vessels - Transportable vacuum insulated vessels of not more than 1000 litres volume - Part 2: Design, fabrication, inspection and testing
• EN 1251-3:2000 Cryogenic Vessels - Transportable Vacuum Insulated Vessels of Not More Than 1000 Litres Volume - Part 3: Operational Requirements
• EN 13544-2:2002 Respiratory therapy equipment - Part 2: Tubing and connectors (Incorporates Amendment A1: 2009)*， 2024-04-19 Update
• EN 980:2003 Graphical Symbols for Use in the Labelling of Medical Devices
• IEC 60079-4:1975 Electrical apparatus for explosive gas atmospheres. Part 4 : Method of test for ignition temperature
• IEC 60529:2001 Degrees of protection provided by enclosure (IP code)*， 2024-04-19 Update
• IEC 60601-1:1988 Medical electrical equipment; part 1: general requirements for safety
• ISO 15001:2003 Anaesthetic and respiratory equipment - Compatibility with oxygen
• ISO 18779 Medical devices for conserving oxygen and oxygen mixtures - Particular requirements
• ISO 4135:2001 Anaesthetic and respiratory equipment - Vocabulary
• ISO 7000 Graphical symbols for use on equipment — Index and synopsis*， 2019-07-12 Update

DIN EN ISO 18777:2009 history

• 2009 DIN EN ISO 18777:2009-07 Transportable liquid oxygen systems for medical use - Particular requirements (ISO 18777:2005); German version EN ISO 18777:2009 / Note: DIN EN ISO 18777 (2005-06) remains valid alongside this standard until 2010-03-21.
• 2009 DIN EN ISO 18777:2009 Transportable liquid oxygen systems for medical use - Particular requirements (ISO 18777:2005); English version of DIN EN ISO 18777:2009-07
• 0000 DIN EN ISO 18777/A1:2008
• 0000 DIN EN ISO 18777:2005

DIN EN ISO 18777:2009 Transportable liquid oxygen systems for medical use - Particular requirements (ISO 18777:2005); English version of DIN EN ISO 18777:2009-07 was changed to EN 4128:2016 Aerospace series - Bolts@ normal hexagonal head@ coarse tolerance shank@ short thread@ in heat resisting nickel base alloy@ aluminium IVD coated - Classification: 1 250 MPa (at ambient temperature) / 425 ��.