Healthcare facilities depend on the correct medical gas being delivered safely at the point of use where the patient needs it, all the time and every time needed. This demands safe systems to ensure correctness, adequacy, continuity and quality of the gases. Staff should be trained and competent to carry out the activities. Plant and equipment should be correctly designed, continuously monitored and maintained to deliver the gases.
These issues are detailed and possibly audited by various international and national regulatory agencies, who have established guidelines and standards applying to medical gases, pipelines and related equipment, personnel and procedures. For further information, we provide some links below. At the same time, you can turn to Linde Healthcare to help you interpret the Standards and implement the systems and procedures you need to ensure compliance
Medical Gas Standards
International Standard for “Medical gas pipeline systems”
Designated as the European Standard for the implementation of
Medical Directive 93/42/EEC. Also published by individual
standards bodies with the European Union, e.g. as BS EN ISO 7396
and NEN ISO 7396-1.
American standard code for Healthcare Facilities.
Published by the National Fire Protection Association (NFPA)- USA.
Standard on Gas and Vacuum systems extracted from NFPA 99.
Published by the National Fire Protection Association (NFPA) – USA.
NHS estates guidance for medical gas pipeline systems (HTM 02-01).
Published by Department of Health, UK.
International Standard Medical Devices - Quality Management Systems
Requirements for Regulatory Purposes.
SIS HB 370
Säkerhetsnorm för medicinska gasanläggningar
Standards for healthcare facilities project published by ANVISA
National healthcare agency.
Medical gas Systems for oxygen, medical air, nitrous oxide and vacuum for health care facilities, published by ABNT
Council of standards, Brazil.
Health assistance Institution – Oxygen concentrator for use with medical oxygen pipeline systems, published by ABNT
Council of standards, Brazil.
AS 2896 -2011
Medical Gas Systems – Installation and Testing of non flammable medical gas pipeline systems
Published by the Council of Standards, Australia.
Medical Gases - Purity of compressed medical breathing air.
The storage and handling of gases in cylinders.
The storage and handling of non - flammable cryogenic and refrigerated liquids.
Dental Equipment - Compressed air systems.
Systèmes de distribution pour gaz médicaux comprimés et vide. France: national standard.
Medical gas Piping systems
Canada National Standard.
Resolución Número 04410 de 2009
“Reglamento Técnico que contiene el Manual de Buenas Prácticas de Manufactura de los Gases Medicinales”
Y DE VERIFICACIÓN Y RESOLUCIÓN NÚMERO 1043 DE 2006
Other relevant ISO standards
Anaesthesia and breathing devices compatible with Oxygen
Pressure reduction devices
Pressure regulators for use with medical gases
Medical supply devices
Flexible low pressure hoses
Flexible high pressure connections for medical gas systems
Compressed air purity and test methods
Seamless round copper tubes for medical gas and vacuum
Anaesthetic and respiratory equipment – vocabulary
Compressed air dryers
Many of the above standards are also issued as National Standards within the countries of the European Union e.g. NEN in the Netherlands, BS in the UK, SIS in Sweden