ISO/TC 121/SC 6 - Medical gas supply systems

IEC 60601-1:2005+A1:2012, 1.1 is replaced by: This document applies to the basic safety and essential performance of medical supply units, hereafter also referred to as ME equipment. This document applies to medical supply units manufactured within a factory or assembled on site, including cabinetry and other enclosures, which incorporate patient care services. NOTE 1 A party that assembles on site various components intended for patient care services into an enclosure is considered the manufacturer of the medical supply unit. Hazards inherent in the intended function of ME equipment or ME systems within the scope of this document are not covered by specific requirements in this standard, except in of IEC 60601-1:2005+A1:2012, 7.2.13 and 8.4.1 (see 201.1.4). NOTE 2 Refer to IEC 60601-1:2005+A1:2012, 4.2.

This document specifies design, type testing, and marking requirements for cylinder valves with integrated pressure regulators [as defined in 3.26 and referred to hereafter as valves with integrated pressure regulators (VIPRs)] intended for the administration of medical gases in the treatment, management, diagnostic evaluation and care of patients or for gases used for driving surgical tools. Examples of gases include oxygen, medical air and oxygen/nitrous oxide mixtures. This document applies to VIPRs mounted on refillable cylinders with a working pressure up to 30 000 kPa (300 bar) intended to be filled in cylinder filling facilities or on self-filling systems as used in homecare applications. VIPRs covered by this document are pressure pre-set and provided with a pressure outlet and/or pre-set flow outlet(s).

ISO 10524-2:2018 specifies design, construction, type testing, and marking requirements for manifold pressure regulators (as defined in 3.7) and line pressure regulators (as defined in 3.5) intended for use in medical gas pipeline systems. Examples of gases include oxygen, medical air and oxygen/nitrous oxide mixtures. ISO 10524-2:2018 applies to manifold pressure regulators and line pressure regulators supplied as individual units or to the relevant components incorporated within an assembly. Manifold pressure regulators are intended to be connected to a manifold system which has a nominal inlet pressure, P1 of up to 30 000 kPa (300 bar). Line pressure regulators are intended to be connected downstream of the manifold pressure regulator with a supply pressure up to 3 000 kPa (30 bar). ISO 10524-2:2018 does not apply to pressure regulators for use with vacuum pipeline systems. NOTE Requirements for pressure regulators for use with vacuum pipeline systems are covered in ISO 10079‑3.

ISO 10524-1:2018 specifies the design, construction, type testing, and marking requirements for pressure regulators (as defined in 3.18) intended for the administration of medical gases and their mixtures in the treatment, management, diagnostic evaluation and care of patients or for gases used for driving surgical tools. Examples of gases include oxygen, medical air and oxygen/nitrous oxide mixtures. ISO 10524-1:2018 applies to pressure regulators: a) intended to be connected to cylinders by the operator; b) with integral flow-metering devices intended to be connected to cylinders by the operator; c) that are an integral part of medical equipment (e.g. anaesthetic workstations, lung ventilators, resuscitators). A pressure regulator can be provided with pressure outlet or flow outlet, and can be adjustable or pre-set. pressure regulators are intended to be fitted to refillable cylinders with a working pressure up to 30 000 kPa ( 300 bar) and can be provided with devices which control and measure the flow of the medical gas delivered.

ISO 9170-1:2017 is intended especially to ensure the gas-specific assembly, mechanical resistance, flow, leakage and pressure drop of terminal units and to prevent their interchange between different gases and services and applies to terminal units: a) intended for use in medical gas pipeline systems in accordance with ISO 7396‑1; b) used as pressure outlets on pressure regulators in accordance with ISO 10524‑1; c) used as pressure outlets on pressure regulators integrated with cylinder valves (VIPR) in accordance with ISO 10524‑3. ISO 9170-1:2017 applies to terminal units for use with the following gases for administration to patients or for medical uses (A): - oxygen (A); - nitrous oxide (A); - medical air (A); - carbon dioxide (A); - oxygen/nitrous oxide mixture (A); - helium/oxygen mixtures (A); - oxygen 93 (A); - gases and gas mixtures classified as medical device (A); - gases delivered to medical devices or intended for medical purposes (A); - gases and gas mixtures for medicinal use not specified above (A). ISO 9170-1:2017 applies to terminal units for use with the following gases (B): - air for driving surgical tools (B); - nitrogen for driving surgical tools (B). This document applies to terminal units for use with vacuum systems (C). NOTE The requirements of this document can be used as guidelines for terminal units for other gases. These other gases will be considered for inclusion in this document when they come into general use. ISO 9170-1:2017 specifies requirements for terminal units for supply and disposal of nitrogen and air for driving surgical tools. ISO 9170-1:2017 specifies requirements for probes intended to be connected to the gas-specific connection point. ISO 9170-1:2017 does not specify the dimensions of probes or of the gas-specific connection points. NOTE Regional or national standards specifying dimensions of probes and gas-specific connection points are given in the Bibliography. Other connection systems in national use may be acceptable under this document. Dimensioning for such connections will be specified by their respective national standards. ISO 9170-1:2017 does not specify the requirements for terminal units for anaesthetic gas scavenging systems (AGSS), which are specified in ISO 9170‑2.

ISO 7396-1:2016 specifies requirements for design, installation, function, performance, testing, commissioning and documentation of pipeline systems used in healthcare facilities for the following: - oxygen; - nitrous oxide; - medical air; - carbon dioxide; - oxygen/nitrous oxide mixtures (see Note 1); - helium/oxygen mixtures; - (*) oxygen 93; - gases and gas mixtures classified as medical device, gases delivered to medical devices or intended for medical purposes or gases and gas mixtures for medicinal use not specified above; - air for driving surgical tools; - nitrogen for driving surgical tools; - vacuum. NOTE 1 Regional or national regulations may prohibit the distribution of oxygen/nitrous oxide mixtures in medical gas pipeline systems. NOTE 2 Anaesthetic gas scavenging disposal systems are covered in ISO 7396‑2. This part of ISO 7396 includes requirements for supply systems, pipeline distribution systems, control systems, monitoring and alarm systems and non-interchangeability between components of different gas/vacuum systems. This part of ISO 7396 specifies safety requirements for pipeline systems used in healthcare facilities, both public and private. It applies to all facilities providing healthcare services regardless of type, size, location or range of services, including, but not limited to: a) acute care healthcare facilities; b) internal patient continuing care healthcare facilities; c) long-term care facilities; d) community-based providers; e) ambulatory and external patient care clinics (e.g. day surgery, endoscopy clinics and doctors' offices). NOTE 3 This part of ISO 7396 may also be used as reference for pipeline systems for medical gases and vacuum intended to be installed in places other than healthcare facilities. ISO 7396-1:2016 applies to the following different types of oxygen supply systems: - supply systems in which all sources of supply deliver oxygen; in this case the concentration of the oxygen will be greater than 99%; - supply systems in which all sources of supply deliver oxygen 93; in this case the concentration of the oxygen may vary between 90% and 96%; NOTE 4 A mixture of oxygen 93 and oxygen may be delivered by a medical gas supply system. In this case the concentration of the gas can vary between 90% and >99%. ISO 7396-1:2016 also applies to: - extensions of existing pipeline distribution systems; - modifications of existing pipeline distribution systems; - modifications or replacement of supply systems or sources of supply. Oxygen concentrators for domiciliary use are excluded from the scope of this part of ISO 7396. NOTE 5 Requirements for oxygen concentrators for domiciliary use are specified in ISO 80601‑2-69. (*) EN 14931 defines additional requirements for hyperbaric application, in particular for flows and pressures of compressed air required to pressurize the hyperbaric chamber and to drive other connected services. Also included are requirements for oxygen and other treatment gases administered to patients. ISO 7396-1:2016 does not apply to vacuum systems intended to be used in dentistry. ISO 7396-1:2016 does not apply to filling systems for transportable cylinders and transportable cylinder bundle systems.

ISO 16571:2014 specifies requirements and guidelines for the design, manufacture, installation, function, performance, maintenance, servicing, documentation, testing, and commissioning of equipment for evacuation of plume generated by medical devices. ISO 16571:2014 is applicable to a) portable and mobile plume evacuation systems, b) local stationary plume evacuation systems, c) dedicated central pipeline systems for plume evacuation systems, and d) plume evacuation systems integrated into other equipment (e.g. laser equipment).

ISO 15001:2010 specifies requirements for the oxygen compatibility of materials, components and devices for anaesthetic and respiratory applications, which can come into contact with oxygen in normal condition or in single fault condition at gas pressures greater than 50 kPa. Additionally, ISO 15001:2010 gives general guidelines for the selection of materials and components based on available data on their oxygen compatibility, and for carrying out a risk analysis, including addressing the toxicity of products of combustion and/or decomposition. Aspects of compatibility that are addressed by ISO 15001:2010 include cleanliness, resistance to ignition and the toxicity of products of combustion and/or decomposition at the design, manufacturing, maintenance and disposal stages. ISO 15001:2010 is applicable to anaesthetic and respiratory equipment that is within the scope of ISO/TC 121, e.g. medical gas pipeline systems, pressure regulators, terminal units, medical supply units, flexible connections, flow-metering devices, anaesthetic workstations and lung ventilators.

ISO 21969:2009 applies to high-pressure flexible connections intended to be connected to cylinders or cylinder bundles with nominal filling pressures up to 25 000 kPa at 15 °C for use with the following medical gases: oxygen; nitrous oxide; air for breathing; helium; carbon dioxide; xenon; mixtures of the gases listed above; air for driving surgical tools; nitrogen for driving surgical tools; oxygen-enriched air. ISO 21969:2009 applies to high-pressure flexible connections intended to connect cylinders or cylinder bundles to manifolds within sources of supply of medical gas pipeline systems complying with ISO 7396-1. ISO 21969:2009 applies to high-pressure flexible connections intended to connect a cylinder to an inlet port of medical equipment (e.g. anaesthetic workstation or lung ventilator) fitted with an integral pressure regulator complying with ISO 10524-1.

ISO 9170-2:2008 specifies the requirements and dimensions for terminal units intended for use in anaesthetic gas scavenging disposal systems in accordance with ISO 7396-2. ISO 9170-2:2008 specifies two types of terminal unit according to whether the power device is upstream or downstream of the terminal unit. ISO 9170-2:2008 also specifies requirements and dimensions for the mating counterpart (probe) of the type-specific connection point which is part of the terminal unit.

ISO 15002:2008 is applicable to: flow-metering devices that are connected, either directly or by means of flexible connecting assemblies, and disconnected by the operator at terminal units of a medical gas pipeline system for flow adjustment, measurement and delivery of medical gases; flow-metering devices that are connected and disconnected by the operator at gas-specific connection points of devices such as pressure regulators. ISO 15002:2008 is applicable to: flow-metering devices intended to be used with the following medical gases: oxygen; nitrous oxide; medical air; carbon dioxide; oxygen/nitrous oxide mixture [50 %/50 % (by volume)] specified mixtures of the gases listed above; flow-metering devices intended to be used with the following gases: oxygen-enriched air; helium; xenon.

ISO 10524-4:2008 applies to the types of low-pressure regulators listed below and intended to be used with the following medical gases in the treatment, management, diagnostic evaluation and care of patients: oxygen; nitrous oxide; medical air; helium; carbon dioxide; xenon; specified mixtures of the gases listed above; air for driving surgical tools; nitrogen for driving surgical tools; oxygen-enriched air. The types of low-pressure regulators covered by ISO 10524-4:2008 are as follows: low-pressure regulators intended to be connected to terminal units of medical gas pipeline systems complying with ISO 7396-1; low-pressure regulators with integral flow-metering devices intended to be connected to terminal units of medical gas pipeline systems complying with ISO 7396-1; low-pressure regulators intended to be connected to terminal units attached to pressure regulators complying with ISO 10524-1 or ISO 10524-3; operator-adjustable low-pressure regulators for air or nitrogen for driving surgical tools that are an integral part of a medical gas pipeline system complying with ISO 7396-1.

ISO 7396-2:2007 specifies requirements for the design, installation, function, performance, documentation, testing and commissioning of anaesthetic gas scavenging disposal systems, to ensure patient safety and to minimize exposure of the operator and other persons to anaesthetic gases and vapours. It includes requirements for the power device, pipeline system, performance, non-interchangeability between key components and avoidance of cross connections between anaesthetic gas scavenging (AGS) disposal systems and medical gas and vacuum pipeline systems. ISO 7396-2:2007 is applicable only to those disposal systems intended to be connected via AGSS terminal units compliant with ISO 9170-2 to AGSS receiving systems compliant with ISO 8835-3. ISO 7396-2:2007 also applies to: extensions of existing AGSS disposal systems; modifications of existing AGSS disposal systems; modifications or replacement of power devices.

ISO 19054:2005 specifies basic requirements to ensure compatibility between rail systems complying with this International Standard and medical equipment in order to facilitate the transfer of medical equipment from one rail system to another. The specifications for rail systems include dimensions, strength and information to be supplied by the manufacturer. ISO 19054:2005 applies only to rail systems intended to be mounted horizontally. ISO 19054:2005 does not specify either the structures to which a rail system can be attached or the types of medical equipment that can be supported nor does it apply to overhead rail systems for supporting curtains and infusion devices.

ISO 18777:2005 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.

IEC 60601-1:2005+A1:2012, 1.1 is replaced by: ISO 11197:2016 applies to the basic safety and essential performance of medical supply units, hereafter also referred to as me equipment. ISO 11197:2016 applies to medical supply units manufactured within a factory or assembled on site, including cabinetry and other enclosures, which incorporate patient care services. NOTE 1 A party that assembles on site various components intended for patient care services into an enclosure is considered the manufacturer of the medical supply unit. Hazards inherent in the intended function of me equipment or me systems within the scope of this International Standard are not covered by specific requirements in this standard except in 7.2.13 and 8.4.1 of IEC 60601-1:2005+A1:2012 (see 201.1.4). NOTE 2 See also IEC 60601-1:2005+A1:2012, 4.2.

ISO 9170-1:2008 applies to: terminal units intended for use in medical gas pipeline systems in accordance with ISO 7396-1, for use with the following medical gases: oxygen, nitrous oxide; medical air; carbon dioxide; oxygen/nitrous oxide mixture [50 %/50 % (by volume)]; terminal units intended for use in medical gas pipeline systems in accordance with ISO 7396-1, for use with the following gases and services: oxygen-enriched air; air for driving surgical tools; nitrogen for driving surgical tools; vacuum. It is intended especially to ensure the gas-specific assembly of terminal units and to prevent their interchange between different gases and services. ISO 9170-1:2008 specifies requirements for terminal units for supply and disposal of nitrogen or air for driving surgical tools and requirements for probes intended to be connected to the gas-specific connection point which is part of the terminal unit.

ISO 7396-1:2007 specifies requirements for design, installation, function, performance, documentation, testing and commissioning of pipeline systems for compressed medical gases, gases for driving surgical tools and vacuum in healthcare facilities to ensure continuous delivery of the correct gas and the provision of vacuum from the pipeline system. It includes requirements for supply systems, pipeline distribution systems, control systems, monitoring and alarm systems and non-interchangeability between components of different gas systems. ISO 7396-1:2007 is applicable to pipeline systems for the following medical gases: oxygen, nitrous oxide, medical air, carbon dioxide, oxygen/nitrous oxide mixtures; to pipeline systems for the following gases: oxygen-enriched air, air for driving surgical tools, nitrogen for driving surgical tools; and to pipeline systems for vacuum. ISO 7396-1:2007 also applies to extensions of existing pipeline distribution systems, modifications of existing pipeline distribution systems and modifications or replacement of supply systems or sources of supply.

ISO 10083:2006 specifies requirements for the design and installation of an oxygen concentrator supply system for use with a medical gas pipeline distribution system that complies with ISO 7396-1. The standard applies only to oxygen concentrator supply systems that produce oxygen-enriched air with an oxygen concentration not less than 90 %. Oxygen concentrators for domiciliary use are excluded from the scope of the standard (they are specified in ISO 8359).

ISO 10524-1:2006 is applicable to the types of pressure regulators listed and is intended for the administration of the following medical gases in the treatment, management, diagnostic evaluation and care of patients: oxygen; nitrous oxide; air for breathing; helium; carbon dioxide; xenon; mixtures of the gases listed above; air for driving surgical tools; nitrogen for driving surgical tools. These pressure regulators are intended to be fitted to cylinders with nominal filling pressures up to 25 000 kPa at 15 °C and can be provided with devices which control and measure the flow of the medical gas delivered. The types of pressure regulators covered by ISO 10524-1:2006 are as follows: pressure regulators intended to be connected to cylinders by the operator; pressure regulators with integral flow-metering devices intended to be connected to cylinders by the operator; pressure regulators that are an integral part of medical equipment (e.g. anaesthetic workstations, lung ventilators, resuscitators).

ISO 10524-3:2005 applies to pressure regulators integrated with cylinder valves intended for the administration of medical gases in the treatment, management, diagnostic evaluation and care of patients for use with the following medical gases: oxygen; nitrous oxide; air for breathing; helium; carbon dioxide; xenon; specified mixtures of the gases listed above; air for driving surgical tools; nitrogen for driving surgical tools. These pressure regulators integrated with cylinder valves are intended to be fitted to cylinders with nominal filling pressures up to 25 000 kPa at 15 °C and can be provided with devices that control and measure the flow of the medical gas delivered.

ISO 10524-2:2005 specifies requirements for manifold pressure regulators intended to be connected to cylinders with nominal filling pressures up to 25 000 kPa at 15 °C and for line pressure regulators for inlet pressures up to 3 000 kPa and intended for use in pipeline systems for the following medical gases: oxygen; nitrous oxide; air for breathing; carbon dioxide; oxygen/nitrous oxide mixtures; air for driving surgical tools; nitrogen for driving surgical tools; oxygen produced by an oxygen concentrator. ISO 10524-2:2005 applies to manifold pressure regulators and line pressure regulators supplied as individual units or to the relevant components incorporated within an assembly. It does not apply to pressure regulators for use with vacuum pipeline systems.

ISO 21969:2005 applies to high-pressure flexible connections intended to be connected to cylinders or cylinder bundles with nominal filling pressures up to 25 000 kPa at 15 °C for use with the following medical gases: oxygen; nitrous oxide; air for breathing;helium; carbon dioxide; xenon; mixtures of these gases; air for driving surgical tools; nitrogen for driving surgical tools. ISO 21969:2005 applies to high-pressure flexible connections intended to connect cylinders or cylinder bundles to manifolds within sources of supply of medical gas pipeline systems complying with ISO 7396-1. It also applies to high-pressure flexible connections intended to connect a cylinder to an inlet port of medical equipment (e.g. anaesthetic workstation or lung ventilator) fitted with an integral pressure regulator complying with ISO 10524-1.

ISO 11197:2004 specifies requirements and test methods for medical supply units intended for use in healthcare facilities to supply electric power and/ medical gases and/or liquids and anaesthetic gas scavenging systems. It is applicable in conjunction with IEC 60601-1:1988. The requirements of ISO 11197:2004 take priority over those of IEC 60601-1:1988.

ISO 15001:2003 specifies minimum requirements for the oxygen compatibility of materials, components and devices for anaesthetic and respiratory applications which can come in contact with oxygen in normal condition or in single fault condition at gas pressures greater than 50 kPa. ISO 15001:2003 is applicable to anaesthetic and respiratory equipment which are within the scope of ISO/TC 121, e.g. medical gas pipeline systems, pressure regulators, terminal units, medical supply units, flexible connections, flow-metering devices, anaesthetic workstations and lung ventilators. Aspects of compatibility that are addressed by ISO 15001:2003 include cleanliness, resistance to ignition and the toxicity of products of combustion and/or decomposition.

ISO 7396-1 specifies requirements for design, installation, function, performance, documentation, testing and commissioning of compressed medical gas and vacuum pipeline systems in health care facilities to ensure continuous delivery of the correct gas from the pipeline system. It includes requirements for supply systems, pipeline distribution systems, control systems, monitoring and alarm systems and non-interchangeability between components of different gas systems. ISO 7396-1 is applicable to pipeline systems for the following medical gases: oxygen; oxygen-enriched air; nitrous oxide; air for breathing; carbon dioxide; oxygen/nitrous oxide mixtures; air for driving surgical tools; nitrogen for driving surgical tools; and to vacuum pipeline systems. ISO 7396-1 is also applicable to pipeline distribution systems for oxygen-enriched air connected to supply systems with oxygen concentrators complying with ISO 10083. ISO 7396-1 also applies to extensions and modifications of existing pipeline systems. ISO 7396-1 is not applicable to provision for gas-specific connectors on mobile or stationary cryogenic vessels or on transport vehicles, or on the inlet/outlet of cylinders for non-cryogenic liquid or gas. ISO 7396-1 does not apply to medical gas pipeline systems supplying hyperbaric chambers.

Contains a great number of corrections regarding the most of the existing clauses.

Applies to medical supply units as defined in 1.3.4 of ISO 11197. Other medical equipment, such as devices for nurse call systems, monitoring, etc., which can be incorporated in or mounted on medical supply units, are not covered by this International Standard. Such medical equipment may be the subject of additional Particular Standards.

Specifies requirements for high- and low-pressure regulators and high- and low-pressure regulators with flow-metering devices intended for the administration of medical gases in the treatment, diagnostic evaluation and care of patients. Does not apply to regulators that are an integral part of medical gas pipeline systems.

Specifies requirements for a concentrator system including a reserve supply, for use with medical gas pipeline systems which comply with ISO 7396, comprising a pressure swing adsorber system and its source of air supply. Includes requirements for safety, quality, purity and availability of supply. Also specifies the air source for oxygen concentrators. Annexes A and B describe recommended minimum requirements for maintenance and recommendations for installation.

Specification of minimum requirements for the installation, construction, function, documentation and testing of these systems to ensure patient safety. The requirements are included which relate to the source of supply, distribution system, terminal units, warning systems and non- interchangeability between key components and service outlets. The standard applies only for the medical gases oxygen, nitrous oxide, medical air, nitrogen, helium, carbon dioxide, specified mixtures of gases and medical vacuum. The annexes A to H contain recommendations for technological characteristics and system-related function.