CEN/TC 215/WG 3 - Medical gas supply systems

This document specifies requirements and guidelines for systems and equipment used to evacuate plume generated by medical devices.
 This document applies to all types of plume evacuation systems (PESs), including
a)       portable;
b)       mobile;
c)        stationary, including dedicated central pipelines;
d)       PESs integrated into other equipment;
e)       PESs for endoscopic procedures (e.g., minimally invasive, laparoscopic)
This document applies to all healthcare facilities where PESs are used, including, but not limited to
a)       surgical facilities;
b)       medical offices;
c)        cosmetic treatment facilities;
d)       medical teaching facilities;
e)       dental clinics;
f)         veterinary facilities.
This document provides guidance on the following aspects of PESs:
a)       importance;
b)       purchasing;
c)        design;
d)       manufacture;
e)       documentation;
f)         function;
g)       performance;
h)       installation;
i)         commissioning;
j)         testing;
k)       training;
l)         use;
m)     risk assessment;
n)       servicing;
o)       maintenance.
This document does not apply to the following:
a)       anaesthetic gas scavenging systems (AGSSs) which are covered in ISO 7396-2;
b)       medical vacuum systems which are covered in ISO 7396-1;
c)        heating, ventilation, and air-conditioning (HVAC) systems;
d)       aspects of laser safety other than airborne contamination; and
e)       aspects of electrosurgery, electrocautery, and mechanical surgical tools other than airborne contamination produced by such equipment resulting from interaction with tissue or materials.

This document specifies requirements for flow control devices that can be connected by the user either directly, by means of a probe or a gas-specific connector, or indirectly by means of a low-pressure hose assembly conforming with ISO 5359 to:
a)    a terminal unit conforming with ISO 9170-1 of a medical gas pipeline system conforming with ISO 7396-1:2016;
b)    the pressure outlet of a regulator conforming with ISO 10524-1:2018; or
c)    to the pressure outlet of a valve integrated pressure regulator (VIPR) conforming with ISO 10524-3 (see 5.2 gas inlets).
This document applies to the following types of flow control devices (FCDs):
a)    flowmeters;
b)    flowgauge FCDs; and
c)    fixed orifice FCDs.
NOTE       Flow control devices that are classed as medical electrical equipment can be subject to additional requirements of IEC 60601-1.
This document applies to flow control devices for the following gases:
—    oxygen;
—    oxygen 93 %;
—    nitrous oxide;
—    medical air;
—    carbon dioxide;
—    oxygen/nitrous oxide mixture 50/50 (% volume fraction);
—    oxygen-enriched air;
—    helium;
—    xenon; and
—    specified mixtures of the gases listed above.
NOTE Flow control devices can be available for other gases.
This document does not apply to flow control devices that are:
a)    for use with gases for driving surgical tools;
b)    an integral part of a regulator (see ISO 10524-1:2018); or
c)           an integral part of a valve with integrated pressure regulator (VIPR) (see ISO 10524-3).

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.

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.

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.

CEN/BT C082/2011:  DOW = DAV + 36 months
20180110 - TAN - Cannot be allocated for publication because of rejected consultant's assessment.
2019-01-14 - JO: BT N 11332 (BT C160/2018) for CEN TC 215 to remove link from the MDD (93/42/EEC) and Mandate M/023

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 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 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 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 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 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.

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.

This Part of CEN/TS 14507 refers to EN 60601 1:1990 "Medical electrical equipment - Part 1: General requirements for safety", as amended by its amendments 1 (1991) and 2 (1995). For brevity Part 1 is referred to in this Part of CEN/TS 14507 either as the General Standard or as the General requirements.  
The scope given in clause 1 of the General Standard applies except that 1.1 is replaced by the following:
1.1   This Part of CEN/TS 14507 specifies particular requirements for inhalational nitric oxide delivery systems and their modules. It covers devices which can be supplied in combined units, integrated into another medical device, for example a lung ventilator, or as individual devices.
This Part of CEN/TS 14507 addresses the monitoring of nitric oxide and oxygen delivery to the patient and minimization of the production of nitrogen dioxide.
This Part of CEN/TS 14507 covers the requirements for inhalational nitric oxide delivery systems intended for medical use, for example, in critical care, anaesthesia, and emergency/transport environments.
NOTE   It is recognized that from time to time innovations and designs will appear that offer advantages and yet are not covered by specific safety-related design or performance aspects of this Part of CEN/TS 14507; such innovations are not to be discouraged. As the techniques and technologies in these innovations advance, it is essential that the safety objectives of this Part of CEN/TS 14507 are considered as minimum requirements.
The requirements of clause 1.3 of the General Standard apply with the following additions:
The numbering of clauses and subclauses of this Part of CEN/TS 14507 corresponds to that of the General Standard. The changes to the text of the General Standard are specified by the use of the following words:
´Replacement´ means that the clause or subclause of the General Standard is replaced completely by the text of this Part of CEN/TS 14507.
(...)

Specifies safety and performance requirements for mobile equipment used to supply nitric oxide/nitrogen mixtures to patients, with particular reference to continuity of therapy.

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 common requirements for transportable liquid oxygen systems and specific requirements for base units. Base units are used as a store for liquid oxygen for recharging portable units. They may also, if fitted with a flow outlet and flow selector, be used as a source for the supply of oxygen direct to the patient.

This document specifies requirements for portable units which are part of a transportable liquid oxygen system. These are used as a supply source for oxygen therapy in home-care and in health-care facilities.
Portable units are intended to be carried by patients whilst moving around and during their off-site activities and can be refilled from a base unit through a transfilling connector. Portable units are used without professional supervision.

This standard applies to proportioning units intended to produce synthetic medical air and air for driving surgical tools by mixing in defined proportions oxygen and nitrogen.
This standard applies to proportioning units intended to be components of a medical gas supply system for medical air which supplies a medical gas pipeline distribution system complying with ISO 7396-1.
The number of proportioning units within the medical air supply system and their combination with other sources of supply (e.g. cylinder manifolds) to ensure that the supply system consists of at least three sources of supply is outside the scope of this standard. Requirements for the supply systems for medical air are given in ISO 7396-1.

2007 04 05 Initially revised WI 00215011.
See WI 00215129

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.

2019-10-07: CEN/BT 169/2019: remove link to MDD + MDR & publish without delay
2019-10-09 - JO- BT decision - BT N 11739 - remove link to MDD
CEN/BT C082/2011:  DOW = DAV + 36 months

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.

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.

1.1 This part of this European standard specifies the dimensions and allocation of probes intended to be connected to terminal units of medical gas pipeline systems specified in EN 737-3 for use with the following medical gases: oxygen; nitrous oxide; air for breathing; carbon dioxide; oxygen/nitrous oxide mixture (50/50 % V/V ); nitric oxide/nitrogen mixture (NO 500 ul/l); air for driving surgical tools; nitrogen for driving surgical tools; vacuum.

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 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 5359:2008 specifies requirements for low-pressure hose assemblies intended for use with the following medical gases:
oxygen;
nitrous oxide;
medical air;
helium;
carbon dioxide;
xenon;
specified mixtures of the gases listed above;
oxygen-enriched air;
air for driving surgical tools;
nitrogen for driving surgical tools;
vacuum.
It is intended in particular to ensure gas-specificity and to prevent cross-connection between systems conveying different gases. These hoses assemblies are intended for use at maximum operating pressures less than 1 400 kPa.
ISO 5359:2008 specifies the allocation of non-interchangeable screw-threaded (NIST) connectors, diameter-index safety system (DISS) connectors and sleeve indexed system (SIS) connectors to medical gases and specifies the dimensions of non-interchangeable screw-threaded (NIST) connectors.

1.1   This European Standard specifies requirements for connectors intended for use with medical gases.
1.2   This European Standard specifies the dimensions and the allocation of non-interchangeable screw-threaded (NIST) connectors intended to be used at nominal operating pressures not greater than 1 400 kPa.
NOTE   As stated in EN ISO 5359, gas-specific quick-connectors conforming to EN ISO 9170-1 are considered as an alternative to NIST connectors.
1.3   The information to be supplied by the manufacturer is excluded from the scope of this European Standard because information about the use of NIST connectors is supplied by the manufacturer of each medical device to which the connectors are permanently fitted.

This European Standard specifies minimum requirements for the oxygen compatibility of materials which can come in contact with oxygen at pressures greater than 50 kPa in medical devices. Aspects of compatibility that are addressed include: cleanliness, resistance to ignition and the toxicity of products of combustion and/or decomposition. NOTE: It is expected that particular device standards will make reference to this horizontal standard but may, if appropriate, strengthen these minimum requirements.

1.1  This European Standard applies to:  - Flow-metering devices which are connected and disconnected by the operator at terminal units of a medical gas pipeline system for measurement and delivery of medical gases. They can be connected either directly or by means of flexible connecting assemblies. - Flow-metering devices which are connected and disconnected by the operator at gas-specific connection points of devices such as pressure regulators.  1.2  It applies only to flow-metering devices for the following medical gases:  - oxygen - nitrous oxide - air for breathing - carbon dioxide - helium - xenon - specified mixtures of the gases listed above - oxygen/nitrous oxide mixture (50/50 % V/V).   1.3  Electrical or electronic flow-metering devices are excluded from the scope of this standard.

1.1 This Part of this European Standard specifies requirements for terminal units intended for use in medical gas pipeline systems specified in prEN 737-3 for use with the following medical gases:   - oxygen;   - nitrous oxide;   - air for breathing;   - carbon dioxide;   - oxygen/nitrous oxide mixture (50/50 % (V/V))   - 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.  1.2 This Part of this European Standard also specifies requirements for:   - terminal units for the supply and disposal of air for driving surgical tools;   - probes intended to be connected to the gas-specific connection point which is part of a terminal unit;  1.3 This Part of this European Standard does not specify:   - the dimensions of probes and of the gas-specific connection points of the terminal unit (see prEN 737-6);   - the dimensions of NIST connectors (see EN 739);   - requirements for terminal units for anaesthetic gas scavenging systems (see   EN 737-4)

This Part of this European Standard specifies requirements and dimensions for terminal units intended for use in anaesthetic gas scavenging systems specified in prEN 737-2 for the scavenging of medical gases and anaesthetic vapours.  It is intended especially to ensure the type-specific assembly of terminal units and to prevent their interchange between different services.  This Part of this European Standard also specifies requirements and dimensions for the mating counterpart (probe) of the type-specific connection point which is part of the terminal unit.  This Part of this European Standard does not specify the ranges of nominal operating pressures for terminal units (see prEN 737-2).  This Part of this European Standard specifies two types of terminal units which are non-interchangeable, for use where the power device is upstream or downstream of the terminal unit. Figure 1 shows the use of the two types of terminal units.

To amend EN 739 so as to include requirements for use with nitric oxide/nitrogen mixtures

1.1 This European Standard specifies requirements for low-pressure hose assemblies intended 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;   - vacuum.  It is intended especially to ensure gas-specificity and to prevent cross-connection between different gases.  These hose assemblies are intended to be used in the pressure range between 300 kPa and 1400 kPa for compressed medical gases and between 10 kPa and 100 kPa absolute pressure for vacuum.   1.2 This European Standard does not specify the intended uses of hose assemblies. Some examples of the intended uses specified in other standards are as follows:  a)  between a terminal unit and medical equipment (see EN 737-1, prEN 740, EN 794-1);  b)  between the fixed pipeline system and a terminal unit of that system (see    prEN 737-3, EN 793);  c)  between a terminal unit and  a second terminal unit (see prEN 737-3);  d)  between an emergency supply and an emergency and maintenance inlet point of a pipeline system (see EN 738-1, prEN 737-3);  e)  between an emergency supply and medical equipment (see EN 738-1, prEN 740,  EN 794- 1).  1.3 This European Standard specifies the dimensions of non-interchangeable screw-threaded (NIST) connectors.  1.4 This European Standard does not specify:   - dimensions of probes and of the mating parts of the socket (see prEN 737-6);   - requirements for hose assemblies for anaesthetic gas scavenging systems;   - requirements for coaxial hoses used for the supply and disposal of air for driving surgical tools;   - requirements for electrical conductivity.

To amend EN 738-4 so as to include requirements for use with nitric oxide/ nitrogen mixtures

1.1 This European Standard applies to low-pressure regulators suitable for inlet pressures between 280 kPa and 600 kPa, supplied and packaged as for use in medical equipment 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.  1.2 This European Standard does not apply to pressure regulators supplied as spare parts for a specific application.  1.3 This European Standard does not apply to pressure regulators for use with  suction services (see EN ISO 10079-3).

This European Standard specifies basic requirements for installation, function, performance, documentation, testing and commissioning of compressed medical gases and vacuum pipeline systems to ensure patient safety by continuous delivery of the correct gas from the pipeline system. It includes basic requirements for the sources of supply, distribution system, control, monitoring and alarm systems and for non-interchangeability between components of different gas systems.

To amend EN 737-2 to correct a small number of minor errors and to reflect current testing practice.

To amend 737-3 so as to remove requirements for medical air that conflict with recent EP monograph.

This Part of this European Standard specifies basic requirements for the installation, function, performance, documentation, testing and commissioning of anaesthetic gas scavenging (AGS) disposal systems to ensure patient and operator safety by the safe removal of excess anaesthetic gases and vapours from the clinical environment. It includes basic requirements for the power device, pipeline system, performance and for non-interchangeability between key components.  This Part of this European standard specifies:   a) the compatibility and safe performance between the disposal system and the other components of the AGSS by design, installation and commissioning;   b) the use of appropriate materials;   c) the testing of correct installation to ensure achievement of the performance intended by the manufacturer;   d) the marking of pipeline and components.  This Part of this European Standard addresses only those disposal systems which are intended to be connected via AGSS terminal units which comply with EN 737-4 to a receiving system which complies with prEN 740.

1.1 This European Standard applies to high-pressure flexible connections intended to be connected to cylinders or cylinder bundles with a working pressure up to23,000 kPa for use with the following medical gases: - oxygen; - nitrous oxide; - air; - helium; - carbon dioxide; - xenon; - nitrogen; - specified mixtures of the gases listed above; 1.2 This European Standard 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 EN 737-3.

This European Standard specifies basic requirements which ensure compatibility between rail systems complying with this Standard and medical equipment in order to permit the interchangeability of medical equipment from one rail system to another.  Medical equipment can be attached to a rail by rail clamps directly or via other components of dimensions which are specified in this Standard. Rail clamps are required to be compatible with rails which are within a range of dimensions specified in this Standard. The specifications for rail systems include dimensions, strength and information to be supplied by the manufacturer. Some medical equipment can be attached to the rail by means which are outside the scope of this Standard.  This Standard only applies to rail systems intended to be mounted horizontally. It specifies neither the structures nor the types of medical equipment that are to be supported. It does not apply to overhead rail systems for supporting curtains and infusion devices.  NOTE: It is expected that particular Standards will be prepared to cover applications for which the rail system specified in this European Standard is unsuitable, and particular device standards will specify whether or not the rail system specified in this Standard is to be fitted to the device.

To amend EN 737-3 so as to include requirements for use with nitric oxide/ nitrogen mixtures

1.1 This European Standard applies to manifold pressure regulators and line pressure regulators intended for the supply of pipeline systems for the following medical gases:  - oxygen; - nitrous oxide; - air for breathing;  - carbon dioxide; - oxygen/nitrous oxide mixture (50/50% (v/v)); - air for driving surgical tools; - nitrogen for driving surgical tools.   1.2  This European Standard does not apply to pressure regulators for use with suction services (see EN ISO 10079-3).

This European Standard 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.  The pressure regulators are intended to be fitted to high pressure cylinders with filling pressure up to 20 000 kPa, and can be provided with devices which control and measure the flow of the medical gas delivered to the patient.