CEN/TC 215/WG 1 - Anaesthetic machines, medical breathing systems and anaesthetic gas scavenging systems

This document gives requirements for labels attached to syringes so that the contents can be identified just before use during anaesthesia. It covers the colour, size, design and general properties of the label and the typographical characteristics of the wording for the drug name.
NOTE    National or regional regulations might require additional labelling, which can include bar coding. No requirements for this additional labelling are given.

This document is applicable to the basic safety and essential performance of an anaesthetic workstation for administering inhalational anaesthesia whilst continuously attended by a professional operator.
This document specifies particular requirements for a complete anaesthetic workstation and the following anaesthetic workstation components which, although considered as individual devices in their own right, may be utilized, in conjunction with other relevant anaesthetic workstation components, to form an anaesthetic workstation to a given specification:
anaesthetic gas delivery system;
anaesthetic breathing system;
anaesthetic gas scavenging system (AGSS);
anaesthetic vapour delivery system;
anaesthetic ventilator;
monitoring equipment;
alarm system;
protection device.
NOTE 1        Monitoring equipment, alarm systems and protection devices are summarized in Table AA.1.
An anaesthetic workstation supplied complete and its individual components are considered as ME equipment or ME systems with regard to the general standard.
NOTE 2        The applicability of this document is indicated in Table AA.2.
This document is also applicable to those accessories intended by their manufacturer to be connected to an anaesthetic workstation where the characteristics of those accessories can affect the basic safety and essential performance of the anaesthetic workstation.
If a clause or subclause is specifically intended to be applicable to anaesthetic workstation components or its accessories only, the title and content of that clause or subclause will say so. If that is not the case, the clause or subclause applies both to an anaesthetic workstation and its individual components including accessories, as relevant.
Hazards inherent in the intended physiological function of an anaesthetic workstation and its individual components including accessories within the scope of this document are not covered by specific requirements in this document except in IEC 60601-1:2005+AMD1:2012+AMD2:2020, 7.2.13 and 8.4.1.
NOTE 3        See also IEC 60601-1:2005+AMD1:2012+AMD2:2020, 4.2.
This document is not applicable to any anaesthetic workstation intended for use with flammable anaesthetic agents, as determined by Annex BB.

2017-08-31 - BTC 110/2017 - BT approve publication of EN ISO with modified Annex ZA & Foreword
2017-08-08 - Cannot allocate for publication due to negative assessment from Consultant.
CEN/BT C082/2011:  DOW = DAV + 36 months

This part of ISO 5356 specifies dimensional requirements for screw-threaded weight-bearing conical connectors intended for use with inhalation anaesthesia apparatus and ventilators. Such connectors are intended for mounting heavy accessories. This part of ISO 5356 specifies requirements for the following screw-threaded, weight-bearing conical connectors: - 22 mm connectors; - 22 mm/15 mm coaxial connectors. Requirements for the application of screw-threaded, weight-bearing conical connectors are not included in this part of ISO 5356, but are or will be given in the relevant International Standards for specific medical devices and accessories.

ISO 5359:2014 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, and for use with vacuum. It applies to hose assemblies operating at pressures up to 1 400 kPa and for vacuum systems at pressures not greater than 60 kPa absolute. It does not specify the dimensions and allocation of the gas-specific inlet and outlet connectors for the hose assemblies.It does not specify requirements for coaxial hoses used for the supply and removal of air for driving surgical tools.Nor does it specify the intended uses of hose assemblies.

ISO 5356-2:2012 specifies dimensional requirements for screw-threaded weight-bearing conical connectors intended for use with inhalation anaesthesia apparatus and ventilators. Such connectors are intended for mounting heavy accessories.
ISO 5356-2:2012 specifies requirements for the following screw-threaded, weight-bearing conical connectors:
22 mm connectors;
22/15 mm coaxial connectors.

ISO 5356-1:2015 specifies dimensional and gauging requirements for cones and sockets intended for connecting anaesthetic and respiratory equipment, e.g. in breathing systems, anaesthetic gas scavenging systems, and vaporizers. The cones and sockets are therefore not regarded as devices in their own right.
It gives requirements for the following cones and sockets: 8,5 mm and 11,5 mm sizes intended for use in neonatal and paediatric breathing systems; 15 mm and 22 mm sizes intended for general use in breathing systems; 22 mm latching sockets (including performance requirements); 23 mm size intended for use with vaporizers, but not for use in breathing systems; 30 mm size intended for the connection of a breathing system to an anaesthetic gas scavenging system.
It does not specify the medical devices and accessories on which these cones and sockets are to be provided.
Requirements for the application of cones and sockets are not included, but are or will be given in the relevant International Standards for specific medical devices and accessories. Requirements for screw-threaded weight-bearing connectors are specified in ISO 5356 2.

ISO 18082:2014 specifies the dimensions, the allocation and marking of non-interchangeable screw-threaded (NIST) connectors intended to be used at operating pressures up to 1 400 kPa, and for vacuum systems at pressures not greater than 60 kPa absolute.
ISO 18082:2014 specifies NIST connectors 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;
use with vacuum.

This European Standard specifies requirements for construction, dimensions and marking of connectors used in gas sampling to transfer gas from the breathing system of anaesthetic and respiratory equipment to diverting gas monitors and back to the breathing system and/or to the anaesthetic gas scavenging system (AGSS).
This European Standard gives requirements for the following ports and connectors:
-   gas sampling port on breathing system;
-   gas return port on breathing system and AGSS;
-   gas sampling and return ports on diverting gas monitors;
-   gas sampling tube inlet and outlet connectors;
-   gas return tube inlet and outlet connectors.
This European Standard does not apply to connection ports intended for connection of sensors in the breathing system.
According to EN 1707, Luer lock fittings are intended to be used for syringes, needles and certain other medical equipment. In order to minimize the risk of misconnection, this standard specifies the arrangements of male and female fittings and the marking requirements to identify the different connectors, ports and tubes. Tables 1 to 4 specify the type of Luer fitting that is used in actual applications.
NOTE 1   Manufacturers are encouraged to use the ports specified in this standard on diverting gas monitors, breathing systems and AGS systems even if these are currently not required by the specific device standards. It is expected that requirements for the application of this standard will be included in these particular standards during forthcoming revisions. Attention is drawn to EN ISO 21647 concerning respiratory gas monitors and the work of CEN/BT/TF 123 Small-bore connectors. Attention is drawn to the work of CEN BT TF 123 to develop new connectors for use in respiratory applications. Those connectors, when validated and published, will be considered in a future revision of this standard to replace those specified in Clause 5. Further attention is drawn to the need of proper risk management according

EN ISO 80601-2-13 was published in 2011. Amendment 1 to EN ISO 80601-2-13:2011 will update this standard with regard to references to IEC 60601-1:2005 (EN 60601-1:2006) and applicable collateral standards. The Amendment 1 also introduces technical modifications to clarify the relationship between this standard and IEC 60601-2-49 and to further specify accessories. It amends requirements on the following aspects, in part due to the publication of amendments that have been published in 2012 and 2013 respectively to IEC 60601-1:2005 and its collateral standards:
— addition of a definition on interchangeable anaesthetic vapour delivery system;
— marking the mass of mobile me equipment;
— movement over a threshold;
— rough handling test;
— multiple socket-outlets;
— specific requirements on anaesthetic gas delivery systems and anaesthetic breathing systems including instructions for use;
— vapour concentration during and after oxygen flush;
— inspiratory pause.
Where appropriate, amendment 1 also includes modifications of specific informative annexes related to the amended requirements as listed above. Finally, minor editorial updates were made.

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
20180720 - TAN - Consultant assessment rejected
CEN/BT C082/2011:  DOW = DAV + 36 months

ISO/IEC 80601-2-13:2011 is applicable to the basic safety and essential performance of an anaesthetic workstation for administering inhalational anaesthesia whilst continuously attended by a professional operator.
ISO/IEC 80601-2-13:2011 specifies particular requirements for a complete anaesthetic workstation and the following anaesthetic workstation components which, although considered as individual devices in their own right, may be utilized, in conjunction with other relevant anaesthetic workstation components, to form an anaesthetic workstation to a given specification:
       anaesthetic gas delivery system;
       anaesthetic breathing system;
       anaesthetic gas scavenging system;
       anaesthetic vapour delivery system;
       anaesthetic ventilator;
       monitoring equipment;
       alarm system;
       protection device.
ISO/IEC 80601-2-13:2011 is also applicable to those accessories intended by their manufacturer to be connected to an anaesthetic workstation where the characteristics of those accessories can affect the basic safety and essential performance of the anaesthetic workstation.
If a clause or subclause is specifically intended to be applicable to anaesthetic workstation components only, the title and content of that clause or subclause will say so. If that is not the case, the clause or subclause applies both to an anaesthetic workstation and its individual components, as relevant.
Hazards inherent in the intended physiological function of an anaesthetic workstation and its individual components within the scope of ISO/IEC 80601-2-13:2011 are not covered by specific requirements in ISO/IEC 80601-2-13:2011 except in 7.2.13 and 8.4.1 of IEC 60601-1:2005.
ISO/IEC 80601-2-13:2011 is not applicable to any anaesthetic workstation intended for use with flammable anaesthetic agents, as determined by Annex BB.

ISO 5356-1:2004 specifies dimensional and gauging requirements for cones and sockets intended for connecting anaesthetic and respiratory equipment, e.g. in breathing systems, anaesthetic-gas scavenging systems and vaporizers.
ISO 5356-1:2004 gives requirements for the following conical connectors:
8,5 mm sizes intended for use in paediatric breathing systems;
15 mm and 22 mm sizes intended for general use in breathing systems;
22 mm latching connectors (including performance requirements);
23 mm size intended for use with vaporizers, but not for use in breathing systems;
30 mm size intended for the connection of a breathing system to an anaesthetic gas scavenging system.
ISO 5356-1:2004 does not specify the medical devices and accessories on which these connections are to be provided.
Requirements for the application of conical connectors are not included in ISO 5356-1:2004, but are or will be given in the relevant International Standards for specific medical devices and accessories.
NOTE Requirements for screw-threaded weight-bearing conical connectors are specified in ISO 5356-2.

For the purposes of ISO 8835-4:2004, the requirements in IEC 60601-1:1988, Clause 1 apply except as follows.
Addition:
ISO 8835-4:2004 specifies particular requirements for the essential performance of anaesthetic vapour delivery devices (AVDDs), as defined in 3.1. ISO 8835-4:2004 is applicable to AVDDs which are a component of an anaesthetic system and are intended to be continuously operator-attended. ISO 8835-4:2004 gives specific requirements for AVDDs which are supplementary to the applicable general requirements in IEC 60601-2-13.
ISO 8835-4:2004 is not applicable to AVDDs intended for use with flammable anaesthetics, as determined by Annex CC, and AVDDs intended for use within anaesthetic breathing systems (e.g. draw-over vaporizers).
The requirements of ISO 8835-4:2004 which replace or modify the requirements of IEC 60601-1:1988 and its Amendments 1 (1991) and 2 (1995) are intended to take precedence over the corresponding general requirements.

ISO 8835-5:2004 specifies particular requirements for the essential performance of anaesthetic ventilators (as defined in 3.1). ISO 8835-5:2004 is applicable to anaesthetic ventilators which are always a component of an anaesthetic system and are intended to be continuously attended by an operator.
ISO 8835-5:2004 is not applicable to anaesthetic ventilators intended for use with flammable anaesthetics, as determined by Annex BB.
The requirements of ISO 8835-5:2004 which replace or modify the requirements of IEC 60601-1:1988 and its Amendments 1 (1991) and 2 (1995) are intended to take precedence over the corresponding general requirements.
This Scope is additional to the Scope given in IEC 60601-1:1988, Clause 1, except as noted above.

ISO 5356-2:2006 specifies requirements for screw-threaded weight-bearing conical connectors intended for use with inhalation anaesthesia apparatus and ventilators; such connectors are intended for mounting heavy accessories.

ISO 5360:2006 specifies the dimensions of agent-specific filling systems for agent-specific anaesthetic vaporizers.
This International Standard does not specify construction materials.
Because of the unique properties of desflurane, dimensions for this agent have not been specified in ISO 5360:2006.

This European Standard specifies requirements for construction, dimensions and marking for the connectors in gas sampling tubes which transfer gas from the breathing system of anaesthetic and respiratory equipment to diverting gas monitors and back to the breathing system and/or to the anaesthetic gas scavenging system (AGSS).

2007-02-09 Sent for assessment to consultant RV
2006-08-03 ON HOLD: Pending ISO publication.
2006-02-06 ON HOLD:  The cancellation date for this CEN project is 9 February 2006, the CEN UAP would normally not be submitted to CMC until the subject ISO publication became available (see below) but in this case, immediate submission is necessary to prevent cancellation. The Secretariat of ISO/TC121/SC1 has proposed to ISO/CS that, instead of publishing the amendment to ISO 5360: 1993 (which is already the subject of Technical Corrigendum 1: 1998), ISO should publish a reprinted version that includes the texts of the corrigendum and the amendment. Until this decision has been finalized, the wording in the attached CEN endorsement notice allows for either possibility, but the CEN Annex ZA will need to be tailored to whichever publication results and therefore table ZA1 is not present yet. It is assumed the launch of the UAP will be deferred until the ISO publication is available, by which t

TC - Modification to title, foreword and addition of Table ZA.1

WIs 107-110 are the result of the splitting of WI 092 - Revision, in parts of EN 740:1998 (CC/000724)
Extension of the DOW for WI 00215108 to DAV + 66 months - Res 440/2002 (NT/030117)
PARTIALLY supersedes EN 740:1998

TC - Modification to title, foreword and addition of Table ZA.1

WIs 107-110 are the result of the splitting of WI 092 - Revision, in parts of EN 740:1998 (CC/000724)
Extension of the DOW for WI 00215109 to DAV + 66 months - Res 440/2002 (NT/030117)
PARTIALLY supersedes EN 740:1998

This Part of EN 1280 specifies requirements for agent-specific filling systems used with agent-specific anaesthetic vaporizers for anaesthetic agents excluding desflurane.  NOTE 1: When used according to the instructions for use, the side effects or undesirable conditions of agent-specific filling systems constitute an acceptable risk when weighed against the performance.  NOTE 2: Specifications for agent-specific filling systems for desflurane will be given in another part of EN 1280.

To amend EN 740 so as to include requirements for use with nitric oxide/ nitrogen mixtures

Clause 1 of EN 60601-1: 1990 applies with the following amendment: This European Standard provides particular requirements for modules which, although considered as individual devices in their own right, may be utilized, in conjunction with other relevant devices, to form an anaesthetic workstation to a given specification. It is the intent of this European Standard that both anaesthetic workstations supplied complete and individual modules be commercially available to users to allow the configuration of an anaesthetic workstation to meet the needs of their clinical practice.

This part of EN 1282 specifies requirements for tracheostomy tubes made of plastics materials/and or rubber having inside diameter of 6,5 mm or greater. Such tubes are primarily designed for patients who require anaesthesia, artificial ventilation or other respiratory support, but need not be restricted to these uses. This standard does not apply to specialized tubes.

Migrated from Progress Sheet (TC Comment) (2000-07-10): WARNING : selected for the experiment in one language (type 'C') cf fax  cf cf f ++ Careful !! DOW for all WIs is 1998-06-13 (BT 21/1997) ++ Special national cond. for prEN 737-1, -6, prEN 738-1 to -4, prEN 739, prEN ++ 740, prEN 793, prEN 794-1 to -3 (Res. BT 21/1997) and in BT N 4457.

NOTE1: See the rationale in annex N.  ISO 11196 is one of a series of International Standards based on IEC 601-1; in IEC 601-1 (the "General Standard"), this type of International Standard is referred to as a "Particular Standard". As stated in 1.3 of IEC 601-1:1988, the requirements of this International Standard take precedence over those of IEC 601-1.  The scope and object given in clause 1 of IEC 601-1:1998 apply except that 1.1 shall be replaced by the following:  This International Standard specifies requirements for anaesthetic gas monitors intended for use in determining the anaesthetic vapour and/or gas level(s) in breathing gas mixtures and/or fresh gas mixtures. Both diverting and non-diverting anaesthetic gas  monitors are covered, irrespective of the measuring technology used. Also included are anaesthetic gas identifying monitors. The field of application includes monitoring patient breathing mixtures, the output of anaesthesia workstations, and the output of vaporizers as well as anaesthesia ventilators and breathing systems.  Anaesthetic gas monitors intended for use in laboratory research, non-human applications or for calibration of anaesthetic agent vaporizers are outside the scope of this International Standard.  Anaesthetic gases addressed in this International Standard include, but are not limited to, halothane, enflurane, isoflurane, sevoflurane, desflurane and nitrous oxide.

This Part of this European Standard specifies dimensional and gauging requirements for cones and sockets and performance requirements for latching connectors intended for use in medical devices, e.g. in breathing systems, anaesthetic gas scavenging systems and vaporizers.  This European Standard does not specify the medical devices and accessories on which these connectors are to be provided.   NOTE 1: It is expected that requirements on the use of suitable materials and for the application of this standard will be included in particular standards for specific medical devices and accessories.   NOTE 2: Requirements for screw-threaded weight-bearing conical connectors are specified in Part 2 of this standard.