ISO/TC 121/SC 1 - Breathing attachments and anaesthetic machines

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.

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.

ISO 80601-2-55:2018 specifies particular requirements for the basic safety and essential performance of a respiratory gas monitor (rgm), hereafter referred to as me equipment, intended for continuous operation for use with a patient. ISO 80601-2-55:2018 specifies requirements for - anaesthetic gas monitoring, - carbon dioxide monitoring, and - oxygen monitoring. NOTE 1 An rgm can be either stand-alone me equipment or integrated into other equipment, e.g. an anaesthetic workstation or a ventilator. ISO 80601-2-55:2018 is not applicable to an rgm intended for use with flammable anaesthetic agents. If a clause or subclause is specifically intended to be applicable to me equipment only or to me systems 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 me equipment and to me systems, as relevant. Hazards inherent in the intended physiological function of me equipment or me systems within the scope of this document are not covered by specific requirements in this document except in IEC 60601‑1:2005+Amd 1:2012, 7.2.13 and 8.4.1. NOTE 2 Additional information can be found in IEC 60601‑1:2005+Amd 1:2012, 4.2.

ISO 11195:2018 specifies requirements for the performance and safety of stand-alone gas mixers intended for mixing oxygen with another gas for medical use. ISO 11195:2018 does not apply to: a) blocks of flowmeters with separate controls for the flow of each gas; b) stand-alone gas mixers which mix oxygen with ambient air; c) stand-alone gas mixers with more than two different gas inlets; d) stand-alone gas mixers connected to an oxygen concentrator.

ISO 5360:2016 specifies requirements, including dimensions, for agent-specific filling systems for agent-specific anaesthetic vaporizers. ISO 5360:2016 does not specify construction materials. NOTE 1 For recommendations on materials, see Annex A. Because of the unique properties of desflurane, dimensions for this agent have not been specified in this International Standard. NOTE 2 Designs of connection systems, which only permit engagement of the agent-specific bottle adaptor to the bottle when the bottle collar is in place, are encouraged.

ISO 18835:2015 specifies basic safety and essential performance requirements for anaesthetic systems utilizing the draw-over method to provide inhalational anaesthesia. Requirements are included to allow the use of these systems with both non-flammable and flammable anaesthetic agents. ISO 18835:2015 also includes requirements for a bellows-type manual ventilator. NOTE 1 Requirements for automatic anaesthetic ventilators are covered by ISO 80601‑2-13. NOTE 2 Requirements for operator-powered self-inflating bags are covered by ISO 10651‑4. ISO 18835:2015 does not specify requirements for monitoring of the equipment or the patient.

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 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 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.

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 8835-7:2011 specifies safety and performance requirements for anaesthetic systems and components that: · can function in the absence of a supply of compressed medical gases or mains electricity; · can withstand a challenging environment, including high temperatures, humidity, shocks and vibration, and dust; · allow local servicing and maintenance; · may be suitable for use with flammable anaesthetic agents.

ISO 5360:2012 specifies requirements, including dimensions, for agent-specific filling systems for agent-specific anaesthetic vaporizers. ISO 5360:2012 does not specify construction materials. Because of the unique properties of desflurane, dimensions for this agent have not been specified in ISO 5360:2012.

ISO 80601-2-55:2011 specifies particular requirements for the basic safety and essential performance of a respiratory gas monitor (RGM) intended for continuous operation for use with a patient. ISO 80601-2-55:2011 specifies requirements for: anaesthetic gas monitoring, carbon dioxide monitoring, and oxygen monitoring. ISO 80601-2-55:2011 is not applicable to an RGM intended for use with flammable anaesthetic agents.

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 26825:2008 gives requirements for labels which the user attaches 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. ISO 26825:2008 does not give requirements for labels applied to a syringe or cartridge by the drug manufacturer.

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.

ISO 8835-2:2007 specifies requirements for anaesthetic breathing systems that are supplied either assembled by the manufacturer or for assembly by the user in accordance with the manufacturer's instructions. ISO 8835-2:2007 also covers circle absorber assemblies, exhaust valves, inspiratory and expiratory valves and, in some designs, those parts of an anaesthetic breathing system that are incorporated within an inhalation anaesthetic system, including the expiratory gas pathway of an anaesthetic ventilator.

ISO 8835-3:2007 specifies requirements for transfer and receiving systems of active anaesthetic gas scavenging systems (active AGSSs) intended to reduce exposure of healthcare personnel to anaesthetic gases and vapours while providing patient protection (e.g. against excessive flow and pressure). ISO 8835-3:2007 also specifies requirements for transfer and receiving systems of active anaesthetic gas scavenging systems in which the power device is integral with the transfer and receiving system.

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.

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 21647:2004 specifies particular requirements for the basic safety and essential performance of respiratory gas monitors (RGM) (as defined in 3.15) intended for continuous operation for use with humans. It supplements the requirements of IEC 60601-1:1988. ISO 21647:2004 specifies requirements for anaesthetic gas monitoring, carbon dioxide monitoring and oxygen monitoring. ISO 21647:2004 is not applicable to monitors intended for use with flammable anaesthetic agents. The requirements of ISO 21647:2004 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. Environmental aspects are addressed in Annex CC. Additional aspects of environmental impact are addressed in ISO 14971.

ISO/TS 18835:2004 specifies safety and performance requirements for draw-over vaporizers and associated equipment to provide draw-over anaesthetic systems for patients weighing greater than 15 kg using both non-flammable and, in places where regulations permit their use, flammable anaesthetic agents. No requirements for monitoring the equipment are given in ISO/TS 18835:2004.

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 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.

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.

Replaces the existing table 2 by a new table 2 which contains some corrections.

Specifies requirements for transfer and receiving systems of active anaesthetic gas scavenging systems (AGSS) intended to reduce the exposure of hospital personnel to anaesthetic gases and vapours.

Specifies dimensional and gauging requirements for cones and sockets intended for connecting anaesthetic and respiratory equipment. Does not apply to medical equipment in general and accessories.

Gives requirements for the performance and safety of stand-alone gas mixers intended for medical use and for connection to a medical gas supply system.

Based on requirements of IEC 601-1. Specifies requirements for anaesthetic gas monitors used for the determination of the anaesthetic vapour and/or gas levels in breathing gas mixtures and/or fresh gas mixtures. Contains additional requirements specific to anaesthetic gas monitors and gives examples of anaesthetic gases.

Specifies the dimensions of details (bottle, bottle collar, bottle adaptor, filler receptacle), but does not specify construction materials. Annex A describes determination of total leakage into atmosphere of anaesthetic agent during filling, annex B types of agent-specific filling systems. Because of the unique properties of desflurane, dimensions for this agent have not been specified.

Specifies requirements for the safety of capnometers and refers to and is applicable in conjunction with IEC 601-1 (Safety of medical electrical equipment, General safety requirements). Applies to capnometers used with adults, children and neonates. Does not apply to devices intended for use as transcutaneous monitors or intended for use in laboratory research applications.