Yhteinen Toimialaliitto

ISO 18562-3:2017 specifies tests for the emissions of volatile organic compounds (vocs) from the gas pathways of a medical device, its parts or accessories, which are intended to provide respiratory care or supply substances via the respiratory tract to a patient in all environments. The tests of this document are intended to quantify emissions of vocs that are added to the respirable gas stream by the materials of the gas pathway. This document establishes acceptance criteria for these tests.ISO 18562-3:2017 addresses potential contamination of the gas stream arising from the gas pathways, which is then conducted to the patient.ISO 18562-3:2017 applies over the expected service life of the medical device in normal use and takes into account the effects of any intended processing or reprocessing.ISO 18562-3:2017 does not address biological evaluation of the surfaces of gas pathways that are in direct contact with the patient. The requirements for direct contact surfaces are found in the ISO 10993 series[1].Medical devices, parts or accessories containing gas pathways that are addressed by this document include, but are not limited to, ventilators, anaesthesia workstations (including gas mixers), breathing systems, oxygen conserving devices, oxygen concentrators, nebulizers, low-pressure hose assemblies, humidifiers, heat and moisture exchangers, respiratory gas monitors, respiration monitors, masks, mouth pieces, resuscitators, breathing tubes, breathing systems filters, Y-pieces and any breathing accessories intended to be used with such devices. The enclosed chamber of an incubator, including the mattress, and the inner surface of an oxygen hood are considered to be gas pathways and are also addressed by this document.ISO 18562-3:2017 does not address contamination already present in the gas supplied from the gas sources while medical devices are in normal use.EXAMPLE Contamination arriving at the medical device from gas sources such as medical gas pipeline systems (including the non-return valves in the pipeline outlets), outlets of pressure regulators connected or integral to a medical gas cylinder or room air taken into the medical device is not addressed by ISO 18562 series.ISO 18562-3:2017 is intended to be read in conjunction with ISO 18562-1.NOTE This document has been prepared to address the relevant essential principles of safety and performance as indicated in Annex B.

ISO 18562-4:2017 specifies tests for substances leached by liquid water condensing into gas pathways of a medical device, its parts or accessories, which are intended to provide respiratory care or supply substances via the respiratory tract to a patient in all environments. The tests of this document are intended to quantify hazardous water-soluble substances that are leached from the medical device, its parts or accessories by condensate and then conveyed by that liquid to the patient. This document establishes acceptance criteria for these tests.ISO 18562-4:2017 addresses potential contamination of the gas stream arising from the gas pathways, which is then conducted to the patient.ISO 18562-4:2017 applies over the expected service life of the medical device in normal use and takes into account the effects of any intended processing or reprocessingISO 18562-4:2017 does not address biological evaluation of the surfaces of gas pathways that are in direct contact with the patient. The requirements for direct contact surfaces are found in the ISO 10993 series.Medical devices, parts or accessories containing gas pathways that are addressed by this document include, but are not limited to, ventilators, anaesthesia workstations (including gas mixers), breathing systems, oxygen conserving devices, oxygen concentrators, nebulizers, low-pressure hose assemblies, humidifiers, heat and moisture exchangers, respiratory gas monitors, respiration monitors, masks, mouth pieces, resuscitators, breathing tubes, breathing systems filters, Y-pieces and any breathing accessories intended to be used with such devices. The enclosed chamber of an incubator, including the mattress, and the inner surface of an oxygen hood are considered to be gas pathways and are also addressed by this document.ISO 18562-4:2017 does not address contamination already present in the gas supplied from the gas sources while medical devices are in normal use.EXAMPLE Contamination arriving at the medical device from gas sources such as medical gas pipeline systems (including the non-return valves in the pipeline outlets), outlets of pressure regulators connected or integral to a medical gas cylinder, or room air taken into the medical device is not addressed by ISO 18562 series.ISO 18562-4:2017 does not address contact with drugs or anaesthetic agents. If a medical device is intended to be used with anaesthetic agents or drugs, then additional testing can be required.This document is intended to be read in conjunction with ISO 18562-1.NOTE This document has been prepared to address the relevant essential principles of safety and performance as indicated in Annex B.

This document provides specific rules for the assessment of the release on dangerous substances from glass products into indoor air of buildings in complement to the horizontal rules given in EN 16516.This document addresses specifically products as mentioned in TC 129 Mandate - M135 Amendment 1 EN (2012), i.e. products covered by the following European Standards: EN 1036 2 and FprEN 16477 2. However, this document can also be applied to other glass products containing volatiles organic compounds (VOC) such as: EN 1279 5, EN 15755 1 and EN 14449. Glass products that do not contain organic compounds are not in the scope of this document (see Annex A).This document address the release of dangerous substances into indoor air from construction products, although it can also be applied to glass products used in other applications such as furniture.

ISO 17510:2015 applies to masks and their accessories used to connect a sleep apnoea breathing therapy equipment to the patient. It specifies requirements for masks and accessories, including any connecting element, that are required to connect the patient-connection port of sleep apnoea breathing therapy equipment to a patient for the application of sleep apnoea breathing therapy (e.g. nasal masks, exhaust ports and headgear).

ISO 18562-1:2017 specifies:- the general principles governing the biological evaluation within a risk management process of the gas pathways of a medical device, its parts or accessories, which are intended to provide respiratory care or supply substances via the respiratory tract to a patient in all environments;- the general categorization of gas pathways based on the nature and duration of their contact with the gas stream;- the evaluation of existing relevant data from all sources;- the identification of gaps in the available data set on the basis of a risk analysis;- the identification of additional data sets necessary to analyse the biological safety of the gas pathway;- the assessment of the biological safety of the gas pathway.ISO 18562-1:2017 covers general principles regarding biocompatibility assessment of medical device materials, which make up the gas pathway, but does not cover biological hazards arising from any mechanical failure, unless the failure introduces a toxicity risk (e.g. by generating particulates). The other parts of ISO 18562 cover specific tests that address potentially hazardous substances that are added to the respirable gas stream and establish acceptance criteria for these substances.ISO 18562-1:2017 addresses potential contamination of the gas stream arising from the gas pathways within the medical device, which might then be conducted to the patient.ISO 18562-1:2017 applies over the expected service life of the medical device in normal use and takes into account the effects of any intended processing or reprocessing.ISO 18562-1:2017 does not address biological evaluation of the surfaces of medical devices that are in direct contact with the patient. The requirements for direct contact surfaces are found in the ISO 10993 series.Medical devices, parts or accessories containing gas pathways that are addressed by this document include, but are not limited to, ventilators, anaesthesia workstations (including gas mixers), breathing systems, oxygen conserving equipment, oxygen concentrators, nebulizers, low-pressure hose assemblies, humidifiers, heat and moisture exchangers, respiratory gas monitors, respiration monitors, masks, mouth pieces, resuscitators, breathing tubes, breathing system filters and Y-pieces as well as any breathing accessories intended to be used with such medical devices. The enclosed chamber of an incubator, including the mattress, and the inner surface of an oxygen hood are considered to be gas pathways and are also addressed by this document.ISO 18562-1:2017 does not address contamination already present in the gas supplied from the gas sources while medical devices are in normal use.EXAMPLE Contamination arriving at the medical device from gas sources such as medical gas pipeline systems (including the non-return valves in the pipeline outlets), outlets of pressure regulators connected or integral to a medical gas cylinder, or room air taken into the medical device is not addressed by ISO 18562 (all parts).Future parts might be added to address other relevant aspects of biological testing including additional contamination that might arise from the gas pathway because of the presence of drugs and anaesthetic agents added to the gas stream.NOTE 1 Some authorities having jurisdiction require evaluation of these risks as part of a biological evaluation.NOTE 2 This document has been prepared to address the relevant essential principles of safety and perfo

ISO 18562-2:2017 specifies tests for the emissions of particulate matter from the gas pathways of a medical device, its parts or accessories, which are intended to provide respiratory care or supply substances via the respiratory tract to a patient in all environments. The tests of this document are intended to quantify particles from 0,2 µm diameter to 10 µm diameter that are emitted by the medical device, its parts or accessories into the respirable gas stream. This document establishes acceptance criteria for these tests. This document does not address nanoparticles. Insufficient data exist to establish exposure limits for particles less than 0,2 µm in diameter.NOTE 1 Smaller and larger particles could also present biological hazards, and additional information outside the scope of this document can be needed to meet requirements of some authorities having jurisdiction.ISO 18562-2:2017 therefore adopts the same approach as the US Environmental Protection Agency (EPA) in setting limits based solely on particle size and not their chemistry.ISO 18562-2:2017 addresses potential contamination of the gas stream arising from the gas pathways, which is then conducted to the patient.ISO 18562-2:2017 applies over the expected service life of the medical device in normal use and takes into account the effects of any intended processing or reprocessing.ISO 18562-2:2017 does not address biological evaluation of the surfaces of gas pathways that are in direct contact with the patient. The requirements for direct contact surfaces are found in the ISO 10993 series.Medical devices, parts or accessories, containing gas pathways that are addressed by this document, include, but are not limited to, ventilators, anaesthesia workstations (including gas mixers), breathing systems, oxygen conserving devices, oxygen concentrators, nebulizers, low-pressure hose assemblies, humidifiers, heat and moisture exchangers, respiratory gas monitors, respiration monitors, masks, mouth pieces, resuscitators, breathing tubes, breathing systems filters, Y-pieces, and any breathing accessories intended to be used with such devices. The enclosed chamber of an incubator, including the mattress, and the inner surface of an oxygen hood are considered to be gas pathways and are also addressed by this document.ISO 18562-2:2017 does not address contamination already present in the gas supplied from the gas sources while medical devices are in normal use.EXAMPLE Contamination arriving at the medical device from gas sources such as medical gas pipeline systems (including the non-return valves in the pipeline outlets), outlets of pressure regulators connected or integral to a medical gas cylinder, or room air taken into the medical device is not addressed by ISO 18562 (all parts).NOTE 2 This document has been prepared to address the relevant essential principles of safety and performance as indicated in Annex B.

This document describes the minimum procedures for the sampling of performance infills used within synthetic turf surfaces to verify compliance with toxicology, environmental and performance regulations and standards. Four sampling procedures are specified:Method 1 is intended based on taking samples during production of the infill material. Method 2 describes how to take samples from big bags. Method 3 describes how to take samples from small bags. Method 4 describes a procedure for taking samples from a synthetic turf (e.g. sports, recreational or landscaping surface). The procedures described are suitable for all forms of infill.

ISO 80601-2-74:2017 applies to the basic safety and essential performance of a humidifier, also hereafter referred to as me equipment, in combination with its accessories, the combination also hereafter referred to as me system.ISO 80601-2-74:2017 is also applicable to those accessories intended by their manufacturer to be connected to a humidifier where the characteristics of those accessories can affect the basic safety or essential performance of the humidifier.EXAMPLE 1 Heated breathing tubes (heated-wire breathing tubes) or me equipment intended to control these heated breathing tubes (heated breathing tube controllers).NOTE 1 Heated breathing tubes and their controllers are me equipment and are subject to the requirements of IEC 60601-1.NOTE 2 ISO 5367 specifies other safety and performance requirements for breathing tubes.ISO 80601-2-74:2017 includes requirements for the different medical uses of humidification, such as invasive ventilation, non-invasive ventilation, nasal high-flow therapy, and obstructive sleep apnoea therapy, as well as humidification therapy for tracheostomy patients.NOTE 3 A humidifier can be integrated into other equipment. When this is the case, the requirements of the other equipment also apply to the humidifier.EXAMPLE 2 Heated humidifier incorporated into a critical care ventilator where ISO 80601-2-12[12] also applies.EXAMPLE 3 Heated humidifier incorporated into a homecare ventilator for dependent patients where ISO 80601-2-72[14] also applies.EXAMPLE 4 Heated humidifier incorporated into sleep apnoea therapy equipment where ISO 80601-2-70[13] also applies.ISO 80601-2-74:2017 also includes requirements for an active hme (heat and moisture exchanger), me equipment which actively adds heat and moisture to increase the humidity level of the gas delivered from the hme to the patient. This document is not applicable to a passive hme, which returns a portion of the expired moisture and heat of the patient to the respiratory tract during inspiration without adding heat or moisture.NOTE 4 ISO 9360-1[5] and ISO 9360-2[6] specify the safety and performance requirements for a passive hme.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+AMD1:2012, 7.2.13 and 8.4.1.NOTE 5 Additional information can be found in IEC 60601-1:2005+AMD1:2012, 4.2.ISO 80601-2-74:2017 does not specify the requirements for cold pass-over or cold bubble-through humidification devices, the requirements for which are given in ISO 20789:?.[8]This document is not applicable to equipment commonly referred to as "room humidifiers" or humidifiers used in heating, ventilation and air conditioning systems, or humidifiers incorporated into infant incubators.ISO 80601-2-74:2017 is not applicable to nebulizers used for the delivery of drugs to patients.NOTE 6 ISO 27427[10] specifies the safety and performance requirements for nebulizers.ISO 80601-2-74:2017 is a particular standard in the IEC 60601-1 and the ISO/IEC 80601 series.

This particular standard is applicable to the basic safety and essential performance of oxygen conserving equipment, hereafter referred to as me equipment, in combination with its accessories intended to conserve supplemental oxygen by delivering gas intermittently and synchronized with the patient's inspiratory cycle, when used in the home healthcare environment. Oxygen conserving equipment is typically used by a lay operator.This particular standard is also applicable to those accessories intended by their manufacturer to be connected to conserving equipment, where the characteristics of those accessories can affect the basic safety or essential performance of the conserving equipment.This particular standard is only applicable to active devices (e.g. Pneumatically or electrically powered) and is not applicable to non-active devices (e.g. Reservoir cannulas).

This document is applicable to inflatable play equipment intended for use by children fourteen years and under, both individually and collectively.This part of the standard specifies additional safety requirements for snappies for which the primary activities are climbing and sliding. It sets measures to address risks and also to minimize accidents to users for those involved in the design, manufacture and supply of inflatable play equipment. It specifies information to be supplied with the equipment. The requirements have been laid down bearing in mind the risk factor based on available data.This document specifies requirements to protect a child from hazards that he or she might be unable to foresee when using the equipment as intended, or in a manner that can be reasonably anticipated.This document is not applicable to inflatable water-borne play and leisure equipment, domestic inflatable toys, air-supported buildings, inflatables used solely for protection, inflatables used for rescue, or other types of inflatable toys where the primary activity is not bouncing or sliding.

This procedure specifies a test method and the minimum requirements for bactericidal activity of teat disinfectants that form a homogeneous, physically stable preparation when diluted with hard water - or in the case of ready-to-use products - with water.This method applies to teat disinfectants that are used in the veterinary area on teat skin without mechanical action as pre-milking and/or post-milking teat disinfectants.NOTE 1 The method described is intended to determine the activity of commercial formulations under the conditions in which they are used.NOTE 2 This method corresponds to a phase 2 step 2 test.NOTE 3 Two types of synthetic skin were assessed in a ring trial with no significant difference in performance. Other synthetic skins may become available and may be used if it can be shown that they give comparable results to the two referenced in this standard.

This document specifies a test method and the minimum requirements for fungicidal or yeasticidal activity of chemical disinfectant and antiseptic products that form a homogeneous, physically stable preparation when diluted with hard water, or - in the case of ready-to-use products - with water. Products can only be tested at a concentration of 80 % or less (97 % with a modified method for special cases) as some dilution is always produced by adding the test organisms and interfering substance.This document applies to products that are used in the medical area in the fields of hygienic handrub, hygienic handwash, surgical handrub, surgical handwash, instrument disinfection by immersion, and surface disinfection by wiping, spraying, flooding or other means.This document applies to areas and situations where disinfection or antisepsis is medically indicated. Such indications occur in patient care, for example:- in hospitals, in community medical facilities and in dental institutions;- in clinics of schools, of kindergartens and of nursing homes;and can occur in the workplace and in the home. It can also include services such as laundries and kitchens supplying products directly for the patients.NOTE 1 The method described is intended to determine the activity of commercial formulations or active substances under the conditions in which they are used.NOTE 2 This method corresponds to a phase 2 step 1 test.EN 14885 specifies in detail the relationship of the various tests to one another and to "use recommendations".