Medicinsk utrustning

Kommittébeteckning: SIS/TK 329 (Anestesi- och respiratorutrustning)
Källa: CEN
Svarsdatum: den 1 okt 2019
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This International Standard applies to masks and their accessories used to connect 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).

Sleep apnoea breathing therapy equipment is covered by ISO 80601-2-70. Figure A.1 shows the

typical elements of this International Standard together with the sleep apnoea breathing therapy

equipment of ISO 80601-2-70 that form a sleep apnoea breathing system.

This International Standard does not cover oral appliances.

Kommittébeteckning: SIS/TK 329 (Anestesi- och respiratorutrustning)
Källa: CEN
Svarsdatum: den 1 okt 2019
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This document 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.

This document 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.

This document addresses potential contamination of the gas stream arising from the gas pathways within the medical device, which might then be conducted to the patient.

This document 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.

This document 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.

This document 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 performance as indicated in Annex B.

Kommittébeteckning: SIS/TK 329 (Anestesi- och respiratorutrustning)
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Svarsdatum: den 1 okt 2019
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This document 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.

This document therefore adopts the same approach as the US Environmental Protection Agency (EPA) in setting limits based solely on particle size and not their chemistry.

This document addresses potential contamination of the gas stream arising from the gas pathways, which is then conducted to the patient.

This document 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.

This document 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.

This document 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.

Kommittébeteckning: SIS/TK 329 (Anestesi- och respiratorutrustning)
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This document 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.

This document addresses potential contamination of the gas stream arising from the gas pathways, which is then conducted to the patient.

This document 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.

This document 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.

This document 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.

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.

Kommittébeteckning: SIS/TK 329 (Anestesi- och respiratorutrustning)
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Svarsdatum: den 1 okt 2019
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This document 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.

This document addresses potential contamination of the gas stream arising from the gas pathways, which is then conducted to the patient.

This document 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

This document 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.

This document 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.

This document 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.

Kommittébeteckning: SIS/TK 329 (Anestesi- och respiratorutrustning)
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This document 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.

This document 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.

This document 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.

This document 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.

This document 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.

This document 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.

This document is a particular standard in the IEC 60601‐1 and the ISO/IEC 80601 series.

Kommittébeteckning: SIS/TK 329 (Anestesi- och respiratorutrustning)
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Svarsdatum: den 17 nov 2019
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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;

- 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 7.2.13 and 8.4.1 of the general standard.

NOTE 3 See also 4.2 of the general standard.

This document is not applicable to any anaesthetic workstation intended for use with flammable anaesthetic agents, as determined by Annex BB.