CR 13903:2000
(Main)General guidance on the equipment used for inhaled nitric oxide therapy
General guidance on the equipment used for inhaled nitric oxide therapy
Gives guidance on inhalational therapeutic use of nitric oxide admixed with nitrogen, including pharmacology, toxicological hazards, compatibility with air/oxygen/device materials and device design parameters.
Guide général sur le matériel utilisé pour la thérapie par l'oxyde nitrique inhalé
Splošna navodila za opremo, uporabljeno pri zdravljenju z vdihavanjem dušikovega oksida
General Information
Standards Content (Sample)
SLOVENSKI STANDARD
01-november-2001
Splošna navodila za opremo, uporabljeno pri zdravljenju z vdihavanjem
dušikovega oksida
General guidance on the equipment used for inhaled nitric oxide therapy
Guide général sur le matériel utilisé pour la thérapie par l'oxyde nitrique inhalé
Ta slovenski standard je istoveten z: CR 13903:2000
ICS:
11.040.10 Anestezijska, respiratorna in Anaesthetic, respiratory and
reanimacijska oprema reanimation equipment
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.
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— 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.
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NOTE 1 There is guidance or rationale for this subclause contained in Clause AA.2.
This document applies to the basic safety and essential performance of ventilatory support equipment, as defined in 201.3.302, for ventilatory insufficiency, as defined in 201.3.302, hereafter also referred to as ME equipment, in combination with its accessories:
— intended for use in the home healthcare environment;
NOTE 2 In the home healthcare environment, the supply mains driving the ventilatory support equipment is often not reliable.
NOTE 3 Such ventilatory support equipment can also be used in professional health care facilities.
— intended for use by a lay operator;
— intended for use with patients who have ventilatory insufficiency or failure, the most fragile of which would likely experience injury with the loss of this artificial ventilation;
— intended for transit-operable use; and
— not intended for patients who are dependent on artificial ventilation for their immediate life support.
EXAMPLE 1 Patients with moderate to severe chronic obstructive pulmonary disease (COPD), moderate amyotrophic lateral sclerosis (ALS), severe bronchopulmonary dysplasia or muscular dystrophy.
Ventilatory support equipment is not considered to use a physiologic closed-loop control system unless it uses a physiological patient variable to adjust the artificial ventilation therapy settings.
This document is also applicable to those accessories intended by their manufacturer to be connected to the ventilator breathing system of ventilatory support equipment for ventilatory insufficiency, where the characteristics of those accessories can affect the basic safety or essential performance of the ventilatory support equipment for ventilatory insufficiency.
EXAMPLE 2 Breathing sets, connectors, water traps, expiratory valve, humidifier, breathing system filter, external electrical power source, distributed alarm system.
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+AMD2:2020, 7.2.13 and 8.4.1.
NOTE 4 Additional information can be found in IEC 60601‑1:2005+AMD1:2012+AMD2:2020, 4.2.
NOTE 5 See ISO/TR 21954 for guidance on the selection of the appropriate ventilator for a given patient.
This document does not specify the requirements for:
— ventilators or accessories for ventilator-dependent patients intended for critical care applications, which are given in ISO 80601‑2‑12;
— ventilators or accessories intended for anaesthetic applications, which are given in ISO 80601‑2‑13;
— ventilators or accessories intended for the emergency medical services environment, which are given in ISO 80601‑2‑84;
— ventilators or accessories intended for ventilator-dependent patients in the home healthcare environment, which are given in ISO 80601‑2‑72;
— ventilatory support equipment or accessories intended for ventilatory impairment, which are given in ISO 80601‑2‑79;
— sleep apnoea therapy ME equipment, which are given in ISO 80601‑2‑70;
— high-frequency jet ventilato
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NOTE 1 There is guidance or rationale for this subclause contained in Clause AA.2.
This document applies to the basic safety and essential performance of ventilatory support equipment, as defined in 201.3.302, for ventilatory impairment, as defined in 201.3.300, hereafter also referred to as ME equipment, in combination with its accessories:
— intended for use in the home healthcare environment;
NOTE 2 In the home healthcare environment, the supply mains driving the ventilatory support equipment is often not reliable.
NOTE 3 Such ventilatory support equipment can also be used in professional health care facilities.
— intended for use by a lay operator;
— intended for use with patients who have ventilatory impairment, the most fragile of these patients, would not likely experience injury with the loss of this artificial ventilation; and
— not intended for patients who are dependent on artificial ventilation for their immediate life support.
EXAMPLE 1 Patients with mild to moderate chronic obstructive pulmonary disease (COPD).
Ventilatory support equipment is not considered to use a physiologic closed-loop control system unless it uses a physiological patient variable to adjust the artificial ventilation therapy settings.
This document is also applicable to those accessories intended by their manufacturer to be connected to the breathing system of ventilatory support equipment for ventilatory impairment, where the characteristics of those accessories can affect the basic safety or essential performance of the ventilatory support equipment for ventilatory impairment.
EXAMPLE 2 Breathing sets, connectors, water traps, expiratory valve, humidifier, breathing system filter, external electrical power source, distributed alarm system.
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+AMD2:2020, 7.2.13 and 8.4.1.
NOTE 4 Additional information can be found in IEC 60601‑1:2005+AMD1:2012+AMD2:2020, 4.2.
NOTE 5 See ISO/TR 21954 for guidance on the selection of the appropriate ventilator for a given patient.
This document does not specify the requirements for:
— ventilators or accessories for ventilator-dependent patients intended for critical care applications, which are given in ISO 80601‑2‑12;
— ventilators or accessories intended for anaesthetic applications, which are given in ISO 80601‑2‑13;
— ventilators or accessories intended for the emergency medical services environment, which are given in ISO 80601‑2‑84;
— ventilators or accessories intended for ventilator-dependent patients in the home healthcare environment, which are given in ISO 80601‑2‑72;
— ventilatory support equipment or accessories intended for ventilatory insufficiency, which are given in ISO 80601‑2‑80;
— sleep apnoea therapy ME equipment, which are given in ISO 80601‑2‑70;
— high-frequency jet ventilators (HFJVs), which are given in ISO 80601‑2‑87;
— high-frequency oscillatory ventilators (HFOVs);
— respiratory high flow equipment, which are given in
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This document specifies requirements for anaesthetic reservoir bags for use with anaesthetic and ventilator breathing systems. It includes requirements for the design of the neck, size designation and elasticity.
This document is not applicable to special-purpose bags, for example bellows, self-inflating bags and bags for use with anaesthetic gas scavenging systems.
The requirements in this device-specific standard take precedence over any conflicting requirements in the general standard for airway devices (ISO 18190). All the common requirements that appear in the general standard for airway devices have been removed from this document.
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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.
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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).
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