BS EN ISO 80601-2-79:2019

This standard BS EN ISO 80601-2-79:2019 Medical electrical equipment is classified in these ICS categories:

• 11.040.10 Anaesthetic, respiratory and reanimation equipment

IEC 60601-1:2005+AMD1:2012, Clause 1, applies, except as follows:

201.1.1 * Scope

Replacement:

This document applies to the basic safety and essential performance of ventilatory support equipment, as defined in 201.3.205, for ventilatory impairment, as defined in 201.3.202, hereafter also referred to as me equipment, in combination with its accessories:

• intended for use in the home healthcare environment;

• intended for use by a lay operator; and

• 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).

NOTE 1 In the home healthcare environment, the supply mains is often not reliable.

NOTE 2 Such ventilatory support equipment can also be used in non-critical care applications of professional health care facilities.

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, 7.2.13 and 8.4.1.

NOTE 3 Additional information can be found in IEC 60601-1:2005+AMD1:2012, 4.2.

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^[4];

• Ventilators or accessories intended for the emergency medical services environment, which are given in ISO 80601-2-84^[5]4, the future replacement for ISO 10651-3^[6];

• 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^[1];

• sleep apnoea therapy me equipment, which are given in ISO 80601-2-70^[7];

• continuous positive airway pressure (CPAP) me equipment;

• high-frequency jet ventilators (HFJVs);

• high-frequency oscillatory ventilators (HFOVs)^[8];

• oxygen therapy constant flow me equipment;

• cuirass or “iron-lung” ventilation equipment.

This document is a document in the IEC 60601 and IEC/ISO 80601 series of documents.

201.1.2 Object

Replacement:

The object of this document is to establish particular basic safety and essential performance requirements for ventilatory support equipment, as defined in 201.3.205, and its accessories.

NOTE Accessories are included because the combination of the ventilatory support equipment and the accessories needs to be adequately safe. Accessories can have a significant impact on the basic safety or essential performance of the ventilatory support equipment.

201.1.3 Collateral standards

Addition:

This document refers to those applicable collateral standards that are listed in Clause 2 of the general standard and Clause 201.2 of this document.

IEC 60601-1-2:2014, IEC 60601-1-6:2010+AMD1:2013, and IEC 60601-1-11:2015 apply as modified in Clauses 202, 206 and 211 respectively. IEC 60601-1-3^[26] does not apply. All other published collateral standards in the IEC 60601-1 series apply as published.

201.1.4 Particular standards

Replacement:

In the IEC 60601 series, particular standards may modify, replace or delete requirements contained in the general standard, including the collateral standards, as appropriate for the particular me equipment under consideration, and may add other basic safety or essential performance requirements.

A requirement of a particular standard takes priority over the general standard.

For brevity, IEC 60601-1:2005+AMD1:2012 is referred to in this particular document as the general standard. Collateral standards are referred to by their document number.

The numbering of clauses and subclauses of this document corresponds to that of the general standard with the prefix “201” (e.g. 201.1 in this document addresses the content of Clause 1 of the general standard) or applicable collateral standard with the prefix “2xx”, where xx is the final digits of the collateral standard document number (e.g. 202.4 in this document addresses the content of Clause 4 of the IEC 60601-1-2 collateral standard, 211.10 in this document addresses the content of Clause 10 of the IEC 60601-1-11 collateral standard, etc.). The changes to the text of the general standard are specified by the use of the following words:

“Replacement” means that the clause or subclause of the general standard or applicable collateral standard is replaced completely by the text of this document.

“Addition” means that the text of this document is additional to the requirements of the general standard or applicable collateral standard.

“Amendment” means that the clause or subclause of the general standard or applicable collateral standard is amended as indicated by the text of this document.

Subclauses, figures or tables that are additional to those of the general standard are numbered starting from 201.101. However, due to the fact that definitions in the general standard are numbered 3.1 through 3.147, additional definitions in this document are numbered beginning from 201.3.201. Additional annexes are lettered AA, BB, etc., and additional items aa), bb), etc.

Subclauses, figures or tables which are additional to those of a collateral standard are numbered starting from 20x, where “x” is the number of the collateral standard, e.g. 202 for IEC 60601-1-2, 203 for IEC 60601-1-3, etc.

The term “this document” is used to make reference to the general standard, any applicable collateral standards and this particular standard taken together.

Where there is no corresponding clause or subclause in this particular document, the clause or subclause of the general standard or applicable collateral standard, although possibly not relevant, applies without modification; where it is intended that any part of the general standard or applicable collateral standard, although possibly relevant, is not to be applied, a statement to that effect is given in this particular document.