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BS EN ISO 80601-2-79:2019

BS EN ISO 80601-2-79:2019

$215.11

Medical electrical equipment – Particular requirements for basic safety and essential performance of ventilatory support equipment for ventilatory impairment

Published By Publication Date Number of Pages
BSI 2019 86
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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.

PDF Catalog

PDF Pages PDF Title
2 undefined
4 European foreword
Endorsement notice
6 Foreword
8 Introduction
10 201.1 Scope, object and related standards
201.1.1 * Scope
11 201.1.2 Object
12 201.1.3 Collateral standards
201.1.4 Particular standards
13 201.2 Normative references
15 201.3 Terms and definitions
16 201.4 General requirements
201.4.3 Essential performance
17 201.4.3.101 * Additional requirements for essential performance
201.4.6 * Me equipment or me system parts that contact the patient
201.4.11.101 * Additional requirements for pressurized gas input
201.4.11.101.1 Overpressure requirement
201.4.11.101.2 Compatibility requirement
18 201.5 General requirements for testing of me equipment
201.5.101 * Additional requirements for the general requirements for testing of me equipment
201.5.101.1 Ventilatory support equipment test conditions
201.5.101.2 * Gas flowrate and leakage specifications
201.5.101.3 * Ventilatory support equipment testing errors
19 201.6 Classification of me equipment and me systems
201.7 Me equipment identification, marking and documents
25 201.8 Protection against electrical hazards from me equipment
201.9 Protection against mechanical hazards of me equipment and me systems
26 201.10 Protection against unwanted and excessive radiation hazards
201.11 Protection against excessive temperatures and other hazards
29 201.12 Accuracy of controls and instruments and protection against hazardous outputs
201.12.1 Accuracy of controls and instruments
30 201.12.1.101 Volume-controlled breath type
33 201.12.1.102 Pressure-controlled breath type
35 201.12.1.103 Other breath types
36 201.12.2.101 Usability of me equipment
201.12.4 Protection against hazardous output
201.12.4.101 * Measurement of airway pressure
201.12.4.101.1 General
201.12.4.101.2 Low airway pressure alarm condition
37 201.12.4.102 Measurement of expired volume
201.12.4.103 * Maximum limited pressure protection device
201.12.4.104 Hypoventilation alarm condition
201.12.4.105 * CO2 rebreathing
38 201.12.101 Protection against accidental adjustments
39 201.13 Hazardous situations and fault conditions for me equipment
201.14 Programmable electrical medical systems (pems)
201.15 Construction of me equipment
201.15.101 Mode of operation
201.15.102 Pre-use check
40 201.16 Me systems
201.17 Electromagnetic compatibility of me equipment and me systems
201.101 Gas connections
201.101.1 Vbs connectors
201.101.1.1 * General
41 201.101.1.2 Other named ports
201.101.1.2.1 General
201.101.1.2.2 Patient-connection port
201.101.1.2.3 * Manual ventilation port
201.101.1.2.4 Accessory port
201.101.1.2.5 Monitoring probe port
42 201.101.1.2.6 Oxygen inlet port
201.101.1.2.7 Flow-direction-sensitive components
201.102 Requirements for the vbs and accessories
201.102.1 * General
201.102.2 Labelling
201.102.3 Breathing sets
43 201.102.4 * Humidification
201.102.4.1 Humidifier
201.102.4.2 Heat and moisture exchanger (hme)
201.102.5 Breathing system filters (bsf)
201.103 * Training
201.104 * Indication of duration of operation
44 201.105 Functional connection
201.105.1 General
201.105.2 * Connection to an electronic health record
201.105.3 Connection for remote control
201.106 Display loops
201.106.1 Pressure-volume loops
201.106.2 Flow-volume loops
45 201.107 Spontaneous breathing during loss of ventilation
202 Electromagnetic disturbances — Requirements and tests
46 206 Usability
47 211 Requirements for medical electrical equipment and medical electrical systems used in the home healthcare environment
49 Annex C(informative)Guide to marking and labelling requirements for me equipment and me systems
55 Annex D(informative)Symbols on marking
57 Annex AA(informative)Particular guidance and rationale
70 Annex BB(informative)Data interface requirements
76 Annex CC(informative)Reference to the essential principles
80 Annex DD(informative)Terminology — Alphabetized index of defined terms
84 Bibliography

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BS EN ISO 80601-2-79:2019
$215.11