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BS EN ISO 20789:2019

BS EN ISO 20789:2019

$198.66

Anaesthetic and respiratory equipment. Passive humidifiers

Published By Publication Date Number of Pages
BSI 2019 56
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This document specifies requirements for so-called “cold bubble-through” or “cold pass-over” humidifying equipment, hereafter referred to as a passive humidifier. Figure 1 and Figure 2 illustrate these passive humidifiers .

NOTE 1 Passive humidifier humidification chambers are at room temperature so they have a lower humidification output than active humidifiers.

Figure 1 Cold pass-over passive humidifier

Figure 2 Cold bubble-through passive humidifier

This document is also applicable to those accessories intended by their manufacturer to be connected to a passive humidifier .

A passive humidifier integrated into another medical device is subject to the requirements of the standard of the other medical device.

EXAMPLE 1 The requirements in ISO 80601‑2‑69 [ 4 ] also apply to a passive humidifier integrated into an oxygen concentrator.

EXAMPLE 2

The requirements in ISO 80601‑2‑70 [ 5 ] also apply a passive humidifier integrated into sleep apnoea therapy equipment.

This document does not specify the requirements for active heated humidifiers, heated breathing tubes, or active heat and moisture exchangers (HMEs), the requirements for which are given in ISO 80601‑2‑74.

NOTE 2 ISO 5367 specifies other safety and performance requirements for breathing tubes.

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, the requirements for which are given in ISO 9360‑1 [ 6 ] and ISO 9360‑2 [ 7 ].

This document is not applicable to nebulizers used for the delivery of liquids to patients, the requirements for which are given in ISO 27427 [ 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.

An asterisk (*) as the first character of a title or at the beginning of a paragraph or table title indicates that there is guidance or rationale related to that item in Annex A.

This document has been prepared to support the essential principles of safety and performance of a passive humidifier and related accessories as medical devices in accordance with ISO 16142‑1:2016. Annex D maps the clauses and subclauses of this document with the essential principles of ISO 16142‑1:2016.

PDF Catalog

PDF Pages PDF Title
2 undefined
4 European foreword
Endorsement notice
7 Foreword
8 Introduction
10 1 * Scope
11 2 Normative references
12 3 Terms and definitions
14 4 General requirements for testing
4.1 Water level
15 4.2 Passive humidifier test conditions
4.3 * Gas flowrate and leakage specifications
4.4 * Passive humidifier testing errors
5 General requirements
5.1 Mechanical basic safety for all passive humidifiers
5.1.1 General
5.1.2 * Requirements for instability from unwanted lateral movement
16 5.1.3 * Requirements for audible acoustic energy
17 5.1.4 * Overflow
5.1.5 * Overpressure requirement
18 5.2 Compatibility requirement
5.3 General requirements for mechanical strength
19 6 Identification, marking and accompanying documentation
6.1 Legibility and durability of markings
6.1.1 Legibility
6.1.2 Durability
6.2 Markings on the outside of the passive humidifier or its parts
6.2.1 Identification
20 6.2.2 Additional requirements
21 6.2.3 Requirements for physiological effects
6.2.4 Requirements for packaging
6.2.5 Symbols
6.3 Units of measurement
6.4 Instructions for use
6.4.1 Identification
22 6.4.2 General requirements
23 6.4.3 * Requirements for warnings and safety notices
6.4.4 Requirements for installation
6.4.5 Requirements for start-up procedure
6.4.6 * Requirements for operating instructions
25 6.4.7 Requirements for cleaning, disinfection, and sterilization
6.4.8 Requirements for maintenance
6.4.9 Requirements for accessories, supplementary equipment and used material
6.4.10 Unique version identifier
26 6.5 Technical description
7 * Humidification output
8 Systems requirements
27 9 Specific single fault conditions
10 * Cleaning and disinfection
10.1 General
10.2 Home healthcare environment
11 * Breathing system connectors and ports
11.1 General
28 11.2 Outlet connector
11.2.1 Directly connected to the supply source
11.2.2 Indirectly connected to the supply source
11.3 ​Flow-direction-sensitive components
11.4 ​* Accessory port
29 11.5 Monitoring probe port
11.6 Oxygen inlet port
11.6.1 Directly connected to the supply source
11.6.2 Indirectly connected to the supply source
11.7 Air inlet port
11.7.1 Directly connected to the supply source
11.7.2 Indirectly connected to the supply source
11.8 Filling port
30 12 * Requirements for the breathing system and accessories
12.1 General
12.2 Accompanying documentation
12.3 ​Breathing tubes
12.4 Liquid container level
12.5 Filling cap
31 13 Compatibility with substances
14 * Biocompatibility
15 * Requirements for fire prevention
32 16 Usability
34 Annex A (informative) Rationale and guidance
42 Annex B (informative) Symbols on marking
44 Annex C (normative) Determination of humidification output
48 Annex D (informative) Reference to the essential principles
50 Annex E (informative) Terminology — Alphabetized index of defined terms
52 Bibliography

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BS EN ISO 20789:2019
$198.66