{"id":408385,"date":"2024-10-20T05:30:24","date_gmt":"2024-10-20T05:30:24","guid":{"rendered":"https:\/\/pdfstandards.shop\/product\/uncategorized\/bs-en-iso-207892019-2\/"},"modified":"2024-10-26T10:01:19","modified_gmt":"2024-10-26T10:01:19","slug":"bs-en-iso-207892019-2","status":"publish","type":"product","link":"https:\/\/pdfstandards.shop\/product\/publishers\/bsi\/bs-en-iso-207892019-2\/","title":{"rendered":"BS EN ISO 20789:2019"},"content":{"rendered":"

This document specifies requirements for so-called \u201ccold bubble-through\u201d or \u201ccold pass-over\u201d humidifying equipment, hereafter referred to as a passive humidifier.<\/small> Figure 1 and Figure 2 illustrate these passive humidifiers <\/small>.<\/p>\n

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NOTE 1 Passive humidifier humidification chambers <\/small> are at room temperature so they have a lower humidification output <\/small> than active humidifiers.<\/p>\n<\/blockquote>\n

Figure 1<\/b> Cold pass-over passive humidifier<\/small><\/p>\n

Figure 2<\/b> Cold bubble-through passive humidifier<\/small><\/p>\n

This document is also applicable to those accessories<\/small> intended by their manufacturer<\/small> to be connected to a passive humidifier <\/small>.<\/p>\n

A passive humidifier <\/small> integrated into another medical device<\/small> is subject to the requirements of the standard of the other medical device<\/small>.<\/p>\n

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EXAMPLE 1 The requirements in ISO 80601\u20112\u201169 [<\/sup> 4<\/sup> ]<\/sup> also apply to a passive humidifier <\/small> integrated into an oxygen concentrator.<\/p>\n<\/blockquote>\n

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EXAMPLE 2<\/p>\n

The requirements in ISO 80601\u20112\u201170 [<\/sup> 5<\/sup> ]<\/sup> also apply a passive humidifier <\/small> integrated into sleep apnoea therapy equipment.<\/p>\n<\/blockquote>\n

This document does not specify the requirements for active heated humidifiers, heated breathing tubes<\/small>, or active heat and moisture exchangers (HMEs), the requirements for which are given in ISO 80601\u20112\u201174.<\/p>\n

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NOTE 2 ISO 5367 specifies other safety and performance requirements for breathing tubes<\/small>.<\/p>\n<\/blockquote>\n

This document is not applicable to a passive HME, which returns a portion of the expired moisture and heat of the patient<\/small> to the respiratory tract during inspiration without adding heat or moisture, the requirements for which are given in ISO 9360\u20111 [<\/sup> 6<\/sup> ]<\/sup> and ISO 9360\u20112 [<\/sup> 7<\/sup> ]<\/sup>.<\/p>\n

This document is not applicable to nebulizers used for the delivery of liquids to patients<\/small>, the requirements for which are given in ISO 27427 [<\/sup> 8<\/sup> ]<\/sup>.<\/p>\n

This document is not applicable to equipment commonly referred to as \u201croom humidifiers\u201d or humidifiers used in heating, ventilation and air conditioning systems, or humidifiers incorporated into infant incubators.<\/p>\n

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.<\/p>\n

This document has been prepared to support the essential principles of safety and performance<\/small> of a passive humidifier <\/small> and related accessories<\/small> as medical devices<\/small> in accordance with ISO 16142\u20111:2016. Annex D maps the clauses and subclauses of this document with the essential principles<\/small> of ISO 16142\u20111:2016.<\/p>\n

PDF Catalog<\/h4>\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n
PDF Pages<\/th>\nPDF Title<\/th>\n<\/tr>\n
2<\/td>\nundefined <\/td>\n<\/tr>\n
4<\/td>\nEuropean foreword
Endorsement notice <\/td>\n<\/tr>\n
7<\/td>\nForeword <\/td>\n<\/tr>\n
8<\/td>\nIntroduction <\/td>\n<\/tr>\n
10<\/td>\n1 * Scope <\/td>\n<\/tr>\n
11<\/td>\n2 Normative references <\/td>\n<\/tr>\n
12<\/td>\n3 Terms and definitions <\/td>\n<\/tr>\n
14<\/td>\n4 General requirements for testing
4.1 Water level <\/td>\n<\/tr>\n
15<\/td>\n4.2 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 <\/td>\n<\/tr>\n
16<\/td>\n5.1.3 * Requirements for audible acoustic energy <\/td>\n<\/tr>\n
17<\/td>\n5.1.4 * Overflow
5.1.5 * Overpressure requirement <\/td>\n<\/tr>\n
18<\/td>\n5.2 Compatibility requirement
5.3 General requirements for mechanical strength <\/td>\n<\/tr>\n
19<\/td>\n6 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 <\/td>\n<\/tr>\n
20<\/td>\n6.2.2 Additional requirements <\/td>\n<\/tr>\n
21<\/td>\n6.2.3 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 <\/td>\n<\/tr>\n
22<\/td>\n6.4.2 General requirements <\/td>\n<\/tr>\n
23<\/td>\n6.4.3 * 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 <\/td>\n<\/tr>\n
25<\/td>\n6.4.7 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 <\/td>\n<\/tr>\n
26<\/td>\n6.5 Technical description
7 * Humidification output
8 Systems requirements <\/td>\n<\/tr>\n
27<\/td>\n9 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 <\/td>\n<\/tr>\n
28<\/td>\n11.2 Outlet connector
11.2.1 Directly connected to the supply source
11.2.2 Indirectly connected to the supply source
11.3 \u200bFlow-direction-sensitive components
11.4 \u200b* Accessory port <\/td>\n<\/tr>\n
29<\/td>\n11.5 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 <\/td>\n<\/tr>\n
30<\/td>\n12 * Requirements for the breathing system and accessories
12.1 General
12.2 Accompanying documentation
12.3 \u200bBreathing tubes
12.4 Liquid container level
12.5 Filling cap <\/td>\n<\/tr>\n
31<\/td>\n13 Compatibility with substances
14 * Biocompatibility
15 * Requirements for fire prevention <\/td>\n<\/tr>\n
32<\/td>\n16 Usability <\/td>\n<\/tr>\n
34<\/td>\nAnnex A (informative) Rationale and guidance <\/td>\n<\/tr>\n
42<\/td>\nAnnex B (informative) Symbols on marking <\/td>\n<\/tr>\n
44<\/td>\nAnnex C (normative) Determination of humidification output <\/td>\n<\/tr>\n
48<\/td>\nAnnex D (informative) Reference to the essential principles <\/td>\n<\/tr>\n
50<\/td>\nAnnex E (informative) Terminology \u2014 Alphabetized index of defined terms <\/td>\n<\/tr>\n
52<\/td>\nBibliography <\/td>\n<\/tr>\n<\/table>\n","protected":false},"excerpt":{"rendered":"

Anaesthetic and respiratory equipment. Passive humidifiers<\/b><\/p>\n\n\n\n\n
Published By<\/td>\nPublication Date<\/td>\nNumber of Pages<\/td>\n<\/tr>\n
BSI<\/b><\/a><\/td>\n2019<\/td>\n56<\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n","protected":false},"featured_media":408391,"template":"","meta":{"rank_math_lock_modified_date":false,"ep_exclude_from_search":false},"product_cat":[137,2641],"product_tag":[],"class_list":{"0":"post-408385","1":"product","2":"type-product","3":"status-publish","4":"has-post-thumbnail","6":"product_cat-11-040-10","7":"product_cat-bsi","9":"first","10":"instock","11":"sold-individually","12":"shipping-taxable","13":"purchasable","14":"product-type-simple"},"_links":{"self":[{"href":"https:\/\/pdfstandards.shop\/wp-json\/wp\/v2\/product\/408385","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/pdfstandards.shop\/wp-json\/wp\/v2\/product"}],"about":[{"href":"https:\/\/pdfstandards.shop\/wp-json\/wp\/v2\/types\/product"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/pdfstandards.shop\/wp-json\/wp\/v2\/media\/408391"}],"wp:attachment":[{"href":"https:\/\/pdfstandards.shop\/wp-json\/wp\/v2\/media?parent=408385"}],"wp:term":[{"taxonomy":"product_cat","embeddable":true,"href":"https:\/\/pdfstandards.shop\/wp-json\/wp\/v2\/product_cat?post=408385"},{"taxonomy":"product_tag","embeddable":true,"href":"https:\/\/pdfstandards.shop\/wp-json\/wp\/v2\/product_tag?post=408385"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}