{"id":278202,"date":"2024-10-19T18:44:50","date_gmt":"2024-10-19T18:44:50","guid":{"rendered":"https:\/\/pdfstandards.shop\/product\/uncategorized\/bs-en-iso-274272019\/"},"modified":"2024-10-25T15:17:02","modified_gmt":"2024-10-25T15:17:02","slug":"bs-en-iso-274272019","status":"publish","type":"product","link":"https:\/\/pdfstandards.shop\/product\/publishers\/bsi\/bs-en-iso-274272019\/","title":{"rendered":"BS EN ISO 27427:2019"},"content":{"rendered":"

*This International Standard specifies requirements for the safety and performance testing of general purpose nebulizing systems <\/b> intended for continuous or breath-actuated delivery of liquids, in aerosol <\/b> form, to humans through the respiratory system.<\/p>\n

This International Standard includes gas-powered nebulizers <\/b> which can be powered by, e.g., compressors, pipeline systems, cylinders, etc., and electrically powered nebulizers <\/b> [e.g., spinning disc, ultrasonic, vibrating mesh (active and passive), and capillary devices] or manually powered nebulizers <\/b>.<\/p>\n

This International Standard does not specify the minimum performance of nebulizing systems <\/b>.<\/p>\n

*This International Standard does not apply to devices intended for nasal deposition.<\/p>\n

This International Standard does not apply to devices intended solely to provide humidification or hydration by providing water in aerosol <\/b> form.<\/p>\n

\n

NOTE ISO 8185 covers this.[<\/sup> 3<\/sup> ]<\/sup><\/p>\n<\/blockquote>\n

*This International Standard does not apply to drug-specific nebulizers <\/b> or their components (e.g., metered dose inhalers, metered liquid inhalers, dry powder inhalers).<\/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\n\n\n\n\n\n\n\n\n
PDF Pages<\/th>\nPDF Title<\/th>\n<\/tr>\n
2<\/td>\nNational foreword <\/td>\n<\/tr>\n
4<\/td>\nEuropean foreword
Endorsement notice <\/td>\n<\/tr>\n
6<\/td>\nForeword <\/td>\n<\/tr>\n
7<\/td>\nIntroduction <\/td>\n<\/tr>\n
8<\/td>\nSection sec_1
Section sec_2
1 Scope
2 Normative references <\/td>\n<\/tr>\n
9<\/td>\nSection sec_3
3 Terms and definitions <\/td>\n<\/tr>\n
10<\/td>\nSection sec_3.1
Section sec_3.2
Section sec_3.3
Section sec_3.4
Section sec_3.5
Section sec_3.6
Section sec_3.7
Section sec_3.8
Section sec_3.9
Section sec_3.10
Section sec_3.11
Section sec_3.12 <\/td>\n<\/tr>\n
11<\/td>\nSection sec_3.13
Section sec_3.14
Section sec_3.15
Section sec_3.16
Section sec_3.17
Section sec_3.18
Section sec_3.19
Section sec_3.20
Section sec_4
Section sec_4.1
Section sec_4.1.1
4 General requirements and requirements for test
4.1 Risk management <\/td>\n<\/tr>\n
12<\/td>\nSection sec_4.1.2
Section sec_4.2
Section sec_4.2.1
Section sec_4.2.1.1
Section sec_4.2.1.2
Section sec_4.2.2
Section sec_4.2.3
Section sec_4.3
Section sec_4.4
4.2 Test methods and alternatives
4.3 Electrical safety
4.4 Mechanical safety <\/td>\n<\/tr>\n
13<\/td>\nSection sec_4.5
Section sec_4.6
Section sec_4.7
Section sec_4.7.1
Section sec_4.7.2
Section sec_4.7.3
Section sec_5
Section sec_5.1
Section sec_5.2
Section sec_5.2.1
4.5 Pneumatic safety
4.6 Protection against inadvertent adjustments
4.7 Usability
5 Marking
5.1 Symbols
5.2 Marking on the device <\/td>\n<\/tr>\n
14<\/td>\nSection sec_5.2.2
Section sec_5.3
5.3 Labelling on the packaging or individual pack <\/td>\n<\/tr>\n
15<\/td>\nSection sec_5.4
Section sec_5.4.1
Section sec_5.4.2
5.4 Instructions for use, inserts, and accompanying documents <\/td>\n<\/tr>\n
16<\/td>\nSection sec_5.4.3 <\/td>\n<\/tr>\n
17<\/td>\nSection sec_5.4.4
Section sec_5.4.5
Section sec_5.4.6
Section sec_5.4.7
Section sec_5.4.8
Section sec_5.4.9 <\/td>\n<\/tr>\n
18<\/td>\nSection sec_5.4.10
Section sec_6
Section sec_6.1
Section sec_6.1.1
Section sec_6.1.2
Section sec_6.1.3
Section sec_6.2
Section sec_6.2.1
Section sec_6.2.2
Section sec_6.2.2.1
6 Construction requirements
6.1 Materials
6.2 Connectors <\/td>\n<\/tr>\n
19<\/td>\nSection sec_6.2.2.2
Table tab_a
Figure fig_1 <\/td>\n<\/tr>\n
20<\/td>\nTable tab_b
Figure fig_2
Section sec_6.2.3
Section sec_6.3
6.3 Rotary controls <\/td>\n<\/tr>\n
21<\/td>\nSection sec_7
Section sec_7.1
Section sec_7.2
Section sec_7.3
Section sec_8
Section sec_8.1
Section sec_8.2
7 Cleaning, sterilization, and disinfection
8 Biocompatibility <\/td>\n<\/tr>\n
22<\/td>\nAnnex sec_A
Annex\u00a0A
\n(informative)<\/p>\n

Rationale <\/td>\n<\/tr>\n

26<\/td>\nAnnex sec_B
Annex\u00a0B
\n(normative)<\/p>\n

Diameters of respirable fraction particles <\/td>\n<\/tr>\n

27<\/td>\nAnnex sec_C
Annex sec_C.1
Table tab_c
Figure fig_C.1
Annex\u00a0C
\n(normative)<\/p>\n

Test methods for aerosol output and aerosol output rate <\/td>\n<\/tr>\n

28<\/td>\nAnnex sec_C.2
Annex sec_C.3
Annex sec_C.4 <\/td>\n<\/tr>\n
29<\/td>\nAnnex sec_C.5 <\/td>\n<\/tr>\n
30<\/td>\nAnnex sec_D
Annex sec_D.1
Annex sec_D.2
Annex sec_D.3
Annex sec_D.3.1
Annex\u00a0D
\n(normative)<\/p>\n

Test methods for particle sizing <\/td>\n<\/tr>\n

31<\/td>\nTable tab_d
Figure fig_D.1
Annex sec_D.3.2
Annex sec_D.3.2.1
Annex sec_D.3.2.2 <\/td>\n<\/tr>\n
32<\/td>\nAnnex sec_D.3.2.3
Annex sec_D.3.2.4
Annex sec_D.3.2.5
Annex sec_D.3.2.6
Annex sec_D.3.2.7
Annex sec_D.3.2.8
Annex sec_D.3.2.9
Annex sec_D.3.2.10
Annex sec_D.3.2.11
Annex sec_D.3.2.12
Annex sec_D.4
Annex sec_D.4.1 <\/td>\n<\/tr>\n
34<\/td>\nTable tab_e
Figure fig_D.2
Annex sec_D.4.2
Annex sec_D.4.2.1
Annex sec_D.4.2.2
Annex sec_D.4.2.3
Annex sec_D.4.2.4 <\/td>\n<\/tr>\n
35<\/td>\nAnnex sec_D.4.2.5
Annex sec_D.4.2.6
Annex sec_D.4.2.7
Annex sec_D.4.2.8
Annex sec_D.4.2.9
Annex sec_D.4.2.10
Annex sec_D.4.2.11
Annex sec_D.4.2.12
Annex sec_D.5
Annex sec_D.5.1 <\/td>\n<\/tr>\n
37<\/td>\nAnnex sec_D.5.2
Table tab_D.1 <\/td>\n<\/tr>\n
38<\/td>\nTable tab_g
Figure fig_D.3 <\/td>\n<\/tr>\n
39<\/td>\nAnnex sec_E
Annex sec_E.1
Annex\u00a0E
\n(informative)<\/p>\n

Hazard identification for risk assessment <\/td>\n<\/tr>\n

41<\/td>\nAnnex sec_E.2
Annex sec_E.2.1
Annex sec_E.2.2 <\/td>\n<\/tr>\n
43<\/td>\nAnnex sec_E.3 <\/td>\n<\/tr>\n
45<\/td>\nAnnex sec_F
Annex sec_F.1
Annex sec_F.2
Annex sec_F.2.1
Annex sec_F.2.2
Annex sec_F.2.3
Annex sec_F.3
Annex sec_F.3.1
Annex\u00a0F
\n(informative)<\/p>\n

Classification of general purpose nebulizers <\/td>\n<\/tr>\n

46<\/td>\nAnnex sec_F.3.2
Annex sec_F.3.3
Annex sec_F.3.4 <\/td>\n<\/tr>\n
47<\/td>\nAnnex sec_G
Annex sec_G.1
Table tab_G.1
Annex\u00a0G
\n(informative)<\/p>\n

Environmental aspects
Annex\u00a0G
\n(informative)<\/p>\n

Environmental aspects <\/td>\n<\/tr>\n

49<\/td>\nAnnex sec_AA
Table tab_i
Annex\u00a0AA
\n(informative)<\/p>\n

Conformance to essential principles
Annex\u00a0AA
\n(informative)<\/p>\n

Conformance to essential principles <\/td>\n<\/tr>\n

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Reference ref_58 <\/td>\n<\/tr>\n<\/table>\n","protected":false},"excerpt":{"rendered":"

Anaesthetic and respiratory equipment. Nebulizing systems and components<\/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":278207,"template":"","meta":{"rank_math_lock_modified_date":false,"ep_exclude_from_search":false},"product_cat":[137,2641],"product_tag":[],"class_list":{"0":"post-278202","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\/278202","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\/278207"}],"wp:attachment":[{"href":"https:\/\/pdfstandards.shop\/wp-json\/wp\/v2\/media?parent=278202"}],"wp:term":[{"taxonomy":"product_cat","embeddable":true,"href":"https:\/\/pdfstandards.shop\/wp-json\/wp\/v2\/product_cat?post=278202"},{"taxonomy":"product_tag","embeddable":true,"href":"https:\/\/pdfstandards.shop\/wp-json\/wp\/v2\/product_tag?post=278202"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}