This document specifies tests for substances leached by liquid water condensing into gas pathways<\/small> of a medical device<\/small>, its parts or accessories,<\/small> which are intended to provide respiratory care or supply substances via the respiratory tract to a patient<\/small> in all environments. The tests of this document are intended to quantify hazardous water-soluble substances that are leached from the medical device<\/small>, its parts or accessories<\/small> by condensate and then conveyed by that liquid to the patient<\/small>. This document establishes acceptance criteria for these tests.<\/p>\n
This document addresses potential contamination of the gas stream arising from the gas pathways<\/small>, which is then conducted to the patient<\/small>.<\/p>\n
This document applies over the expected service life<\/small> of the medical device<\/small> in normal use<\/small> and takes into account the effects of any intended processing or reprocessing<\/p>\n
This document does not address biological evaluation of the surfaces of gas pathways<\/small> that are in direct contact with the patient<\/small>. The requirements for direct contact surfaces are found in the ISO 10993 series.<\/p>\n
Medical devices<\/small>, parts or accessories<\/small> containing gas pathways<\/small> that are addressed by this document include, but are not limited to, ventilators, anaesthesia workstations (including gas mixers), breathing systems, oxygen conserving devices, oxygen concentrators, nebulizers, low-pressure hose assemblies, humidifiers, heat and moisture exchangers, respiratory gas monitors, respiration monitors, masks, mouth pieces, resuscitators, breathing tubes, breathing systems filters, Y-pieces and any breathing accessories<\/small> intended to be used with such devices. The enclosed chamber of an incubator, including the mattress, and the inner surface of an oxygen hood are considered to be gas pathways<\/small> and are also addressed by this document.<\/p>\n
This document does not address contamination already present in the gas supplied from the gas sources while medical devices<\/small> are in normal use<\/small>.<\/p>\n EXAMPLE Contamination arriving at the medical device<\/small> from gas sources such as medical gas pipeline systems<\/small> (including the non-return valves in the pipeline outlets), outlets of pressure regulators connected or integral to a medical gas cylinder, or room air taken into the medical device<\/small> is not addressed by ISO 18562 series.<\/p>\n<\/blockquote>\n This document does not address contact with drugs or anaesthetic agents. If a medical device<\/small> is intended to be used with anaesthetic agents or drugs, then additional testing can be required.<\/p>\n This document is intended to be read in conjunction with ISO 18562\u20111.<\/p>\n NOTE This document has been prepared to address the relevant essential principles of safety and performance as indicated in Annex B.<\/p>\n<\/blockquote>\n Biocompatibility evaluation of breathing gas pathways in healthcare applications – Tests for leachables in condensate<\/b><\/p>\n\n
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PDF Catalog<\/h4>\n
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\n PDF Pages<\/th>\n PDF Title<\/th>\n<\/tr>\n \n 2<\/td>\n National foreword <\/td>\n<\/tr>\n \n 4<\/td>\n European foreword <\/td>\n<\/tr>\n \n 6<\/td>\n Foreword <\/td>\n<\/tr>\n \n 7<\/td>\n Introduction <\/td>\n<\/tr>\n \n 9<\/td>\n 1 Scope
2 Normative references <\/td>\n<\/tr>\n\n 10<\/td>\n 3 Terms and definitions
4 General principles
4.1 Type tests
4.2 General <\/td>\n<\/tr>\n\n 11<\/td>\n 5 Leachable substances in condensate
5.1 General
5.2 * Test method <\/td>\n<\/tr>\n\n 13<\/td>\n Annex A (informative) Rationale and guidance <\/td>\n<\/tr>\n \n 15<\/td>\n Annex B (informative) Reference to the essential principles <\/td>\n<\/tr>\n \n 16<\/td>\n Annex C (informative) Terminology \u2014 Alphabetized index of defined terms <\/td>\n<\/tr>\n \n 17<\/td>\n Bibliography <\/td>\n<\/tr>\n<\/table>\n","protected":false},"excerpt":{"rendered":" \n\n
\n Published By<\/td>\n Publication Date<\/td>\n Number of Pages<\/td>\n<\/tr>\n \n BSI<\/b><\/a><\/td>\n 2020<\/td>\n 18<\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n","protected":false},"featured_media":278231,"template":"","meta":{"rank_math_lock_modified_date":false,"ep_exclude_from_search":false},"product_cat":[137,2641],"product_tag":[],"class_list":{"0":"post-278225","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\/278225","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\/278231"}],"wp:attachment":[{"href":"https:\/\/pdfstandards.shop\/wp-json\/wp\/v2\/media?parent=278225"}],"wp:term":[{"taxonomy":"product_cat","embeddable":true,"href":"https:\/\/pdfstandards.shop\/wp-json\/wp\/v2\/product_cat?post=278225"},{"taxonomy":"product_tag","embeddable":true,"href":"https:\/\/pdfstandards.shop\/wp-json\/wp\/v2\/product_tag?post=278225"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}