This document specifies:<\/p>\n
the general principles governing the biological evaluation within a risk management process<\/small> of the 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;<\/p>\n<\/li>\n the general categorization of gas pathways<\/small> based on the nature and duration of their contact with the gas stream;<\/p>\n<\/li>\n the evaluation of existing relevant data from all sources;<\/p>\n<\/li>\n the identification of gaps in the available data set on the basis of a risk analysis<\/small>;<\/p>\n<\/li>\n the identification of additional data sets necessary to analyse the biological safety of the gas pathway <\/small>;<\/p>\n<\/li>\n the assessment of the biological safety of the gas pathway <\/small>.<\/p>\n<\/li>\n<\/ul>\n This document covers general principles regarding biocompatibility <\/small> assessment of medical device <\/small> materials, which make up the gas pathway <\/small>, but does not cover biological hazards<\/small> arising from any mechanical failure, unless the failure introduces a toxicity risk<\/small> (e.g. by generating particulates <\/small>). The other parts of ISO 18562 cover specific tests that address potentially hazardous substances that are added to the respirable gas stream and establish acceptance criteria for these substances.<\/p>\n This document addresses potential contamination of the gas stream arising from the gas pathways<\/small> within the medical device <\/small>, which might then be 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 medical devices <\/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 equipment, oxygen concentrators, nebulizers, low-pressure hose assemblies, humidifiers, heat and moisture exchangers, respiratory gas monitors, respiration monitors, masks, mouth pieces, resuscitators, breathing tubes, breathing system filters and Y-pieces as well as any breathing accessories <\/small> intended to be used with such medical devices <\/small>. 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 ( all parts ).<\/p>\n<\/blockquote>\n Future parts might be added to address other relevant aspects of biological testing including additional contamination that might arise from the gas pathway <\/small> because of the presence of drugs and anaesthetic agents added to the gas stream.<\/p>\n NOTE 1 Some authorities having jurisdiction<\/small> require evaluation of these risks<\/small> as part of a biological evaluation.<\/p>\n<\/blockquote>\n NOTE 2 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 – Evaluation and testing within a risk management process<\/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 <\/td>\n<\/tr>\n \n 10<\/td>\n 2 Normative references
3 Terms and definitions <\/td>\n<\/tr>\n\n 14<\/td>\n 4 General principles applying to biocompatibility evaluation of medical devices
4.1 General <\/td>\n<\/tr>\n\n 15<\/td>\n 4.2 Type tests <\/td>\n<\/tr>\n \n 16<\/td>\n 4.3 Biocompatibility hazard identification
4.4 Extent of risk assessment <\/td>\n<\/tr>\n\n 17<\/td>\n 4.5 Biocompatibility evaluation plan <\/td>\n<\/tr>\n \n 18<\/td>\n 4.6 Selection of tests
4.7 Subsequent evaluation <\/td>\n<\/tr>\n\n 19<\/td>\n 5 Contamination of breathing gas from gas pathways
5.1 * Duration of use <\/td>\n<\/tr>\n\n 21<\/td>\n 5.2 Particulate matter (pm) emissions
5.3 Volatile organic compound (voc) emissions
5.4 Leachable substances in condensate
6 Adjustment for different patient groups
6.1 General considerations
6.2 Adjustment for body weight <\/td>\n<\/tr>\n\n 22<\/td>\n 6.3 * Deriving a permitted concentration from a tolerable exposure
7 * Deriving allowable limits
7.1 General process <\/td>\n<\/tr>\n\n 23<\/td>\n 7.2 For medical devices intended for limited exposure use (\u226424 h) <\/td>\n<\/tr>\n \n 24<\/td>\n 7.3 For medical devices intended for prolonged exposure use (>24 h but <30 d)
7.4 For medical devices intended for permanent contact (\u226530 d)
8 Risk benefit analysis <\/td>\n<\/tr>\n\n 25<\/td>\n 9 Assess the biocompatibility of the medical device <\/td>\n<\/tr>\n \n 26<\/td>\n Annex A (informative) Rationale and guidance <\/td>\n<\/tr>\n \n 28<\/td>\n Annex B (informative) Reference to the essential principles <\/td>\n<\/tr>\n \n 29<\/td>\n Annex C (informative) Terminology \u2014 Alphabetized index of defined terms <\/td>\n<\/tr>\n \n 31<\/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 32<\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n","protected":false},"featured_media":278228,"template":"","meta":{"rank_math_lock_modified_date":false,"ep_exclude_from_search":false},"product_cat":[137,2641],"product_tag":[],"class_list":{"0":"post-278222","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\/278222","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\/278228"}],"wp:attachment":[{"href":"https:\/\/pdfstandards.shop\/wp-json\/wp\/v2\/media?parent=278222"}],"wp:term":[{"taxonomy":"product_cat","embeddable":true,"href":"https:\/\/pdfstandards.shop\/wp-json\/wp\/v2\/product_cat?post=278222"},{"taxonomy":"product_tag","embeddable":true,"href":"https:\/\/pdfstandards.shop\/wp-json\/wp\/v2\/product_tag?post=278222"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}