{"id":277824,"date":"2024-10-19T18:42:50","date_gmt":"2024-10-19T18:42:50","guid":{"rendered":"https:\/\/pdfstandards.shop\/product\/uncategorized\/bs-en-iso-237472015\/"},"modified":"2024-10-25T15:14:16","modified_gmt":"2024-10-25T15:14:16","slug":"bs-en-iso-237472015","status":"publish","type":"product","link":"https:\/\/pdfstandards.shop\/product\/publishers\/bsi\/bs-en-iso-237472015\/","title":{"rendered":"BS EN ISO 23747:2015"},"content":{"rendered":"

This International Standard specifies requirements for a peak expiratory flow meter<\/small> (pefm<\/small>) intended for the assessment of pulmonary function in spontaneously breathing humans.<\/p>\n

This International Standard covers all medical devices<\/small> that measure peak expiratory flowrate<\/small> in spontaneously breathing humans either as part of an integrated lung function medical device<\/small> or as a stand-alone medical device<\/small>.<\/p>\n

Planning and design of products applying to this International Standard are to consider the environmental impact from the product during its life cycle. Environmental aspects are addressed in Annex E.<\/p>\n

\n

NOTE Additional aspects of environmental impact are addressed in ISO 14971.<\/p>\n<\/blockquote>\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
PDF Pages<\/th>\nPDF Title<\/th>\n<\/tr>\n
4<\/td>\nEuropean foreword <\/td>\n<\/tr>\n
5<\/td>\nAnnex ZA (informative) Relationship between this Document and the Essential Requirements of EU Directive 93\/42\/EEC <\/td>\n<\/tr>\n
10<\/td>\nForeword <\/td>\n<\/tr>\n
11<\/td>\nIntroduction <\/td>\n<\/tr>\n
13<\/td>\n1\tScope
2\tNormative references
3\tTerms and definitions <\/td>\n<\/tr>\n
15<\/td>\n4\tGeneral requirements
4.1\tSafety for a pefm that utilizes electricity
4.2\tMechanical basic safety for all pefms
5\tIdentification, marking and documents
5.1\tMarking of the scale or display <\/td>\n<\/tr>\n
16<\/td>\n5.2\tMarking of the pefm or packaging
5.2.1\tMarking of the pefm
5.2.2\tMarking of the pefm packaging <\/td>\n<\/tr>\n
17<\/td>\n5.3\tInstructions for use
5.4\tTechnical description
6\t\u200bpefm measurement range <\/td>\n<\/tr>\n
18<\/td>\n7\tPerformance requirements
7.1\tError of measurement
7.2\tLinearity
7.3\tResistance to flow
7.4\tFrequency response
8\tDismantling and reassembly
9\tEffects of mechanical ageing <\/td>\n<\/tr>\n
19<\/td>\n10\tEffects of dropping a hand-held pefm
11\tCleaning, sterilization, and disinfection
11.1\tReusable pefm and parts
11.2\t\u200bpefm and parts delivered sterile
12\tCompatibility with substances
13\tBiocompatibility <\/td>\n<\/tr>\n
20<\/td>\nAnnex\u00a0A (informative) Rationale for tests and examples of test apparatus <\/td>\n<\/tr>\n
23<\/td>\nAnnex\u00a0B (normative) Determination of error, repeatability, and resistance to pefm output <\/td>\n<\/tr>\n
26<\/td>\nAnnex\u00a0C (normative) Determination of frequency response <\/td>\n<\/tr>\n
28<\/td>\nAnnex\u00a0D (normative) Test methods for determination of the effectsof dismantling, ageing and dropping <\/td>\n<\/tr>\n
30<\/td>\nAnnex\u00a0E (informative) Environmental aspects <\/td>\n<\/tr>\n
32<\/td>\nAnnex\u00a0F (informative) Reference to the Essential Principles <\/td>\n<\/tr>\n
36<\/td>\nAnnex\u00a0G (informative) Terminology \u2014 Alphabetized index of defined terms <\/td>\n<\/tr>\n
37<\/td>\nBibliography <\/td>\n<\/tr>\n<\/table>\n","protected":false},"excerpt":{"rendered":"

Anaesthetic and respiratory equipment. Peak expiratory flow meters for the assessment of pulmonary function in spontaneously breathing humans<\/b><\/p>\n\n\n\n\n
Published By<\/td>\nPublication Date<\/td>\nNumber of Pages<\/td>\n<\/tr>\n
BSI<\/b><\/a><\/td>\n2015<\/td>\n42<\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n","protected":false},"featured_media":277830,"template":"","meta":{"rank_math_lock_modified_date":false,"ep_exclude_from_search":false},"product_cat":[137,2641],"product_tag":[],"class_list":{"0":"post-277824","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\/277824","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\/277830"}],"wp:attachment":[{"href":"https:\/\/pdfstandards.shop\/wp-json\/wp\/v2\/media?parent=277824"}],"wp:term":[{"taxonomy":"product_cat","embeddable":true,"href":"https:\/\/pdfstandards.shop\/wp-json\/wp\/v2\/product_cat?post=277824"},{"taxonomy":"product_tag","embeddable":true,"href":"https:\/\/pdfstandards.shop\/wp-json\/wp\/v2\/product_tag?post=277824"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}