{"id":408485,"date":"2024-10-20T05:30:55","date_gmt":"2024-10-20T05:30:55","guid":{"rendered":"https:\/\/pdfstandards.shop\/product\/uncategorized\/bs-en-iso-81060-22019a12020\/"},"modified":"2024-10-26T10:02:31","modified_gmt":"2024-10-26T10:02:31","slug":"bs-en-iso-81060-22019a12020","status":"publish","type":"product","link":"https:\/\/pdfstandards.shop\/product\/publishers\/bsi\/bs-en-iso-81060-22019a12020\/","title":{"rendered":"BS EN ISO 81060-2:2019+A1:2020"},"content":{"rendered":"

This document specifies the requirements and methods for the clinical investigation<\/small> of me equipment<\/small> used for the intermittent<\/small> non-invasive automated estimation of the arterial blood pressure<\/small> by utilizing a cuff<\/small>.<\/p>\n

This document is applicable to all sphygmomanometers<\/small> that sense or display pulsations, flow or sounds for the estimation, display or recording of blood pressure<\/small>. These sphygmomanometers<\/small> need not have automatic cuff<\/small> inflation.<\/p>\n

This document covers sphygmomanometers<\/small> intended for use in all patient<\/small> populations (e.g. all age and weight ranges), and all conditions of use (e.g. ambulatory blood pressure<\/small> monitoring, stress testing blood pressure<\/small> monitoring and blood pressure<\/small> monitors for the home healthcare environment<\/small> for self-measurement as well as use in a professional healthcare facility).<\/p>\n

\n

EXAMPLE Automated sphygmomanometer<\/small> as given in IEC 80601\u20112\u201130 undergoing clinical investigation<\/small> according to this document.<\/p>\n<\/blockquote>\n

This document specifies additional disclosure requirements for the accompanying documents<\/small> of sphygmomanometers<\/small> that have passed a clinical investigation<\/small> according to this document.<\/p>\n

This document is not applicable to clinical investigations<\/small> of non-automated sphygmomanometers<\/small> as given in ISO 81060\u20111 or invasive blood pressure monitoring equipment<\/small> as given in IEC 60601\u20112\u201134.<\/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
PDF Pages<\/th>\nPDF Title<\/th>\n<\/tr>\n
2<\/td>\nNational foreword <\/td>\n<\/tr>\n
4<\/td>\nEuropean foreword <\/td>\n<\/tr>\n
5<\/td>\nAnchor 21
Foreword to amendment A1 <\/td>\n<\/tr>\n
6<\/td>\nAnnex ZA (informative) Relationship between this European Standard and the essential requirements of Directive 93\/42\/EEC [OJ L 169] aimed to be covered <\/td>\n<\/tr>\n
9<\/td>\nForeword <\/td>\n<\/tr>\n
10<\/td>\nIntroduction <\/td>\n<\/tr>\n
11<\/td>\n1 Scope
2 Normative references <\/td>\n<\/tr>\n
12<\/td>\n3 Terms and definitions
4 General requirements for clinical investigations
4.1 Clinical investigation methods <\/td>\n<\/tr>\n
13<\/td>\n4.2 Good clinical practice
4.3 Status of previous clinical investigations
4.4 Disclosure of summary of clinical investigation
5 Clinical investigation with an auscultatory reference sphygmomanometer
5.1 Subject requirements
5.1.1 * Number
5.1.2 * Gender distribution <\/td>\n<\/tr>\n
14<\/td>\n5.1.3 * Age distribution
5.1.4 * Limb size distribution <\/td>\n<\/tr>\n
15<\/td>\n5.1.5 Blood pressure distribution
5.1.6 * Special patient populations <\/td>\n<\/tr>\n
16<\/td>\n5.2 Clinical investigation method with a reference sphygmomanometer
5.2.1 * Subject preparation
5.2.2 * Observer preparation
5.2.3 * Reference readings <\/td>\n<\/tr>\n
18<\/td>\n5.2.4 Clinical investigation methods <\/td>\n<\/tr>\n
25<\/td>\n5.2.5 * Additional requirements for a sphygmomanometer intended for use in exercise stress testing environments <\/td>\n<\/tr>\n
26<\/td>\n5.2.6 * Additional requirements for a sphygmomanometer intended for use in ambulatory monitoring <\/td>\n<\/tr>\n
27<\/td>\n6 Clinical investigation with reference invasive blood pressure monitoring equipment
6.1 Patient requirements
6.1.1 Number
6.1.2 * Gender distribution
6.1.3 * Age distribution <\/td>\n<\/tr>\n
28<\/td>\n6.1.4 \uea01* Limb size distribution <\/td>\n<\/tr>\n
29<\/td>\n6.1.5 Blood pressure distribution
6.1.6 Special patient populations
6.2 Clinical investigation methods with reference invasive blood pressure monitoring equipment
6.2.1 * Reference measurement <\/td>\n<\/tr>\n
30<\/td>\n6.2.2 * Arterial reference site <\/td>\n<\/tr>\n
31<\/td>\n6.2.3 Procedure
6.2.4 * Determining the reference blood pressure <\/td>\n<\/tr>\n
32<\/td>\n6.2.5 Determining the error of the blood pressure measurement
6.2.6 Data analysis <\/td>\n<\/tr>\n
33<\/td>\n6.2.7 Mean arterial pressure (map)
7 * Pregnant patient populations <\/td>\n<\/tr>\n
35<\/td>\nAnnex A (informative) Rationale and guidance <\/td>\n<\/tr>\n
43<\/td>\nAnnex B (informative) Reference to the essential principles <\/td>\n<\/tr>\n
44<\/td>\nAnnex C (informative) Terminology \u2014 alphabetized index of defined terms <\/td>\n<\/tr>\n
45<\/td>\nBibliography <\/td>\n<\/tr>\n<\/table>\n","protected":false},"excerpt":{"rendered":"

Non-invasive sphygmomanometers – Clinical investigation of intermittent automated measurement type<\/b><\/p>\n\n\n\n\n
Published By<\/td>\nPublication Date<\/td>\nNumber of Pages<\/td>\n<\/tr>\n
BSI<\/b><\/a><\/td>\n2020<\/td>\n48<\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n","protected":false},"featured_media":408495,"template":"","meta":{"rank_math_lock_modified_date":false,"ep_exclude_from_search":false},"product_cat":[143,2641],"product_tag":[],"class_list":{"0":"post-408485","1":"product","2":"type-product","3":"status-publish","4":"has-post-thumbnail","6":"product_cat-11-040-55","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\/408485","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\/408495"}],"wp:attachment":[{"href":"https:\/\/pdfstandards.shop\/wp-json\/wp\/v2\/media?parent=408485"}],"wp:term":[{"taxonomy":"product_cat","embeddable":true,"href":"https:\/\/pdfstandards.shop\/wp-json\/wp\/v2\/product_cat?post=408485"},{"taxonomy":"product_tag","embeddable":true,"href":"https:\/\/pdfstandards.shop\/wp-json\/wp\/v2\/product_tag?post=408485"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}