{"id":460137,"date":"2024-10-20T10:08:00","date_gmt":"2024-10-20T10:08:00","guid":{"rendered":"https:\/\/pdfstandards.shop\/product\/uncategorized\/bs-en-iso-81060-22019a22024-2\/"},"modified":"2024-10-26T18:43:40","modified_gmt":"2024-10-26T18:43:40","slug":"bs-en-iso-81060-22019a22024-2","status":"publish","type":"product","link":"https:\/\/pdfstandards.shop\/product\/publishers\/bsi\/bs-en-iso-81060-22019a22024-2\/","title":{"rendered":"BS EN ISO 81060-2:2019+A2:2024"},"content":{"rendered":"
PDF Pages<\/th>\n | PDF Title<\/th>\n<\/tr>\n | ||||||
---|---|---|---|---|---|---|---|
2<\/td>\n | undefined <\/td>\n<\/tr>\n | ||||||
6<\/td>\n | European foreword <\/td>\n<\/tr>\n | ||||||
7<\/td>\n | Anchor 21 Foreword to amendment A1 <\/td>\n<\/tr>\n | ||||||
8<\/td>\n | Annex 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 | ||||||
11<\/td>\n | Foreword <\/td>\n<\/tr>\n | ||||||
12<\/td>\n | Introduction <\/td>\n<\/tr>\n | ||||||
13<\/td>\n | 1 Scope 2 Normative references <\/td>\n<\/tr>\n | ||||||
14<\/td>\n | 3 Terms and definitions 4 General requirements for clinical investigations 4.1 Clinical investigation methods <\/td>\n<\/tr>\n | ||||||
15<\/td>\n | 4.2 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 | ||||||
16<\/td>\n | 5.1.3 * Age distribution 5.1.4 * Limb size distribution <\/td>\n<\/tr>\n | ||||||
17<\/td>\n | 5.1.5 Blood pressure distribution 5.1.6 * Special patient populations <\/td>\n<\/tr>\n | ||||||
18<\/td>\n | Blank Page <\/td>\n<\/tr>\n | ||||||
19<\/td>\n | 5.2 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 | ||||||
21<\/td>\n | 5.2.4 Clinical investigation methods <\/td>\n<\/tr>\n | ||||||
28<\/td>\n | 5.2.5 * Additional requirements for a sphygmomanometer intended for use in exercise stress testing environments <\/td>\n<\/tr>\n | ||||||
29<\/td>\n | 5.2.6 * Additional requirements for a sphygmomanometer intended for use in ambulatory monitoring <\/td>\n<\/tr>\n | ||||||
30<\/td>\n | 6 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 | ||||||
31<\/td>\n | 6.1.4 \uea01* Limb size distribution <\/td>\n<\/tr>\n | ||||||
32<\/td>\n | Blank Page <\/td>\n<\/tr>\n | ||||||
33<\/td>\n | 6.1.5 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 | ||||||
34<\/td>\n | 6.2.2 * Arterial reference site <\/td>\n<\/tr>\n | ||||||
35<\/td>\n | 6.2.3 Procedure 6.2.4 * Determining the reference blood pressure <\/td>\n<\/tr>\n | ||||||
36<\/td>\n | 6.2.5 Determining the error of the blood pressure measurement 6.2.6 Data analysis <\/td>\n<\/tr>\n | ||||||
37<\/td>\n | 6.2.7 Mean arterial pressure (map) 7 * Pregnant patient populations <\/td>\n<\/tr>\n | ||||||
39<\/td>\n | Annex A (informative) Rationale and guidance <\/td>\n<\/tr>\n | ||||||
47<\/td>\n | Annex B (informative) Reference to the essential principles <\/td>\n<\/tr>\n | ||||||
48<\/td>\n | Annex C (informative) Terminology \u2014 alphabetized index of defined terms <\/td>\n<\/tr>\n | ||||||
49<\/td>\n | Bibliography <\/td>\n<\/tr>\n<\/table>\n","protected":false},"excerpt":{"rendered":" Non-invasive sphygmomanometers – Clinical investigation of intermittent automated measurement type<\/b><\/p>\n |