{"id":278146,"date":"2024-10-19T18:44:33","date_gmt":"2024-10-19T18:44:33","guid":{"rendered":"https:\/\/pdfstandards.shop\/product\/uncategorized\/bsi-18-30377771-dc\/"},"modified":"2024-10-25T15:16:37","modified_gmt":"2024-10-25T15:16:37","slug":"bsi-18-30377771-dc","status":"publish","type":"product","link":"https:\/\/pdfstandards.shop\/product\/publishers\/bsi\/bsi-18-30377771-dc\/","title":{"rendered":"BSI 18\/30377771 DC"},"content":{"rendered":"
PDF Pages<\/th>\n | PDF Title<\/th>\n<\/tr>\n | ||||||
---|---|---|---|---|---|---|---|
1<\/td>\n | 30377771 <\/td>\n<\/tr>\n | ||||||
3<\/td>\n | 62D_1610e_CD <\/td>\n<\/tr>\n | ||||||
11<\/td>\n | 1 Scope 2 Normative references <\/td>\n<\/tr>\n | ||||||
12<\/td>\n | 3 Terms and definitions <\/td>\n<\/tr>\n | ||||||
13<\/td>\n | 4 General requirements <\/td>\n<\/tr>\n | ||||||
14<\/td>\n | 5 Requirements for clinical investigations 5.1 General 5.2 Good clinical practice 5.3 Reference methods 6 Requirements on the accuracy of the blood pressure determination 6.1 * Accuracy of blood pressure determination 6.1.1 Invasive reference method 6.1.1.1 General 6.1.1.2 Procedure <\/td>\n<\/tr>\n | ||||||
15<\/td>\n | 6.1.2 Simultaneous auscultatory reference method 6.1.2.1 General 6.1.2.2 Procedure <\/td>\n<\/tr>\n | ||||||
16<\/td>\n | 6.1.2.3 Lateral difference <\/td>\n<\/tr>\n | ||||||
18<\/td>\n | 6.1.3 * Data analysis <\/td>\n<\/tr>\n | ||||||
19<\/td>\n | 6.2 Accuracy of blood pressure changes 6.2.1 General 6.2.2 Invasive reference determination 6.2.3 Auscultatory reference reading <\/td>\n<\/tr>\n | ||||||
20<\/td>\n | 6.2.4 * Data analysis 6.3 * Stability 6.3.1 General 6.3.2 Procedure <\/td>\n<\/tr>\n | ||||||
21<\/td>\n | 7 Clinical investigation with reference invasive blood pressure monitoring equipment 7.1 Subject requirements 7.1.1 Number 7.1.2 Gender distribution 7.1.3 * Age distribution 7.1.3.1 Sphygmomanometers intended for use in adults, adolescents or children <\/td>\n<\/tr>\n | ||||||
22<\/td>\n | 7.1.3.2 Sphygmomanometer for neonatal or infant populations <\/td>\n<\/tr>\n | ||||||
23<\/td>\n | 7.1.4 Subject distribution 7.1.5 Blood pressure distribution 7.1.6 * Special subject populations 7.2 Clinical investigation methods with reference invasive blood pressure monitoring equipment 7.2.1 * Reference reading 7.2.2 * Arterial reference site <\/td>\n<\/tr>\n | ||||||
24<\/td>\n | 7.2.3 Procedure 7.2.4 Determining the reference blood pressure <\/td>\n<\/tr>\n | ||||||
25<\/td>\n | 8 Auscultatory reference method 8.1 General 8.2 Subject requirements 8.2.1 * Number 8.2.2 * Gender distribution 8.2.3 * Age distribution <\/td>\n<\/tr>\n | ||||||
26<\/td>\n | 8.2.4 Determination of systolic blood pressure and diastolic blood pressure values from the continuous blood pressure determination 8.2.5 Blood pressure distribution 8.2.6 * Special subject populations <\/td>\n<\/tr>\n | ||||||
27<\/td>\n | 8.2.7 * Observer preparation 8.2.8 * Reference determination <\/td>\n<\/tr>\n | ||||||
29<\/td>\n | 8.3 * Procedure <\/td>\n<\/tr>\n | ||||||
30<\/td>\n | Annex A (informative) Rationale and guidance A.1 General guidance A.2 Rationale for particular clauses and subclauses <\/td>\n<\/tr>\n | ||||||
39<\/td>\n | Annex B (informative) Reference to the essential principles <\/td>\n<\/tr>\n | ||||||
40<\/td>\n | Annex C (informative) Terminology \u2014 alphabetized index of defined terms <\/td>\n<\/tr>\n | ||||||
42<\/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<\/table>\n","protected":false},"excerpt":{"rendered":" BS ISO 81060-3. Non-invasive sphygmomanometers – Part 3. Clinical investigation of continuous automated measurement type<\/b><\/p>\n |