BSI 18/30377771 DC:2018 Edition
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BS ISO 81060-3. Non-invasive sphygmomanometers – Part 3. Clinical investigation of continuous automated measurement type
| Published By | Publication Date | Number of Pages |
| BSI | 2018 | 46 |
PDF Catalog
| PDF Pages | PDF Title |
|---|---|
| 1 | 30377771 |
| 3 | 62D_1610e_CD |
| 11 | 1 Scope 2 Normative references |
| 12 | 3 Terms and definitions |
| 13 | 4 General requirements |
| 14 | 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 |
| 15 | 6.1.2 Simultaneous auscultatory reference method 6.1.2.1 General 6.1.2.2 Procedure |
| 16 | 6.1.2.3 Lateral difference |
| 18 | 6.1.3 * Data analysis |
| 19 | 6.2 Accuracy of blood pressure changes 6.2.1 General 6.2.2 Invasive reference determination 6.2.3 Auscultatory reference reading |
| 20 | 6.2.4 * Data analysis 6.3 * Stability 6.3.1 General 6.3.2 Procedure |
| 21 | 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 |
| 22 | 7.1.3.2 Sphygmomanometer for neonatal or infant populations |
| 23 | 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 |
| 24 | 7.2.3 Procedure 7.2.4 Determining the reference blood pressure |
| 25 | 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 |
| 26 | 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 |
| 27 | 8.2.7 * Observer preparation 8.2.8 * Reference determination |
| 29 | 8.3 * Procedure |
| 30 | Annex A (informative) Rationale and guidance A.1 General guidance A.2 Rationale for particular clauses and subclauses |
| 39 | Annex B (informative) Reference to the essential principles |
| 40 | Annex C (informative) Terminology — alphabetized index of defined terms |
| 42 | Annex ZA (informative) Relationship between this European Standard and the essential requirements of Directive 93/42/EEC [OJ L 169] aimed to be covered |
