BS EN ISO 81060-2:2019+A2:2024
$198.66
Non-invasive sphygmomanometers – Clinical investigation of intermittent automated measurement type
| Published By | Publication Date | Number of Pages |
| BSI | 2024 | 52 |
PDF Catalog
| PDF Pages | PDF Title |
|---|---|
| 2 | undefined |
| 6 | European foreword |
| 7 | Anchor 21 Foreword to amendment A1 |
| 8 | Annex ZA (informative) Relationship between this European Standard and the essential requirements of Directive 93/42/EEC [OJ L 169] aimed to be covered |
| 11 | Foreword |
| 12 | Introduction |
| 13 | 1 Scope 2 Normative references |
| 14 | 3 Terms and definitions 4 General requirements for clinical investigations 4.1 Clinical investigation methods |
| 15 | 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 |
| 16 | 5.1.3 * Age distribution 5.1.4 * Limb size distribution |
| 17 | 5.1.5 Blood pressure distribution 5.1.6 * Special patient populations |
| 18 | Blank Page |
| 19 | 5.2 Clinical investigation method with a reference sphygmomanometer 5.2.1 * Subject preparation 5.2.2 * Observer preparation 5.2.3 * Reference readings |
| 21 | 5.2.4 Clinical investigation methods |
| 28 | 5.2.5 * Additional requirements for a sphygmomanometer intended for use in exercise stress testing environments |
| 29 | 5.2.6 * Additional requirements for a sphygmomanometer intended for use in ambulatory monitoring |
| 30 | 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 |
| 31 | 6.1.4 * Limb size distribution |
| 32 | Blank Page |
| 33 | 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 |
| 34 | 6.2.2 * Arterial reference site |
| 35 | 6.2.3 Procedure 6.2.4 * Determining the reference blood pressure |
| 36 | 6.2.5 Determining the error of the blood pressure measurement 6.2.6 Data analysis |
| 37 | 6.2.7 Mean arterial pressure (map) 7 * Pregnant patient populations |
| 39 | Annex A (informative) Rationale and guidance |
| 47 | Annex B (informative) Reference to the essential principles |
| 48 | Annex C (informative) Terminology — alphabetized index of defined terms |
| 49 | Bibliography |
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BS EN ISO 81060-2:2019+A2:2024
Non-invasive sphygmomanometers – Clinical investigation of intermittent automated measurement type Published By Publication Date Number…
