AAMI 81060 2 2019
$131.66
ANSI/AAMI/ ISO 81060-2:2019 – Non-invasive sphygmomanometers-Clinical investigation of intermittent automated measurement type
| Published By | Publication Date | Number of Pages |
| AAMI | 2019 | 47 |
Specifies the requirements and methods for the clinical investigation of medical electrical equipment used for the intermittent non-invasive automated estimation of the arterial blood pressure by utilizing cuff. This document is applicable to all sphygmomanometers that sense or display pulsations, flow, or sounds for the estimation, display, or recording of blood pressure. These sphygmomanometers need not have automatic cuff inflation. This document covers sphygmomanometers intended for use in all patient populations (i.e. all age and weight ranges), and all conditions of use, (e.g., ambulatory blood pressure monitoring, stress testing blood pressure monitoring and blood pressure monitors for the home healthcare environment for self-measurement as well as use in a professional healthcare facility).
PDF Catalog
| PDF Pages | PDF Title |
|---|---|
| 1 | ANSI/AAMI/ISO 81060-2:2019; Non-invasive sphygmomanometers—Part 2: Clinical investigation of intermittent automated measurement type |
| 2 | Objectives and uses of AAMI standardsand recommended practices |
| 3 | Title page |
| 4 | AAMI Standard Copyright information |
| 5 | Contents |
| 6 | Committee representation |
| 8 | Background of ANSI/AAMI adoption of ISO 81060-2:2018 |
| 9 | Foreword |
| 10 | Introduction |
| 11 | 1 Scope 2 Normative references |
| 12 | 3 Terms and definitions 4 General requirements for clinical investigations 4.1 Clinical investigation methods |
| 13 | 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 |
| 14 | 5.1.2 * Gender distribution 5.1.3 * Age distribution 5.1.4 * Limb size distribution |
| 15 | 5.1.5 Blood pressure distribution 5.1.6 * Special patient populations |
| 16 | 5.2 Clinical investigation method with a reference sphygmomanometer 5.2.1 * Subject preparation 5.2.2 * Observer preparation |
| 17 | 5.2.3 * Reference readings |
| 18 | 5.2.4 Clinical investigation methods 5.2.4.1 Same arm sequential method 5.2.4.1.1 * Procedure |
| 19 | Figure 1 — Illustration of the same arm sequential method |
| 20 | 5.2.4.1.2 Data analysis |
| 22 | Table 1 — Averaged subject data acceptance (criterion 2) in mmHg Table 2 — Averaged subject data acceptance (criterion 2) in kPa |
| 23 | 5.2.4.2 * Opposite limb simultaneous method 5.2.4.2.1 Procedure |
| 24 | Figure 2 — Illustration of opposite arm simultaneous method |
| 25 | 5.2.4.2.2 * Data analysis |
| 27 | 5.2.5 * Additional requirements for a sphygmomanometer intended for use in exercise stress testing environments 5.2.6 * Additional requirements for a sphygmomanometer intended for use in ambulatory monitoring |
| 28 | 6 Clinical investigation with reference invasive blood pressure monitoring equipment 6.1 Patient requirements 6.1.1 Number |
| 29 | 6.1.2 * Gender distribution 6.1.3 * Age distribution 6.1.3.1 Sphygmomanometers intended for use in adults, adolescents or children 6.1.3.2 Sphygmomanometer for neonatal or infant populations |
| 30 | 6.1.4 Limb size distribution 6.1.5 Blood pressure distribution 6.1.6 Special patient populations |
| 31 | 6.2 Clinical investigation methods with reference invasive blood pressure monitoring equipment 6.2.1 * Reference measurement 6.2.2 * Arterial reference site |
| 32 | 6.2.3 Procedure |
| 33 | 6.2.4 * Determining the reference blood pressure |
| 34 | 6.2.5 Determining the error of the blood pressure measurement 6.2.6 Data analysis 6.2.7 Mean arterial pressure (map) |
| 35 | 7 * Pregnant patient populations |
| 36 | Annex A (informative) Rationale and guidance A.1 General |
| 39 | Table A.1 — Committees’ multiple-centre study results |
| 41 | Table A.2 — Suggested age ranges of paediatric subgroups from FDA guidance |
| 44 | Annex B (informative) Reference to the essential principles Table B.1 — Correspondence between this document and the essential principles |
| 45 | Annex C (informative) Terminology—alphabetized index of defined terms |
| 46 | Bibliography |
