AAMI 80601 2 30 2018
$140.32
ANSI/AAMI/IEC 80601-2-30:2018 – Medical electrical equipment-Part 2-30: Particular requirements for basic safety and essential performance of automated type non-invasive sphygmomanometers
| Published By | Publication Date | Number of Pages |
| AAMI | 2018 | 62 |
Applies to basic safety and essential performance of automated sphygmomanometers which are used for the non-invasive blood pressure measurement.
PDF Catalog
| PDF Pages | PDF Title |
|---|---|
| 1 | ANSI/AAMI/IEC 80601-2-30:2018; Medical electrical equipment—Part 2-30: Particular requirements for the basic safety and essential performance of automated type non-invasive sphygmomanometers |
| 3 | Title page |
| 4 | AAMI Standard Untitled |
| 5 | Contents |
| 6 | Committee representation |
| 8 | Background of ANSI/AAMI adoption of IEC 80601-2-30:2018 |
| 9 | Foreword |
| 12 | Introduction |
| 13 | 201.1 Scope, object and related standards 201.1. 1 Scope |
| 14 | 201.1. 2 Object 201.1. 3 Collateral standards 201.1. 4 Particular standards |
| 15 | 201.2 Normative references |
| 16 | 201.3 Terms and definitions |
| 18 | 201.4 General requirements 201.4. 3 Essential performance 201.4. 3.101 Additional essential performance requirements Table 201.101 – Distributed ESSENTIAL PERFORMANCE requirements |
| 19 | 201.5 General requirements for testing me equipment 201.6 Classification of me equipment and me systems 201.7 Me equipment identification, marking and documents 201.7. 2 Marking on the outside of me equipment or me equipment parts 201.7. 2.4 * Accessories 201.7. 2.101 Display of automated sphygmomanometers 201.7. 2.102 * Automated sphygmomanometer with neonatal mode 201.7. 2.103 * Automated sphygmomanometer intended for self-use in public areas |
| 20 | 201.7. 2.104 * Component replacement 201.7. 2.105 Disposal 201.7. 9.2 Instructions for use 201.7. 9.2.1 General |
| 21 | 201.7. 9.2.2 Warning and safety notices 201.7. 9.2.5 Me equipment description 201.7. 9.2.9 Operating instructions |
| 22 | 201.7. 9.2.13 * Maintenance 201.7. 9.2.101 Compatibility with hf surgical equipment 201.7. 9.2.102 Automated sphygmomanometers for use in neonatal mode 201.8 Protection against electrical hazards from me equipment |
| 23 | 201.8. 5.5 Defibrillation-proof applied parts 201.8. 5.5.101 * Patient connections of automated sphygmomanometers 201.9 Protection against mechanical hazards of me equipment and me systems 201.10 Protection against unwanted and excessive radiation hazards 201.11 Protection against excessive temperatures and other hazards 201.11. 8 Interruption of the power supply/supply mains to me equipment 201.11. 8.101 * Switching off Table 201.102 – CUFF deflation pressure 201.11. 8.102 Interruption of the supply mains |
| 24 | 201.11. 8.103 * Internal electrical power source 201.12 Accuracy of controls and instruments and protection against hazardous outputs 201.12. 1 Accuracy of controls and instruments 201.12. 1.101 Measuring and display ranges |
| 25 | 201.12. 1.102 Limits of the error of the manometer from environmental conditions 201.12. 1.103 * Nominal blood pressure indication range 201.12. 1.104 Maximum pressure in normal condition 201.12. 1.105 * Maximum pressure in single fault condition |
| 26 | Figure 201.101 – CUFF pressure PROTECTION DEVICE, triggered by overpressure in SINGLE FAULT CONDITION 201.12. 1.106 * Manometer test mode |
| 27 | Figure 201.102 – CUFF pressure PROTECTION DEVICE, triggered by prolonged overpressure in SINGLE FAULT CONDITION 201.12. 1.107 * Reproducibility of the blood pressure determination |
| 28 | 201.12. 3 Alarm systems 201.12. 3.101 Additional alarm system requirements 201.13 Hazardous situations and fault conditions for me equipment |
| 29 | 201.14 Programmable electrical medical systems (pems) 201.15 Construction of me equipment 201.15. 3.5 Rough handling test 201.15. 3.5.101 * Shock and vibration (robustness) |
| 30 | 201.16 Me systems 201.17 Electromagnetic compatibility of me equipment and me systems 201.101 Requirements for cuffs 201.101. 1 * Construction 201.101. 2 * Pressurization 201.101. 3 * Automated sphygmomanometer intended for self-use in public areas with a single cuff size |
| 31 | 201.102 * Connection tubing and cuff connectors 201.103 Unauthorized access 201.104 * Maximum inflating time Table 201.103 – CUFF inflation pressure |
| 32 | Figure 201.103 – CUFF pressure and maximum inflation time, NORMAL CONDITION and SINGLE FAULT CONDITION 201.105 * Automatic cycling modes 201.105. 1 Long-term automatic mode |
| 33 | Figure 201.104 – LONG-TERM AUTOMATIC MODE CUFF pressure in NORMAL CONDITION Figure 201.105 – LONG-TERM AUTOMATIC MODE CUFF pressure in SINGLE FAULT CONDITION |
| 34 | 201.105. 2 * Short-term automatic mode Figure 201.106 – SHORT-TERM AUTOMATIC MODE CUFF pressure 201.105. 3 * Self-measurement automatic mode 201.105. 3.1 General |
| 35 | Figure 201.107 – SELF-MEASUREMENT AUTOMATIC MODE CUFF pressure |
| 36 | 201.105. 3.2 Normal condition 201.105. 3.3 * Single fault condition 201.106 * Clinical accuracy 202 Electromagnetic disturbances – Requirements and tests 202.4.3.1 Configurations 202.5.2.2.1 Requirements applicable to all me equipment and me systems |
| 37 | 202.8 Electromagnetic immunity requirements for me equipment and me systems 202.8.1 General 202.8.1.101 Additional general requirements 202.8.101 * Electrosurgery interference recovery |
| 38 | Figure 202.101 – HF SURGICAL EQUIPMENT test layout |
| 39 | Figure 202.102 – Simulated PATIENT test set-up for HF SURGICAL EQUIPMENT 206 Usability |
| 40 | 210 Requirements for the development of physiologic closed-loop controllers 210.4 General requirements 211 Requirements for medical electrical equipment and medical electrical systems used in the home healthcare environment 211.4.2.2 Environmental conditions of transport and storage between uses 211.4.2.3.1 Continous operating conditions 211.7.4.5 Additional requirements for operating instructions 211.8.3.1 Ingress of water or particulate matter into me equipment 212 Requirements for medical electrical equipment and medical electrical systems intended for use in the emergency medical services environment |
| 41 | 212.10.1.1 General requirements for mechanical strength |
| 42 | Annexes |
| 43 | Annex C (informative) Guide to marking and labelling requirements for me equipment and me systems 201.C.1 Marking on the outside of me equipment, me systems or their parts Table 201.C.101 – Marking on the outside of AUTOMATED SPHYGMOMANOMETERS or their parts 201.C.3 Marking of controls and instruments |
| 44 | Table 201.C.102 – Marking of controls and instruments of AUTOMATED SPHYGMOMANOMETERS or their parts 201.C.4 Accompanying documents, general Table 201.C.103 – ACCOMPANYING DOCUMENTS, general information for AUTOMATED SPHYGMOMANOMETERS 201.C.5 Accompanying documents, Instructions for use Table 201.C.104 – ACCOMPANYING DOCUMENTS, instructions for use of AUTOMATED SPHYGMOMANOMETERS |
| 46 | 201.C.6 Accompanying documents, technical description Table 201.C.105 – ACCOMPANYING DOCUMENTS, technical description of AUTOMATED SPHYGMOMANOMETERS |
| 47 | Annex AA (informative) Particular guidance and rationale AA.1 General guidance AA.2 Rationale for particular clauses and subclauses |
| 53 | Table AA.1 – Summary of requirements by mode |
| 55 | Annex BB (informative) Environmental aspects Table BB.1 – Environmental aspects addressed by clauses of this document |
| 56 | Annex CC (informative) Reference to the essential principles Table CC.1 – Correspondence between this particular standard and the ESSENTIAL PRINCIPLES |
| 59 | Bibliography |
| 61 | Index of defined terms |
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