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eLibrary > 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 >

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, 2018

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
Title page
AAMI Standard
Untitled
Contents
Committee representation
Background of ANSI/AAMI adoption of IEC 80601-2-30:2018
Foreword
Introduction
201.1 Scope, object and related standards [Go to Page]
201.1. 1 Scope
201.1. 2 Object
201.1. 3 Collateral standards
201.1. 4 Particular standards
201.2 Normative references
201.3 Terms and definitions
201.4 General requirements [Go to Page]
201.4. 3 Essential performance
201.4. 3.101 Additional essential performance requirements [Go to Page]
Table 201.101 – Distributed ESSENTIAL PERFORMANCE requirements
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 [Go to Page]
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
201.7. 2.104 * Component replacement
201.7. 2.105 Disposal
201.7. 9.2 Instructions for use
201.7. 9.2.1 General
201.7. 9.2.2 Warning and safety notices
201.7. 9.2.5 Me equipment description
201.7. 9.2.9 Operating instructions
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 [Go to Page]
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 [Go to Page]
201.11. 8 Interruption of the power supply/supply mains to me equipment
201.11. 8.101 * Switching off [Go to Page]
Table 201.102 – CUFF deflation pressure
201.11. 8.102 Interruption of the supply mains
201.11. 8.103 * Internal electrical power source
201.12 Accuracy of controls and instruments and protection against hazardous outputs [Go to Page]
201.12. 1 Accuracy of controls and instruments
201.12. 1.101 Measuring and display ranges
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 [Go to Page]
Figure 201.101 – CUFF pressure PROTECTION DEVICE, triggered by overpressure in SINGLE FAULT CONDITION
201.12. 1.106 * Manometer test mode [Go to Page]
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
201.12. 3 Alarm systems
201.12. 3.101 Additional alarm system requirements
201.13 Hazardous situations and fault conditions for me equipment
201.14 Programmable electrical medical systems (pems)
201.15 Construction of me equipment [Go to Page]
201.15. 3.5 Rough handling test
201.15. 3.5.101 * Shock and vibration (robustness)
201.16 Me systems
201.17 Electromagnetic compatibility of me equipment and me systems
201.101 Requirements for cuffs [Go to Page]
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
201.102 * Connection tubing and cuff connectors
201.103 Unauthorized access
201.104 * Maximum inflating time [Go to Page]
Table 201.103 – CUFF inflation pressure
Figure 201.103 – CUFF pressure and maximum inflation time, NORMAL CONDITION and SINGLE FAULT CONDITION
201.105 * Automatic cycling modes [Go to Page]
201.105. 1 Long-term automatic mode [Go to Page]
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
201.105. 2 * Short-term automatic mode [Go to Page]
Figure 201.106 – SHORT-TERM AUTOMATIC MODE CUFF pressure
201.105. 3 * Self-measurement automatic mode
201.105. 3.1 General [Go to Page]
Figure 201.107 – SELF-MEASUREMENT AUTOMATIC MODE CUFF pressure
201.105. 3.2 Normal condition
201.105. 3.3 * Single fault condition
201.106 * Clinical accuracy
202 Electromagnetic disturbances – Requirements and tests [Go to Page]
202.4.3.1 Configurations
202.5.2.2.1 Requirements applicable to all me equipment and me systems
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 [Go to Page]
Figure 202.101 – HF SURGICAL EQUIPMENT test layout
Figure 202.102 – Simulated PATIENT test set-up for HF SURGICAL EQUIPMENT
206 Usability
210 Requirements for the development of physiologic closed-loop controllers [Go to Page]
210.4 General requirements
211 Requirements for medical electrical equipment and medical electrical systems used in the home healthcare environment [Go to Page]
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 [Go to Page]
212.10.1.1 General requirements for mechanical strength
Annexes
Annex C (informative) Guide to marking and labelling requirements for me equipment and me systems [Go to Page]
201.C.1 Marking on the outside of me equipment, me systems or their parts [Go to Page]
Table 201.C.101 – Marking on the outside of AUTOMATED SPHYGMOMANOMETERS or their parts
201.C.3 Marking of controls and instruments [Go to Page]
Table 201.C.102 – Marking of controls and instruments of AUTOMATED SPHYGMOMANOMETERS or their parts
201.C.4 Accompanying documents, general [Go to Page]
Table 201.C.103 – ACCOMPANYING DOCUMENTS, general information for AUTOMATED SPHYGMOMANOMETERS
201.C.5 Accompanying documents, Instructions for use [Go to Page]
Table 201.C.104 – ACCOMPANYING DOCUMENTS, instructions for use of AUTOMATED SPHYGMOMANOMETERS
201.C.6 Accompanying documents, technical description [Go to Page]
Table 201.C.105 – ACCOMPANYING DOCUMENTS, technical description of AUTOMATED SPHYGMOMANOMETERS
Annex AA (informative) Particular guidance and rationale
AA.1 General guidance
AA.2 Rationale for particular clauses and subclauses [Go to Page]
Table AA.1 – Summary of requirements by mode
Annex BB (informative) Environmental aspects [Go to Page]
Table BB.1 – Environmental aspects addressed by clauses of this document
Annex CC (informative) Reference to the essential principles [Go to Page]
Table CC.1 – Correspondence between this particular standard and the ESSENTIAL PRINCIPLES
Bibliography
Index of defined terms [Go to Page]

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