Medical electrical equipment-Part 2-30:Particular requirements for the basic safety and essential performance of automated non-invasive sphygmomanometers
Medical electrical equipment -Part 2-30: Particular requirements for the basic safety and essential performance of automated non-invasive sphygmomanometers
201.1 Scope, object and related standards
Clause 1 of GB 9706.1-2020 applies, except as follows:
201.1.1 Scope
Replacement:
This document specifies requirements for the basic safety and essential performance for automated non-invasive sphygmomanometer and its accessories, including the requirements for the accuracy of a determination.
This document applies to the automated non-invasive sphygmomanometers, hereafter referred to as ME equipment, which, by means of an inflatable cuff, are used for non-continuous indirect estimation of the blood pressure without arterial puncture.
Note 1: Equipment that performs indirect determination of the blood pressure without arterial puncture does not directly measure the blood pressure. It only estimates the blood pressure.
Note 2: This document covers automatic electrically-powered ME equipment used for the intermittent, indirect estimation of the blood pressure without arterial puncture, including blood pressure monitors for the home healthcare environment.
This document does not apply to equipment for determination of the blood pressure with an electrically-powered pressure transducer and/or displays used in conjunction with a stethoscope or other manual methods (non-automated non-invasive sphygmomanometers). Requirements for such equipment are specified in document ISO 81060-1.
Note 3: If a clause or subclause is specifically intended to be applicable to ME equipment only, or to ME systems only, the title and content of that clause or subclause will say so. If that is not the case, the clause or subclause applies both to ME equipment and to ME systems, as relevant.
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Hazards inherent in the intended physiological function of ME equipment or ME systems within the scope of this document are not covered by specific requirements in this document except in 201.11 and 201.105.3.3, as well as 7.2.13 and 8.4.1 of GB 9706.1-2020.
201.1.2 Object
Replacement:
The object of this particular standard is to establish particular basic safety and essential performance requirements for an automated non-invasive sphygmomanometer as defined in 201.3.201.
201.1.3 Collateral standards
Addition:
This particular standard refers to those applicable collateral standards that are listed in Clause 2 of the general standard and 201.2 of this particular standard.
YY 9706.102, YY/T 9706.106, YY/T 9706.110, YY 9706.111 and YY 9706.112 apply as modified in Clauses 202, 206, 210, 211 and 212 respectively. GB 9706.103-2020 does not apply. All other published collateral standards in the 9706 series apply as published.
201.1.4 Particular standards
Replacement:
In the 9706 series, particular standards may modify, replace or delete requirements contained in the general standard and collateral standards as appropriate for the particular ME equipment under consideration, and may add other basic safety and essential performance requirements.
A requirement of a particular standard takes priority over the general standard.
For brevity, GB 9706.1-2020 is referred to in this particular standard as the general standard. Collateral standards are referred to by their document number.
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The numbering of clauses and subclauses of this particular standard corresponds to that of the general standard with the prefix "201" (e.g. 201.1 in this document addresses the content of Clause 1 of the general standard) or applicable collateral standard with the prefix "20×", where × is the final digit(s) of the collateral standard document number (e.g. 202.4 in this particular standard addresses the content of Clause 4 of the international standard IEC 60601-1-2 corresponding to the collateral standard YY 9706.102, 203.4 in this particular standard addresses the content of Clause 4 of the international standard IEC 60601-1-3 corresponding to the collateral standard GB 9706.103, etc.). The changes to the text of the general standard are specified by the use of the following words:
"Replacement" means that the clause or subclause of the general standard or applicable collateral standard is replaced completely by the text of this particular standard.
"Addition" means that the text of this particular standard is additional to the requirements of the general standard or applicable collateral standard.
"Amendment" means that the clause or subclause of the general standard or applicable collateral standard is amended as indicated by the text of this particular standard.
Subclauses, figures or tables which are additional to those of the general standard are numbered starting from 201.101. However, due to the fact that definitions in the general standard are numbered 3.1 through 3.147, additional definitions in this document are numbered beginning from 201.3.201. Additional annexes are lettered AA, BB, etc., and additional items aa), bb), etc.
Subclauses, figures or tables which are additional to those of a collateral standard are numbered starting from "20×", where "×" is the final digit(s) of the collateral standard document number, e.g. 202 for the international standard IEC 60601-1-2 corresponding to YY 9706.102, 203 for the international standard IEC 60601-1-3 corresponding to GB 9706.103, etc.
The term "this document" is used to make reference to the general standard, any applicable collateral standards and this particular standard taken together.
Where there is no corresponding clause or subclause in this particular standard, the clause or subclause of the general standard or applicable collateral standard, although possibly not relevant, applies without modification; where it is intended that any part of the general standard or applicable collateral standard, although possibly relevant, is not to be applied, a statement to that effect is given in this particular standard.
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Foreword III
Introduction VI
201.1 Scope, object and related standards
201.2 Normative references
201.3 Terms and definitions
201.4 General 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
201.8 Protection against electrical hazards from ME equipment
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
201.12 Accuracy of controls and instruments and protection against hazardous outputs
201.13 Hazardous situations and fault conditions for ME equipment
201.14 Programmable electrical medical systems (PEMS)
201.15 Construction of ME equipment
201.16 ME systems
201.17 Electromagnetic compatibility of ME equipment and ME systems
201.101 Requirements for cuffs
201.102 * Connection tubing and cuff connectors
201.103 Unauthorized access
201.104 * Maximum inflating time
201.105 * Automatic cycling modes
201.106 * Clinical accuracy
202 Electromagnetic compatibility – Requirements and tests
206 Usability
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
212 Requirements for medical electrical equipment and medical electrical systems intended for use in the emergency medical services environment
Annex C (Informative) Guide to marking and labelling requirements for ME equipment and ME systems
Annex AA (Informative) Particular guidance and rationale
Bibliography
Index of defined terms
Figure 201.101 Cuff pressure protection device, triggered by overpressure in single fault condition
Figure 201.102 Cuff pressure protection device, triggered by prolonged overpressure in single fault condition
Figure 201.103 Cuff pressure and maximum inflation time, normal condition and single fault condition
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
Figure 201.106 Short-term automatic mode cuff pressure
Figure 201.107 Self-measurement automatic mode cuff pressure
Figure 202.101 HF surgical equipment test layout
Figure 202.102 Simulated patient test set-up for HF surgical equipment
Table 201.101 Distributed essential performance requirements
Table 201.102 Cuff deflation pressure
Table 201.103 Cuff inflation pressure
Table 201.C.101 Marking on the outside of automated non-invasive sphygmomanometers or their parts
Table 201.C.102 Marking of controls and instruments of automated non-invasive sphygmomanometers or their parts
Table 201.C.103 Accompanying documents, general information for automated non-invasive sphygmomanometers
Table 201.C.104 Accompanying documents, instructions for use of automated non-invasive sphygmomanometers
Table 201.C.105 Accompanying documents, technical description of automated non-invasive sphygmomanometers
Table AA.101 Summary of requirements by mode
