Non-invasive automated sphygmomanometer
1 Scope
This standard establishes safety and validity requirements for all sphygmomanometers, whether automated, or electronic, that are used with an occluding cuff for the indirect determination of arterial blood pressure.
1.1 Inclusions
This standard is applicable to electronic sphygmomanometer completing non-invasive blood pressure measurement via oscillography or other similar methods or other devices having such function, including all devices that inflate and deflate through cuff and sense or display pulsations, flow, or sounds in connection with the measurement, display, or recording of blood pressure.
This standard covers the blood pressure measurement devices for neonatal or newborn through adult categories.
Ambulatory blood pressure monitors, which are portable, lightweight, automated devices worn or carried by the patient that are able to obtain and store the results of repeated determinations of blood pressure and heart rate during activities of ordinary daily living, are included in this standard.
Note: For an explanation of the need for this standard and the rationale for its provisions, see annex A.
1.2 Exclusions
This standard is not applicable to devices for direct, intra-arterial measurement of blood pressure.
The use of automated monitors that measure blood pressure on the finger or through thoracic impedance are not covered in this standard.
2 Normative references
The following normative documents contain provisions which, through reference in this text, constitute provisions of this standard. For dated references, subsequent amendments(excluding corrections), or revisions, of any of these publications do not apply to this standard. However parties to agreements based on this standard are encouraged to investigate the possibility of applying the most recent editions of the normative documents indicated below. For undated references, the latest edition of the normative document referred to applies.
GB 9706.1-2007 Medical electrical equipment - Part 1:General requirements for safety (IEC 60601-1: 1988, IDT)
GB/T 14710-1993 The environmental requirements and test methods for medical electrical equipment
YY 0505-2005 Medical electrical equipment - Part 1-2: General requirements for safety - Collateral standards: Electromagnetic compatibility - Requirements and tests (IEC 60601-1-2: 2001, IDT)
YY 0667-2008 Medical electrical equipment - Part 2-30: Particular requirements for the safety including essential performance of automatic cycling non-invasive blood pressure monitoring equipment (IEC 60601-2-30: 1999, IDT)
3 Terms and definitions
For the purpose of this standard, the following terms and definitions apply.
3.1
adult
individuals greater than 12 years of age
Foreword i
1 Scope
1.1 Inclusions
1.2 Exclusions
2 Normative references
3 Terms and definitions
4 Requirements
4.1 Operating conditions
4.2 Labeling requirements
4.3 life
4.4 Safety requirements
4.5 Performance requirements
4.6 Requirements for inflation source and pressure control valves
4.7 Requirements for the inflatable bladder and cuff
4.8 System leakage
4.9 Environmental requirements
4.10 Electrical safety
4.11 Electromagnetic compatibility
5 Tests
5.1 Test conditions
5.2 Labeling
5.3 Life
5.4 Safety requirements
5.5 Performance requirements
5.6 Requirements for inflation source and pressure control valves
5.7 Requirements for the inflatable bladder and cuff
5.8 System pressure drop
5.9 Environmental test
5.10 Electrical safety
5.11 Electromagnetic compatibility
Annex A (Informative) Rationale for the development of this standard
Annex B (Informative) Verification of overall system efficacy by comparison with manual auscultatory measurements
Annex C (informative) Verification of overall system efficacy by comparison with intra-arterial measurements
Annex D (Informative) Data analysis and reporting
Annex E (Informative) Special considerations for the assessment of ambulatory blood pressure monitoring systems
Annex F (Informative) Statistical considerations
Bibliography
Foreword
