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Position: Chinese Standard in English/YY 0670-2008
YY 0670-2008   Non-invasive automated sphygmomanometer (English Version)
Standard No.: YY 0670-2008 Status:to be superseded remind me the status change

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Language:English File Format:PDF
Word Count: 25000 words Price(USD):750.0 remind me the price change

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Implemented on:2010-6-1 Delivery: via email in 1 business day
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Standard No.: YY 0670-2008
English Name: Non-invasive automated sphygmomanometer
Chinese Name: 无创自动测量血压计
Chinese Classification: C30    Medical apparatus and devices in general
Professional Classification: YY    Professional Standard - Pharmaceutics
ICS Classification: 11.040.30 11.040.30    Surgical instruments and materials 11.040.30
Issued by: China Food and Drug Administration
Issued on: 2008-10-17
Implemented on: 2010-6-1
Status: to be superseded
Superseded by:YY 9706.230-2023 Medical electrical equipment-Part 2-30:Particular requirements for the basic safety and essential performance of automated non-invasive sphygmomanometers
Superseded on:2026-1-15
Language: English
File Format: PDF
Word Count: 25000 words
Price(USD): 750.0
Delivery: via email in 1 business day
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
Referred in YY 0670-2008:
*GB 9706.1-2007 Medical electrical equipment—Part 1:General requirements for safety
*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 stanards: Electromagnetic compatibility?Requirements and tests
*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
Code of China
Standard
YY 0670-2008  Non-invasive automated sphygmomanometer (English Version)
Standard No.YY 0670-2008
Statusto be superseded
LanguageEnglish
File FormatPDF
Word Count25000 words
Price(USD)750.0
Implemented on2010-6-1
Deliveryvia email in 1 business day
Detail of YY 0670-2008
Standard No.
YY 0670-2008
English Name
Non-invasive automated sphygmomanometer
Chinese Name
无创自动测量血压计
Chinese Classification
C30
Professional Classification
YY
ICS Classification
Issued by
China Food and Drug Administration
Issued on
2008-10-17
Implemented on
2010-6-1
Status
to be superseded
Superseded by
YY 9706.230-2023 Medical electrical equipment-Part 2-30:Particular requirements for the basic safety and essential performance of automated non-invasive sphygmomanometers
Superseded on
2026-1-15
Abolished on
Superseding
Language
English
File Format
PDF
Word Count
25000 words
Price(USD)
750.0
Keywords
YY 0670-2008, YY/T 0670-2008, YYT 0670-2008, YY0670-2008, YY 0670, YY0670, YY/T0670-2008, YY/T 0670, YY/T0670, YYT0670-2008, YYT 0670, YYT0670
Introduction of YY 0670-2008
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
Contents of YY 0670-2008
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
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Keywords:
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