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Medical electrical equipment. Part 2-30: Particular requirements for the safety, including essential performance, of automatic cycling non-invasive blood pressure monitoring equipment
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YY 0667-2008
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Basic data | Standard ID | YY 0667-2008 (YY0667-2008) | | Description (Translated English) | Medical electrical equipment. Part 2-30: Particular requirements for the safety, including essential performance, of automatic cycling non-invasive blood pressure monitoring equipment | | Sector / Industry | Medical Device & Pharmaceutical Industry Standard | | Classification of Chinese Standard | C39 | | Classification of International Standard | 11.040.01 | | Word Count Estimation | 33,344 | | Date of Issue | 2008-10-17 | | Date of Implementation | 2010-06-01 | | Quoted Standard | GB 9706.1-2007; YY 0505-2005; IEC 60601-1-4-1996 | | Adopted Standard | IEC 60601-2-30-1999, IDT | | Regulation (derived from) | SFDA [2008] No. 605 | | Issuing agency(ies) | State Food and Drug Administration | | Summary | This standard specifies the definition about 2. 102 automatic cycling non-invasive blood pressure monitoring equipment, safety and essential performance requirements. Thereafter referred to the specific standard automatic cycling non-invasive blood pressure monitoring equipment for the equipment. Devices can be someone care equipment, it can be unattended equipment. This standard does not apply to exclusive use of finger blood pressure measuring devices or sensors need to manually start each measurement semi-automatic blood pressure measurement devices. |
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
---This is a DRAFT version for illustration, not a final translation. Full copy of true-PDF in English version (including equations, symbols, images, flow-chart, tables, and figures etc.) will be manually/carefully translated upon your order.
Medical electrical equipment.Part 2-30. Particular requirements for the safety, including essential performance, of automatic cycling non-invasive blood pressure monitoring equipment
ICS 11.040.01
C39
People's Republic of China pharmaceutical industry standards
YY 0667-2008/IEC 60601-2-30.1999
Medical electrical equipment -
Part 2-30. automatic cycling non-invasive blood pressure monitor
Safety and essential performance requirements for equipment
(IEC 60601-2-30.1999, IDT)
Posted 2008-10-17
2010-06-01 implementation
State Food and Drug Administration issued
Table of Contents
Introduction Ⅲ
The first chapter Overview 1
1 Scope and purpose 1
2 Terms and definitions 1
3 3 General requirements
4 General test requirements 3
5 Category 3
6 Identification, marking and documents 3
The second environmental conditions 4
Third of the risk of electric shock protection 4
Requirements concerning classification 4 14
17 Isolated 4
19 Continuous leakage currents and patient auxiliary current 5
20 Dielectric strength 5
Title IV of the mechanical hazards Protection 5
21 Mechanical strength 5
22 moving parts 5
The fifth chapter for unnecessary or excessive radiation hazard protection 6
36 Electromagnetic compatibility 6
Title VI of flammable anesthetic mixture ignition hazard protection 7
Title VII of the ultra-mild other security risk protection 7
42 Overtemperature 8
44 overflow, liquid spill, leak, damp, into the liquid, cleaning, disinfection, sterilization and compatibility 8
45 pressure vessels and pressure parts 8
Interrupt the power supply 49 8
Accuracy and prevent dangerous work output data eighth chapter 9
9 50 Operating data accuracy
Prevent dangerous output of 9 51
Chapter 9. abnormal operation and fault conditions; environmental testing 13
Tenth Canto structural requirements 13
56 components and assembly 13
Net power supply section 57, components and wiring 13
Annex L (normative) Normative documents 20
Annex AA (informative) General and Rationale 21
Appendix BB (informative) alarm Chart 25
101 defibrillator discharge protection test pattern [see 17h)] 14
Under single fault state diagram 102 adults (newborn) prescribed security measures [see 22.4.1b) 1)] 15
YY 0667-2008/IEC 60601-2-30.1999
The figure below 103 single fault condition, adults (newborn) prescribed security measures [see 22.4.1b) 2)] 15
The figure below 104 normal and single fault condition, adults (newborn) defined maximum inflation time (see 22.4.2 and 22.4.3) 16
Long-term automatic mode 105 normal adults (newborn) provisions [see 22.4.3a)] 16
Long-term automatic mode 106 single fault condition, adults (newborn) provisions [see 22.4.3b)] 17
107 short-term under the automatic mode, adults (newborn) regulations (see 22.4.5) 17
108 test apparatus of FIG. [See 36.202.2.2d) and 36.202.6] 18
Figure 109 ESU test apparatus of FIG. (See 36.202.7) 18
Figure 110 patient simulator (see 36.202.7) 19
YY 0667-2008/IEC 60601-2-30.1999
Foreword
This standard is equivalent to using the International Electrotechnical Commission IEC 60601-2-30.1999 "Medical electrical equipment - Part 2-30. No automatic cycle
Create safety and essential performance requirements for blood pressure monitoring device. "
Since IEC 60601-2-30.1999 is referenced in IEC 60601-1-2 "Medical electrical equipment - Part 1-2. General requirements for safety
Collateral standard. Electromagnetic compatibility requirements and tests "1993 first edition, the latest version of the standard is 2004, Version 2.1, and domestic
Uses a second edition in 2001, the requirements relating to electromagnetic compatibility to reference IEC 60601-1-2 2nd edition, namely the 2001 edition,
That is YY 0505-2005 industry standards. This does not affect the degree of consistency.
To IEC 60601-2-30.1999, this standard made the following editorial changes.
--- For the international standard quoted in the standard, if it has converted to our standards, this standard will replace the standard number of international and domestic standards
Numbering;
--- Remove the IEC 60601-2-30.1999 standard covers, foreword and introduction;
--- According to industry standards YY 0505-2005 (IEC 60601-1-2.2001, IDT), Chapter 36 EMC number, title
And content been adjusted accordingly, does not affect the degree of consistency;
--- According to Chinese layout characteristics of IEC 60601-2-30.1999 term in uppercase letters, are shown in bold font.
Appendix L of this standard is a normative appendix, appendix AA, BB appendix is informative appendix.
This standard was proposed by the National Standardization Technical Committee on Medical Electrical Medical Electronic Instrument Standardization Technical Committee.
This standard by the National Standardization Technical Committee on Medical Electrical Medical Electronic Instrument Standardization Technical Committee.
This standard was drafted. Shenzhen Mindray Bio-Medical Electronics Co., Ltd., Shanghai Medical Device detection.
The main drafters of this standard. Ye Jilun, and Yu.
YY 0667-2008/IEC 60601-2-30.1999
Medical electrical equipment -
Part 2-30. automatic cycling non-invasive blood pressure monitor
Safety and essential performance requirements for equipment
The first chapter outlines
Except as follows General Standard Benpian chapter shall apply.
1 Scope and purpose
Except as follows, common standards in this chapter apply.
1.1 Scope
Addition.
The specific standard describes the requirements for automatic cycling non-invasive blood pressure monitoring equipment safety and essential performance requirements as defined in 2.102.
The specific standard thereafter referred automatic cycling non-invasive blood pressure monitoring equipment for the device. Equipment can someone take care of the equipment, it can be no
Unattended equipment.
This standard does not apply to special semi-automatic blood pressure measurements using a finger blood pressure measurement devices or sensors for each measurement need to manually start the
The amount of equipment.
1.2 Purpose
replace.
The specific standard aims to define automatic cycle safety and essential performance of non-invasive blood pressure monitoring equipment, in particular to avoid
Inflatable process produced a hazard.
1.3 Specific Standard
Addition.
The specific reference standard GB 9706.1-2007. The Common Criteria also take into account YY 0505-2005 and IEC 60601-1-
4.1996.
In short, this specific standard called the General Standard or to GB 9706.1 General requirements.
"This standard" is the term generally refers to the common standards and of the specific standard.
, Chapters and articles of the present terms of the number of each standard are dedicated to the general standard correspondence, given the content of the modified following ways.
"Replace" indicates that the provisions of the General Standard chapter or completely substituted by a corresponding portion of the specific standards.
"Supplement" means this specific standard for this part of the text corresponding to the requirements of the General Standard additions.
"Amendment" means that the general standard of this chapter or article will correspond to specific standard part of the revision.
With respect to the common standards, the specific standard bar and the increased numbers starting from 101, additional annexes are part expressed as AA, BB
Etc., to increase the strip expressed as aa, bb, etc.
For this common standard articles, chapters and bars, this specific standard if there is no corresponding entry, even if it is unrelated to articles, chapters and strip,
In the case without any modification also applies; if it is the common standard in some parts to be replaced, even if the content is not
And then applies this standard will be dedicated to this declaration.
The special priority higher than the above standard requirements of the General Standard and Collateral Standard.
2 Terms and definitions
Except as follows, common standards in this chapter apply.
YY 0667-2008/IEC 60601-2-30.1999
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