YY 0667-2008Medical electrical equipment - Part 2-30: Particular requirements for the safety including essential performance of automatic cycling non-invasive blood pressure monitoring equipment (English PDF)
医用电气设备 第2部分:自动循环无创血压监护设备的安全和基本性能专用要求
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Issued by
NMPA
Level / Type
Industry · Mandatory
Issue date
October 17, 2008
Implementation date
June 1, 2010
Scope
YY 0667-2008 is the English-translated version of 医用电气设备 第2部分:自动循环无创血压监护设备的安全和基本性能专用要求.
YY 0667-2008 is the Chinese pharmaceutical industry standard for the safety and essential performance of automatic cycling non-invasive blood pressure monitoring equipment, whether the device is attended or works unattended.
It is part 2-30 of the series and applies together with the general standard for medical electrical equipment, whose clauses it modifies one by one, covering the accuracy of the pressure measurement and its determination, the cuff and the inflation and deflation, the limits on pressure and on the time the cuff stays inflated, the alarms, and the protection of the patient. Issued on 17 October 2008, it has applied since 1 June 2010.
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Document preview — YY 0667-2008
National Standard of the People's Republic of China
- ICS
- 11.040.01
- Classification
- C 39
Issued by: National Medical Products Administration of the People's Republic of China
Contents
- Introduction The first chapter Overview
- 1 Scope and purpose
- 2 Terms and definitions
- 3 General requirements
- 4 General test requirements
- 5 Category
- 6 Identification, marking and documents
- 17 Isolated
- 19 Continuous leakage currents and patient auxiliary current
- 20 Dielectric strength
- 21 Mechanical strength
- 22 moving parts
- 36 Electromagnetic compatibility
- 42 Overtemperature
- 44 overflow, liquid spill, leak, damp, into the liquid, cleaning, disinfection, sterilization and compatibility
- 45 pressure vessels and pressure parts
- 9 50 Operating data accuracy Prevent dangerous output of
- 56 components and assembly
- Annex L (normative) Normative documents
- Annex AA (informative) General and Rationale
- Appendix BB (informative) alarm Chart
- 101 defibrillator discharge protection test pattern [see 17h)]
- 107 short-term under the automatic mode, adults (newborn) regulations (see 22.4.5)
- 108 test apparatus of FIG. [See 36.202.2.2d) and 36.202.6]
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.
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.
......
This preview omits tables, figures, formulas and parts of the technical clauses. The complete document — 51 pages — is available in the English PDF.
Referenced standards
Normative references
- GB 9706.1-2007Medical electrical equipment - Part 1: General requirements for basic safety and essential performance
- YY 0505-2005Medical electrical equipment - Part 1-2: General requirements for safety - Collateral standard: Electromagnetic compatibility - Requirements and tests
IEC 60601-1-4-1996
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