YY 0668-2008Medical electrical equipment - Part 2-49: Particular requirements for the safety of multifunction patient monitoring equipment (English PDF)
医用电气设备 第2部分：多参数患者监护设备安全专用要求
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Issued by
NMPA
Level / Type
Industry · Mandatory
Issue date
October 17, 2008
Implementation date
June 1, 2010
Scope
YY 0668-2008 is the English-translated version of 医用电气设备 第2部分：多参数患者监护设备安全专用要求.
YY 0668-2008 is the Chinese pharmaceutical industry standard for the safety of multifunction patient monitoring equipment, the monitor that performs more than one measuring function on a single patient.
It is part 2-49 of the series and applies together with the general standard for medical electrical equipment, whose clauses it modifies one by one, covering the interaction between the functions and the effect a failure in one may have on another, the alarms and their priorities, the display and the recording, the protection against electric shock through the several patient connections and the electrical safety. Issued on 17 October 2008, it has applied since 1 June 2010.
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Document preview — YY 0668-2008
National Standard of the People's Republic of China
- ICS
- 11.040.55
- Classification
- C 39
Issued by: National Medical Products Administration of the People's Republic of China
Contents
- Foreword
- Introduction
- 1 Scope and purpose
- 2 Terms and definitions
Foreword
Safety requirements for medical electrical equipment standard series consists of two parts.
--- Part 1. General requirements for safety of medical electrical equipment;
--- Part 2. Medical electrical equipment requirements for the safety. This special standard - Part 2-49 Medical electrical equipment. This is a specific standard GB 9706.1-2007 modifications and additions.
The specific standard equivalent to international standard IEC 60601-2-49:2001 "Medical electrical equipment - Part 2-49. multi-parameter patient monitoring Protective equipment requirements for the safety. " The specific standard IEC 60601-2-49:2001 made the following editorial changes.
--- For other international standards quoted in the standard, if it has the appropriate standards into our country, places of reference standards prevail;
--- International standards Appendix L supplemented and modified.
The special requirements for standard software 51.101 and industry standards are being developed, "Medical Electrical Equipment Part 1-4. editable Cheng medical electrical equipment and medical electrical systems General safety requirements "implemented simultaneously.
The specific standard is the latest revision of GB 9706.1-2007 changes and additions. Therefore, this specific standard and GB 9706.1-2007 simultaneous implementation.
The Standard Appendix L normative appendix, appendix AA, Appendix BB, appendix EE, KK appendix is informative appendix.
Introduction
This standard relates to special security multi-parameter patient monitoring devices. This standard is GB 9706.1-2007 modifications and additions to Hereinafter referred to as the General Standard. In this specific standard take precedence over the requirements of the General Standard of the corresponding requirements.
Concerning the specific requirements of the standard "general guidelines and preparation instructions" contained in Annex AA.
Article number have an asterisk (*), and this represents the total lead in the special and standard preparation instructions are given some additional statements.
When this specific standard was drafted in the equivalent international standards IEC 60601-1-8 industry standard "Medical electrical equipment unit 1-8 Score. General requirements for safety Collateral standard. medical electrical equipment and medical electrical systems alarm General requirements and test guidelines "are drafted into Line. After publication, the present standard can be coordinated with the above-mentioned collateral standard. Medical electrical equipment - Part 2-49.
Secure multi-parameter patient monitoring equipment requirements The first chapter outlines Except the following clauses, common standards Benpian apply.
1 Scope and purpose
1.1 Scope
This standard applies to specific safety requirements 2.2.101 defined multi-parameter patient monitoring devices.
The scope of the standard has limited application or part of a more than a single function, and connected to a single patient device.
This standard does not make for a separate monitoring function requirements.
1.2 Purpose
The purpose of this standard is to provide specific safety requirements for multi-parameter patient monitoring devices.
1.3 Specific Standard
The specific standard references 9706.1.
For simplicity, this specific standard covered by Part 1 or as the "General Standard" or as "General requirements." The specific standard of articles, chapters, of the number corresponding to the General Standard. Changes to the General Standard by using the following vocabulary Provisions. "Replace" refers to the content of the General Standard of the chapter or completely replaced by the contents of this specific standards. "Complementary" refers to the contents of this specific standard Common Criteria claims. "Modify" refers to the content of the chapter or the General Standard shall be modified in accordance with the contents of this specific standards.
Attached to the General Standard bar or diagram to 101 numbered starting with the letter attached Appendix AA, BB and other start number, additional bar to aa), bb), etc. start number.
The term "this standard" is used as the common standards and of the specific standard collectively.
If this specific standard no corresponding article, chapter or article, though may not be relevant, universal standard parts, chapters or bar, there will be no changes to apply; if Not going to quote any part of the common standard, although that may be relevant, in the present description is given in the specific standard.
The specific requirements of the standard take precedence over the above-mentioned common standards and parallel standards.
1.5 Collateral Standard
supplement.
YY 0505-2005 Medical electrical equipment - Part 1-2. General requirements for safety Collateral standard. Electromagnetic compatibility requirements and tests
IEC 60601-1-4.19961) Medical electrical equipment - Part 1-4. General requirements for safety Collateral Standard. Programmable Electrical Medical system
1) identical with the international standards of the industry standard being drafted.
2 Terms and definitions
*2.1.5 Remove the second dash.
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This preview omits tables, figures, formulas and parts of the technical clauses. The complete document — 15 pages — is available in the English PDF.
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