YY 0668-2008 English PDF

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YY 0668-2008: Medical electrical equipment. Part 2-49: Particular requiremens for the safety of multifunction patient monitoring equipment

Standard ID	USD	BUY PDF	Lead-Days	Standard Title (Description)	Status
YY 0668-2008	1114	Add to Cart	4 days	Medical electrical equipment. Part 2-49: Particular requiremens for the safety of multifunction patient monitoring equipment

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Basic data

Standard ID: YY 0668-2008 (YY0668-2008)
Description (Translated English): Medical electrical equipment. Part 2-49: Particular requiremens for the safety of multifunction patient monitoring equipment
Sector / Industry: Medical Device & Pharmaceutical Industry Standard
Classification of Chinese Standard: C39
Classification of International Standard: 11.040.55
Word Count Estimation: 35,346
Date of Issue: 2008-10-17
Date of Implementation: 2010-06-01
Adopted Standard: IEC 60601-2-49-2001, IDT
Regulation (derived from): SFDA [2008] No. 605
Issuing agency(ies): State Food and Drug Administration
Summary: This standard applies to 2. 2. 101 defined multi-parameter patient monitoring equipment safety requirements. The scope of this application is limited to one or more than one single part or function, and a device connected to a single patient. This standard does not make for a separate monitoring function requirements. The specific purpose of the standard is to provide for multi-parameter patient monitoring equipment safety requirements.

YY 0668-2008: Medical electrical equipment. Part 2-49: Particular requiremens for the safety of multifunction patient 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 2-49. Particular requiremens for the safety of multifunction patient monitoring equipment ICS 11.040.55 C39 People's Republic of China pharmaceutical industry standards YY 0668-2008/IEC 60601-2-49.2001 Medical electrical equipment - Part 2-49. Secure multi-parameter patient monitoring equipment requirements (IEC 60601-2-49.2001, IDT) Posted 2008-10-17 2010-06-01 implementation State Food and Drug Administration issued

Table of Contents

Introduction Ⅲ Introduction Ⅳ The first chapter Overview 1 1. Scope and purpose 1 2 Terms and definitions 1 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 6 Title IV of the mechanical hazards Protection 7 The fifth chapter of unwanted or excessive radiation hazard protection 7 36 7 Electromagnetic Compatibility Title VI of flammable anesthetic mixture ignition hazard protection 7 Title VII of the ultra-mild other security risk protection 7 Interrupt the power supply 49 8

8 output accuracy and prevent the risk of the eighth chapter of the job data

8 50 Operating data accuracy 851 output to prevent dangerous Chapter 9. abnormal operation and fault conditions; environmental testing 12 Tenth Canto structural requirements 12 56 components and assembly 12 Annex L (normative) Normative documents 14 Annex AA (informative) overall guidelines and preparation instructions 15 Appendix BB (informative) Chapter 51 Alarm 19 Appendix EE (informative) measurement of the insulation path and the test circuit 22 Appendix KK (informative) Patient leakage current measurement Example 23 YY 0668-2008/IEC 60601-2-49.2001

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. 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 by the Shanghai Medical Device Testing is responsible for drafting. The main drafters of this standard. Ho Chun, Liu. YY 0668-2008/IEC 60601-2-49.2001

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. YY 0668-2008/IEC 60601-2-49.2001 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 supplement. 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. YY 0668-2008/IEC 60601-2-49.2001 ......

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