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www.ChineseStandard.net Database: 189759 (19 Oct 2025)

YY 0669-2008 English PDF

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YY 0669-2008: Medical electrical equipment. Part 2-50: Particular requirements for the safety of infant phototherapy equipment
Status: Obsolete

Standard ID	Contents [version]	USD	STEP2	[PDF] delivered in	Standard Title (Description)	Status	PDF
YY 0669-2008	English	719	Add to Cart	4 days [Need to translate]	Medical electrical equipment. Part 2-50: Particular requirements for the safety of infant phototherapy equipment	Obsolete	YY 0669-2008

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Basic data

Standard ID	YY 0669-2008 (YY0669-2008)
Description (Translated English)	Medical electrical equipment. Part 2-50: Particular requirements for the safety of infant phototherapy equipment
Sector / Industry	Medical Device & Pharmaceutical Industry Standard
Classification of Chinese Standard	C40
Classification of International Standard	11.040.60
Word Count Estimation	18,169
Date of Issue	2008-10-17
Date of Implementation	2010-06-01
Adopted Standard	IEC 60601-2-50-2005, IDT
Regulation (derived from)	SFDA [2008] No. 605
Issuing agency(ies)	State Food and Drug Administration
Summary	This standard applies to 2. 1. 101 defined infant phototherapy device, this device uses less than a month to reduce the visible radiation jaundice bilirubin in the patient's body.

YY 0669-2008: Medical electrical equipment. Part 2-50: Particular requirements for the safety of infant phototherapy equipment

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Medical electrical equipment.Part 2-50. Particular requirements for the safety of infant phototherapy equipment ICS 11.040.60 C40 People's Republic of China pharmaceutical industry standards YY 0669-2008/IEC 60601-2-50.2005 Medical electrical equipment - Part 2. infant phototherapy equipment Requirements for safety (IEC 60601-2-50.2005, IDT) Posted 2008-10-17 2010-06-01 implementation State Food and Drug Administration issued

Introduction Ⅲ Introduction Ⅳ The first chapter Overview 1 1. Scope and purpose 1 2 terms and definitions 2 4 2 General test requirements 5 Category 3 6 Identification, marking and documents 3 The second environmental conditions 4 Third of the risk of electric shock protection 4 Title IV of the mechanical hazards Protection 5 21 Mechanical strength 5 Stability of 524 normal use 25 spatter 5 26 vibration and noise 5 The fifth chapter of unwanted or excessive radiation hazard protection 5 32 optical radiation (including laser) 6 33 infrared radiation 6 34 ultraviolet radiation 6 36 Electromagnetic compatibility 6 Title VI of the danger of ignition of flammable anesthetic mixture Protection 6 Title VII of the ultra-mild additional safety hazard protection 6 42 Overtemperature 6 43 Fire 7

7 accuracy and prevent the risk of output data of the eighth chapter of the work

7 50 Operating data accuracy 851 output to prevent dangerous Chapter 9. abnormal operation and fault conditions; environmental testing 8 52 abnormal operation and fault status 8 Tenth Canto structural requirements 8 Housing 55 and cover 8 56 components and subassemblies 8 101 patients with eye protection symbol (see 6.1) 9 102 measurement grid Example 9 Annex L (Normative references) standard reference publications mentioned in this standard --- 10 Guide Appendix AA (informative) specific provisions and basic principles 11 YY 0669-2008/IEC 60601-2-50.2005

Foreword

This standard is equivalent to using the international standard IEC 60601-2-50.2005 "Medical electrical equipment - Part 2-50. An infant phototherapy equipment Full-specific requirements. " For ease of use, to IEC 60601-2-50.2005, this standard made the following editorial changes. --- Remove IEC 60601-2-50 standard cover and preface; --- Clause 2.12.4 Change in 2.1.102 2.1.101, here is an editorial error. The Standard Appendix AA is informative appendix. This standard is proposed and managed (SAC/TC103/SC1) and by the National Medical Optics Instrument Standardization Technical Committee. This standard was drafted. State Food and Drug Administration Hangzhou Medical Device Quality Supervision and Inspection Center, Ningbo David Medical Device have Limited. The main drafters of this standard. Ye Yueshun, Zheng, Yu Lin set, Sun Yu, Han Jian City, Huang Dan, Du . YY 0669-2008/IEC 60601-2-50.2005

Introduction

This standard relates to special safety of infant phototherapy equipment. Minimum requirements of this specific standard prescribed period should ensure co-operation Li degree of safety. This is a specific standard GB 9706.1-2007 "Medical Electrical Equipment Part 1. General Requirements for Safety" (hereinafter Referred to revise and supplement the "General Standard") of. The specific requirements of the standard in preference to "universal standards". Guidelines and basic principles of the special requirements of the standard contained in Annex AA. Learn the preparation of the reasons for these requirements will not only help the correct application of this standard, and in time to accelerate due to changes in clinical practice Or the result of technological development and the need to revise the standard process. Nevertheless, this appendix is not part of the requirements of this standard. Marked with an asterisk () chapter, the terms given in the explanatory notes in the appendix of this standard AA "specific provisions of guidelines and basic principles" on. YY 0669-2008/IEC 60601-2-50.2005 Medical electrical equipment - Part 2. infant phototherapy equipment Requirements for safety The first chapter outlines Except for the following provisions of the "General Standard" clauses in this Title apply.

1 Scope and purpose

Except for the following provisions of the "General Standard" in this chapter apply. 1.1 Scope Addition. Specific requirements of this standard apply to defined 2.1.101 infant phototherapy device, this device is not to reduce the use of visible radiation Full month jaundice patient bilirubin. 1.2 Purpose replace. The specific standard is intended to determine as far as possible to reduce the infant phototherapy device to the patient and operator safety hazard requirements and regulations These requirements validation required for compliance testing. 1.3 Specific Standard Addition. The specific reference standard GB 9706.1-2007 "Medical Electrical Equipment Part 1. General requirements for safety." For simplicity, this special standard GB 9706.1 referred to as "General Standard" or general requirements. The specific standard of articles, chapters of the number corresponding to a "common standard." Change the text of "universal standards" by using the following words Language to specify. "Replace" means the General Standard chapter or article dedicated completely replaced by the standard text. "Supplement" means this specific standard text is complementary to the universal standard. "Edit" means the General Standard article under this chapter or dedicated standard text to be modified. Appended to the "General Standard" in Article 101 or FIG starting numbers attached appendix AA, BB, etc. No, but with additional entries aa), bb) and other numbers. The term "this standard" is used as a "common standard" and this specific standard collectively. There is no corresponding article, chapter or article in this specific standard, although may not be relevant, but the "General Standard" in the article, chapter or article should be no change to use. On the "General Standard" we do not intend to use any part of, although it may be relevant, but it should make a statement in this specific standard. 1.5 Collateral Standard Addition. GB 9706.15-1999 Medical electrical equipment - Part 1. General requirements for safety 1. Collateral standard. medical electrical systems security Claim YY 0505-2005 Medical electrical equipment - Part 1-2. General requirements for safety Collateral standard. Electromagnetic compatibility requirements and tests GB 9706.12-1997 Medical electrical equipment Part 1. General requirements for safety. Collateral Standard. diagnostic X-ray provided General requirements for radiation protection equipment IEC 60601-1-4.2000 Medical electrical equipment - Part 1-4. General requirements for safety Collateral Standard. Programmable Electrical Medical system YY 0669-2008/IEC 60601-2-50.2005

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