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YY 0455-2011 English PDF

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YY 0455-2011: Medical electrical equipment. Part 2: Particular requirements for the safety of infant radiant warmers
Status: Obsolete

YY 0455: Evolution and historical versions

Standard ID	Contents [version]	USD	STEP2	[PDF] delivered in	Standard Title (Description)	Status	PDF
YY 0455-2011	English	999	Add to Cart	5 days [Need to translate]	Medical electrical equipment. Part 2: Particular requirements for the safety of infant radiant warmers	Obsolete	YY 0455-2011
YY 0455-2003	English	RFQ	ASK	4 days [Need to translate]	Medical electrical equipment-Part 2: Particular requirments for the safety of infant radiant warmers	Obsolete	YY 0455-2003

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Basic data

Standard ID	YY 0455-2011 (YY0455-2011)
Description (Translated English)	Medical electrical equipment. Part 2: Particular requirements for the safety of infant radiant warmers
Sector / Industry	Medical Device & Pharmaceutical Industry Standard
Classification of Chinese Standard	C39
Classification of International Standard	11.040.55
Word Count Estimation	25,284
Date of Issue	2011-12-31
Date of Implementation	2013-06-01
Older Standard (superseded by this standard)	YY 0455-2003
Adopted Standard	IEC 60601-2-21-1994, MOD; IEC 60601-2-21-1994/Amd 1-1996, MOD
Regulation (derived from)	China Food & Drug Administration Announcement 2011 No.106; Industry Standard Filing Announcement 2013 No.6 (Total No.162)
Issuing agency(ies)	State Food and Drug Administration
Summary	This standard specifies the safety of infant radiant warmer special requirements as defined in 2. 2. 101.

YY 0455-2011: Medical electrical equipment. Part 2: Particular requirements for the safety of infant radiant warmers

---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. Particular requirements for the safety of infant radiant warmers ICS 11.040.55 C39 People's Republic of China pharmaceutical industry standards Replacing YY 0455-2003 Medical electrical equipment - Part 2. infant radiant warmer requirements for the safety Part 2. Particularrequirementsforthesafetyof (IEC 60601-2-21.1994, A1.1996, MOD) Issued on. 2011-12-31 2013-06-01 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 3 3 General requirements 4 General test requirements 3 6 Identification, marking and documents 3 The second environmental conditions 4 10 4 environmental conditions Third of the risk of electric shock protection 5 20 Dielectric strength 5 Title IV of the mechanical hazards Protection 5 21 Mechanical strength 5 Stability of 524 normal use The fifth chapter of unwanted or excessive radiation hazard protection 6 33 * 6 infrared radiation 36 Electromagnetic compatibility 6 Title VII of the ultra-mild additional safety hazard protection 6 42 Overtemperature 6 43 Fire 7 44 overflow, liquid spill, leak, damp, into the liquid, cleaning, disinfection, sterilization and compatibility 7 46 human error 8 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 Tenth Canto structural requirements 9 54 Overview 9 56 10 components and subassemblies Article 101 Supplementary requirements 10 101 ALARM 10 102 SPL 11 103 Carbon dioxide (CO2) concentration 11 101 experimental device 12 Layout 102 experimental apparatus 12 Figure 103 diagrams illustrate the main requirements of the standard 13 Appendix 14 Annex L (normative) Publication 14 mentioned standards Annex AA (informative) preparation instructions 15 References 18

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 for medical electrical equipment - Part 2. The infant radiant warmer requirements for the safety. This is a specific standard GB 9706.1-2007 "Medical Electrical Equipment Part 1. General requirements for safety" of changes and additions. The specific standard should be GB 9706.1-2007 "Medical Electrical Equipment Part 1. General requirements for safety" used in conjunction. The special Standard take precedence over the corresponding requirements of the standard. This standard was drafted in accordance with GB/T 1.1-2009 given rules. The specific standard replaces YY 0455-2003 "Medical electrical equipment - Part 2. infant radiant warmer requirements for safety." The specific standard and YY 0455-2003 compared to the main technical content differences are as follows. --- Removed YY 0455-2003 and GB 9706.1-2007 "Medical Electrical Equipment Part 1. General requirements for safety" repeat Part (General Standard Rev. 2); --- Modified YY 0455-2003 some clerical error, and according to GB/T 1.1-2009 specification modifications made; --- Modify IEC 60601-2-21 Amendment 1 (1996-10) in 36.202.2.1a) in the frequency band of the requirements from 26MHz ~ 1GHz Change 80MHz ~ 2.5GHz. The specific criteria used to redraft the law revision adopted IEC 60601-2-21.1994 "Medical electrical equipment - Part 2. Radiation baby Warmer requirements for safety "and its Amendment 1 (1996). The specific standard IEC 60601-2-21.1994 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 60601-2-21 standard cover, foreword and introduction. Please note that some of the content of this document may involve patents. Release mechanism of the present document does not assume responsibility for the identification of these patents. This standard by the National Standardization Medical Electrical Medical Electronic Instrument Standardization Technical Committee Technical Committee (SAC/TC10/SC5) And focal points. This standard was drafted. Shanghai Medical Device detection, Ningbo David Medical Device Co., Ltd., Shanghai Food and Drug Authority Certification Evaluation Center. The main drafters of this standard. Gu Zhengyu, I'm set, Yu Yongwei, Zhu Yingfeng. This standard replaces the standard for the previous editions. --- YY 0455-2003.

Introduction

This standard relates to specific safety requirements for infant radiant warmer in. The amendments and supplements to the specific standard GB 9706.1-2007 "Medical Electrical equipment - Part 1. General requirements for safety ", hereinafter referred to as" common standards. " The specific requirements of the standard takes precedence over generic standards. General standards related, but any part of the NA, in this specific standard has been pointed out. The specific standard of articles, chapters and numbered in accordance with the General Standard of the agreement. Supplement the General Standard Terms and numbered starting from 101. Appendix No. supplement from AA, BB began. Supplementary items Head from aa), bb) begins. Followed by corresponding test requirements specified. Annex AA correspondence gives some important requirements of the principles described. Taking into account the principle of understanding these requirements is not only conducive to the proper The implementation of standards, but also to promote the appropriate changes in clinical practice, the development of technology, resulting in the revision of the standard requirements. But this part of the appendix and Not part of the special requirements of the standard. Compiled a description of the terms of the principle behind the serial number with "*" sign. Medical electrical equipment - Part 2. infant radiant warmer requirements for the safety The first chapter outlines Except the following clauses of the General Standard of the articles apply.

1 Scope and purpose

In addition to these provisions, the General Standard applicable. 1.1 Scope instead. This standard specifies the special baby 2.2.101 of this standard as defined radiant warmer requirements for the safety. 1.2 Purpose instead. The purpose of this standard is to provide a dedicated infant 2.2.101 defined radiant warmer requirements for the safety. 1.3 Specific Standard supplement. Modifications of the specific standard, according to the GB 9706.1-2007 "Medical Electrical Equipment Part 1. General requirements for safety." For simplicity, in this specific standard, the content portion relates to the first is called "common standards." This chapter of the specific standard number corresponding to the General Standard of the chapter number. Changes to the General Standard of the original, with the following words Provisions. "Substitute" means the General Standard chapter or replace all the provisions of this article is dedicated standards. "Supplement" means this specific standard provisions of the Common Criteria requirements are increased. "Modification" means a specific standard required under this provision, changes to the General Standard chapters or pieces of content. And the additional money to add articles, chapters, bars and numbered starting from 101, supplementary appendices letters AA, BB, etc. with aa), bb), etc. FIG. The term "this standard" is used to this while using common standards and specific standards involved. If this does not correspond to specific standard parts, chapters or article, the general standard parts, chapters or strip fully applicable; that some portion of the common standards Points, although that may be relevant, but does not apply, in this standard, which only make a statement. The specific standards take precedence over generic standards. 1.5 Collateral Standard supplement. GB 9706.15-2008 Medical electrical equipment - Part 1-1. General requirements for safety Collateral standard. Safety requirements for medical electrical systems

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