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YY 0827-2011 English PDF

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YY 0827-2011: Medical electrical equipment. Part 2: Particular requirements for the safety of transport incubators
Status: Obsolete

Standard ID	Contents [version]	USD	STEP2	[PDF] delivered in	Standard Title (Description)	Status	PDF
YY 0827-2011	English	1079	Add to Cart	5 days [Need to translate]	Medical electrical equipment. Part 2: Particular requirements for the safety of transport incubators	Obsolete	YY 0827-2011

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Basic data

Standard ID	YY 0827-2011 (YY0827-2011)
Description (Translated English)	Medical electrical equipment. Part 2: Particular requirements for the safety of transport incubators
Sector / Industry	Medical Device & Pharmaceutical Industry Standard
Classification of Chinese Standard	C39
Classification of International Standard	11.040.55
Word Count Estimation	27,280
Date of Issue	2011-12-31
Date of Implementation	2013-06-01
Adopted Standard	IEC 60601-2-20-1990/Amd 1-1996, MOD
Regulation (derived from)	State Food and Drug Administration Notice 2011 No. 106; industry standard filing Notice 2013 No. 6 (No. 162 overall)
Issuing agency(ies)	State Food and Drug Administration
Summary	This standard specifies the terms defined in 2. 1. 101 transport incubator safety requirements. This standard does not apply to infant incubator dedicated (see GB 11243).

YY 0827-2011: Medical electrical equipment. Part 2: Particular requirements for the safety of transport incubators

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Medical electrical equipment.Part 2. Particular requirements for the safety of transport incubators ICS 11.040.55 C39 People's Republic of China pharmaceutical industry standards Medical electrical equipment - Part 2. Safety requirements for the transport incubator Part 2. Particularrequirementsforthesafetyof (IEC 60601-2-20.1990, 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 5 Category 3 6 Identification, marking and documents 3 7 Input Power 5 The second environmental conditions 5 10 environmental conditions 5 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 22 moving parts 6 23 face, edge and corner 6 24 Stability in normal use 6 The fifth chapter of unwanted or excessive radiation hazard protection 7 Electromagnetic compatibility 7 36 Title VI of the danger of ignition of flammable anesthetic gases mixed protection 7 Title VII of the ultra-mild other security risk protection 7 42 overtemperature 7 43 8 Fire 44 overflow, liquid spill, leak, damp, into the liquid, cleaning, disinfection, sterilization and compatibility 8 45 pressure vessels and pressure parts 9 Human errors 9 46 Interrupt the power supply 49 10 10 accuracy and prevent the risk of the output data of the eighth chapter of the work The accuracy of the data work 50 10 1251 to prevent the risk of output Chapter 9. abnormal operation and fault conditions; environmental testing 12 Tenth Canto structural requirements 12 54 Overview 12 55 housing and housing 12 56 components and assembly 12 Chapter 11. Additional requirements 13 101 ALARM 13 102 SPL 14 103 humidifying device 14 The maximum rate of 104 air tank inside the hood 15 105 dioxide (CO2) concentration 15 106 oxygen supply 15 107 Power 15 Appendix 18 Annex L (normative) References --- this special publication mentioned standards 18 Annex AA (informative) Guidelines and Rationale 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 2-20. Particular requirements for safety of transport incubators. This is a specific standard GB 9706.1-2007 "Medical Electrical Equipment Part 1. General requirements for safety" of changes and additions. All the technical content of this specific standard is mandatory. This standard was drafted in accordance with GB/T 1.1-2009 given rules. The specific standard revise international standards IEC 60601-2-20.1990 "Medical electrical equipment - Part 2. Security transport incubator Special requirements "and Amendment 1 (1996-10). The specific standard IEC 60601-2-20.1990 made the following changes. --- Terms 36.202.2.1a) in the frequency band of the requirements from IEC 60601-2-20 Amendment 1 (1996-10) of 26MHz ~ 1GHz Change 80MHz ~ 2.5GHz, for the reasons listed in the Annex AA; --- Provisions for 106.1 IEC 60601-2-20 referenced in ISO 32 and ISO 407, in accordance with our standards for cylinders and cylinders Valve requirements, to cite GB 7144 and GB 15382; --- Provisions for 50.111 IEC 60601-2-20 referenced in ISO 7767, according to China's standard for respiratory gas monitors to Seeking instead a reference YY 0601. --- For the international standard quoted in the standard, if it has converted to our standards, this standard will be dedicated to international standards into domestic standard number Registration number; --- Remove the IEC 60601-2-20 standard cover, foreword and introduction; The term --- IEC 60601-2-20 standard in capital letters, this specific standard expressed in bold. 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. 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. The specific standard of medical equipment by the National Standardization Technical Committee of Standardization Technical Committee of Medical Appliances (SAC/TC10 / SC5) and focal points. The specific standard drafting units. Shanghai Medical Device detection, Ningbo David Medical Device Co., Ltd. The main drafters of this specific standard. excellence, Xu Chang, I'm set, Xu Fangfang.

Introduction

This standard relates to specific safety requirements for transport incubator. The amendments and supplements to the specific standard GB 9706.1-2007 "Medical Electrical - Part 1. General requirements for safety ", hereinafter referred to as the General Standard. 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. 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. Safety requirements for the transport incubator The first chapter outlines

1 Scope and purpose

In addition to these provisions, the General Standard applicable. 1.1 Scope supplement. This standard specifies the special safety requirements as defined in clause 2.1.101 transport incubator. This standard does not apply to special infant incubator (see GB 11243). 1.2 Purpose supplement. The specific standard is intended for the transport incubator shall specify the requirements for patients and users to minimize harm, and shall specify Identification of compliance with the requirements of the test. 1.3 Specific Standard supplement. The specific reference standard GB 9706.1-2007 "Medical Electrical Equipment Part 1. General requirements for safety." For simplicity, this specific standard by "General Standard" or "General requirements" referred to GB 9706.1. The term "this specific standard" refers to the specific case of common standards and criteria for use with the present. The specific standard of articles, chapters, clauses numbers correspond to common standards. To amend the General Standard, the following words describe. "Substitute" means the General Standard Terms chapter or be completely replaced by this specific standard text. "Complementary" is expressed as additional common standards on this specific standard text. "Edit" means the General Standard Terms are modified in this chapter or specific standard text. General Standard for the additional terms or FIG numbered starting from 101, additional annexes to AA etc., to increase the term of aa), bb) and the like. This article does not mention specific standard, chapter and provisions of the General Standard of these articles, chapters and provisions apply without modification. The specific requirements of the standard to replace or modify the general requirements in the standard, and thus take precedence over the corresponding general requirements. 1.5 Collateral Standard supplement. The following standards apply in parallel. GB 9706.15-2008 Medical electrical equipment - Part 1-1. General requirements for safety 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 test

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