HOME   Cart(0)   Quotation   About-Us Policy PDFs Standard-List
www.ChineseStandard.net Database: 189760 (18 Oct 2025)

YY 0834-2011 English PDF

US$1479.00 · In stock
Delivery: <= 6 days. True-PDF full-copy in English will be manually translated and delivered via email.
YY 0834-2011: Medical electrical equipment. Part 2-35: Particular requirements for the safety of blankets, pads and mattesses, intended for heating in medical use
Status: Obsolete
Standard IDContents [version]USDSTEP2[PDF] delivered inStandard Title (Description)StatusPDF
YY 0834-2011English1479 Add to Cart 6 days [Need to translate] Medical electrical equipment. Part 2-35: Particular requirements for the safety of blankets, pads and mattesses, intended for heating in medical use Obsolete YY 0834-2011

PDF similar to YY 0834-2011


Standard similar to YY 0834-2011

YY 0778   YY 0950   YY/T 1095   YY 0838   YY/T 0833   YY 0839   

Basic data

Standard ID YY 0834-2011 (YY0834-2011)
Description (Translated English) Medical electrical equipment. Part 2-35: Particular requirements for the safety of blankets, pads and mattesses, intended for heating in medical use
Sector / Industry Medical Device & Pharmaceutical Industry Standard
Classification of Chinese Standard C42
Classification of International Standard 11.040
Word Count Estimation 37,370
Date of Issue 2011-12-31
Date of Implementation 2013-06-01
Adopted Standard IEC 60601-2-35-1996, IDT
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 requirements for electric blankets, heating pads and electric mattress requirements including air mattresses and inflatable electric system. Defined 2. 2. 102, 2. 2. 106 and 2. 2. 107. The specific standard does not apply to: heating equipment for physical therapy, infant radiant warmer, see YY 0455, infant incubator, see GB 11243, transport incubator, see IEC 601-2-20.

YY 0834-2011: Medical electrical equipment. Part 2-35: Particular requirements for the safety of blankets, pads and mattesses, intended for heating in medical use


---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 2-35. Particular requirements for the safety of blankets, pads and mattesses, intended for heating in medical use ICS 11.040 C42 People's Republic of China pharmaceutical industry standards YY 0834-2011/IEC 60601-2-35.1996 Medical electrical equipment - Part II. medical blankets, Electric mattress pads and requirements for the safety Part 2-35. Particularrequirementsforthesafetyofblankets, padsand mattresses, intendedforheatinginmedicaluse (IEC 60601-2-35.1996, IDT) Issued on. 2011-12-31 2013-06-01 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 2 3 3 General requirements 5 Category 3 6 Identification, marking and documents 3 The second environmental conditions 5 9 removable protection device (not used) 5 12 (not used) 5 Third of the risk of electric shock protection 5 17 isolation 5 19 Continuous leakage currents and patient auxiliary current 5 Title IV of mechanical hazard protection 6 21 Mechanical strength 6 The fifth chapter of unwanted or excessive radiation hazard protection 6 Electromagnetic compatibility 7 36 Title VI of flammable anesthetic mixture ignition hazard protection 7 Title VII of the ultra-mild other security risk protection 7 42 overtemperature 7 44 overflow, liquid spill, leak, damp, into the liquid, cleaning, sterilization, disinfection and compatibility 8 46 human error 8 49 power supply interruption 8 Accuracy and prevent dangerous work output data eighth chapter 9 9 50 Operating data accuracy 1051 to prevent the risk of output Chapter 9. abnormal operation and fault conditions; environmental testing 11 52 abnormal operation and fault status 11 Tenth Canto structural requirements 13 54 Overview 14 56 components and assembly 15 Net power supply section 57, components and wiring 16 YY 0834-2011/IEC 60601-2-35.1996 59 and the wiring structure 16 Annex L (normative) Normative documents 24 Preparation of Annex AA (informative) Description of special sub-clause 25 Provisions of Annex BB (normative) insulating material 28 Annex CC (normative) heating device from the heat source to the contact surface (that is passed to the patient) to provide high or low thermal conductivity measurement program 29 Appendix DD (normative) heating equipment to provide high or low heat conduction from the contact surface to the heat source (ie, from the patient to pass out) measurement program 30 Appendix EE (normative) suitable thermal conditions 31 YY 0834-2011/IEC 60601-2-35.1996

Foreword

Medical electrical equipment standard series of standards, the series standard consists of two parts. --- Part 1. General requirements for safety of medical electrical equipment; --- Part 2. Medical electrical equipment requirements for the safety. The amendments and additions to the specific standard GB 9706.1-2007 "Medical Electrical Equipment Part 1. General Requirements for Safety" (hereinafter referred to as Common Criteria). The specific standard is equivalent to using the International Electrotechnical Commission IEC 60601-2-35 "Medical electrical equipment - Part 2-35. Medical Electric blankets, heating pads and electric mattresses requirements for safety "(in English). The specific standard compared with IEC 60601-2-35, the main difference as follows. --- For other international standards quoted in the standard, if it has converted to our standards, the specific reference standard will replace the International Standard The corresponding number of national standards and Appendix L marked on the relationship; --- IEC 60601-2-35, the term "Part 1" in this specific standard both use "common standards" instead of the corresponding specific standard By deleting the term "Part 1" of interpretation; --- IEC 60601-2-35 Fig 101a and 101b of FIG pattern reversed, and this figure does not match the title of the specific standard has been modified; --- IEC 60601-2-35 Appendix L, Annex ZA and Annex ZB incorporated in this specific standard for Appendix L. The specific requirements of the standard should take precedence over generic standards. The specific standard of articles, chapters and numbered in accordance with the General Standard article in the agreement. Increase in the General Standard are numbered starting from 101 bar. Appendix increased upper-case letters AA, BB and so on. The small increase in branded items Letters aa), bb) and the like. There is a corresponding principle, the terms or sub-clause, the clause made after the symbol "*." The specific standard Chapter 36 Electromagnetic compatibility and YY 0505-2005 "Medical electrical equipment - Part 1-2. General requirements for safety and Standard column. EMC requirements and tests "earlier implementation. The specific standard Appendix L, Appendix Appendix BB to EE normative annex, appendix AA informative appendices. The specific criteria proposed by the State Food and Drug Administration. The specific standard by the National Technical Committee of Standardization for medical electrical physical therapy equipment at the Technical Committee (SAC/TC10/SC4) Centralized. The specific standard drafted by the State Food and Drug Administration of Tianjin Medical Device Quality Supervision and Inspection Center. The main drafters of this specific standard. Duan Chuan Ying, Li Libin, mountain road, Zhang Yun, Li Yanan. YY 0834-2011/IEC 60601-2-35.1996

Introduction

The amended and supplemented specific standard GB 9706.1-2007 "Medical Electrical Equipment Part 1. General requirements for safety" (idtIEC 60601-1. 1988 A1.1991 A2.1995) (see 1.3). Due to the special nature of the heating device, that it is frequently used in the operating room, ICU and other patients may not make excessive temperatures Anti It should be the case, so this specific standard is required. The specific standard pointed out additional safety requirements beyond common standards. 108 provides all the elements of the main requirements of this specific standard. Should be K (Kelvin) temperature and the temperature difference between the absolute value of the unit, however, this specific standard of all used ℃, because all measurements Amount is usually used in Celsius temperature scale devices. For some with the clause or sub-clause numbers asterisk (*) in Annex AA after specific standard given in explanatory notes. YY 0834-2011/IEC 60601-2-35.1996 Medical electrical equipment - Part II. medical blankets, Electric mattress pads and requirements for the safety The first chapter outlines Except as follows, common standards this Title Chapter shall apply.

1 Scope and purpose

Except as follows, common standards in this chapter apply. 1.1 * Range increase. This standard provides for special electric blankets, heating pads and electric mattress requirements, including electric mattresses and inflatable air cushion system. Defined 2.2.102,2.2.106 and 2.2.107. Note. The specific standard, respectively, said electric blankets, heating pads or electric mattress, but with all of them to refer to the heating device. Heating device is a device for medical and paramedical care. 1.2 Purpose increase. The purpose of this standard is dedicated heating equipment requirements and compliance verification method to reduce the risk to the patient and to the operator Min. 1.3 Specific Standard increase. The specific reference standard GB 9706.1-2007 "Medical Electrical Equipment Part 1. General requirements for safety" (IEC 60601-1. 1988 A1.1991 A2.1995, IDT). The specific standard of articles, chapters, article numbering, corresponding with the General Standard. General Standard for the contents of the change, with the following words express. "Substitute" means the General Standard chapter or completely replace the contents of this article are specific standards. "Increase" means specific standard based contents are additional general standards requirements. "Amendment" means the General Standard or chapter shall be amended in accordance with the contents of this specific standards. For the general increase in the standard bar or FIG numbered starting from 101, additional annexes to AA, BB and other listed items increased to aa), bb) and other listed. The term "this standard" includes common standards and this specific standard. In this specific standard is not mentioned in the General Standard to the corresponding chapter, chapter shall apply (although may not be relevant); General Standard A part of the expected does not apply in this specific standards are clearly defined. 1.101 * Excluding equipment The specific standard does not apply to. --- For heating equipment physical therapy; YY 0834-2011/IEC 60601-2-35.1996

Tips & Frequently Asked Questions:

Question 1: How long will the true-PDF of YY 0834-2011_English be delivered?

Answer: Upon your order, we will start to translate YY 0834-2011_English as soon as possible, and keep you informed of the progress. The lead time is typically 4 ~ 6 working days. The lengthier the document the longer the lead time.

Question 2: Can I share the purchased PDF of YY 0834-2011_English with my colleagues?

Answer: Yes. The purchased PDF of YY 0834-2011_English will be deemed to be sold to your employer/organization who actually pays for it, including your colleagues and your employer's intranet.

Question 3: Does the price include tax/VAT?

Answer: Yes. Our tax invoice, downloaded/delivered in 9 seconds, includes all tax/VAT and complies with 100+ countries' tax regulations (tax exempted in 100+ countries) -- See Avoidance of Double Taxation Agreements (DTAs): List of DTAs signed between Singapore and 100+ countries

Question 4: Do you accept my currency other than USD?

Answer: Yes. If you need your currency to be printed on the invoice, please write an email to [email protected]. In 2 working-hours, we will create a special link for you to pay in any currencies. Otherwise, follow the normal steps: Add to Cart -- Checkout -- Select your currency to pay.