YY 0601-2009 English PDF

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YY 0601-2009: Medical electrical equipment. Particular requirements for basic safety and essential performance of respiratory gas monitors
Status: Valid

YY 0601: Historical versions

Standard ID	USD	BUY PDF	Lead-Days	Standard Title (Description)	Status
YY 0601-2009	754	Add to Cart	4 days	Medical electrical equipment. Particular requirements for basic safety and essential performance of respiratory gas monitors	Valid
YY 0601-2007	RFQ	ASK	4 days	Anesthetic gas monitor	Obsolete

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YY/T 0636.1   YY 0571   YY 0600.2   YY/T 0339   YY 0600.4   YY 0600.5   

Basic data

Standard ID: YY 0601-2009 (YY0601-2009)
Description (Translated English): Medical electrical equipment. Particular requirements for basic safety and essential performance of respiratory gas monitors
Sector / Industry: Medical Device & Pharmaceutical Industry Standard
Classification of Chinese Standard: C46
Classification of International Standard: 11.040.10
Word Count Estimation: 38,380
Date of Issue: 2009-12-30
Date of Implementation: 2011-06-01
Older Standard (superseded by this standard): YY 0601-2007
Quoted Standard: GB/T 1962.2-2001; GB/T 2423.5-1995; GB/T 2423.8-1995; GB/T 2423.56-2006; GB/T 5332-2007; GB 9706.1-2007; GB/T 16273.1-2008; YY 0466 - 2000; YY 0505-2005; YY/T 0753.1-2009; YY/T 0753.2-2009; YY 0709-2009; IEC 60601-1-6; ISO 7000-2004
Adopted Standard: ISO 21647-2004, IDT
Issuing agency(ies): State Food and Drug Administration
Summary: This standard specifies the expected continuous operation, and applied to the patient's respiratory gas monitors (RGM) (defined by the 3. 15) of the basic safety and essential performance of special requirements. This standard specifies the following requirements: aa) anesthetic gas detection, bb) carbon dioxide detector, cc) oxygen detector. This standard does not apply to the expectation for use with flammable anesthetic respiratory gas monitor. Requirements of this standard GB 9706. 1-2007 replace or amend the relevant requirements, and will take precedence over the corresponding general requirements.

YY 0601-2007: Anesthetic gas monitor

---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.
Anesthetic gas monitor ICS 11.040.10 C46 People's Republic of China pharmaceutical industry standards YY 0601-2007/ISO 11196.1995 Anesthetic gas monitors (ISO 11196.1995, IDT) Posted 2007-01-31 2008-02-01 implementation State Food and Drug Administration issued

Table of Contents

Introduction Ⅲ Introduction Ⅳ The first chapter Overview 1 1.1 range 1 1.2 Normative references 1 1.3 Terms and Definitions 1 1.4 General requirements General requirements and test 5 1.5 Category 5 1.6 Identification, marking and documents 5 1.7 Input power 8 The second environmental conditions 8 2.1 Basic Security Type 8 2.2 removable protective device 8 2.3 Environmental conditions 8 Third of the risk of electric shock protection 8 3.1 Overview 8 3.2 Requirements concerning classification of 8 3.3 voltage and (or) energy limit of 8 3.4 8 housing and protective cover 3.5 Isolation 8 3.6 protective earthing, functional earthing and potential equalization 9 3.7 Continuous leakage currents and patient auxiliary current 9 3.8 Dielectric strength 9 Title IV of the mechanical hazards Protection 9 4.1 Mechanical strength 9 4.2 9 moving parts 4.3 surface, corners and edges 9 Stability in normal use 4.4 9 4.5 spatter 9 4.6 vibration and noise 9 4.7 pneumatic and hydraulic power 9 4.8 pedants 9 The fifth chapter of unwanted or excessive radiation hazard protection 10 5.1 X-ray radiation 10 5.2 α, β, γ, neutron radiation and other particle radiation 10 5.3 Microwave radiation 10 5.4 optical radiation (including laser) 10 5.5 infrared radiation 10 YY 0601-2007/ISO 11196.1995 5.6 UV radiation 10 5.7 acoustic energy (including ultrasound) 10 5.8 Electromagnetic Compatibility 10 Title VI of flammable anesthetic mixture ignition risk protection 10 10 6.1 Location and basic requirements 6.2 mark, random file 11 Universal 6.3 AP and APG class equipment requirements 11 6.4 AP equipment, parts and components requirements and testing 11 6.5 APG requirements for equipment, parts and components and test 11 Title VII of the ultra-mild other security risk protection 11 7.1 overtemperature 11 7.2 Fire 11 7.3 overflow, liquid spill, leak, damp, penetration of liquids, cleaning, sterilization and disinfection 11 7.4 pressure vessels and pressure parts 12 7.5 Human Error 12 7.6 electrostatic charge 12 7.7 Materials in contact with the body of a patient application part 12 7.8 Power interruption 12 12 accuracy and prevent the risk of the output data of the eighth chapter of the work The accuracy of the data 12 8.1 Job 12 8.2 prevents dangerous output Chapter 9. abnormal operation and fault conditions. Environmental Testing 15 9.1 abnormal operation and fault status 15 15 9.2 Environmental Testing Tenth Canto structural requirements 16 10.1 Overview 16 10.2 housings and covers 16 10.3 16 components and subassemblies 10.4 network power supply section, components and wiring 16 10.5 --- protective earthing terminals and connectors 16 10.6 Structure and wiring 16 Chapter 11. Anesthesia gas monitors 16 additional requirements for 11.1 interfering gases and evaporative effect (except steam outside) 16 11.2 Sampling pipe blockage 17 17 11.3 Respiratory System Connection 17 11.4 contamination of the respiratory system Appendix 18 Non-flammability test Annex M (informative) anesthetic 18 Annex N (informative) Fundamentals 19 Appendix P (normative) References 23 YY 0601-2007/ISO 11196.1995

Foreword

This standard is identical with ISO 11196.1995 "anesthetic gas monitor" (in English). This standard and ISO 11196.1995 main Differences are as follows. --- Quoted in the standard IEC 79-3.1990, IEC 801-2.1991 has been IEC 60079-11.1999 and IEC 61000-4-2. Instead of 1999, so the standard is modified in reference GB 3836.4-2000 (eqv IEC 60079-11.1999) and GB/T 17626.2- 1998 (idt IEC 61000-4-2.1999). This standard is based on GB 9706.1-2007 (IEC 60601-1. 1988 + Amd1.1991 + Amd2.1995, IDT) "Medical Electrical - Part 1. General requirements for safety, "the specific standard, used in conjunction with GB 9706.1 support, and with GB 9706.1-2007 (IEC 60601-1. 1988 + Amd1.1991 + Amd2.1995, IDT) to implement the same period. The standard 5.8 Electromagnetic Compatibility YY 0505-2005 "Medical electrical equipment - Part 1-2. General requirements for safety - Collateral standard. EMC requirements and test the implementation of the same period. " The Standard Appendix M, N and Appendices Appendix P informative appendices. This standard by the National Standardization Technical Committee of anesthesia and respiratory equipment and focal points. This standard drafting unit. Beijing Aerospace Changfeng Co., Ltd Medical Devices Branch. The main drafters of this standard. Liang Chen, Xuming Zhou, Jin Xiao Rui. YY 0601-2007/ISO 11196.1995

Introduction

The concentration of inhaled anesthetic gas measurement is becoming routine. This standard gives the anesthetic gas monitors requirements, which now With the technical scope can be achieved. Calibration gas (ie, having a molar concentration accurate anesthetic gas) is in accordance with GB/T 5274-1985 defined by gravimetric method generated can Through direct inquiries to national standards. These gases can be used as. a) directly used to calibrate gas monitors anesthetic gas, or; b) for anesthetic gas monitor calibration calibration gas may also need some way to verify the calibration of these methods other Outside the gas may be used. For example, such a method may be a refractive assays, mass spectrometry and the like. When this standard in terms of an asterisk () the basic principles described in Appendix N of. Appendix N contains important basic principle is to To let people understand the requirements of this standard and recommendations. YY 0601-2007/ISO 11196.1995 Anesthetic gas monitors The first chapter outlines 1.1 range This standard is based on the basis of standard GB 9706.1. GB 9706.1 (General Standard) at such a standard has been designated as "private label Quasi. "As described in GB 9706.1-2007 1.3, the requirements of this standard take precedence over the requirements of GB 9706.1. GB 9706.1-2007 1.1, and the following conditions apply. This standard specifies the gas mixture used to measure breathing fresh gas and steam mixture anesthesia or anesthetic gas anesthetic gas index Body monitor requirements. No matter what kind of measuring non-application of automatic identification technology, including next to the stream and mainstream anesthesia gas monitor, and Automatic Identification and gas monitor. Applications include a mixture of patient respiratory monitoring, anesthesia workstations for the output of the evaporator output Monitor and ventilator for anesthesia and respiratory monitoring. The scope of this standard does not include laboratory research, or the use of non-human anesthetic anesthetic gas monitor calibration evaporating agent used. The standard refers to anesthetic gases, including halothane, enflurane, isoflurane, sevoflurane, desflurane and nitrous oxide, but not limited to These ones.  Appendix N basic principles. 1.2 Normative references The following documents contain provisions which, through reference in this standard and become the standard terms. For dated references, subsequent Amendments (not including errata content) or modified versions do not apply to this standard. However, according to research encourages the parties to the agreement Whether the latest versions of these documents. For undated reference documents, the latest versions apply to this standard. GB 3836.4-2000 Electrical equipment for explosive gas atmospheres Part 4 by. Intrinsic safety "i" (eqv IEC 60079-11. 1999) GB/T 4999-2003 term anesthesia breathing equipment (ISO 4135.2001, IDT) GB 7144-1999 cylinders color logo GB 9706.1-2007 Medical electrical equipment - Part 1. General requirements for safety (IEC 60601-1. 1988 + Amd1.1991+ Amd2.1995, IDT) GB/T 17626.2-1998 Electromagnetic compatibility - Testing and measurement techniques - Electrostatic discharge immunity test (idt IEC 61000-4-2. 1995) YY 0505-2005 Medical electrical equipment - Part 1-2. General requirements for safety Collateral standard. Electromagnetic compatibility requirements and tests (IEC 60601-1-2.2001, IDT) YY 0574.1-2005 anesthesia and respiratory care alarm signals - Part 1. Visual alarm signals (ISO 9703-1.1992, IDT) YY 0574.2-2005 anesthesia and respiratory care alarm signals - Part 2. audible alarm signal (ISO 9703-2.1992, IDT) YY 0574.3-2005 anesthesia and respiratory care alarm signals - Part 3. Application guide alarm (ISO 9703-3.1992, IDT) YY 1040.1-2003 anesthesia and respiratory equipment - Conical fittings - Part 1. cone and cone sleeve (ISO 5356-1.1996, IDT) IEC 60079-4. 1975 Part 4 electrical installations explosive atmospheres. the ignition temperature of the test method ISO 5359.2000 for low-pressure hose assemblies for medical gas systems 1.3 Terms and Definitions GB 9706.1 and GB/T 4999-2003 established in Chapter 2 and the following terms and definitions apply to this standard. YY 0601-2007/ISO 11196.1995 ......

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