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YY 0635.1-2013 English PDF

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YY 0635.1-2013: Inhalational anaesthesia systems. Part 1: Anaesthetic breathing systems(ISO 8835-2: 2007, IDT)
Status: Obsolete

YY 0635.1: Evolution and historical versions

Standard IDContents [version]USDSTEP2[PDF] delivered inStandard Title (Description)StatusPDF
YY 0635.1-2013English999 Add to Cart 5 days [Need to translate] Inhalational anaesthesia systems. Part 1: Anaesthetic breathing systems(ISO 8835-2: 2007, IDT) Obsolete YY 0635.1-2013
YY 0635.1-2008English919 Add to Cart 4 days [Need to translate] Inhalational anaesthesia systems. Part 1: Anaesthetic breathing system for adults Obsolete YY 0635.1-2008

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YY/T 0636.1   YY 0571   YY 0671.1   YY/T 0636.3   YY/T 0636.2   

Basic data

Standard ID YY 0635.1-2013 (YY0635.1-2013)
Description (Translated English) Inhalational anaesthesia systems. Part 1: Anaesthetic breathing systems(ISO 8835-2: 2007, IDT)
Sector / Industry Medical Device & Pharmaceutical Industry Standard
Classification of Chinese Standard C46
Classification of International Standard 11.040.10
Word Count Estimation 25,235
Older Standard (superseded by this standard) YY 0635.1-2008
Quoted Standard ISO 594-2; ISO 2878-2005; ISO 4135; ISO 5356-1; ISO 5356-2; ISO 5362; ISO 5367; ISO 7000-2004; IEC 60601-1; IEC 60601-1-2; IEC 60601-2-13: 2003
Adopted Standard ISO 8835-2-2007, IDT
Regulation (derived from) State Food and Drug Administration Notice No. 36 of 2013; industry standard for filing Notice 2013 No. 12 (No. 168 overall)
Issuing agency(ies) State Food and Drug Administration
Summary This standard specifies the offer or assembled by the manufacturer, or a special request by the user in the manufacturer's instructions assembled anesthesia breathing systems. This section also contains components for anesthesia respiratory cycle absorpti

YY 0635.1-2013: Inhalational anaesthesia systems. Part 1: Anaesthetic breathing systems(ISO 8835-2: 2007, IDT)


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Inhalational anaesthesia systems Part 1. Anaesthetic breathing systems (ISO 8835-2.2007, IDT) ICS 11.040.10 C46 People's Republic of China pharmaceutical industry standards YY 0635.1-2013/ISO 8835-2.2007 Replacing YY 0635.1-2008 Inhalation anesthesia systems - Part 1. anesthesia breathing system Inhalationalanaesthesiasystems-Part 1. Anaestheticbreathingsystems (ISO 8835-2.2007, IDT) Issued on. 2013-10-21 2014-10-01 implementation China Food and Drug Administration released

Table of Contents

Introduction Ⅲ Introduction Ⅳ * Range 1 1 2 Normative references 1 3 Terms and definitions 2 4 3 General requirements 4.1 material 3 4.2 anesthesia breathing system components package 3 4.3 Electrical requirements 3 4.4 Test Mode Select 3 5 port 3 5.1 patient connection port 3 5.2 Y-shaped tube 4 5.3 exhaust connection port 4 5.4 Interchangeable non-rebreathing exhaust valve 4 5.5 * port reservoir balloon 4 5.6 anesthesia ventilator port 4 5.7 ports interchangeable anesthesia breathing system components 4 5.8 * interchangeable loop suction absorbent assembly and outgoing connection port 4 5.9 Other ports 4 6 reservoir balloon/anesthesia ventilator selector switch 5 7 supply assembly or full anesthesia breathing system according to the manufacturer's instructions supplied assembled 5 7.1 * Leak 5 7.2 * inhalation and exhalation pressure - flow characteristics 5 8 interchangeable anesthesia breathing system components - exhaust valve 5 8.1 The controller direction of rotation 5 8.2 Pressure - flow characteristics 5 8.3 Opening pressure 5 8.4 Leak 5 9 circulating absorbent assembly 6 9.1 structure 6 9.2 absorber bypass mechanism 6 9.3 Pressure - flow characteristics 6 9.4 suction valve and exhalation valve 6 10 pressure monitoring and limitation of 7 10.1 Pressure Monitoring 7 YY 0635.1-2013/ISO 8835-2.2007 10.2 Pressure limiting device 7 * Location 11 contains a circular absorbent assembly (the same as defined in 3.3) anesthesia breathing system components 7 11.1 exhaust valve 7 11.2 reservoir airbag connector 7 11.3 fresh gas inlet 7 11.4 intake valve and exhalation valve 7 12 mark 7 Logo 12.1 complete anesthesia breathing systems and anesthetic breathing system components 7 12.2 Package Marking 8 13 manufacturer or supplier information 9 13.1 Overview 9 13.2 provides complete anesthesia respiratory system 9 13.3 anesthesia breathing system components 9 Appendix A (normative) typical test procedures and methods 11 Annex B (informative) Basic principles 15 Annex C (informative) Environmental Impact 17 Annex D (informative) antistatic requirements 18 References 19 YY 0635.1-2013/ISO 8835-2.2007

Foreword

This section drafted in accordance with GB/T 1.1-2009 given rules. YY 0635 "inhalation anesthesia system" is divided into the following sections. --- Part 1. anesthesia breathing systems; --- Part 2. anesthetic gas purification system delivery and collection system; --- Part 3. anesthetic gas delivery device; --- Part 4. anesthesia ventilator. This is Part 1 YY 0635 of. This section identical with the international standard ISO 8835-2.2007 "inhalation anesthesia systems - Part 2. anesthetic respiratory system" (English Version), this part of ISO 8835-2.2007 as compared to the following editorial changes were made. --- Remove the ISO 8835-2.2007 Foreword; This part of the amendment is YY 0635.1-2008 the major technical differences between the original and revised standard criteria include. --- Increasing the electrical requirements of section 4.3; --- Increase the basic principles of Part B of the Annex; --- Added Appendix C and Appendix D antistatic environmental impact requirements. Consistency correspondence between this part of international documents and normative references of our files are as follows. --- GB/T 1962.2-2001 syringes, needles and other medical equipment - 6% (Luer) taper fittings - Part 2. Lock Fixed joints (idtISO 594-2.1998) --- GB/T 4999-2003 term anesthesia breathing equipment (ISO 4135.2001, IDT) --- GB 9706.1-2007 Medical electrical equipment - Part 1. General requirements for safety (IEC 60601-1. 1988 Amd1. 1992 Amd2.1995, IDT) --- GB 9706.29-2006 Medical electrical equipment - Part 2. safety and essential performance of anesthetic systems (IEC 60601-2-13.2003, MOD) --- GB 11210-1989 Rubber, vulcanized - Antistatic and conductive products - Determination of electrical resistance (eqvISO 2878. 1987) --- GB/T 16273.1-2008 equipment - Graphical symbols - Part 1. Common symbols (ISO 7000.2004, NEQ) --- YY 0461-2003 anesthesia machine and ventilator with respiratory tract (ISO 5367.2000, IDT) --- YY 0505-2012 Medical electrical equipment - Part 1-2. General requirements for safety Collateral standard. Electromagnetic compatibility requirements and Test (IEC 60601-1-2.2004, IDT) --- YY 1040.1-2003 anesthesia and respiratory equipment - Conical fittings - Part 1. cone and cone sleeve (ISO 5356-1.1996, IDT) --- YY 1040.2-2008 anesthesia and respiratory equipment - Conical fittings - Part 2. Screw load-bearing joints (ISO 5356-2. 2006, IDT) 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 part of the National Standardization Technical Committee on Narcotic breathing apparatus and (SAC/TC116) and focal points. This section is drafted. Draeger Medical Devices Co., Ltd., Shanghai Medical Device detection. The main drafters of this section. Ding Deping, Wang Wei, Li Min. This section first published in 2008. YY 0635.1-2013/ISO 8835-2.2007

Introduction

Anesthesia breathing system consists of pipes and fittings components composed, may include a valve, a balloon and a cycle storage absorbent assembly. its His device, such as a humidifier, filters, spirometer, thermometer and gas analyzers can be combined into the ventilation system. Anesthesia Respiratory function is to transport gas mixing and transporting of the mixed gas from the patient to the patient. Appendix A gives a type test methods. Appendix B describes the basic principles YY 0635 some requirements of this section. Appendix B contains an overview of some of the basic principles required YY 0635 this section. This chapter or section number with an asterisk (*) in Terms, there is a corresponding basic principles in Appendix B, is added to the basic principles in order to provide additional comments in Notes This section contains this requirement And reasons suggested. Appendix C lists the impact YY 0635 this section anesthesia breathing systems on the environment. YY 0635.1-2013/ISO 8835-2.2007 Inhalation anesthesia systems - Part 1. anesthesia breathing system 1 * Range This section provides YY 0635 provided or assembled by the manufacturer or by the user in the manufacturer's instructions assembled anesthesia breathing system Special requirements. This section also contains circulating absorbent assembly, exhaust valve, inhalation and exhalation valve requirements, and composition for inhalation anesthesia department in some designs The system requires anesthesia breathing system components, these components include anesthesia ventilator exhalation gas passage. This section does not cover performance concerning the anesthesia breathing systems eliminate exhaled carbon dioxide, because it is complex and depends on the patient, fresh air Flow rate, the interaction between carbon dioxide absorber and the respiratory system. This section does not apply to the expectations and IEC 60601-2-13.2003 anesthetic flammable anesthetic defined in Appendix DD/gas used together Breathing circuit.

2 Normative references

The following documents for the application of this document is essential. For dated references, only the dated version suitable for use herein Member. For undated references, the latest edition (including any amendments) applies to this document. ISO 594-2 syringes, needles and other medical equipment - 6% (Luer) taper fittings - Part 2. Lock fittings (Conical fittingswitha6% (Luer) taperforsyringes, needlesandcertainothermedicalequipment-Part 2. Lockfittings) ISO 2878.2005 Determination of rubber products, antistatic and conductive resistance (Rubber-Antistaticandconductive products-Determinationofelectricalresistance) ISO 4135 anesthesia-respiratory term (Anaestheticandrespiratoryequipment-Vocabulary) ISO 5356-1 Anaesthetic and respiratory equipment conical fittings - Part 1. cone and cone sleeve (Anaestheticandrespiratory equipment-Conicalconnectors-Part 1. Conesandsockets) ISO 5356-2 Anaesthetic and respiratory equipment - Conical fittings - Part 2. Screw load-bearing joints (Anaestheticandrespiratory equipment-Conicalconnectors-Part 2. Screw-threadedweight-bearingconnectors) ISO 5362 anesthesia reservoir balloon (Anaestheticreservoirbags) ISO 5367 anesthesia machine and ventilator with respiratory tract (Breathingtubesintendedforusewithanaestheticapparatus andventilators) ISO 7000.2004 Graphical symbols for equipment index and abstracts (Graphicalsymbolsforuseonequipment-Index andsynopsis) IEC 60601-1 Medical electrical equipment - Part 1. General basic safety and essential performance requirements (Medicalelectrical equipment-Part 1. Generalrequirementsforbasicsafetyandessentialperformance) IEC 60601-1-2 Medical electrical equipment - Part 1-2. General requirements for safety Collateral standard. Electromagnetic compatibility requirements and tests (Medicalelectricalequipment-Part 1-2. Generalrequirementsforsafety-Colateralstandard. Elec- tromagneticcompatibility-Requirementsandtests) IEC 60601-2-13.2003 Medical electrical equipment - Part 2-13. Particular requirements for safety and essential performance of anesthetic systems (Medicalelectricalequipment-Part 2-13. Particularrequirementsforthesafetyandessentialper- formanceofanaestheticsystems) YY 0635.1-2013/ISO 8835-2.2007

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