YY 0635.1-2013Inhalational anaesthesia systems - Part 1: Anaesthetic breathing systems (English PDF)

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.

--- 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.

--- YY 1040.2-2008 anesthesia and respiratory equipment - Conical fittings - Part 2. Screw load-bearing joints (ISO 5356-2. 2006, IDT)

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.

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.

1 Scope

This part of YY 0635 provides special requirements for the anaesthesia breathing system supplied or assembled by the manufacturer, or assembled by the user as the manufacturer's instructions require.

This part also contains requirements for the circulating absorbent assembly, the exhaust valve and the inhalation and exhalation valves, and for the components of the anaesthesia breathing system that some designs of inhalational anaesthesia system need, among them the expiratory gas passage of the anaesthesia ventilator.

This part does not cover the performance of the anaesthesia breathing system in eliminating exhaled carbon dioxide, because that is complex and depends on the patient, on the fresh gas flow rate and on the interaction between the carbon dioxide absorber and the breathing system.

This part does not apply to breathing circuits intended to be used together with the flammable anaesthetic gases defined in Annex DD of IEC 60601-2-13:2003.

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.

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)