YY 0635.2-2009Inhalational anaesthesia systems - Part 2: Anaesthetic gas scavenging systems transfer and receiving systems (English PDF)

Foreword

YY 0635 "inhalation anesthesia system" consists of the following components.

--- Part 1. Adult 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 2 YY 0635 of.

This part identical with ISO 8835-3:1997 "inhalation anesthesia systems - Part 3. anesthetic gas purification system delivery and collection system". This part of ISO 8835-3:1997 main differences are as follows.

--- ISO 8835-3:1997 Introduction The conversion of the present introduction, delete ISO 8835-3:1997 Foreword;

--- ISO 8835-3. ISO 1997 international standard referenced, has been adopted as the corresponding national standards and industry standards, in order to lead this part Use these national standards and industry standards as the norm; now no correspondence has been adopted as national standards and industry standards, places cited With international standards as ISO standard use;

--- Because ISO 8835-3:1997 normative references in ISO 8835-1 standard only be referenced in the introductory part, and This partial deletion of the ISO 8835-3:1997 Foreword, therefore, this part of the normative references of this standard also deleted References;

Over the same period to implement the provisions of international standards --- referenced in this section, to be the appropriate international standards into national or industry standards.

This section of the Appendix A, Appendix B, Appendix C and Appendix D normative appendix.

Introduction

It has been recognized that there are many factors beyond the anesthetic gas purification system (AGSS) manufacturers to control the impact of the operator's working environment Conditions, including room ventilation, equipment leaks and choice of anesthetic technique, all of which are uncertain. In addition, other factors also affect staff The total absorption of pollution, such as exposure time, the positional relationship between sources of pollution and the like.

The purpose of this section is to ensure that all applications, anesthetic gas purification system (AGSS) purify it all leads will fundamentally Gas, thereby reducing air pollution to a very low level of non-controllable.

Air pollution is the subject of anesthetic gases widely discussed, but due to criteria of environmental pollution is inconsistent, so This section is not recommended to allow purification indicators, there may be provisions in other standards.

TC121 committee has been responsible for the first part of the participation restrictions anesthetic gas purification system (AGSS) delivery and collection systems due to Risk to the patient to change the function of the ventilation system caused. Now a wide range of commonly used anesthesia machine, ventilator and associated equipment Already under consideration.

Generating means for limiting the use of anesthesia in the ventilation system of the gas purification system (AGSS) caused by pressure changes, and should Ventilation system or as close as possible in the ventilation system.

Negative security assurances and induced flow is not easy, experience has shown that under certain conditions, anesthetic gas purification system (AGSS) any negative patient end can cause air flows from the ventilation system. Such air flow is very dangerous, for example, will Leading to the fresh gas flow rate is reduced to minimum flow rate required by the patient or less; composition changes lead to a gas mixture; and its influence break alarm His breathing is normal function measuring device or dangerous combinations of these.

Because of the design in any condition can be prevented from introducing any flow from the ventilation system to the anesthetic gas purification system (AGSS) air inlet The collection system is very difficult to decide which provisions restricting flow. Induction flow and cautionary statements included in the requests for information This section, if applicable, provided by the manufacturer [(see 11b)].

Passive (passive) anesthetic gas purification system (passive AGSS) (for example. the air flow is not its processing system is generated by the power plant A) are not included in this section, because they do not meet safety requirements under all conditions specified. Adjacent gas suction system (for example. non Ventilation system directly connected to the system) is not included in this section. Therefore, this section is limited to active anesthetic gas purification system (active AGSS) delivery and collection systems, and integrated systems for collecting and processing systems anesthetic gas purification system (AGSS).

Anesthetic gas purification system (AGSS) Examples of typical configuration shown in Figure 1.

1 Scope

YY 0635 This section specifies the requirements for active anesthetic gas purification system (active AGSS) delivery and collection system. This section Also provides for collection systems and treatment system combines integrated anesthesia gas purification system (AGSS) requirements.

This section does not apply to passive anesthetic gas purification system (passive AGSS) or similar gas suction system.

This section does not include requirements for the following two parts.

a) separating the processing system;

b) mounting processing system.

YY 0635 provisions of this section are not used as gas monitors anesthetic gas vent and purge systems (AGSS) connector; this Prescribed class joints are under consideration.

2 Normative references

The following documents contain provisions which, through reference YY 0635 present, constitute provisions of this section. For dated references, All subsequent amendments (not including errata content) or revisions do not apply to this section, however, encourage the agreement on this section Whether the parties can study the latest versions of these documents. For undated reference documents, the latest versions apply to this section.

GB 9706.1-2007 Medical electrical equipment - Part 1. General requirements for safety (IEC 60601-1. 1988, IDT)

GB 15608-2006 Chinese color system

YY 1040.1-2003 anesthesia-respiratory conical fittings - Part 1. Cones and sockets (ISO 5356-1:1996, IDT)

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

ISO 5359:2000 Flexible low-pressure medical gas system used to connect hose assembly

3 Terms and Definitions

The following terms and definitions apply to this part YY 0635.