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YY 0635.4-2009 English PDF

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YY 0635.4-2009: Inhalational anaesthesia systems. Part 4: Requirements for anaesthetic ventilators
Status: Obsolete
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Basic data

Standard ID YY 0635.4-2009 (YY0635.4-2009)
Description (Translated English) Inhalational anaesthesia systems. Part 4: Requirements for anaesthetic ventilators
Sector / Industry Medical Device & Pharmaceutical Industry Standard
Classification of Chinese Standard C46
Classification of International Standard 11.040.10
Word Count Estimation 16,135
Date of Issue 2009-06-16
Date of Implementation 2010-12-01
Quoted Standard GB 3836.4; GB/T 4999-2003; GB/T 5332-2007; GB/T 7899-2006; GB 9706.1-2007; GB 9706.29-2006; GB 15382-1994; YY 0505-2005; YY 1040.1-2003; YY 1040.2-2008; YY 0635.1-2009; YY 0635.2-2009; ISO 5359-2000; ISO 7396-1
Adopted Standard ISO 8835-5-2004, MOD
Regulation (derived from) Industry standard filing Notice 2009 No. 9
Issuing agency(ies) State Food and Drug Administration
Summary This standard specifies the anesthesia ventilator (see Definition 2. 1) essential performance requirements. This section is based on a special standard GB 9706. 1-2007. As the 1. 3 GB 9706. 1-2007 expressed, the requirements of this than the relevant requirements of GB 9706. 1 more effective. If this part of the statement GB 9706. 1-2007 chapter applies, means that the terms of the demands made only on the considered anesthesia ventilator when applicable. This section refers to anesthesia ventilator is usually a component of anesthetic systems, and is a continuous operator intervention. Type of equipment with flammable anesthetics used in conjunction with anesthesia ventilator, as described in Appendix BB identified in this part of the scope of application.

YY 0635.4-2009: Inhalational anaesthesia systems. Part 4: Requirements for anaesthetic ventilators


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Inhalational anaesthesia systems.Part 4. Requirements for anaesthetic ventilators ICS 11.040.10 C46 People's Republic of China Pharmaceutical Industry Standard Inhalation anesthesia system Part 4. Anesthesia ventilator (ISO 8835-5..2004, MOD) 2009-06-16 release 2010-12-01 implementation State Food and Drug Administration issued

Foreword

YY 0635 "Inhalation Anesthesia System" consists of the following components. - Part 1. Adult anesthetic respiratory system; - Part 2. Anesthetic gas purification system delivery and collection system; - Part 3. Anesthetic gas delivery device; Part 4. Anesthesia ventilator. This section is part 4 of YY 0635. This section is modified using the international standard ISO 8835-5..2004 "Inhalation Anesthesia System Part 5. Anesthesia Ventilator". The main differences between this section and ISO 8835-5..2004 are as follows. This part is based on GB 9706.1-2007 (IEC 60601-1. 1988, IDT) "Medical electrical equipment Part 1. Safety links With the requirements "(common standard) of the special standards, with the use of GB 9706.1-2007 supporting. The requirements of this section take precedence Relevant requirements in GB 9706.1-2007. --- Section 36 Electromagnetic compatibility and YY 0505-2005 "Medical electrical equipment Part 1-2. General requirements for safety Parallel standard. electromagnetic compatibility requirements and test "the same period of implementation. --- The international standards cited in this section shall be implemented in the same period when they are converted into national or industry standards. Appendix AA to this section is an informative appendix and appendix BB is a normative appendix. This section is proposed by the National Standardization Technical Committee on Anesthesia and Respiratory Equipment. This part of the drafting unit. Beijing Yi An Medical System Co., Ltd. This part of the main drafters. Deng Yiruo, Li Yunfei.

Introduction

This part of YY 0635 is a specific requirement for anesthesia ventilators for inhalation anesthesia systems. These devices must meet the hemp The definition of drunk ventilators (lung ventilators used with anesthesia ventilation systems during anesthesia), which in some cases are subject to different Training personnel are used in hospitals. YY 0635 this part is based on GB 9706.1-2007 "medical electrical equipment part 1. general requirements for safety" special standard Standard, GB 9706.1-2007 is referred to herein as the "General Standard". The generic standard is all in the general medical and patient environment by qualified personnel Use or monitor the safety of medical equipment based on the basic standards, it also includes some reliable operation to ensure the safety requirements. Common standards are used in conjunction with side-by-side standards and proprietary standards. The juxtaposition criteria include special technical and/or dangerous requirements and are applicable There are application equipment, such as medical systems, EMC, diagnostic X-ray equipment, ray protection, software and so on. Special standards apply to special equipment types, examples Such as medical electronic accelerator, high frequency electric knife, bed and so on. The description of the parallel standard and the specific standard is described in 1.5 and A. of GB 9706.1-2007, respectively. Chapter 2. YY 0635 part of the chapter, chapter and article number consistent with the common standards. Changes to the common standard text and the complementarity of the parallel standards Charge, by using the following words. --- "Replace" means that the chapter or the clause of the generic standard is completely replaced by the text of this part. - "Increased" means that the relevant text in this section is new content (eg, bar, column item, note, table, figure) attached to the common standard. --- "Modification" means that the existing content of the common standard is partially modified. In order to avoid confusion with the modified version of the generic standard itself, the YY 0635 part of this chapter increases the number of chapters, bars, tables and figures starting from 101; Charge the column to the letter aa), bb) number; supplementary appendix to AA, BB and other numbers. This part of YY 0635 is marked by the asterisk () in Appendix AA. Inhalation anesthesia system Part 4. Anesthesia ventilator

1 Scope

In addition to the following, GB 9706.1-2007 Chapter 1 applies. This part of YY 0635 is based on the specific standards of GB 9706.1-2007. As described in 1.3 of GB 9706.1-2007 , The requirements of this part are more effective than the relevant requirements of GB 9706.1. If in this section the clause of GB 9706.1-2007 is declared Is applicable, it means that the provision applies only if the request is related to the anesthesia ventilator under consideration. This section specifies the specific requirements for the basic performance of anesthesia ventilator (see definition of 2.1). The anesthesia ventilator referred to in this section is usually The components of an anesthesia system are intermittently engaged by an operator. Anesthesia ventilators for use with flammable anesthesia equipment, as defined in Appendix BB, are outside the scope of application of this section.

2 normative reference documents

The terms of this document are the terms of this part of the terms of this part of YY 0635. Any reference to the date of the document, All subsequent amendments (excluding corrigenda) or revisions do not apply to this part, however, it is encouraged to enter into an agreement under this Part Of the parties to study whether the latest version of these documents can be used. For undated references, the latest edition of this section applies. GB 3836.4 Electrical equipment for explosive gas atmospheres - Part 4. Intrinsically safe "i" (GB 3836.4-2000, eqv IEC 60079-11..1999) GB/T 4999-2003 Terminology for anesthesia and respiratory equipment (ISO 4135..2001, IDT) Test method for flammable liquids and gases - Ignition temperature (IEC 60079-4. 1975, IDT) GB/T 5332-2007 GB 7899-2006 Cylinder pressure reducers for welding, cutting and similar processes (ISO 2503..1998, MOD) GB 9706.1-2007 Medical electrical equipment - Part 1. General requirements for safety (IEC 60601-1. 1988, IDT) GB 9706.29-2006 Medical electrical equipment - Part 2. Particular requirements for the safety and basic performance of anesthesia systems (IEC 60601- 2-13.2003, MOD) General technical conditions for cylinder valves GB 15382-1994 YY 0505-2005 Medical electrical equipment - Part 1-2. General requirements for safety - Parallel standards. Electromagnetic compatibility requirements and tests (IEC 60601-1-2..2001, IDT) YY 1040.1-2003 Anesthesia and respiratory equipment - Conical joints - Part 1. Cone and taper sleeves (ISO 5356-1..1996, IDT) YY 1040.2-2008 Conjugates for anesthesia and respiratory equipment - Part 2. Threaded load - bearing joints (ISO 5356-2..2006, IDT) Inhalation anesthesia system - Part 1. Adult anesthetic respiratory system (ISO 8835-2..1999, IDT) Inhalation anesthesia systems - Part 2. Anesthetic gas purification system delivery and collection systems (ISO 8835 - 3..1997, IDT) ISO 5359..2000 Low pressure flexible connection hose assemblies for medical gas systems ISO 7396-1 Medical gas piping systems - Part 1. Compressed medical gases and vacuum piping

3 terms and definitions

GB 9706.1-2007, GB/T 4999-2003 and GB 9706.29-2007 and the following terms and definitions apply to YY 0635 this part.

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