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YY 0635.3-2009 English PDF

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YY 0635.3-2009: Inhalational anaesthesia systems. Part 3: Anaesthetic vapour delivery devices
Status: Obsolete
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Basic data

Standard ID YY 0635.3-2009 (YY0635.3-2009)
Description (Translated English) Inhalational anaesthesia systems. Part 3: Anaesthetic vapour delivery devices
Sector / Industry Medical Device & Pharmaceutical Industry Standard
Classification of Chinese Standard C46
Classification of International Standard 11.040.10
Word Count Estimation 18,162
Date of Issue 2009-06-16
Date of Implementation 2010-12-01
Quoted Standard GB 3836.4-2000; GB/T 4999-2003; GB/T 5332-2007; GB 9706.1-2007; GB 9706.29-2006; YY 0505-2005; YY 0601-2007; YY 1040.1-2003; YY 0635.2-2009; IEC 60601-1-6; ISO 5360-2006
Adopted Standard ISO 8835-4-2004, MOD
Regulation (derived from) Industry standard filing Notice 2009 No. 9
Issuing agency(ies) State Food and Drug Administration
Summary This standard specifies requirements for anesthetic gas delivery device (AVDD) (as defined in 3. 1) of the basic safety and performance requirements. It is suitable for use as an anesthesia system components and surgical care for continuous anesthetic gas delivery device (AVDD). This section anesthetic gas delivery device (AVDD) presents special requirements of its general requirements are GB 9706. 29-2006 apply. This section does not apply, as defined in Appendix CC use flammable anesthetic anesthesia systems, and the use of anesthesia breathing system anesthetic gas delivery device (AVDD) (eg suction evaporator). If the requirements of this part of the GB 9706. 1-2007 replace or modify the corresponding requirements, the requirements take precedence over the corresponding general requirements.

YY 0635.3-2009: Inhalational anaesthesia systems. Part 3: Anaesthetic vapour delivery devices

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Inhalational anaesthesia systems.Part 3. Anaesthetic vapour delivery devices ICS 11.040.10 C46 People's Republic of China pharmaceutical industry standards Inhalation anesthesia system Part 3. anesthetic gas delivery device (ISO 8835-4.2004, MOD) Posted 2009-06-16 2010-12-01 implementation State Food and Drug Administration issued

Foreword

YY 0635 "inhalation anesthesia system" consists of the following components. --- Part 1. Adult anesthesia ventilation system; --- Part 2. anesthetic gas purification system delivery and collection systems. --- Part 3. anesthetic gas delivery device; --- Part 4. anesthesia ventilator. This is Part 3 YY 0635 of. The partial modification of the use of ISO 8835-4.2004 "inhalation anesthesia systems - Part 4. anesthetic gas delivery device." Part of this ISO 8835-4.2004 main differences are as follows. --- 51.104.1,51.104.2 the "volume flow" before "output vapor concentration (volume percent)." --- ISO 8835-4. ISO 2004 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. The same period when the implementation of international standards --- referenced in this section, to be transformed into national or industry standards. --- This section is based on GB 9706.1-2007 (IEC 60601-1. 1988, IDT) "Medical electrical equipment - Part 1. Safety through With the requirements "(General Standard) of the specific standard, used in conjunction with GB 9706.1-2007 deals. Take precedence over the requirements of this GB 9706.1-2007 the relevant requirements. --- Part 36 Chapter electromagnetic compatibility and YY 0505-2005 "Medical electrical equipment - Part 1-2. General requirements for safety Collateral standard. Electromagnetic compatibility - Requirements and test the implementation of the same period. " Appendix AA in this section and Appendix BB informative appendices; Appendix CC normative appendix. This part of the National Standardization Technical Committee of anesthesia and respiratory equipment and focal points. This section is drafted. Beijing Aerospace Changfeng Co., Ltd Medical Devices Branch, Medical Systems Co., Ltd. Beijing Yi An. The main drafters of this section. to Wei Tao, Wu Qiang, Zhang Hongyu, Li Yunfei.

Introduction

YY 0635 This part is related to GB 9706.1-2007 version as a common standard based on Prepared. In general Medical and patient environment, use common standards as a professional medical electronic equipment on the basis of safety standards, including some to ensure that Required for safe operation requirements. Standards and specific standards associated with the General Standard parallel. Collateral Standard provides for special technical or hazardous equipment requirements, such as Medical systems, electromagnetic compatibility, X-ray diagnostic equipment, radiation protection and software. Specific standards applicable to a particular device, such as medical electronics Accelerators, high frequency surgical equipment and hospital beds. Note. The parallel standard and proprietary standard definition, see GB 9706.1-2007 1.5, respectively, and A. 2. Corresponding to the number of common standard parts, chapters or strips of this section. Changes to the General Standard for the use of the following words to the text states. "Replace" means the General Standard chapter or article entirely replaced by the text of this section. "Increase" means the text of this section is attached to the common standards go up. "Edit" means the General Standard or chapter should be amended in accordance with the text in this section. Added chapter on common standards, bar charts and tables are numbered starting from 101, supplemental appendix AA, BB and other numbers to add items to the column aa), bb) and other numbers. The term "this part" means the part of the common standards and criteria for use with parallel. If there is no corresponding article, chapter or article in this section, shall be completely common standard parts, chapters or strips. If the requirements of this section to replace or modify the General Standard or Collateral standard relevant requirements, the requirements in the relevant priority of universal Claim. Inhalation anesthesia system Part 3. anesthetic gas delivery device

1 Scope

Except for the following, GB 9706.1-2007 Chapter 1 apply. increase. YY 0635 This section provides for the anesthetic gas delivery device (AVDD) (as defined in 3.1) basic safety and performance requirements. it Suitable for use as a component of the anesthesia system and anesthetic gases for continuous operative care of the delivery device (AVDD). This section Anesthetic gas delivery device (AVDD) presents special requirements then its general requirements GB 9706.29-2006 apply. This section does not apply, as defined in Appendix CC flammable anesthetic anesthesia systems, and the use of anesthesia in the respiratory system Anesthetic gas delivery device (the AVDD) (e.g. suction evaporator). If the requirements of this section to replace or modify the relevant requirements GB 9706.1-2007, the priority claim in the corresponding general Claim.

2 Normative references

The following documents contain provisions which, through reference in this section YY 0635 constitute provisions of this section. Cited documents dated, its All subsequent amendments (excluding corrections) or revisions do not apply to this section, however, encourage an agreement under this section Parties to study the latest versions of these documents. For undated reference documents, the latest versions apply to this section. 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) Temperature test method GB/T 5332-2007 ignition of flammable liquids and gases (IEC 60079-4. 1975, IDT) 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. safety and essential performance of anesthetic systems (IEC 60601-2-13. 2003, MOD) 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 0601-2007 anesthetic gas monitors (ISO 11196.1995, IDT) YY 1040.1-2003 anesthesia and respiratory equipment - Conical fittings - Part 1. Cone and drogue (ISO 5356-1.1996, IDT) YY 0635.2-2009 inhalation anesthesia systems - Part 2. anesthetic gas purification system delivery and collection systems (ISO 8835- 3.1997, IDT) IEC 60601-1-6 Medical electrical equipment - Part 1-6. General requirements for safety - Collateral standard. Usability ISO 5360-2006 anesthesia machine evaporator special agent filling system

3 Terms and Definitions

GB/T 4999-2003, GB 9706.29-2006 established and the following terms and definitions apply to this part YY 0635. 3.1 Providing anesthetic vapor concentration controllable devices.

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