YY/T 0735.1-2009 English PDF

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YY/T 0735.1-2009: Anaesthetic and respiratory equipment. Heat and moisture exchangers (HMEs) for humidifying respired gases in humans. Part 1: HMEs for use with minimum tidal volumes of 250 mL
Status: Valid

Standard ID	USD	BUY PDF	Lead-Days	Standard Title (Description)	Status
YY/T 0735.1-2009	354	Add to Cart	3 days	Anaesthetic and respiratory equipment. Heat and moisture exchangers (HMEs) for humidifying respired gases in humans. Part 1: HMEs for use with minimum tidal volumes of 250 mL	Valid

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Basic data

Standard ID: YY/T 0735.1-2009 (YY/T0735.1-2009)
Description (Translated English): Anaesthetic and respiratory equipment. Heat and moisture exchangers (HMEs) for humidifying respired gases in humans. Part 1: HMEs for use with minimum tidal volumes of 250 mL
Sector / Industry: Medical Device & Pharmaceutical Industry Standard (Recommended)
Classification of Chinese Standard: C46
Classification of International Standard: 11.040.10
Word Count Estimation: 18,126
Date of Issue: 2009-11-15
Date of Implementation: 2010-12-01
Quoted Standard: GB/T 4999-2003; GB 9706.1-2007; GB/T 16273.1-2008; GB 19633; YY 1040.1-2003; YY 1040.2-2008
Adopted Standard: ISO 9360-1-2000, IDT
Regulation (derived from): Industry standard filing Notice 2010 No. 2 (No. 122 overall)
Issuing agency(ies): State Food and Drug Administration
Summary: This standard specifies the tidal volume is equal to or greater than 250mL, mainly intended for the patient breathing gas humidifier, and includes at least one machine port heat and moisture exchanger (including those with respiratory filter HME) with the relevant requirements and regulations its evaluation of the test methods.

YY/T 0735.1-2009: Anaesthetic and respiratory equipment. Heat and moisture exchangers (HMEs) for humidifying respired gases in humans. Part 1: HMEs for use with minimum tidal volumes of 250 mL

---This is a DRAFT version for illustration, not a final translation. Full copy of true-PDF in English version (including equations, symbols, images, flow-chart, tables, and figures etc.) will be manually/carefully translated upon your order.
Anaesthetic and respiratory equipment.Heat and moisture exchangers (HMEs) for humidifying respired gases in humans.Part 1. HMEs for use with minimum tidal volumes of 250 mL ICS 11.040.10 C46 People's Republic of China pharmaceutical industry standards YY/T 0735.1-2009/ISO 9360-1.2000 Anaesthetic and respiratory equipment human respiratory gas humidification The heat and moisture exchanger (HME) Part 1. The minimum tidal volumes for (ISO 9360-1.2000, IDT) Posted 2009-11-15 2010-12-01 implementation State Food and Drug Administration issued

Foreword

YY/T 0735 the general title "Anaesthetic and respiratory equipment respiratory gas humidification body heat and moisture exchanger (HME)", includes the following Section a few. --- Part 1. For a minimum tidal volume of 250mL of HME; --- Part 2. minimum tidal volume for tracheotomy surgery patients was 250mL of HME. This section YY/T Section 10735 of. This part identical with ISO 9360-1.2000 "Anaesthetic and respiratory equipment respiratory gas humidification body heat and moisture exchanger (HME) Part 1. The minimum tidal volume for 250mL of the HME. " This section Appendices A and B are informative appendices. This part of the National Standardization Technical Committee on Narcotic breathing apparatus and (SAC/TC116) centralized. This section is drafted. Shandong Medical Devices Product Quality Inspection Center. The main drafters of this section. Wu Ping, Zhang Bo, Song Jinzai, Wan Min. YY/T 0735.1-2009/ISO 9360-1.2000

Introduction

General medical gases lack of sufficient water, it is difficult to adapt to the physical needs of patients in the respiratory tract. HME to call for improving the delivery Getter track moisture content and temperature. They are primarily expected to be used independently or as part of the respiratory system. YY/T 0735.1-2009/ISO 9360-1.2000 Anaesthetic and respiratory equipment human respiratory gas humidification The heat and moisture exchanger (HME) Part 1. The minimum tidal volumes for

1 Scope

YY/T 0735 provisions of this part of the tidal volume equal to or greater than 250mL, primarily intended for patient respiratory gas humidification, and to It includes at least one machine port HME (including HME respiratory system with filter) with the relevant requirements, and provides them into Standard Test Method for Evaluation row.

2 Normative references

The following documents contain provisions which, through reference YY/T 0735 and become part of the 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/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, IDT) GB/T 16273.1-2008 Graphical symbols for equipment Common symbols (ISO 7000.2004, NEQ) GB 19633 Packaging for terminally sterilized medical devices (GB 19633-2005, ISO 11607.2003, 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. Threaded cone bearing joints (ISO 5356-2. 1987, IDT)

3 Terms and Definitions

GB/T 4999 and established the following terms and definitions apply YY/T 0735 of this section. 3.1 Reserved part of a patient breath moisture and heat, and in the process of breathing in its return to the respiratory equipment. 3.2 HME patients with respiratory system interface ports. 3.3 HME patient airway connection port. 3.4 HME and auxiliary equipment connected to the port. Example. assistive devices can be a gas sampling line. 3.5 HME contained when not pressurized volume, minus the volume of all solid elements, minus all internal fittings within the conical volume. YY/T 0735.1-2009/ISO 9360-1.2000 ......

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