YY/T 0735.2-2010Anaesthetic and respiratory equipment - Heat and moisture exchangers (HMEs) for humidifying respired gases in humans - Part 2: HMEs for use with tracheostomised patients (English PDF)

Foreword

YY/T 0735 the general title "Anaesthetic and respiratory equipment for respiratory gas humidification body heat and moisture exchangers (HMEs)", including The following sections.

--- Part 1. For a minimum tidal volume of 250mL of HME;

--- Part 2. tracheostomy for patients with more than 250mL tidal volume HMEs. This section YY/T Section 20735 of. This section drafted in accordance with GB/T 1.1-2009 given rules. This section identical with the international standard ISO 9360-2. HME 2001 "Anaesthetic and respiratory equipment for humidifying the human respiratory gases Device (HMEs) - Part 2. for tracheostomy patients over 250mL tidal volume HMEs ". This section and ISO 9360-2.2001 as compared to the major differences include.

--- Remove the ISO 9360-2.2001 Foreword in the part. ISO international standard

--- referenced in this section, have been adopted as the corresponding national standards and industry standards, this section to refer to these National standards and industry standards as the standard use, no correspondence now been adopted as national standards and industry standards, places cited ISO international standards as the standard use. This standard requires certain basic principles are given in Appendix A. These provisions are shown in the text by (R). This part of the National Standardization Technical Committee on Narcotic breathing apparatus and (SAC/TC116) centralized. This part by the Shanghai Medical Device Testing is responsible for drafting. The main drafters of this section. Wang Wei, Li Min. Anaesthetic and respiratory equipment For humidifying the human respiratory gas heat and moisture exchanger (HMEs) - Part 2. for tracheostomy 250mL tidal volume than patients HMEs

1 Scope

YY/T 0735.2 is Part 2 of the Chinese standard for heat and moisture exchangers, covering the devices used by tracheostomised patients. A tracheostomy bypasses the nose, which is the body's own humidifier, and without replacement the airway dries, secretions thicken and the tube blocks, so an HME on a tracheostomy is not a comfort measure but the thing that keeps the airway patent. These devices differ from circuit HMEs in that the patient wears them continuously and often manages them independently, which changes the requirements around resistance, secretion tolerance and the fixing arrangement. Part 1 covers HMEs used in breathing circuits. For a manufacturer or an importer of tracheostomy HMEs for the Chinese market, this is the governing standard.

YY/T 0735 based in part on the present YY/T 0735.1-2009, provides no mechanical connection port HME comprising even as Specific requirements and test methods for respiratory filters one. These devices are used for more than 250mL tidal volume tracheotomy patients By respiratory gas humidification.

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.

GB/T 4999-2003 term anesthesia breathing equipment (1SO4135.2001, IDT)

GB/T 16273.1-2008 equipment - Graphical symbols - Part 1. 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 sleeve ( ISO 5356-1.1996, IDT)

YY 1040.2-2008 anesthesia and respiratory equipment - Conical fittings - Part 2. Screw load-bearing joints ( ISO 5356-2.2006, IDT)

YY/T 0735.1-2009 anesthesia equipment and respiratory gas humidification human respiratory heat and moisture exchanger (HME) - Part 1. The minimum tidal volume of 250mL of HME ( ISO 9360-1.2000, IDT)

3 Terms and Definitions

GB/T 4999-2003 and YY/T 0735.1-2009 defined and the following terms and definitions apply to this document. 3.1 (R) HME internal volume HMEinternalvolume HME The HME volume minus the volume of all solid ingredients, minus the volume of all the inner conical joint remaining volume. In the case of non-compressed, HME in volume by an inner surface and a boundary surface HME theory impermeable material composition, the edge The minimum surface area of the interface is closed HME active ingredient.

4 Symbols and Abbreviations

Symbol YY/T 0735.1-2009 and abbreviations given in the application of this document.

5 General requirements and recommendations

5.1 (R) HME patient port connector Patient connector port should be able to comply with the YY 1040.1-2003 15mm outer conical connector mating.