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YY/T 0753.2-2009 English PDF

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YY/T 0753.2-2009: Breathing system filters for anaesthetic and respiratory use. Part 2: Non-filtration aspets
Status: Valid

Standard ID	Contents [version]	USD	STEP2	[PDF] delivered in	Standard Title (Description)	Status	PDF
YY/T 0753.2-2009	English	154	Add to Cart	3 days [Need to translate]	Breathing system filters for anaesthetic and respiratory use. Part 2: Non-filtration aspets	Valid	YY/T 0753.2-2009

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Basic data

Standard ID	YY/T 0753.2-2009 (YY/T0753.2-2009)
Description (Translated English)	Breathing system filters for anaesthetic and respiratory use. Part 2: Non-filtration aspets
Sector / Industry	Medical Device & Pharmaceutical Industry Standard (Recommended)
Classification of Chinese Standard	C46
Classification of International Standard	11.040.10
Word Count Estimation	8,897
Date of Issue	2009-11-15
Date of Implementation	2010-12-01
Quoted Standard	GB 9706.1-2007; GB/T 19633; YY 1040.1; YY 1040.2-2008; YY/T 0735.1-2009
Adopted Standard	ISO 23328-2-2002, 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 provides for Anesthesia Breathing Breathing system filters (BSF) of non-filtered aspects, including its ports, leak, choke, packaging, marking and information provided.

YY/T 0753.2-2009: Breathing system filters for anaesthetic and respiratory use. Part 2: Non-filtration aspets

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Breathing system filters for anaesthetic and respiratory use.Part 2. Non-filtration aspets ICS 11.040.10 C46 People's Republic of China pharmaceutical industry standards YY/T 0753.2-2009/ISO 23328-2.2002 Anesthesia and respiratory breathing system filters Part 2. Non-filtration aspects (ISO 23328-2.2002, IDT) Posted 2009-11-15 2010-12-01 implementation State Food and Drug Administration issued

Foreword

YY/T 0753 "anesthesia and respiratory breathing system filters," including the following sections. --- Part 1. Evaluation of filter salt test methods; --- Part 2. Non-filtration aspects. This is Part 2. This part identical with ISO 23328-2.2002 "anesthesia and respiratory breathing system filters - Part 2. Non-filtration aspects." This part of the National Standardization Technical Committee on Narcotic breathing apparatus and (SAC/TC116) and focal points. This section is drafted. Shandong Medical Devices Product Quality Inspection Center. The main drafters of this section. Wan Min, Zhang Bo, Gu Yufei, Limei. YY/T 0753.2-2009/ISO 23328-2.2002

Introduction

YY/T 0753 This section gives breathing system filters (BSF) non-filter requirements. Breathing system filters for reducing inhaled or exhaled by the number of particulate matter (including microbial). Breathing system filters in clinical use are exposed to various levels of humidity. Since this exposure may affect the respiratory system filters The filter performance test method of breathing system filters in order to simulate clinical use it is exposed to moist air. Involving filtration Test can see YY/T 0753.1-2009. YY/T 0753.2-2009/ISO 23328-2.2002 Anesthesia and respiratory breathing system filters Part 2. Non-filtration aspects

1 Scope

YY/T 0753 provisions of this section for respiratory anesthesia breathing system filters (BSF) non-filter, including its connection end Mouth, leaks, choke, packaging, labeling, and information provided. Test Method BSF intended for clinical use in the respiratory system. This section does not apply to other types of filters, such as specifically to protect a source of vacuum or gas sampling line, the filter pressurized gas Respiratory protection or measuring physiological test equipment filters. Note. YY/T 0753.1 gives evaluate respiratory filter performance test method.

2 Normative references

The following documents contain provisions which, through reference in this text, constitute provisions of this part. For dated references, subsequent Amendments (not including errata content) or revisions do not apply to this section, however, encourage the parties to this part of the research agreement Whether 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/T 19633 Packaging for terminally sterilized medical devices (GB/T 19633-2005, ISO 11607.2003, IDT) YY 1040.1 respiratory and anesthesia equipment taper fittings - Part 1. cone and cone sleeve (YY 1040.1-2003, ISO 5356- 1.1996, IDT) YY 1040.2-2008 respiratory and anesthesia equipment conical fittings - Part 2. Threaded cone bearing joints (ISO 5356-2. 1987, 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

The following terms and definitions apply YY/T 0753 of this section. 3.1 Is expected to reduce the respiratory system, including the device includes microbial biomass particles spread. 3.2 Breathing system filters connected to the respiratory system port. 3.3 Breathing system filters expectations and intubation, tracheal or bronchial tube connectors masks and other equipment connected to the port. 3.4 Breathing system filters and auxiliary equipment (such as for gas sampling, monitoring and pressure measurement) port. YY/T 0753.2-2009/ISO 23328-2.2002

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