YY 0469-2004 (YY0469-2004)

Standard ID	Contents [version]	USD	STEP2	[PDF] delivered in	Standard Title (Description)	Related Standard	Status	PDF
YY 0469-2004	English	559	Add to Cart	4 days [Need to translate]	Technical requirements for surgical mask	YY 0469-2004	Obsolete	YY 0469-2004

YY 0469-2004
Technical requirements for surgical mask
ICS 11.140
C48
People's Republic of China Pharmaceutical Industry Standard
Medical surgical mask technical requirements
Released on.2004-03-23
2005-01-01 implementation
State Food and Drug Administration released
Foreword
4.2 and 4.7 of this standard are recommended, others are mandatory.
Appendix A and Appendix B of this standard are normative appendices.
This standard was proposed by the State Food and Drug Administration.
This standard is under the jurisdiction of Beijing Medical Device Testing Center.
This standard was drafted. Beijing Medical Device Inspection Institute.
The main drafters of this standard. Hu Dongmei, Song Lianyou, Su Jian.
Medical surgical mask technical requirements
1 range
This standard specifies the technical requirements, test methods, signs and instructions for use, and packaging and transportation of medical surgical masks (hereinafter referred to as masks).
And storage.
This standard applies to patients who are worn by clinical staff during invasive procedures, for patients undergoing treatment and for invasive procedures.
Medical staff provide protective surgical masks that block the spread of blood, body fluids and spatters.
2 Normative references
The terms in the following documents become the terms of this standard by reference to this standard. All dated references, followed by all
Modifications (not including errata content) or revisions do not apply to this standard, however, parties to agreements based on this standard are encouraged to study
Is it possible to use the latest version of these files? For undated references, the latest edition applies to this standard.
GB/T 191 packaging storage and transportation icon
GB/T 4745-1997 Textile fabrics - Determination of moisture resistance
GB/T 14233.2-1993 Methods of test for medical infusion, blood transfusion, and injecting machines - Part 2
GB 15980-1995 Hygienic standard for disposable medical supplies
GB/T 16886.10-2000 Biological evaluation of medical devices - Part 10. Stimulation and sensitization test
3 Terms and definitions
The following terms and definitions apply to this standard.
3.1
Provided by clinical staff during invasive procedures, for patients who are treated and for medical staff who perform invasive procedures
A mask that protects against the spread of blood, body fluids and splashes.
3.2
a mixture of red dyes, surfactants, thickeners and distilled water, whose surface tension and viscosity can represent blood and other
Body fluids and have a color similar to blood.
[ASTMF1862-00a, definition 3.1.9]
Note. The synthetic blood used in this standard test does not have all the characteristics of blood or body fluids, such as polarity (wet), coagulability, and cellular matter.
3.3
The effectiveness of medical mask materials to prevent the passage of bacteria in aerosol form; expressed as aerosols from medical mask materials at specified flow rates
The percentage of filtration.
[ASTMF2101-01, definition 3.1.4]
3.4
A particulate, solid, liquid or solid and liquid particulate matter such as dust, smoke, mist and microorganisms suspended in the air.
[GB/T 18664-2002, definition 3.1.15]