1 Scope
This Standard specifies the technical requirements, test methods, markings and instructions for use, as well as packaging, transportation and storage of surgical masks (hereinafter referred to as the "masks").
This Standard is applicable to the disposable surgical masks worn by the clinical medical staff during the process of invasive operation.
2 Normative References
The following referenced documents are indispensable for the application of this Document. For dated references, only the dated edition applies. For undated references, the latest edition of the referenced document (including any amendment) applies.
GB/T 14233.1-2008 Test Methods for Infusion, Transfusion, Injection Equipments for Medical Use - Part 1: Chemical Analysis Methods
GB/T 14233.2-2005 Test Methods for Infusion, Transfusion, Injection Equipment for Medical Use - Part 2: Biological Test Methods
GB 15979-2002 Hygienic Standard for Disposable Sanitary Products
GB/T 16886.5-2003 Biological Evaluation of Medical Devices - Part 5: Test for In Vitro Cytotoxicity
GB/T 16886.10-2005 Biological Evaluation of Medical Devices - Part 10: Tests for Irritation and Delayed-type Hypersensitivity
3 Terms and Definitions
For the purpose of this Standard, the following terms and definitions apply.
3.1 Surgical mask
It is applied to cover the mouth, nose and lower jaw of the user to provide physical barrier to prevent pathogen microorganism, body fluid and particles etc. against direct penetration.
3.2 Synthetic blood
A mixture, in the color similar to the blood, composed of orchil, surfactant, thickener and distilled water, the surface tension and viscosity of which can represent the blood and other body fluids.
Note: the synthetic blood for test use in this Standard does not have all the characteristics of blood or body fluid, e.g. polarity (wettability), coagulability and cellular materials.
Foreword I
1 Scope
2 Normative References
3 Terms and Definitions
4 Technical Requirements
5 Test Methods
6 Markings
7 Packaging, Transportation and Storage
Appendix A (Normative) Preparation Method of Synthetic Blood
Appendix B (Normative) Test Methods for Bacterial Filtration Efficiency (BFE)
Bibliography
