Standard No.:	YY 0469-2011
English Name:	Surgical mask
Chinese Name:	医用外科口罩
Chinese Classification:	C48    Medical sanitary products
Professional Classification:	YY    Professional Standard - Pharmaceutics
Source Content Issued by:	China Food and Drug Administration
Issued on:	2011-12-31
Implemented on:	2013-6-1
Status:	to be superseded
Superseded by:	YY 0469-2023 Sterile drainage catheters and accessory devices for single use
Superseded on:	2026-12-1
Superseding:	YY 0469-2004 Technical requirements for surgical mask
Target Language:	English
File Format:	PDF
Word Count:	8000 words
Translation Price(USD):	80.0
Delivery:	via email in 1 business day

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