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YY/T 1803-2021: (Polyvinyl alcohol hemostatic sponge)
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YY/T 1803-2021
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Basic data | Standard ID | YY/T 1803-2021 (YY/T1803-2021) | | Description (Translated English) | (Polyvinyl alcohol hemostatic sponge) | | Sector / Industry | Medical Device & Pharmaceutical Industry Standard (Recommended) | | Classification of Chinese Standard | C48 | | Word Count Estimation | 11,142 | | Issuing agency(ies) | State Drug Administration | YY/T 1803-2021: (Polyvinyl alcohol hemostatic sponge)---This is a DRAFT version for illustration, not a final translation. Full copy of true-PDF in English version (including equations, symbols, images, flow-chart, tables, and figures etc.) will be manually/carefully translated upon your order.
(Polyvinyl alcohol hemostatic sponge)
ICS 11.120.20
CCSC48
People's Republic of China Pharmaceutical Industry Standard
Polyvinyl alcohol hemostatic sponge
Published on 2021-09-06
2022-09-01 Implementation
Released by the State Drug Administration
foreword
This document is in accordance with the provisions of GB/T 1.1-2020 "Guidelines for Standardization Work Part 1.Structure and Drafting Rules of Standardization Documents"
drafted.
Please note that some content of this document may be patented. Publication of this document
Institutions do not assume responsibility for identifying patents.
This document is proposed by the State Drug Administration.
This document is under the jurisdiction of Shandong Medical Device Product Quality Inspection Center.
This document is drafted by. Shandong Medical Device Product Quality Inspection Center, Shandong Weigao Xinsheng Medical Device Co., Ltd., Beijing Yingjia
Medico Medical Materials Co., Ltd., Medtronic (Shanghai) Management Co., Ltd., and Buster Medical Technology (Changzhou) Co., Ltd.
The main drafters of this document. Wu Changyan, Wang Xiuxiu, Lv Hongmin, Zhu Tieqiao, Jin Yaxi, Sun Xiaoxia, Xu Hui, Liu Lili, Lin Zechen,
Yang Baoxin and Lu Ruju.
Introduction
At present, the commercially available polyvinyl alcohol hemostatic sponge is polyvinyl acetal sponge, mainly through cross-linking, foaming, curing, washing, compression, sterilization, etc.
Made by a series of processes, this is a non-fibrous porous material with good biocompatibility and stable chemical properties, making it an excellent material.
Hydrophilic, absorbent and physical compression hemostatic properties after absorbent expansion.
The polyvinyl alcohol material itself does not contain some coagulation substances, nor does it have a hemostatic mechanism. cannot be produced under a specific manufacturing process
The absorbed polyvinyl alcohol hemostatic sponge has the characteristics that ordinary sponges do not have, that is, its external volume expands continuously with the absorption of liquid.
characteristics. When it is placed in a narrow cavity of the human body (such as the nasal cavity, anorectum, etc.), the swelling property after suction can also physically compress the bleeding point.
effect of blood. Therefore, it is called "hemostatic sponge" in these special applications. Commercially available products are usually based on different clinical application requirements.
The polyvinyl alcohol hemostatic sponge in the compressed state is processed into different shapes and configurations, making it suitable for medical treatment such as otolaryngology, anorectal and so on.
process.
This document does not address sponges incorporating other degrading, haemostatic or antibacterial ingredients into the polyvinyl alcohol material. Therefore, this document does not address these
evaluation requirements.
In order to prevent the polyvinyl alcohol hemostatic sponge from absorbing moisture in the air and swelling during the storage period, which affects its expected performance, its single-pack
Most of the packaging is in a packaging type that can prevent the permeation of water vapor. The most common sterilization method at present is radiation sterilization.
Polyvinyl alcohol hemostatic sponge
1 Scope
This document specifies a single-use, sterile supply, non-absorbable compressed
Basic performance requirements of polyvinyl alcohol hemostatic sponge (hereinafter referred to as hemostatic sponge).
This document is applicable to the non-absorbable polyvinyl alcohol hemostasis that can be used for hemostasis by physical compression of the bleeding point through self-volume expansion after suction.
sponge.
This document does not apply to uncompressed polyvinyl alcohol sponges for liquid absorption, nor does it apply to absorbable components containing any drug or hemostatic component.
points and polyvinyl alcohol sponges with other therapeutic functions.
2 Normative references
The contents of the following documents constitute essential provisions of this document through normative references in the text. Among them, dated citations
documents, only the version corresponding to that date applies to this document; for undated references, the latest edition (including all amendments) applies to
this document.
GB/T 6682 Analysis Laboratory Water Specifications and Test Methods
GB/T 16886.1 Biological Evaluation of Medical Devices Part 1.Evaluation and Testing in Risk Management Process
GB/T 19633.1 Terminally sterilized medical device packaging - Part 1.Requirements for materials, sterile barrier systems and packaging systems
YY/T 0466.1 Medical Devices Symbols for Medical Device Labeling, Marking and Providing Information Part 1.General Requirements
YY/T 0615.1 Requirements for labelling "sterile" medical devices Part 1.Requirements for terminally sterilized medical devices
Pharmacopoeia of the People's Republic of China (four volumes of the 2020 edition)
3 Terms and Definitions
There are no terms and definitions that need to be defined in this document.
4 Requirements
4.1 Appearance
Visual inspection with normal or corrected vision, the hemostatic sponge should be white or white-like compressed, and its surface should be clean, free of mildew, damage, etc.
sign.
4.2 Expansion
4.2.1 When the test is carried out according to 6.2.1, the dimensions of the hemostatic sponge before and after liquid absorption and expansion shall be within the deviation range claimed by the manufacturer.
4.2.2 When the test is carried out according to 6.2.2, the maximum expansion ratio of the hemostatic sponge after absorbing liquid should not be less than 2.0.
NOTE. The hemostatic sponge may expand to varying degrees in multiple directions after aspiration. The maximum expansion factor refers to the expansion of a product in multiple directions
The largest expansion factor in the expansion degree.
4.3 Identification
When testing according to 6.3, there should be characteristic absorption peaks at (2940±10) cm-1 and (2920±10) cm-1 wavenumbers.
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