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GB/T 42770-2023: Colostomy plug
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| Standard ID | Contents [version] | USD | STEP2 | [PDF] delivered in | Standard Title (Description) | Status | PDF |
| GB/T 42770-2023 | English | 219 |
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Colostomy plug
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GB/T 42770-2023
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PDF similar to GB/T 42770-2023
Basic data | Standard ID | GB/T 42770-2023 (GB/T42770-2023) | | Description (Translated English) | Colostomy plug | | Sector / Industry | National Standard (Recommended) | | Classification of Chinese Standard | C45 | | Classification of International Standard | 11.180.20 | | Word Count Estimation | 10,119 | | Date of Issue | 2023-05-23 | | Date of Implementation | 2023-12-01 | | Issuing agency(ies) | State Administration for Market Regulation, China National Standardization Administration | GB/T 42770-2023: Colostomy plug---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.
ICS 11:180:20
CCSC45
National Standards of People's Republic of China
stoma plug
Released on 2023-05-23
2023-12-01 implementation
State Administration for Market Regulation
Released by the National Standardization Management Committee
table of contents
Preface I
1 Scope 1
2 Normative references 1
3 Terms and Definitions 1
4 Structure 1
5 requirements 2
5:1 Appearance 2
5:2 Size 2
5:3 Packaging tightness 2
5:4 Peel strength 2
5:5 Tensile strength 2
5:6 Absorbed swelling time 2
5:7 Odor dispersion 2
5:8 Chemical properties 2
5:9 Microbiological limits3
5:10 Biocompatibility3
6 Test method 3
6:1 Appearance 3
6:2 Size 3
6:3 Packaging tightness 3
6:4 Peel strength3
6:5 Tensile strength3
6:6 Absorbed swelling time 3
6:7 Odor dispersion 3
6:8 Chemical properties 4
6:9 Microbiological limits5
6:10 Biocompatibility5
7 Signs and Instructions for Use 5
7:1 Flag 5
7:2 Instructions for use 5
8 Packaging, transportation and storage 6
8:1 Packaging 6
8:2 Transport and storage 6
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 for Standardization Documents"
drafting:
Please note that some contents of this document may refer to patents: The issuing agency of this document assumes no responsibility for identifying patents:
This document is proposed by the Ministry of Civil Affairs of the People's Republic of China:
This document is under the jurisdiction of the National Standardization Technical Committee for Rehabilitation and Special Equipment for the Disabled (SAC/TC148):
This document was drafted by: National Rehabilitation Assistive Devices Research Center, Zhende Medical Supplies Co:, Ltd:, Coloplast (China) Medical Supplies Co:, Ltd:
Co:, Ltd:, National Rehabilitation Aids Research Center Rehabilitation Aids Quality Supervision and Inspection Center, Xiamen Yixi Intelligent Technology Co:, Ltd:, Beijing Medical
Institute of Device Testing, Shandong Shengquan Pension Service Group Co:, Ltd:, Beijing Institute of Drug Testing (Beijing Vaccine Testing Center), British
Special Testing and Certification Co:, Ltd:, Chuangbiao (Beijing) Testing Technology Service Co:, Ltd:, Shandong Provincial Product Quality Inspection Research Institute, Qingdao University, China Quality
Biaoyan (Beijing) Standardization Service Center:
The main drafters of this document: Guo Huan, Gu Huiru, Chen Ming, Luan Huiqin, Yun Xiao, Liu Yongjie, Hu Xiuyuan, Huang Yongfu, Zhang Weikang, Lian Lian, Zhong Shusen,
Zeng Yali, Lin Hongsong, Qiu Shijie, Wang Huan, Guan Jie, Lu Yuesong, Wei Shangzhu, Zhang Changan:
stoma plug
1 Scope
This document defines the terms and definitions of ostomy plugs, specifies the structure, requirements, test methods, signs, instructions for use and packaging of ostomy plugs:
Packing, transportation and storage:
This document applies to single-use one-piece ostomy plug products for patients after colostomy surgery:
This document does not apply to other types of ostomy plug products:
2 Normative references
The contents of the following documents constitute the essential provisions of this document through normative references in the text: Among them, dated references
For documents, only the version corresponding to the date is applicable to this document; for undated reference documents, the latest version (including all amendments) is applicable to
this document:
GB/T 191 Packaging, storage and transportation icon marks
GB/T 14233:1-2022 Test methods for medical infusion, blood transfusion and injection equipment Part 1: Chemical analysis methods
GB/T 15171-1994 Test method for sealing performance of flexible packaging
GB 15979 Hygienic Standards for Disposable Sanitary Products
GB/T 16886:1 Biological evaluation of medical devices Part 1: Evaluation and testing in the risk management process
YY/T 1293:4-2016 Contact wound dressings Part 4: Hydrocolloid dressings
3 Terms and Definitions
The following terms and definitions apply to this document:
3:1
Adhere to the skin around the stoma through the substrate structure to protect the skin and provide attachment of the embolus, and use the embolus to partially insert
In a colostomy, an object that seals the intestinal lumen and blocks the colostomy by its swelling action to prevent the leakage of intestinal excrement:
4 structures
The ostomy plug is generally composed of two parts: the base plate and the plug: The schematic diagram of the structure is shown in Figure 1:
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