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GB/T 42770-2023Colostomy plug (English PDF)

造口栓

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Issued by

SAMR; SAC

Level / Type

National · Recommended

Issue date

May 23, 2023

Implementation date

December 1, 2023

Scope

GB/T 42770-2023 is the English-translated version of 造口栓.

This document defines the terms used for colostomy plugs and specifies their construction, the requirements they have to meet, the test methods, the marking, the instructions for use, and the packaging, transport and storage.

The document applies to single-use one-piece colostomy plugs for patients who have undergone a colostomy. It does not apply to colostomy plugs of other types.

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Document preview — GB/T 42770-2023

National Standard of the People's Republic of China

ICS: 11.180.20
Classification: C 45

Issued by: State Administration for Market Regulation; Standardization Administration of the PRC

Preface
1 Scope
2 Normative references
3 Terms and Definitions
4 Structure
5 requirements
5.1 Appearance
5.2 Size
5.3 Packaging tightness
5.4 Peel strength
5.5 Tensile strength
5.6 Absorbed swelling time
5.7 Odor dispersion
5.8 Chemical properties
5.9 Microbiological limits
5.10 Biocompatibility
6 Test method
6.1 Appearance
6.2 Size
6.3 Packaging tightness
6.4 Peel strength
6.5 Tensile strength
6.6 Absorbed swelling time
6.7 Odor dispersion
6.8 Chemical properties
6.9 Microbiological limits
6.10 Biocompatibility
7 Signs and Instructions for Use
7.1 Flag
7.2 Instructions for use
8 Packaging, transportation and storage
8.1 Packaging
8.2 Transport and storage

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.

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 Colostomy plug

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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This preview omits tables, figures, formulas and parts of the technical clauses. The complete document — 15 pages — is available in the English PDF.

Referenced standards

Normative references

Similar standards

GB/T 19545.2-2026|GB/T 24434-2025|GB/T 45264-2025|GB/T 45933-2025|GB/T 47000-2025|GB/T 12996-2024

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