YY/T 1803-2021Polyvinyl alcohol hemostatic sponge (English PDF)

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.

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.

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