YY/T 1283-2016Absorbable gelatin foam (English PDF)

Foreword

This standard is drafted in accordance with the rules given in GB/T 1.1-2009.

This standard refers to the 1993 edition of the British Pharmacopoeia and the 2015 edition of the "People's Republic of China Pharmacopoeia" on the absorbable gelatin sponge Regulations.

Introduction

Gelatin is the skin of the animal, bones, tendons and ligaments in the appropriate hydrolysis of collagen (acid, alkali, acid-base mixed or enzymatic)

Purified. Absorbable gelatin sponge with medicinal gelatin as raw material, dissolved in water to formaldehyde as a cross-linking agent, the bubble, frozen, dry, off Bacteria and a series of processes made of porous and surface roughness characteristics, applied to the bleeding site, can form a good coagulation environment, accelerate blood solidification. For bleeding trauma bleeding area, emergency bleeding and a variety of surgery to stop bleeding.

1 Scope

This standard specifies the requirements and test methods for absorbable gelatin sponge (hereinafter referred to as gelatin sponge).

This standard applies to gelatin as raw material, sterile, insoluble in water absorbable gelatin sponge.

2 Normative reference documents

The following documents are indispensable for the application of this document. For dated references, only the dated edition applies to this document. For undated references, the latest edition (including all modifications) applies to this document.

GB/T 6682 Analytical laboratory water specifications and test methods

GB/T 16886.1 Biological evaluation of medical devices - Part 1. Evaluation and testing in risk management

GB/T 19633.1 Packaging of final sterilized medical devices - Part 1. Requirements for materials, sterile barrier systems and packaging systems

YY/T 0466.1 Symbols for medical devices for labeling, labeling and providing information on medical devices - Part 1. General requirements

YY/T 0615.1 Requirements for "sterile" medical devices - Part 1. Requirements for final sterilization of medical devices Pharmacopoeia of the People's Republic of China (2).2015 edition People's Republic of China Pharmacopoeia (four).2015 edition

3 Raw materials

The gelatin raw materials used in the production of gelatin sponges should meet the requirements of 2015 edition of the Pharmacopoeia of the People's Republic of China (Part II).

4 Requirements