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YY/T 1283-2016 English PDF

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YY/T 1283-2016: Absorbable gelatin sponge
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Basic data

Standard ID YY/T 1283-2016 (YY/T1283-2016)
Description (Translated English) Absorbable gelatin sponge
Sector / Industry Medical Device & Pharmaceutical Industry Standard (Recommended)
Classification of Chinese Standard C48
Classification of International Standard 11.120.20
Word Count Estimation 12,198
Date of Issue 2016-03-23
Date of Implementation 2017-01-01
Regulation (derived from) Notice of the General Administration of Food and Drug Administration (No. 74 of 2016)
Issuing agency(ies) State Food and Drug Administration

YY/T 1283-2016: Absorbable gelatin 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.
Absorbable gelatin sponge ICS 11.120.20 C48 People's Republic of China Pharmaceutical Industry Standard Absorbable gelatin sponge 2016-03-23 release 2017-01-01 Implementation State Food and Drug Administration issued

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. Please note that some of the contents of this document may involve patents. The issuer of this document does not assume responsibility for the identification of these patents. This standard is proposed by the State Food and Drug Administration. This standard by the State Food and Drug Administration Jinan Medical Device Quality Supervision and Inspection Center. The drafting of this standard. Shandong Province, medical equipment product quality inspection center, Jinling Pharmaceutical Co., Ltd. Nanjing Jinling pharmaceutical factory. The main drafters of this standard. Luo Hongyu, Huang Jian, Zhang Limei.

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. Gelatin sponge raw materials mainly from animal tissue, YY/T 0771 series of standards given animal-derived medical device virus control aspects Claim. Absorbable gelatin sponge

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 article Pieces. 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

4.1 traits Absorbable gelatin sponge is white or white, light, soft and porous sponge-like material. 4.2 Identification When tested in accordance with 6.2, gelatin sponge should be blue and purple after dripping copper sulfate and sodium hydroxide. 4.3 Loss on drying When tested in accordance with 6.3, the quality of specimen loss should not exceed 18.0%. 4.4 Liquid Absorbency When tested in accordance with 6.4, the moisture absorbed by the specimen shall be not less than 35 times of its own weight. 4.5 pH When tested in accordance with 6.5, the pH should be 3.6 to 7.6.

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