YY/T 1293.1-2016 English PDF

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YY/T 1293.1-2016: Contacting wound dressing--Part 1: Paraffin gauze
Status: Valid

Standard ID	USD	BUY PDF	Lead-Days	Standard Title (Description)	Status
YY/T 1293.1-2016	159	Add to Cart	3 days	Contacting wound dressing--Part 1: Paraffin gauze	Valid

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Basic data

Standard ID: YY/T 1293.1-2016 (YY/T1293.1-2016)
Description (Translated English): Contacting wound dressing--Part 1: Paraffin gauze
Sector / Industry: Medical Device & Pharmaceutical Industry Standard (Recommended)
Classification of Chinese Standard: C48
Classification of International Standard: 11.120.20
Word Count Estimation: 8,814
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 1293.1-2016: Contacting wound dressing--Part 1: Paraffin gauze

---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.
Contacting wound dressing - Part 1. Paraffin gauze ICS 11.120.20 C48 People's Republic of China Pharmaceutical Industry Standard Contact wound dressings Part 1. Vaseline gauze 2016-03-23 release 2017-01-01 Implementation State Food and Drug Administration issued

Foreword

YY/T 1293 "Contact Woven Dressings" consists of the following. - Part 1. Vaseline gauze; - Part 2. Polyurethane foam dressings; This part is part 1 of YY/T 1293. This part is drafted in accordance with the rules given in GB/T 1.1-2009. This section refers to the.1993 edition of the British Pharmacopoeia "Vaseline gauze dressing". 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 section is proposed by the State Food and Drug Administration. This part of the State Food and Drug Administration Jinan Medical Device Quality Supervision and Inspection Center. This part of the main drafting unit. Shaoxing Zhende Medical Dressing Co., Ltd., Shandong Province, medical equipment product quality inspection center. This part participates in the drafting unit. Henan Piaoyan Hi-Tech Co., Ltd. The main drafters of this section. Hu Xiuyuan, Chen Fang, Fan Xiangyang, Xu Hui.

Introduction

Vaseline gauze for burns, burns, skin grafts for skin grafts and skin grafts and other wound protection, packing, need to drain the exudate wound As well as surgical dressing. Vaseline gauze by the fabric impregnated white petrolatum or yellow petrolatum, the fabric in the production process should avoid the problem of thread scattered, Thereby reducing the risk of strand retention in the wound. Vaseline gauze is sterilized in irradiated form and is supplied as a sterile package. Not suitable for heat and oxygen and ethylene oxide (EO) sterilization. Contact wound dressings Part 1. Vaseline gauze

1 Scope

This part of YY/T 1293 specifies the requirements for sterile supply of vaseline gauze. This part is applicable to the Vaseline gauze which is impregnated with white vaseline or yellow vaseline 1). This section does not address the requirements for antibiotic species and their content in Vaseline gauze containing antibiotic drugs.

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 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 ISO 11607-1..2006 Packaging of final sterilized medical devices - Part 1. Materials, sterile barrier systems and packaging systems. 2) (PackagingforterminalysterilizedmedicaldevicesPart 1. Materials, sterilebarriersystemsand packagingsystems 1) Vaseline can add a certain proportion of the "People's Republic of China Pharmacopoeia" provisions of the liquid paraffin, to reduce the viscosity of Vaseline, to improve the penetration Nature; can also add a small amount of paraffin, to enhance the Vaseline in the gauze on the adhesion. 2) ISO 11607-1 corresponding to our standard GB 19633, the latest version has been approved, please pay attention to the standard release.

3 terms and definitions

The following terms and definitions apply to this document. 3.1 Vaseline gauze paraffingauze Made of fabric impregnated with white petrolatum or yellow petrolatum, fabric for cotton or absorbent cotton blended gauze.

4 classification

Vaseline gauze in the ether soluble content is divided into. light-loaded, medium and general type; can also be divided into shape. gauze, gauze, yarn Cloth and gauze balls. ......

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