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