YY/T 1293.2-2022 English PDF

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YY/T 1293.2-2022: Contacting wound dressing - Part 2: Polyurethane foam dressing
Status: Valid

YY/T 1293.2: Historical versions

Standard ID	USD	BUY PDF	Lead-Days	Standard Title (Description)	Status
YY/T 1293.2-2022	219	Add to Cart	3 days	Contacting wound dressing - Part 2: Polyurethane foam dressing	Valid
YY/T 1293.2-2016	319	Add to Cart	3 days	Contacting wound dressing--Part 2: Polyurethane foam dressing	Obsolete

Similar standards

YY 1293.5   YY/T 1293.5   YY/T 1291   YY/T 1282   YY/T 1293.6   YY/T 1293.4   

Basic data

Standard ID: YY/T 1293.2-2022 (YY/T1293.2-2022)
Description (Translated English): Contacting wound dressing - Part 2: Polyurethane foam dressing
Sector / Industry: Medical Device & Pharmaceutical Industry Standard (Recommended)
Classification of Chinese Standard: C31
Word Count Estimation: 10,198
Date of Issue: 2022-10-17
Date of Implementation: 2023-10-01
Older Standard (superseded by this standard): YY/T 1293.2-2016
Issuing agency(ies): State Drug Administration
Summary: This standard specifies the requirements and test methods for polyurethane foam dressings. This standard applies to dressings supplied sterile with a polyurethane foam as the liquid-absorbing layer. This standard does not apply to polyurethane foam dressings containing silver and other bacteriostatic agents, substances containing active ingredients or substances that can release active substances/energy, materials of human/animal origin, tissue engineering materials, degradable materials, etc., and polyurethane for negative pressure drainage Foam dressing (sponge).

YY/T 1293.2-2016: Contacting wound dressing--Part 2: Polyurethane foam dressing

---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 2. Polyurethane foam dressing ICS 11.120.20 C48 People's Republic of China Pharmaceutical Industry Standard Contact wound dressings Part 2. Polyurethane foam dressings 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 2 of YY/T 1293. This part is drafted in accordance with the rules given in GB/T 1.1-2009. This part refers to the.1993 edition of the British Pharmacopoeia "polyurethane foam 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 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 standard drafting unit. Shandong Province, medical equipment product quality inspection center, Leisure Music (China) Medical Supplies Co., Ltd., health care Group Limited. The main drafters of this standard. Zhang Limei, Wang Jinhong, Shen Yong, Wei Ruoxue, Bai Bing, Zheng Douzi.

Introduction

Contact wound dressing as a mechanical barrier to the wound for the absorption of wound secretions, providing an environment conducive to wound healing. At present, medical dressings are developing rapidly, and gradually appear functional and diversified development trend, polyurethane foam dressing structure with porous Nature, the liquid has a larger absorption capacity, with light, soft, non-adhesive, good biocompatibility and other characteristics, is gradually replacing the traditional dressing often Application. Contact wound dressings Part 2. Polyurethane foam dressings

1 Scope

This part of YY/T 1293 specifies the requirements for polyurethane foam dressings. This part applies to the sterile supply of the liquid absorbent layer for the polyurethane foam dressing. This part does not include antimicrobial agents such as silver and polyurethane foam dressings for negative pressure drainage.

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 14233.1-2008 Methods of test for medical infusion, transfusion, and injectable utensils - Part 1. Chemical analysis 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 0471.1-2004 Test method for contact wound dressings - Part 1. Liquid absorption YY/T 0471.2-2004 Test method for contact wound dressings - Part 2. Permeability of breathable film dressings Methods of test for exposure to wound dressings - Part 3. Water blocking resistance YY/T 0471.3-2004 Methods of test for contact wound dressings - Part 5. Antibacterial properties ISO /TS YY/T 0615.1 Requirements for "sterile" medical devices - Part 1. Requirements for final sterilization of medical devices ISO 11607-1..2006 Packaging of final sterilized medical devices - Part 1. Materials, sterile barrier systems and packaging systems. Find 1) (PackagingforterminalysterilizedmedicaldevicesPart 1. Materials, sterilebarriersystemsand packagingsystems 1) ISO 11607-1 corresponding to our standard GB 19633, the latest version has been approved, please pay attention to the standard release.

3 structure

Polyurethane foam dressing common structure shown in Figure 1. ......

Image     

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