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YY/T 1293.4-2016 English PDF

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YY/T 1293.4-2016: Contacting wound dressing--Part 4: Hydrocolloid dressing
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Standard similar to YY/T 1293.4-2016

YY 1293.5   YY/T 1293.5   YY/T 1291   YY/T 1282   YY/T 1293.2   YY/T 1293.6   

Basic data

Standard ID YY/T 1293.4-2016 (YY/T1293.4-2016)
Description (Translated English) Contacting wound dressing--Part 4: Hydrocolloid dressing
Sector / Industry Medical Device & Pharmaceutical Industry Standard (Recommended)
Classification of Chinese Standard C31
Word Count Estimation 8,847
Date of Issue 2016-07-29
Date of Implementation 2017-06-01
Quoted Standard GB/T 6682; GB/T 14233.1-2008; GB/T 16886.1; YY/T 0466.1; YY/T 0471.1-2004; YY/T 0471.3-2004; YY/T 0471.4-2004; YY/T 0471.5-2004; YY/T 0615.1; ISO 11607-1-2006
Regulation (derived from) State Food and Drug Administration Notice 2016 (No.129)
Issuing agency(ies) State Food and Drug Administration
Summary This standard specifies the performance requirements and test methods for hydrocolloid dressings. This standard applies to flaky sterile watercolor dressings. This standard does not apply to paste, powder water colloidal dressings.

YY/T 1293.4-2016: Contacting wound dressing--Part 4: Hydrocolloid 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 4. Hydrocolloid dressing ICS 11.120.20 C31 People's Republic of China Pharmaceutical Industry Standard Contact wound dressings Part 4. hydrocolloid dressings Contactingwounddressing-Part 4. Hydrocoloiddressing 2016-07-29 released 2017-06-01 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; - Part 4. hydrocolloid dressings; - Part 5. alginate dressings; This part is part 4 of YY/T 1293. This part is drafted in accordance with the rules given in GB/T 1.1-2009. 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 drafting unit. Shandong Province, medical equipment product quality inspection center, robust Industrial (Shenzhen) Co., Ltd., Shandong 赛 赛 Sai Si drug Technology Co., Ltd. The main drafters of this part. Song Jinzi, Guo Lun, Zheng Duozi, Xu Yanli.

Introduction

Water colloid dressing is based on the wound wet healing theory based on the new dressing, by the water-soluble polymer particles (such as carboxymethyl fiber Pectin, etc.) and rubber sticky material mixed processing, with the outer substrate. Water-soluble polymer particles absorb the wound exudate after swelling into Hydrogel-like, can maintain a wet wound environment. Applicable to superficial wound, a small amount to the amount of exudate wound and for the skin area. Water colloidal dressings are currently widely used for radiation sterilization. Contact wound dressings Part 4. hydrocolloid dressings

1 Scope

YY/T 1293 This section specifies the performance requirements and test methods for hydrocolloid dressings. This part applies to flaky sterile watercolor dressings. This part does not apply to paste, powder water colloidal dressings.

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 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 4. Comfortability YY/T 0471.4-2004 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. Requirements for materials, sterile barrier systems, packaging systems 1) (Packagingforterminalysterilizedmedicaldevices-Part 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 and classification

3.1 structure A colloidal dressing on an outer substrate (such as a polyurethane film or polyurethane foam with polyurethane foam) is accompanied by a layer of self- Colloidal matrix, the substrate is covered with a removable protective layer. Its common structure shown in Figure 1.

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