YY/T 1293.4-2016Contacting wound dressing - Part 4: Hydrocolloid dressing (English PDF)
接触性创面敷料第4部分:水胶体敷料
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Issued by
NMPA
Level / Type
Industry · Recommended
Issue date
July 29, 2016
Implementation date
June 1, 2017
Scope
YY/T 1293.4-2016 is the English-translated version of 接触性创面敷料第4部分:水胶体敷料.
YY/T 1293.4-2016 is the Chinese pharmaceutical industry standard for hydrocolloid wound dressings, the sheet dressings whose colloid layer sits on a polyurethane film or foam backing and adheres to the skin around the wound.
It is the fourth part of the YY/T 1293 series on contacting wound dressings and sets the performance requirements and the test methods that go with them, drawing the test methods for liquid absorption, water vapour permeability, waterproofness, conformability and antibacterial performance from the YY/T 0471 series, chemical analysis from GB/T 14233.1, biological evaluation from GB/T 16886.1, sterility from YY/T 0615.1 and packaging from ISO 11607-1.
It applies to sterile hydrocolloid dressings supplied in sheet form and not to pastes or powders. Issued on 29 July 2016, it has applied since 1 June 2017.
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Document preview — YY/T 1293.4-2016
National Standard of the People's Republic of China
- Classification
- C 31
Issued by: National Medical Products Administration of the People's Republic of China
Contents
- Foreword
- Introduction
- 1 Scope
- 2 Normative reference documents
- 3 Structure and classification
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.
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.
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 document. 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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This preview omits tables, figures, formulas and parts of the technical clauses. The complete document — 19 pages — is available in the English PDF.
Referenced standards
Normative references
- GB/T 6682Water for analytical laboratory use - Specification and test methods
- GB/T 14233.1-2008Test methods for infusion, transfusion, injection equipments for medical use - Part 1: Chemical analysis methods
- GB/T 16886.1Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process
- YY/T 0466.1Medical devices - Symbols to be used with information to be supplied by the manufacturer - Part 1: General requirements
- YY/T 0471.1-2004Test methods for primary wound dressing - Part 1: Aspects of absorbency
- YY/T 0615.1Requirements for medical devices to be designated STERILE - Part 1: Requirements for terminally sterilized medical devices
YY/T 1293 · ISO 11607-1
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Related Standards
GB/T 14233.1-2008 — Test Methods for Infusion, Transfusion, Injection Equipment for Medical Use — Part 1: Chemical Analysis Methods
GB/T 16886.1-2022 — Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process
GB/T 6682-2008 — Water for analytical laboratory use - Specification and test methods
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