YY/T 1293.2-2022_English: PDF (YY/T1293.2-2022)
Standard ID | Contents [version] | USD | STEP2 | [PDF] delivered in | Standard Title (Description) | Status | PDF |
YY/T 1293.2-2022 | English | 219 |
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Contacting wound dressing - Part 2: Polyurethane foam dressing
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YY/T 1293.2-2022
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YY/T 1293.2-2016 | English | 319 |
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3 days [Need to translate]
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Contacting wound dressing--Part 2: Polyurethane foam dressing
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YY/T 1293.2-2016
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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) | Word Count Estimation | 10,111 | Date of Issue | 2022-10-17 | Date of Implementation | 2023-10-01 | Older Standard (superseded by this standard) | YY/T 1293.2-2016 | Administrative Organization | State Food and Drug Administration | Summary | This standard specifies the requirements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). | Standard ID | YY/T 1293.2-2016 (YY/T1293.2-2016) | Description (Translated English) | Contacting wound dressing -- Part 2: Polyurethane foam dressing | Sector / Industry | Medical Device & Pharmaceutical Industry Standard (Recommended) | Classification of Chinese Standard | C48 | Classification of International Standard | 11.120.20 | Word Count Estimation | 8,846 | Date of Issue | 2016-03-23 | Date of Implementation | 2017-01-01 | Drafting Organization | Shandong Province, medical equipment, product quality inspection center, Leisure Music (China) Medical Supplies Co., Ltd., Health and Medical Group Co., Ltd. | Administrative Organization | State Food and Drug Administration Jinan Medical Device Quality Supervision and Inspection Center | Regulation (derived from) | Notice of the General Administration of Food and Drug Administration (No. 74 of 2016) | Proposing organization | State Administration of Food and Drug Administration | Issuing agency(ies) | State Administration of Food and Drug Administration |
YY/T 1293.2-2016
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
Preface
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.
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