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YY/T 1293.5-2017 (YYT 1293.5-2017)

YY/T 1293.5-2017_English: PDF (YYT1293.5-2017)
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YY/T 1293.5-2017English145 Add to Cart 0--3 minutes. Auto-delivered. Contacting wound dressing—Part 5: Alginate dressing YY/T 1293.5-2017 Valid YY/T 1293.5-2017

BASIC DATA
Standard ID YY/T 1293.5-2017 (YY/T1293.5-2017)
Description (Translated English) Contacting wound dressing. Part 5: Alginate dressing
Sector / Industry Medical Device & Pharmaceutical Industry Standard (Recommended)
Classification of Chinese Standard C31
Classification of International Standard 11.120.20
Word Count Estimation 10,156
Date of Issue 2017-05-02
Date of Implementation 2018-04-01
Quoted Standard GB/T 6682; GB/T 16886.1; YY/T 0466.1; YY/T 0471.1-2004; YY/T 0615.1; ISO 11607-1-2006
Drafting Organization Shandong Medical Device Quality Inspection Center
Administrative Organization State Food and Drug Administration Jinan Medical Device Quality Supervision and Inspection Center
Regulation (derived from) Notice of the State Food and Drug Administration of the People's Republic of China No. 49 of 2017; Announcement of the Industry Standards Proclamation No. 1 of 2018 (Total No. 217)
Summary This standard specifies the performance requirements and test methods for alginate dressings. This standard applies to aseptically supplied alginate dressings consisting only of alginate fibers. This standard does not include the requirements for alginate dressings containing antibacterial agents such as silver.

YY/T 1293.5-2017
Contacting wound dressing-Part 5. Alginate dressing
ICS 11.120.20
C31
People's Republic of China Pharmaceutical Industry Standard
YY 1293.5-2017
Contact wound dressing
Part 5. Alginate dressings
Published by.2017-05-02
2018-04-01 implementation
State Food and Drug Administration issued
Foreword
The full technical content of this standard is mandatory.
YY 1293 "Contact Wound Dressing" consists of the following parts.
--- Part 1. Vaseline gauze;
---Part 2. Polyurethane foam dressings;
---Part 4. Hydrocolloid dressings;
---Part 5. Alginate dressings;
This part is the fifth part of YY 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 issuing organization of this document is not responsible for identifying these patents.
This part is proposed by the State Food and Drug Administration.
This part is under the jurisdiction of the State Food and Drug Administration Jinan Medical Device Quality Supervision and Inspection Center.
This section drafted by. Shandong Province Medical Device Product Quality Inspection Center, Steady Industry (Shenzhen) Co., Ltd., Shandong Shengna Medical System
Product Co., Ltd.
The main drafters of this section. Zhang Limei, Wu Changyan, Bai Bing, Zheng Duozi, Wang Lexin.
YY 1293.5-2017
introduction
The alginate dressing is a dressing containing an inorganic salt of alginic acid, which is made from alginate fibers by a nonwoven process. Its main feature is high absorption, gelatinization
Sex, suitable for medium to large amount of exudate wounds. After the alginate fiber absorbs a large amount of wound exudate, the alginate dressing contains calcium ions.
Ion exchange with sodium ions in the wound exudate to form a hydrophilic gel on the wound surface to maintain a certain humidity in the wound.
Alginate dressings are currently used for radiation sterilization.
YY 1293.5-2017
Contact wound dressing
Part 5. Alginate dressings
1 Scope
This section of YY 1293 specifies the performance requirements and test methods for alginate dressings.
This section applies to a sterile supply of alginate dressings consisting only of alginate fibers.
This section does not include the requirements for alginate dressings containing bacteriostatic agents such as silver.
2 Normative references
The following documents are indispensable for the application of this document. For dated references, only the dated version applies to this article.
Pieces. For undated references, the latest edition (including all amendments) 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 the process of risk management
YY/T 0466.1 Medical devices for the labeling, marking and information of medical devices - Part 1. General requirements
YY/T 0471.1-2004 Test methods for contact wounds - Part 1 . Fluid absorption
YY/T 0615.1 Requirements for "sterile" medical devices - Part 1. Requirements for terminally sterilized medical devices
Pharmacopoeia of the People's Republic of China (2010 Edition)
ISO 11607-1.2006 Packaging of terminally sterilized medical devices Part 1 Materials, sterile barrier systems, packaging systems
1) (Packagingforterminalysterilizedmedicaldevices-Part 1.Materials,sterilebarriersystemsand
Packagingsystems)
1) The standard corresponding to ISO 11607-1 is GB 19633. The latest version has been submitted for approval. Please pay attention to the standard release.
3 classification
According to the clinical use of alginate dressings, there are two main categories.
a) Surface wounds are made with an alginate dressing, made from a nonwoven process and cut into sheets.
b) Filling the sinus wound with alginate dressing, made from a non-woven fabric process and cut into strips, or processed after combing
In the form of strips, formed by cutting.
4 requirements
4.1 traits
The alginate dressing consists of off-white or yellowish fibers; odorless or almost odorless.
4