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YY/T 1627-2018: General requirements of acute adhesive wound dressing and woundplast
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| Standard ID | Contents [version] | USD | STEP2 | [PDF] delivered in | Standard Title (Description) | Status | PDF |
| YY/T 1627-2018 | English | 259 |
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General requirements of acute adhesive wound dressing and woundplast
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YY/T 1627-2018
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PDF similar to YY/T 1627-2018
Standard similar to YY/T 1627-2018 YY/T 1633 YY/T 1642 YY/T 1632 Basic data | Standard ID | YY/T 1627-2018 (YY/T1627-2018) | | Description (Translated English) | General requirements of acute adhesive wound dressing and woundplast | | Sector / Industry | Medical Device & Pharmaceutical Industry Standard (Recommended) | | Classification of Chinese Standard | C48 | | Classification of International Standard | 11.120.20 | | Word Count Estimation | 13,156 | | Date of Issue | 2018-11-07 | | Date of Implementation | 2019-11-01 | | Quoted Standard | GB/T 14233.1-2008; GB/T 16886.1; GB/T 19633.1; YY/T 0148-2006; YY/T 0466.1; YY/T 0471.1-2004; YY/T 0471.3-2004; YY/T 0471.4-2004; YY/T 0615.1 | | Regulation (derived from) | Announcement No. 87 of 2018 by the State Drug Administration | | Issuing agency(ies) | State Drug Administration | | Summary | This standard specifies the general requirements for the application and creation of acute wounds for surgical incisions, punctures or mechanical wounds. This standard is applicable to acute wound dressing and plastering, which consists of adhesive layer, absorbent pad and release layer. This standard does not apply to hydrocolloid application and creation of acute wounds. This standard does not apply to the application and creation of specific substances (silver, chitosan, etc.) containing antibacterial and anti-inflammatory effects. | YY/T 1627-2018: General requirements of acute adhesive wound dressing and woundplast---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.
General requirements of acute adhesive wound dressing and woundplast
ICS 11.120.20
C48
People's Republic of China Pharmaceutical Industry Standard
General requirements for application and creation of acute wounds
Published on.2018-11-07
2019-11-01 implementation
State Drug Administration issued
Foreword
This standard was 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. Publication of this document
The organization does not assume responsibility for identifying these patents.
This standard was proposed by the State Drug Administration.
This standard is under the jurisdiction of Shandong Medical Device Product Quality Inspection Center.
This standard was drafted. Shandong Medical Device Product Quality Inspection Center, Shanghai Johnson & Johnson Co., Ltd., Minnesota Mining Manufacturing Medical
Equipment (Shanghai) Co., Ltd., Zhende Medical Products Co., Ltd., Qingdao Hainuo Biological Engineering Co., Ltd.
The main drafters of this standard. Zhang Limei, Fang Jun, Zhang Bo, Zhao Changshuai, Hua Yuran, Lu Jianguo, Gao Rongsheng.
Introduction
Adhesive dressings for acute wounds are divided into two categories depending on the application. One type is cleaning used in medical institutions,
Dressings for acute wounds after disinfection or suture; one type is outside the medical institution (such as in the public, workshops, etc.)
A dressing for temporary dressing of unsterilized or unstitched acute wounds caused by accidental injury. The application of the two dressings is not
The corresponding requirements are different. The main role of the application is to keep the sterilized or closed wound sterile and provide a suitable healing ring.
The main role of the creation is to provide temporary closure of hemostasis and isolation from uninsulated or unsewed wounds. This standard puts
The former is named as a dressing, and the latter is named as a plaster to show the difference. These two terms apply only within the scope of this standard.
This standard only specifies the general requirements for these two types of dressings, and does not specify their own special requirements.
General requirements for application and creation of acute wounds
1 Scope
This standard specifies the general requirements for the application and creation of acute wounds for surgical incisions, punctures or mechanical wounds.
This standard is applicable to acute wound dressing and plastering, which consists of adhesive layer, absorbent pad and release layer.
This standard does not apply to hydrocolloid application and creation of acute wounds.
This standard does not apply to the application and creation of specific substances (silver, chitosan, etc.) containing antibacterial and anti-inflammatory effects.
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 14233.1-2008 Methods of test for infusions, blood trans
GB/T 16886.1 Biological evaluation of medical devices - Part 1. Evaluation and testing in the process of risk management (GB/T 16886.1-
2011, ISO 10993-1..2009, IDT)
GB/T 19633.1 End-sterilized medical device packaging - Part 1. Requirements for materials, sterile barrier systems and packaging systems
YY/T 0148-2006 General requirements for medical tapes
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 0471.3-2004 Test methods for contact wound dressings - Part 3
YY/T 0471.4-2004 Test methods for contact wounds - Part 4. Comfort
YY/T 0615.1 Requirements for "sterile" medical devices - Part 1. Requirements for terminally sterilized medical devices
3 Terms and definitions
The following terms and definitions apply to this document.
3.1
Acute wound acupewound
Wounds caused by external forces that are expected to heal within two weeks, including post-operative suture wounds, mechanical trauma, catheterization
Waiting at the mouth, as well as bruises, stab wounds and cuts.
3.2
Applying wounddressing
It consists of a differently shaped adhesive layer that can be adapted to various different pasting parts, an absorbent pad that is integrated with it, and a peelable release layer.
The absorbent pad is mainly a variety of sheet-like absorbent materials, and some of the absorbent pads have a layer of perforated plastic film or the like to prevent adhesion to the wound surface.
Provides a mechanical barrier to the wound and absorbs the wound exudate. It is commonly used in a variety of cleansed, disinfected or sutured acute wounds.
3.3
Wound woundplast
It consists of a differently shaped adhesive layer that can be adapted to various adhesive parts, an absorbent pad that is integrated with it, and a peelable release layer.
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