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Performance requirements for pure cotton nonwoven surgical compresses. Part 2: Finished compress
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YY 0854.2-2011
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Basic data | Standard ID | YY 0854.2-2011 (YY0854.2-2011) | | Description (Translated English) | Performance requirements for pure cotton nonwoven surgical compresses. Part 2: Finished compress | | Sector / Industry | Medical Device & Pharmaceutical Industry Standard | | Classification of Chinese Standard | C48 | | Classification of International Standard | 11.120.20 | | Word Count Estimation | 8,887 | | Date of Issue | 2011-12-31 | | Date of Implementation | 2013-06-01 | | Quoted Standard | GB/T 16886.7; GB/T 19973.1; YY/T 0472.2; YY 0594-2006; YY 0854.1 | | Regulation (derived from) | State Food and Drug Administration Notice 2011 No. 106; industry standard filing Notice 2013 No. 6 (No. 162 overall) | | Issuing agency(ies) | State Food and Drug Administration | | Summary | This standard provides for the surgical cotton non-woven fabric as the main raw material for manufacture of the finished dressing performance requirements and test methods. This section does not involve a drug-containing non-woven cotton fabric dressing. This section does not include dressing logo and packaging requirements. |
YY 0854.2-2011: Performance requirements for pure cotton nonwoven surgical compresses. Part 2: Finished compress ---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.
Performance requirements for pure cotton nonwoven surgical compresses.Part 2. Finished compress
ICS 11.120.20
C48
People's Republic of China pharmaceutical industry standards
Nonwovens cotton surgical dressings performance requirements
Part 2. Finished dressing
Part 2. Finishedcompress
Issued on. 2011-12-31
2013-06-01 implementation
State Food and Drug Administration issued
Foreword
YY 0854 "cotton non-woven fabric surgical dressings performance requirements" is divided into two parts.
--- Part 1. Production of non-woven fabric dressing;
--- Part 2. finished dressing.
This is Part 2 YY 0854 of.
This section drafted in accordance with GB/T 1.1-2009 given rules.
This part is proposed by the State Food and Drug Administration.
This part of the jurisdiction of the State Food and Drug Administration Jinan Medical Device Quality Supervision and Inspection Center.
This part mainly drafted by. Shandong Province Medical Devices Product Quality Inspection Center, robust Industrial (Shenzhen) Co., Ltd.
Participated in the drafting of this section. Hi-Tech Co., Ltd. Henan floating shares.
The main drafters of this section. Sun Haipeng, Wang Hong, Li, Ning Mei, Fan Xiangyang.
Introduction
YY 0854 this part of cotton non-woven fabric according to end-use surgical dressings, combining the characteristics of cotton non-woven fabric, with reference to
YY/T 0472 "non-woven medical compress test methods" and YY 0594 "surgical gauze dressings General requirements" identified with cotton nonwovens
Production of finished dressing performance requirements.
Before and after surgical dressings should not contain substances harmful to health, sterilization under the intended conditions of use should not be released to endanger health
substance.
With or without wound care commonly used drugs (such as antibacterial agents, cleaning fluid), a non-woven fabric should be stabilized.
Once the biological evaluation, in routine quality control, only to control the physical and chemical properties.
Note. GB/T 16886 specifies the requirements for the evaluation of biocompatibility of medical devices.
Nonwovens cotton surgical dressings performance requirements
Part 2. Finished dressing
1 Scope
YY 0854 this section provides for surgical cotton non-woven fabric as the main raw material for the manufacture of the finished dressing and performance requirements
experiment method.
This section does not involve dressing cotton non-woven fabric containing drugs.
This section does not include dressing marking and packaging requirements.
2 Normative references
The following documents for the application of this document is essential. For dated references, only the dated version suitable for use herein
Member. For undated references, the latest edition (including any amendments) applies to this document.
GB/T 16886.7 Biological evaluation of medical devices - Part 7. Ethylene oxide sterilization residuals (GB/T 16886.7-2001,
ISO 10993-7.1995, IDT)
Microbiological sterilization method GB/T 19973.1 medical devices - Part 1. Total estimated microorganisms
(GB/T 19973.1-2005, ISO 11737-1.1995, IDT)
YY/T 0472.2 medical nonwovens compress Test methods - Part 2. Finished compresses
YY 0594-2006 surgical gauze dressings General requirements
YY 0854.1 cotton non-woven fabric surgical dressings performance requirements - Part 1. Non-woven fabric dressing production
3 Terms and Definitions
YY 0594 defined with the following terms and definitions apply to this document.
3.1
Finished dressing finishedcompress
In any shape YY 0854.1 nonwoven fabric as specified in the main raw material for one or more purposes, or type
Product specifications.
--- Clean the skin or wound;
--- Absorbed during surgery in vivo exudates;
--- Use with drugs commonly used wound care;
--- Surgical procedure support organ, tissue and the like.
3.2
Luoxu linting
During operation the fiber floc and release of other particles.
4 Conditioning
Unless otherwise specified, according to YY/T 0472.2 regulations state regulation.
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