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YY 0854.1-2011 English PDF

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YY 0854.1-2011: Performance requirements for pure cotton nonwoven surgical sompresses. Part 1: Nonwovens used in the manufacture of surgical compresses
Status: Obsolete

Standard ID	Contents [version]	USD	STEP2	[PDF] delivered in	Standard Title (Description)	Status	PDF
YY 0854.1-2011	English	599	Add to Cart	3 days [Need to translate]	Performance requirements for pure cotton nonwoven surgical sompresses. Part 1: Nonwovens used in the manufacture of surgical compresses	Obsolete	YY 0854.1-2011

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Basic data

Standard ID	YY 0854.1-2011 (YY0854.1-2011)
Description (Translated English)	Performance requirements for pure cotton nonwoven surgical sompresses. Part 1: Nonwovens used in the manufacture of surgical compresses
Sector / Industry	Medical Device & Pharmaceutical Industry Standard
Classification of Chinese Standard	C31
Classification of International Standard	11.120.20
Word Count Estimation	14,192
Date of Issue	2011-12-31
Date of Implementation	2013-06-01
Quoted Standard	GB/T 19973.1; YY 0331-2006; YY/T 0472.1-2004; YY/T 0472.2-2004
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 specifies the medical surgical dressings cotton nonwovens production performance requirements and test methods. YY 0854 This part does not involve the production of non-woven fabric dressing logo and packaging requirements.

YY 0854.1-2011: Performance requirements for pure cotton nonwoven surgical sompresses. Part 1: Nonwovens used in the manufacture of surgical compresses

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Performance requirements for pure cotton nonwoven surgical sompresses.Part 1. Nonwovens used in the manufacture of surgical compresses ICS 11.120.20 C31 People's Republic of China pharmaceutical industry standards Nonwovens cotton surgical dressings performance requirements Part 1. The production of non-woven fabric dressing Part 1. Nonwovensusedinthemanufactureofsurgicalcompresses 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 1 YY 0854 of. This section drafted in accordance with GB/T 1.1-2009 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. Wu Ping, Liu Lili, Jia Yufei, Qin Yang, Zhou Ronghong, 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 0331 "cotton gauze, cotton viscose blended yarn and fabric performance requirements Test "to determine the surgical dressings used in the production of cotton non-woven fabric performance requirements. Surgical dressings used in the production of cotton non-woven fabric should not contain substances harmful to health, before and after sterilization under the intended conditions of use shall not release enough To the health hazards of substances. Once the biological evaluation, in routine quality control, only to control the physical and chemical properties. Note. GB/T 16886 specifies the evaluation of biocompatibility of medical devices with the requirements. Nonwovens cotton surgical dressings performance requirements Part 1. The production of non-woven fabric dressing

1 Scope

YY 0854 This section provides medical surgical dressings cotton nonwovens production performance requirements and test methods. YY 0854 This part of the dressing does not involve the production of non-woven fabric logo 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. Microbiological sterilization method GB/T 19973.1 medical devices - Part 1. Total estimated microorganisms YY 0331-2006 cotton gauze, cotton viscose blended fabric performance requirements and test methods YY/T 0472.1-2004 non-woven medical compress Test methods - Part 1. compress the production of non-woven fabric YY/T 0472.2-2004 non-woven medical compress Test methods - Part 2. Finished compresses

3 Terms and Definitions

The following terms and definitions apply to this document. 3.1 Dressing compress Mainly made of cotton spunlace non-woven fabric production, for one or more purposes in any shape, form or specification sheet material. --- 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 Bioburden bioburden The total number of microorganisms on the product viable. 3.3 Luoxu linting During operation the fiber floc and release of other particles. 3.4 Luoxu coefficient coefficientoflinting All particles entering the measuring channel or the numeric portion of the particle counting.

4 Conditioning

Unless otherwise specified, according to YY/T 0472.1-2004 Appendix A state regulation.

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