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YY/T 0331-2024: Performance requirements and test methods for absorbent cotton gauze and absorbent cotton and viscose gauze
Status: Valid YY/T 0331: Evolution and historical versions
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Performance requirements and test methods for absorbent cotton gauze and absorbent cotton and viscose gauze
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YY/T 0331-2024
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| YY 0331-2006 | English | 155 |
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Performance requirements and test methods for absorbent cotton gauze and absorbent cotton and viscose gauze
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YY 0331-2006
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| YY 0331-2002 | English | 319 |
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Medical purified gauze
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YY 0331-2002
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PDF similar to YY/T 0331-2024
Basic data | Standard ID | YY/T 0331-2024 (YY/T0331-2024) | | Description (Translated English) | Performance requirements and test methods for absorbent cotton gauze and absorbent cotton and viscose gauze | | Sector / Industry | Medical Device & Pharmaceutical Industry Standard (Recommended) | | Classification of Chinese Standard | C48 | | Classification of International Standard | 11.120.20 | | Word Count Estimation | 21,281 | | Date of Issue | 2024-02-07 | | Date of Implementation | 2025-03-01 | | Older Standard (superseded by this standard) | YY/T 0331-2006 | | Issuing agency(ies) | State Drug Administration | | Summary | This standard specifies the performance requirements for absorbent cotton gauze and absorbent cotton viscose blended gauze, and describes the corresponding test methods. This document applies to absorbent cotton gauze and absorbent cotton viscose blended gauze. This document does not apply to all gauze with viscose fiber yarns and gauze containing medicine. | YY/T 0331-2024: Performance requirements and test methods for absorbent cotton gauze and absorbent cotton and viscose gauze
---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.
ICS 11.120.20
CCSC48
Pharmaceutical Industry Standards of the People's Republic of China
Replaces YY/T 0331-2006
Properties of absorbent cotton gauze and absorbent cotton-viscose blended gauze
Requirements and test methods
Released on 2024-02-07
2025-03-01 Implementation
The State Drug Administration issued
Table of Contents
Preface III
Introduction IV
1 Scope 1
2 Normative references 1
3 Terms and Definitions 1
4 Requirements 1
4.1 Fiber Identification 1
4.2 pH 2
4.3 Foreign fibers 2
4.4 Fluorescent substances 2
4.5 Number of yarns 2
4.6 Mass per square meter 3
4.7 Minimum breaking force 3
4.8 Sinking time 3
4.9 Ether soluble matter 3
4.10 Surface active substances 3
4.11 Soluble matter in water 3
4.12 Starch and dextrin 3
4.13 Extractable colouring matter 3
4.14 Loss on drying 3
4.15 Sulfated ash 3
4.16 Ethylene oxide residue 4
4.17 Bioburden 4
4.18 Sterility 4
5 Test methods 4
5.1 General Principles 4
5.2 Fiber Identification 4
5.3 pH 5
5.4 Foreign fibers 5
5.5 Fluorescent substances 5
5.6 Number of yarns 6
5.7 Mass per square meter 6
5.8 Minimum breaking force 6
5.9 Sinking time 6
5.10 Ether soluble matter 7
5.11 Surface active substances 7
5.12 Soluble matter in water 7
5.13 Starch and dextrin 7
5.14 Extractable colouring matter 7
5.15 Loss on drying 7
5.16 Sulfated ash 8
5.17 Ethylene oxide residue 8
5.18 Bioburden 8
6 Packaging and storage 8
Appendix A (Normative) Solutions for determining the color of liquids 9
A.1 Primary solution 9
A.2 Standard solution 9
A.3 Control solution 10
Appendix B (Normative) Preparation of test solution S 11
Appendix C (Informative) Bioburden Test Method 12
C.1 Principle 12
C.2 Instruments and reagents 12
C.3 Test method 12
C.4 Method description 14
C.5 Test report 14
Reference 15
Foreword
This document is in accordance with the provisions of GB/T 1.1-2020 "Guidelines for standardization work Part 1.Structure and drafting rules for standardization documents"
Drafting.
This document replaces YY/T 0331-2006 "Performance requirements and test methods for absorbent cotton gauze and absorbent cotton-viscose blended gauze" and is consistent with
Compared with YY/T 0331-2006, in addition to editorial changes, the main technical changes are as follows.
a) The requirements for “surfactants” have been changed (see 4.10, 4.10 of the.2006 edition);
b) Added the requirements and test methods for “ethylene oxide residue” (see 4.16 and 5.17);
c) Added “bioburden” requirements and test methods (see 4.17 and 5.18);
d) Added “sterility” requirement (see 4.18);
e) The test method for “extractable coloring matter” has been changed (see 5.14, 5.14 of the.2006 edition);
f) The test method for “loss on drying” has been changed (see 5.15, 5.15 of the.2006 edition);
g) Added “Packaging and Storage” requirements (see Chapter 6).
Please note that some of the contents of this document may involve patents. The issuing organization of this document does not assume the responsibility for identifying patents.
This document is proposed by the State Food and Drug Administration.
This document is under the jurisdiction of Shandong Medical Device and Drug Packaging Inspection Institute.
This document was drafted by. Shandong Medical Device and Drug Packaging Inspection Institute, Yadu Holding Group Co., Ltd., Ogilvy Medical Supplies
Co., Ltd., Henan Tuoren Best Medical Equipment Co., Ltd., and Weihai Weigao Medical Materials Co., Ltd.
The main drafters of this document are. Zhao Changshuai, Lin Zechen, Liu Bin, Yin Jiangxin, Cao Mengjie, Ma Heng, Cui Jingqiang, Xing Yushan, Meng Kai, Cao Xinlong.
The previous versions of this document and the documents it replaces are as follows.
---First issued in.2002 as YY/T 0331-2002, first revised in.2006;
---This is the second revision.
Introduction
This document does not specify the requirements for gauze whiteness, but the whiteness of gauze and its retention of whiteness after corresponding sterilization are indicators of gauze quality.
As an aspect of quality, if the purchaser has requirements, the corresponding evaluation methods and evaluation indicators can be clearly stated in the quality agreement.
Absorbent cotton gauze and absorbent cotton viscose blended gauze are available in sterile and non-sterile supply.
Spun yarn has high adsorption capacity. If it is sterilized with ethylene oxide, the adsorbed ethylene oxide will cause high harm to patients and medical staff.
Therefore, this document does not recommend the use of ethylene oxide to sterilize absorbent cotton gauze and absorbent cotton-viscose blended gauze.
For gauze, absorbent cotton and viscose blended gauze, the bioburden data provided by the manufacturer can be used as the basis for determining the sterilization parameters during sterilization in medical institutions.
The requirements for surgical gauze dressings made of gauze that meets the requirements of this document as the main raw material are shown in YY 0594 "Surgical Gauze Dressings
common enquiries".
Properties of absorbent cotton gauze and absorbent cotton-viscose blended gauze
Requirements and test methods
1 Scope
This document specifies the performance requirements for absorbent cotton gauze and absorbent cotton-viscose blended gauze and describes the corresponding test methods.
This document is applicable to absorbent cotton gauze and absorbent cotton-viscose blended gauze.
This document does not apply to gauze made entirely of viscose yarn and gauze containing drugs.
2 Normative references
The contents of the following documents constitute the essential clauses of this document through normative references in this document.
For referenced documents without a date, only the version corresponding to that date applies to this document; for referenced documents without a date, the latest version (including all amendments) applies to
This document.
GB/T 14233.1 Inspection methods for medical infusion, blood transfusion and injection equipment Part 1.Chemical analysis methods
GB/T 19633.1 Terminally sterilized medical device packaging Part 1.Requirements for materials, sterile barrier systems and packaging systems
GB/T.19973.1 Microbiological methods for sterilization of medical devices Part 1.Determination of the total number of microorganisms on the product
YY/T 0615.1 Requirements for labeling “sterile” medical devices Part 1.Requirements for terminally sterilized medical devices
Pharmacopoeia of the People's Republic of China (2020 Edition) Part II
3 Terms and definitions
The following terms and definitions apply to this document.
3.1
absorbent cotton gauze
Continuously woven cloth made of cotton yarn, which is degreased, bleached or dyed, and purified.
3.2
Continuous woven fabric made of cotton yarn, viscose yarn or a mixture of cotton and viscose yarn, which is degreased, bleached or dyed and purified.
3.3
Continuous woven cloth made of cotton yarn with selvedges, which is made by degreasing, bleaching or dyeing and purification.
3.4
Continuous woven fabrics made of cotton yarn, viscose yarn or mixed yarn of cotton and viscose and with selvedges, degreased, bleached or dyed, purified
Become.
4 Requirements
4.1 Fiber Identification
4.1.1 Absorbent cotton gauze
When tested according to 5.2.1, cotton fibres shall comply with the requirements of identification tests A, B and C.
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