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YY/T 0330-2015: Medical absorbent cotton
Status: Valid YY/T 0330: Evolution and historical versions
| Standard ID | Contents [version] | USD | STEP2 | [PDF] delivered in | Standard Title (Description) | Status | PDF |
| YY/T 0330-2015 | English | 259 |
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3 days [Need to translate]
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Medical absorbent cotton
| Valid |
YY/T 0330-2015
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| YY 0330-2002 | English | 319 |
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3 days [Need to translate]
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Medical purified cotton
| Obsolete |
YY 0330-2002
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PDF similar to YY/T 0330-2015
Basic data | Standard ID | YY/T 0330-2015 (YY/T0330-2015) | | Description (Translated English) | Medical absorbent cotton | | Sector / Industry | Medical Device & Pharmaceutical Industry Standard (Recommended) | | Classification of Chinese Standard | C48 | | Classification of International Standard | 11.120.20 | | Word Count Estimation | 12,161 | | Date of Issue | 2015-03-02 | | Date of Implementation | 2016-01-01 | | Older Standard (superseded by this standard) | YY 0330-2002 | | Quoted Standard | GB/T 14233.1; GB/T 19973.1; YY/T 0615.1 | | Regulation (derived from) | The State Food and Drug Administration Announcement 2015 No. 8 | | Issuing agency(ies) | State Food and Drug Administration | | Summary | This Standard specifies requirements for medical cotton wool. This Standard applies to the use of cotton grass cotton plants mature sunflower seeds furry by removing inclusions, degreasing, bleaching, without adding any processing of non-ferrous Absorbent materials. Absorbent main hospital for clinical use as a dressing. | YY/T 0330-2015: Medical absorbent cotton---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.
Medical absorbent cotton
ICS 11.120.20
C48
People's Republic of China pharmaceutical industry standards
Replacing YY 0330-2002
Absorbent
Issued on. 2015-03-02
2016-01-01 implementation
China Food and Drug Administration released
Foreword
This standard was drafted in accordance with GB/T 1.1-2009 given rules.
This standard replaces YY 0330-2002 "Absorbent." Compared with YY 0330-2002 main technical differences are as follows.
--- Remove the white degree requirements (2002 Version 3.2) and test methods (2002 Version 4.3);
--- Easy to remove oxide requirements (2002 Version 3.5) and test methods (2002 Version 4.6);
--- Modify the absorption time sinking time (see 37, 2002. Version 3.6.);
--- Increased identification (see 3.2) and test methods (see 4.3);
--- Increased foreign fiber requirements (see 3.3);
--- Increased neps requirements (see 3.4);
--- Can increase the leaching colored substances requirements (see 3.14) and test methods (see 4.12);
--- Of cotton non-sterile medical supplies, increased labeling requirements for microbial limits (see 3.16) and test methods (see 4.14);
--- Modify the pH requirements (see 36, 2002 Version 3.4.) And test methods (see 45, 2002 Version 4.5.);
--- The residue on ignition is amended as sulfated ash (see 3.12, 3.11, 2002 edition), and modify the test methods (see section 4.10, 2002
Version 4.12);
--- Modify the surface active materials (see 313, 2002 edition 3.12.);
--- Canceled Inspection Rules (2002 Edition 5);
--- Cancel the request flag, the label (2002 Version 6).
This standard reference the 2010 edition of the British Pharmacopoeia "cotton."
Please note that some content of this document may involve patents, the issuing authority of this document does not assume responsibility for the identification of these patents.
This standard was proposed by the China Food and Drug Administration.
This standard by the State Food and Drug Administration Jinan Medical Device Quality Supervision and Inspection Center.
This standard is drafted by. Shandong Medical Devices Product Quality Inspection Center.
Participated in the drafting of this standard. Henan floating the Group Co., Ltd. Shandong Overseas Chinese licensing Group.
The main drafters. Zhang Bo, Like Fang, Guo Lun, Linze Chen, Wang Jiyong, Sun defense, Fan Xiangyang.
This standard was first released in April 2002, this is the first revision.
Introduction
Absorbent After rinsing and drying only in self purification conditions for production and processing, in order to make the pollution of the environment caused by products
Minimized. However, no international evaluation Absorbent contaminated foreign substance approach.
Absorbent stars sterile non-sterile supplies supply two. Because cotton has a high adsorption, if ethylene oxide sterilization, suck
Ethylene oxide disease patients and will bring a higher officer attached to the harm, so this standard does not recommend the use of ethylene oxide sterilization of cotton wool.
For Absorbent non-sterile supply manufacturer Microbiological parameters can be determined as the sterilization of medical sterilization agency basis.
Comply with the standards required Absorbent brain can not meet the performance requirements of a piece of cotton products.
Absorbent
1 Scope
This standard specifies requirements for medical cotton wool.
This standard applies to any free use of cotton grass cotton plants mature sunflower seeds furry by removing inclusions, degreasing, bleaching, processing of
He added Absorbent colored substance. Absorbent main hospital for clinical use as a dressing.
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 14233.1 Infusion, transfusion, injection equipment - Part 1. Chemical analysis
Microbiological sterilization method GB/T 19973.1 medical devices - Part 1. Total estimated microorganisms
YY/T 0615.1 labeling requirements "sterile" medical devices - Part 1. terminally sterilized medical devices
British Pharmacopoeia
3 Requirements
3.1 Characters
Visually, Absorbent appearance should be white or white with a mean length of not less than 10mm of fibers 1), no blade,
Peel, seed coat residue or other impurities. There is some resistance when stretched, rocked, there should not be any dust off.
3.2 Identification
The test results should meet the 4.3.
3.3 foreign fibers
When examined under a microscope, it should only contain the typical cotton fiber, allowing a small amount of occasional exotic fiber isolated existence.
3.4 Nep
About 1g Absorbent spread evenly in 2 colorless and transparent flat plate, each of the flat plate area of 10cm × 10cm, by transmitted light
Nep standards (RM) ray neps and with the "British Pharmacopoeia" provisions by comparing the number of cotton samples shall bear no more than standard.
3.5 water solubles
When you press the test 4.4, total soluble in water should not exceed 0.50%.
1) GB/T 19617 Test Method given length of cotton.
PH 3.6
4.5 When you press the test, there should be no solution was pink.
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