YY/T 0921-2015Medical absorbent viscose wadding (English PDF)
医用吸水性粘胶纤维
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Issued by
NMPA
Level / Type
Industry · Recommended
Issue date
March 2, 2015
Implementation date
January 1, 2016
Scope
YY/T 0921-2015 is the English-translated version of 医用吸水性粘胶纤维.
YY/T 0921-2015 is the Chinese pharmaceutical industry standard for medical absorbent viscose wadding, made of newly regenerated cellulose fibre that has been bleached and is free of any colouring or other added treatment.
It sets the requirements and the test methods for it, covering the absorbency and the sinking time, the water-soluble and alcohol-soluble substances, the surface active substances and the fluorescence, the acidity and alkalinity, the ash and the foreign matter and the microbial limits. Issued on 2 March 2015, it has applied since 1 January 2016.
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Document preview — YY/T 0921-2015
National Standard of the People's Republic of China
- ICS
- 11.120.20
- Classification
- C 48
Issued by: National Medical Products Administration of the People's Republic of China
Contents
- Foreword
- Introduction
- 1 Scope
- 2 Normative references
- 3 Terms and Definitions
- 4 Requirements
Foreword
This standard was drafted in accordance with GB/T 1.1-2009 given rules.
This standard reference the 2010 edition of the British Pharmacopoeia "water-absorbing viscose fiber." 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.
Introduction
Viscose or medical dressings containing adhesives have been widely used in foreign countries. Medical-absorbent Absorbent viscose fiber alternative for hospital clinical Use for cleaning wounds, wipe, skin disinfection. Separable sterile and non-sterile supplies supply.
Due to the high adsorption, if sterilized with ethylene oxide, propylene oxide and their patients sick officer adsorbed lead to higher risk Damage, therefore, this standard does not recommend the use of ethylene oxide sterilization of medical-absorbent viscose fiber. For water-absorbent viscose non-sterile medical supplies Fiber manufacturer bioburden to determine the sterilization parameters sterilization as a medical institution basis. Medical-absorbent viscose fiber
1 Scope
This standard specifies requirements for medical-absorbent viscose fiber and test methods.
This standard applies to viscose production by new regenerated cellulose fibers, bleached, crude without any treatment from colored to add Medical-absorbent material viscose fibers. Medical-absorbent cotton viscose fiber alternative medical use.
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 GB/sterilization Microbiological methods - Part 1 T 19973.1 medical equipment.
YY/T 0615.1 labeling requirements "sterile" medical devices - Part 1.
3 Terms and Definitions
The following terms and definitions apply to this document.
3.1 Medical absorbent viscose wadding
New fiber produced by the viscose regenerated cellulose, bleached, careless treatment, with or without additives of titanium dioxide, a linear density 1.0dtex ~ 8.9dtex (mass 1dtex = 10000m fiber unit. g) and cut to the appropriate length of the fiber. It does not contain any non-ferrous Adding substance.
4 Requirements
4.1 Characters
White or slightly yellow, shiny or matte appearance, soft touch.
4.2 Identification
The test results should meet the 5.3.
PH 4.3 By 5.4 test, there should be no solution was pink.
4.4 Foreign fibers
When examined under a microscope, it should only contain viscose, occasionally a small amount of foreign fibers exist in isolation.
4.5 Phosphors
5.5 press test, medical-absorbent viscose fibers should only brown purple fluorescence microscopy. In addition to the small number of isolated fiber, should not significantly strong blue fluorescence.
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This preview omits tables, figures, formulas and parts of the technical clauses. The complete document — 15 pages — is available in the English PDF.
Referenced standards
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Related Standards
GB/T 14233.1-2008 — Test Methods for Infusion, Transfusion, Injection Equipment for Medical Use — Part 1: Chemical Analysis Methods
GB/T 14233.1-2022 — Test methods for infusion, transfusion, injection equipments for medical use - Part 1: Chemical analysis methods
YY/T 0615.1-2007 — Requirements for medical devices to be designated STERILE - Part 1: Requirements for terminally sterilized medical devices
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