YY 0854.1-2011Performance requirements for pure cotton nonwoven surgical compresses - Part 1: Nonwovens used in the manufacture of surgical compresses (English PDF)
全棉非织造布外科敷料性能要求 第1部分：敷料生产用非织造布
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Issued by
NMPA
Level / Type
Industry · Mandatory
Issue date
December 31, 2011
Implementation date
June 1, 2013
Scope
YY 0854.1-2011 is the English-translated version of 全棉非织造布外科敷料性能要求 第1部分：敷料生产用非织造布.
YY 0854.1-2011 is the Chinese pharmaceutical industry standard that sets the performance requirements and the test methods for the pure cotton nonwoven fabric used to make surgical compresses.
It is the first part of the YY 0854 series and covers the mass per unit area, the absorbency and the water retention, the cleanliness and the extractable matter, the fluorescence and the freedom from foreign matter of the nonwoven, and the tests by which each is determined.
It does not deal with the marking and packaging of the fabric. Issued on 31 December 2011, it has applied since 1 June 2013.
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Document preview — YY 0854.1-2011
National Standard of the People's Republic of China
- ICS
- 11.120.20
- Classification
- C 31
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 Conditioning
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.
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.
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.
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
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.
......
This preview omits tables, figures, formulas and parts of the technical clauses. The complete document — 18 pages — is available in the English PDF.
Referenced standards
Normative references
- YY 0331-2006Performance requirements and test methods for absorbent cotton gauze and absorbent cotton and viscose gauze
- YY/T 0472.1-2004Test methods for nonwoven compresses for medical use - Part 1: Nonwovens used in the manufacture of compresses
- YY/T 0472.2-2004Test methods for nonwoven compresses for medical use - Part 2: Finished compresses
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Related Standards
YY 0331-2006 — Performance requirements and test methods for absorbent cotton gauze and absorbent cotton and viscose gauze
YY/T 0472.1-2004 — Test methods for nonwoven compresses for medical use - Part 1: Nonwovens used in the manufacture of compresses
YY/T 0472.2-2004 — Test methods for nonwoven compresses for medical use - Part 2: Finished compresses
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YY 0854.1-2011
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