YY 0854.2-2011Performance requirements for pure cotton nonwoven surgical compresses - Part 2: Finished compress (English PDF)
全棉非织造布外科敷料性能要求 第2部分：成品敷料
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Issued by
NMPA
Level / Type
Industry · Mandatory
Issue date
December 31, 2011
Implementation date
June 1, 2013
Scope
YY 0854.2-2011 is the English-translated version of 全棉非织造布外科敷料性能要求 第2部分：成品敷料.
YY 0854.2-2011 is the Chinese pharmaceutical industry standard that sets the performance requirements and the test methods for the finished surgical compress made mainly of pure cotton nonwoven fabric.
It is the second part of the YY 0854 series and covers the dimensions and the number of layers, the absorbency, the freedom from loose fibres and from foreign matter, the radiopaque element where present and the cleanliness of the compress.
It does not apply to compresses containing a medicinal substance, and it does not deal with their marking and packaging. Issued on 31 December 2011, it has applied since 1 June 2013.
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Document preview — YY 0854.2-2011
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 YY 0594 defined with the following
- 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 2 YY 0854 of. This section drafted in accordance with GB/T 1.1-2009 given 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 0594 "surgical gauze dressings General requirements" identified with cotton nonwovens Production of finished dressing performance requirements.
Before and after surgical dressings should not contain substances harmful to health, sterilization under the intended conditions of use should not be released to endanger health substance.
With or without wound care commonly used drugs (such as antibacterial agents, cleaning fluid), a non-woven fabric should be stabilized.
Once the biological evaluation, in routine quality control, only to control the physical and chemical properties.
1 Scope
YY 0854 this section provides for surgical cotton non-woven fabric as the main raw material for the manufacture of the finished dressing and performance requirements experiment method.
This section does not involve dressing cotton non-woven fabric containing drugs. This section does not include dressing marking 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.
GB/T 16886.7 Biological evaluation of medical devices - Part 7. Ethylene oxide sterilization residuals (GB/T 16886.7-2001, ISO 10993-7:1995, IDT)
Microbiological sterilization method GB/T 19973.1 medical devices - Part 1. Total estimated microorganisms (GB/T 19973.1-2005, ISO 11737-1:1995, IDT)
YY/T 0472.2 medical nonwovens compress Test methods - Part 2. Finished compresses
YY 0594-2006 surgical gauze dressings General requirements
YY 0854.1 cotton non-woven fabric surgical dressings performance requirements - Part 1. Non-woven fabric dressing production
3 Terms and Definitions
YY 0594 defined with the following terms and definitions apply to this document.
3.1 Finished dressing
finishedcompress In any shape YY 0854.1 nonwoven fabric as specified in the main raw material for one or more purposes, or type Product specifications.
--- 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 Luoxu linting
During operation the fiber floc and release of other particles.
4 Conditioning
Unless otherwise specified, according to YY/T 0472.2 regulations state regulation.
......
This preview omits tables, figures, formulas and parts of the technical clauses. The complete document — 20 pages — is available in the English PDF.
Referenced standards
Normative references
- GB/T 16886.7Biological evaluation of medical devices—Part 7: Ethylene oxide sterilization residuals
- YY/T 0472.2Test methods for nonwoven compresses for medical use - Part 2: Finished compresses
- YY 0594-2006General requirements for surgical gauze dressings
- YY 0854.1Performance requirements for pure cotton nonwoven surgical compresses - Part 1: Nonwovens used in the manufacture of surgical compresses
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Related Standards
GB/T 16886.7-2015 — Biological evaluation of medical devices—Part 7: Ethylene oxide sterilization residuals
YY 0594-2006 — General requirements for surgical gauze dressings
YY 0854.1-2011 — Performance requirements for pure cotton nonwoven surgical compresses - Part 1: Nonwovens used in the manufacture of surgical compresses
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