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YY/T 0454-2003 (YYT 0454-2003)

YY/T 0454-2003_English: PDF (YYT0454-2003)
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YY/T 0454-2003English319 Add to Cart 3 days Disposable scalper YY/T 0454-2003 Obsolete YY/T 0454-2003

Standard ID YY/T 0454-2003 (YY/T0454-2003)
Description (Translated English) Disposable scalper
Sector / Industry Medical Device & Pharmaceutical Industry Standard (Recommended)
Classification of Chinese Standard C30
Classification of International Standard 11.040.30
Word Count Estimation 8,861
Date of Issue 2003/6/20
Date of Implementation 2004/1/1
Drafting Organization Huaiyin Medical Equipment Co., Ltd
Administrative Organization State Food and Drug Administration National Surgical Instruments Standardization Technical Committee
Regulation (derived from) State-Food-Drug-Supervision-Device [2008] 605
Proposing organization State Food and Drug Administration
Issuing agency(ies) State Food and Drug Administration

YY/T 0454-2003
Disposable scalper
ICS 11.040.30
People's Republic of China Pharmaceutical Industry Standard
Aseptic plastic scalpel
Released on June 30,.2003
2004-01-01 implementation
State Food and Drug Administration released
In order to standardize the technical requirements of aseptic plastic shank scalpel, the requirements, inspection rules, test methods and classification of aseptic plastic shank scalpel
Uniform provisions have been made with markings, signs, instructions for use, packaging, transportation, storage, etc.
Appendix A of this standard is a normative appendix.
This standard was proposed by the State Food and Drug Administration.
This standard is under the jurisdiction of the National Surgical Instrument Standardization Technical Committee of the State Food and Drug Administration.
This standard was drafted. Huaiyin Medical Devices Co., Ltd.
The main drafters of this standard. Si Huaixi, Lu Guangheng, Shi Jun.
Aseptic plastic scalpel
1 range
This standard specifies the requirements, inspection rules, test methods, classification and marking, signs, instructions for use, packaging, aseptic plastic handle scalpels.
Transportation, storage, etc.
This standard is applicable to sterile single-use sterile scalpel scalpel (hereinafter referred to as scalpel) after sterilization. This product is suitable for surgical cutting soft.
Weaving and weaving.
2 Normative references
The terms in the following documents become the terms of this standard by reference to this standard. All dated references, followed by all
Modifications (not including errata content) or revisions do not apply to this standard, however, parties to agreements based on this standard are encouraged to study
Is it possible to use the latest version of these files? For undated references, the latest edition applies to this standard.
GB/T 191-2000 packaging storage and transportation icon mark
GB/T 1220-1992 stainless steel rod
GB/T 1299-2000 alloy tool steel
GB/T 2828-1997 Batch-by-batch inspection sampling procedure and sampling table (for continuous batch inspection)
GB 9969.1-1998 General instructions for the use of industrial products
GB/T 14233.1-1998 Methods of test for infusions and infusions - Part 1 . Chemical analysis
GB/T 14436-1993 General rules for industrial product guarantee documents
YY/T 0174-1994 surgical blade
The Second Edition of the Pharmacopoeia of the People's Republic of China
3 requirements
3.1 The surface of the plastic shank should be smooth and free of injection molding defects.
3.2 The handle of the plastic handle should be neat and clear.
3.3 The marking of the scalpel should be clear and complete.
3.4 Surgical blades assembled with plastic shanks shall comply with the provisions of 4.3 of YY/T 0174-1994.
3.5 The blade and tool holder assembly should be secure.
3.6 The scalpel should have a cutting edge protection device.
3.7 The scalpel is sterilized with ethylene oxide and its residual amount should be no more than 10μg/g.
3.8 The scalpel should be sterile.
3.9 The small package logo should be clear.
4 Inspection rules
4.1 Acceptance
The scalpel should be inspected by the technical inspection department of the manufacturer and submitted for acceptance after passing the test.
4.2 Group Approval Rules
Each inspection lot shall consist of the same batch number, the same type of unit product with the same production and production time. Several production
The batch constitutes an inspection lot and should be produced under the same sterilization conditions.
4.3 Factory inspection