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PDF YY/T 0454-2008 English (YY/T 0454-2003: Older version)


Search result: YY/T 0454-2008 (YY/T 0454-2003 Older version)
Standard IDContents [version]USDSTEP2[PDF] delivered inName of Chinese StandardStatus
YY/T 0454-2008English230 Add to Cart 0-9 seconds. Auto-delivery. Disposable scalpel Valid
YY/T 0454-2003English319 Add to Cart 3 days Disposable scalper Obsolete

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YY/T 0454-2008: PDF in English (YYT 0454-2008)

YY/T 0454-2008 PHARMACEUTICALS INDUSTRY STANDARD OF THE PEOPLE’S REPUBLIC OF CHINA ICS 11.040.30 C 31 Replacing YY/T 0454-2003 Disposable scalpel ISSUED ON: OCTOBER 17, 2008 IMPLEMENTED ON: JANUARY 01, 2010 Issued by: China Food and Drug Administration Table of Contents Foreword ... 3  1 Scope ... 4  2 Normative references ... 4  3 Structure and marking ... 5  4 Requirements ... 5  5 Test method ... 6  6 Inspection rules ... 6  7 Sign ... 8  8 Packing, transportation, storage, use period ... 8  Appendix A (Normative) Test of connection firmness between blade and handle ... 10  References ... 11  Disposable scalpel 1 Scope This standard specifies the structure and marking, requirements, test methods, inspection rules, signs, packaging, transportation, storage, use period of disposable scalpels. This standard applies to disposable scalpels (hereinafter referred to as scalpels), in sterile packaging for single use, which are used to cut soft tissue, during surgery or dissection. 2 Normative references The provisions in following documents become the provisions of this Standard through reference in this Standard. For the dated references, the subsequent amendments (excluding corrections) or revisions do not apply to this Standard; however, parties who reach an agreement based on this Standard are encouraged to study if the latest versions of these documents are applicable. For undated references, the latest edition of the referenced document applies. GB/T 1220-2007 Stainless steel bars GB/T 1298-1986 Carbon tool steels - Technical requirements GB/T 1299-2000 Alloy tool steels GB/T 2828.1-2003 Sampling procedures for inspection by attributes - Part 1: Sampling schemes indexed by acceptance quality limit (AQL) for lot-by-lot inspection (ISO 2859-1:1999, IDT) GB/T 16886.7-2001 Biological evaluation of medical devices - Part 7: Ethylene oxide sterilization residuals (idt ISO 10993-7:1995) YY/T 0171-2008 Surgical instruments - Packaging, marking and instructions YY 0174-2005 Scalpel blade YY/T 0466-2003 Medical devices - Symbols to be used with medical device labels, labelling and information to be supplied (ISO 15223:2000, IDT) Pharmacopoeia of the People's Republic of China, 2005 edition, Part 2 4.4 The surgical blade, which is connected with the plastic handle, shall comply with the provisions of 4.2, 4.3, 4.4 in YY 0174-2005. 4.5 The connection between the scalpel blade and the handle shall be firm. 4.6 The scalpel shall be provided with the cutting-edge protection device. 4.7 The sterilization process, for which the scalpel has been confirmed, shall be sterile. 4.8 When using ethylene oxide for sterilization, the residual amount of ethylene oxide shall not exceed 10 μg/g. 5 Test method 5.1 Appearance test Carry out visual observation. It shall comply with the provisions of 4.1, 4.2, 4.3, 4.6. 5.2 Scalpel blade test Carry out the test according to the provisions of 5.2, 5.3, 5.4 in YY 0174-2005. The results shall meet the provisions of 4.4. 5.3 Connection firmness test Carry out the test, according to the test method of Appendix A. The results shall meet the requirements of 4.5. 5.4 Sterility inspection Randomly select 10 scalpels, from each sterilized batch. Use the aseptic method, which is specified in the "Pharmacopoeia of the People's Republic of China, 2005 edition Part 2". The results shall meet the requirements of 4.7. 5.5 Residual amount of ethylene oxide It is carried out, according to the "Gas chromatography" in GB/T 16886.7-2001. It shall comply with the provisions of 4.8. 6 Inspection rules 6.1 Acceptance The scalpel shall be inspected by the technical inspection department of the manufacturer. It can be submitted for acceptance, only after passing the inspection. 6.2 Inspection method 6.4.3 Judgment rules for periodic inspection: If all the test items in the periodic inspection are qualified, the current periodic inspection is determined to be qualified; otherwise, the periodic inspection is determined to be unqualified. 7 Sign 7.1 Product sign At an appropriate part of each scalpel (or its small package), it shall be marked with the model, which is specified in 3.2. 7.2 Packaging sign 7.2.1 The packaging sign shall comply with the provisions of 4.1.1, 4.1.3, 4.2.1, 4.2.3 in YY/T 0171-2008. 7.2.2 The certificate of conformity shall comply with the provisions in 4.3 of YY/T 0171-2008. 7.2.3 The signs and/or symbols, on the package, shall comply with the relevant provisions in YY 0466. 8 Packing, transportation, storage, use period 8.1 Packaging 8.1.1 Each scalpel shall be packaged in an independent, sealed bag. 8.1.2 The packaging of each scalpel shall be able to ensure the sterility of the product within the period of use, meanwhile ensure that the blade does not rust. 8.1.3 A certain number of small packaged products consist of medium packaging, which is the smallest packaging unit for inspection and sales. 8.1.4 The large package shall have sufficient strength, to ensure that the product will not be damaged, under normal transportation and storage conditions. The words and graphic signs, on the large package, shall be guaranteed not to be blurred, due to a long period of time. The packaging of special requirements shall be carried out, according to the provisions of the order contract. 8.2 Transportation Transportation is carried out, according to the provisions of the order contract. ......
 
Source: Above contents are excerpted from the PDF -- translated/reviewed by: www.chinesestandard.net / Wayne Zheng et al.

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