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YY/T 0454-2008 PDF English

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YY/T 0454-2008: Disposable scalpel
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YY/T 0454: Evolution and historical versions

Standard IDContents [version]USDSTEP2[PDF] deliveryName 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: Disposable scalpel

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PHARMACEUTICALS INDUSTRY STANDARD 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

Foreword

This standard replaces YY/T 0454-2003. Compared with YY/T 0454-2003, the main changes of this standard are as follows. - ADJUST the arrangement structure of the original standard; - ADD the content of "3.1 Product structure"; - ADD "6.4.3 Periodic inspection and judgment rules"; - MAKE reference to the relevant provisions of YY/T 0171-2008, in "7 Signs"; - MODIFY "8.4 Use period", into that the validity period is 2 years from the date of sterilization; - MODIFY "Appendix A.1 Device requirements", adding that "The upper plane of the support blocks (fixing block and adjustment block), which support both ends of the scalpel, shall be kept on the same plane". Appendix A of this standard is a normative appendix. This standard was proposed by AND shall be under the jurisdiction of the National Surgical Instrument Standardization Technical Committee. Drafting organization of this standard. Huaiyin Medical Devices Co., Ltd. The main drafters of this standard. Lu Guangheng, Wu Shuguang, Pan Yong. This standard was first published in June 2003. 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

3 Structure and marking

3.1 Product structure The product structure of the scalpel is as shown in Figure 1. 3.2 Model marking Example. HY production, No.11 disposable scalpel 3.3 Materials 3.3.1 The plastic handle of the scalpel shall be made of non-toxic ABS (acrylonitrile- butadiene-styrene) OR other materials, that meet the requirements of Chapter 4.

4 Requirements

4.1 The surface of the plastic handle shall be smooth, without obvious injection molding defects. 4.2 The handle pattern of the plastic handle shall be neat and clear. 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. 5.4 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. 6.3 Batch-by-batch inspection 6.3.1 Batch-by-batch inspection shall be carried out, in accordance with the relevant provisions of GB/T 2828.1. 6.3.2 The sampling plan adopts one-time sampling. The strictness of the sampling plan starts from normal inspection sampling. The disqualification category, inspection item, inspection level, acceptance quality limit (AQL) shall be in accordance with the provisions of Table 1. 6.4 Periodic inspection 6.4.1 Periodic inspection shall be carried out, under any of the following circumstances. 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. 8.2 Transportation Transportation is carried out, according to the provisions of the order contract. 8.3 Storage The packaged scalpel shall be stored in a room, which has a relative humidity of not greater than 80%, no corrosive gas, clean and well-ventilated. 8.4 Use period The scalpel is valid for 2 years, from the date of sterilization, provided that the storage rules are observed.

Appendix A

(Normative) Test of connection firmness between blade and handle A.1 Device requirements A.1.1 The upper plane of the support blocks (fixed block and adjustment block), which support both ends of the scalpel, shall be kept on the same plane. A.1.2 The adjustment block shall be adjustable, along the left and right directions (as shown in the Figure). The adjustment range shall meet the length requirements of different specifications of scalpels. A.2 Test method A.2.1 Remove (or take off) the cutting-edge protection sheet (or blade cover) of the scalpel. A.2.2 Adjust the position of the adjustment block, to make it fit with the scalpel of the corresponding specification. A.2.3 Place the scalpel in the position, as shown in the Figure, so that the plane of the scalpel is in contact with the upper plane of the adjustment block. A.2.4 In the middle of the plastic handle, apply a load of 10 N without impact; keep it for 30 s. ......
Source: Above contents are excerpted from the full-copy PDF -- translated/reviewed by: www.ChineseStandard.net / Wayne Zheng et al.


      

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