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YY/T 0454-2008Disposable scalpel (English PDF)

无菌塑柄手术刀

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Issued by

NMPA

Level / Type

Industry · Recommended

Issue date

October 17, 2008

Implementation date

January 1, 2010

Scope

YY/T 0454-2008 is the English-translated version of 无菌塑柄手术刀.

YY/T 0454-2008 is the Chinese pharmaceutical industry standard for disposable scalpels, supplied sterile for single use and used to cut soft tissue in surgery or dissection.

It describes the product structure and model marking and the materials, such as a non-toxic ABS plastic handle and blades to YY 0174 in stainless or tool steel, and sets the requirements, test methods and inspection rules, including periodic inspection, with the ethylene oxide residuals assessed under GB/T 16886.7.

It also covers marking with reference to YY/T 0171, packaging, transport, storage and a use period of two years from sterilization, while Annex A gives the test of the connection strength between blade and handle.

It replaces YY/T 0454-2003. Issued on 17 October 2008, it has applied since 1 January 2010.

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Document preview — YY/T 0454-2008

National Standard of the People's Republic of China

Replacing: YY/T 0454-2003

Issued by: National Medical Products Administration of the People's Republic of China

Foreword3
1 Scope4
2 Normative references4
3 Structure and marking5
4 Requirements5
5 Test method6
6 Inspection rules6
7 Sign8
8 Packing, transportation, storage, use period8
Appendix A (Normative) Test of connection firmness between blade and handle10
References11

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.

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. […]

......
This preview omits tables, figures, formulas and parts of the technical clauses. The complete document — 15 pages — is available in the English PDF.

Referenced standards

Normative references

Editions of YY/T 0454

Edition	Title	Revision	Status
YY/T 0454-2008	Disposable scalpel	current edition	Current
YY/T 0454-2003	Disposable scalpel	previous edition	Superseded

This page sells the current edition, YY/T 0454-2008. Earlier editions are listed for reference only.

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