YY/T 0174-2019Scalpel blade (English PDF)

Foreword

This Standard was drafted in accordance with the rules given in GB/T 1.1-2009.

This Standard replaces YY 0174-2005 "Scalpel blade".

Compared with YY 0174-2005, the main changes in this Standard are as follows.

- modified the scope of application (see Clause 1 of this Edition, Clause 1 of Edition 2005);

- modified the manufacturing materials (see 3.3 of this Edition, 3.2 of Edition

2005);

- added the marking requirements for the blade (see 3.4 of this Edition);

- modified the hardness requirements (see 4.4 of this Edition, 4.4.1 of Edition

2005);

- added the anti-rust performance requirements (see 4.6 of this Edition);

- added the ethylene oxide residue requirements (see 4.8 of this Edition);

- added the packaging label and instructions requirements (see 4.9 of this Edition);

- modified the test method for surface roughness (see 5.2.1 of this Edition, 5.2.1 of Edition 2005);

- modified the test method for edge sharpness (see 5.3 of this Edition, 5.3 of Edition 2005);

- modified the type inspection (see Clause 6 of this Edition, Clause 6 of Edition 2005);

- modified the labeling and instructions requirements (see Clause 7 of this Edition, Clause 7 of Edition 2005);

- modified the packaging, transportation and storage requirements (see Clause 8 of this Edition, Clause 8 of Edition 2005).

Attention is drawn to the possibility that some of the elements of this Standard may be the subject of patent rights. The issuing authority shall not be held responsible for identifying any or all such patent rights.

This Standard was proposed by National Medical Products Administration.

This Standard shall be under the jurisdiction of National Technical Committee on Surgical Instruments of Standardization Administration of China (SAC/TC

1 Scope

This Standard specifies the classification and marks, requirements, test methods, type inspection, labels and instructions on use, packaging, transportation, storage and valid period of scalpel blade.

This Standard is applicable to the scalpel blade that is installed on the scalpel handle for cutting soft tissue (hereinafter referred to as the blade).

2 Normative references

The following referenced documents are indispensable for the application of this document. For dated references, only the edition cited applies. For undated references, the latest edition of the referenced document (including any amendments) applies.

GB/T 191, Packaging and storage marks GB/T 1299, Alloy tool steels GB/T 4340.1, Metallic materials - Vickers hardness test - Part 1: Test method GB 8662, Fitting dimension between scalpel blades and handles GB/T 9969, General Principles for Preparation of Instructions for Use of Industrial Products GB/T 14233.1, Test methods for infusion transfusion injection equipment for medical use - Part 1: Chemical analysis methods YY 0167-2005, Non-absorbable surgical suture

3 Classification and marks

4 Requirements

5 Test methods

6 Type inspection

The inspection items, inspection quantity and determination rules of the blade are shown in Table 1.

7 Labels and instructions on use

8 Packaging, transportation, storage and validity period

8.1 The initial packaging consists of a single sterile blade or multiple non-sterile blades. The initial packaging shall be the minimum packaging.

8.2 The medium packaging consists of 1 or more small packages. The medium packaging shall be the minimum sales unit.