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YY 0174-2019

Chinese Standard: 'YY 0174-2019'
Standard IDContents [version]USDSTEP2[PDF] delivered inStandard Title (Description)StatusRelated Standard
YY 0174-2019English289 Add to Cart Days<=3 Scalpel blade Valid YY 0174-2019
YY 0174-2019Chinese15 Add to Cart <=1-day [PDF from Chinese Authority, or Standard Committee, or Publishing House]  

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Detail Information of YY 0174-2019; YY0174-2019
Description (Translated English): Scalpel blade
Sector / Industry: Medical Device & Pharmaceutical Industry Standard
Classification of Chinese Standard: C31
Classification of International Standard: 11.040.30
Word Count Estimation: 14,175
Date of Issue: 2019-05-31
Date of Implementation: 2020-06-01
Drafting Organization: Shanghai Pudong Jinhuan Medical Products Co., Ltd., Shanghai Medical Device Testing Institute, Huaiyin Medical Devices Co., Ltd.
Administrative Organization: National Technical Committee for Surgical Instrument Standardization (SAC/TC 94)
Proposing organization: State Drug Administration
Issuing agency(ies): State Drug Administration

YY 0174-2019
Scalpel blade
ICS 11.040.30
C31
People's Republic of China Pharmaceutical Industry Standard
Replacing YY 0174-2005
Surgical blade
Published on.2019-05-31
2020-06-01 implementation
State Drug Administration issued
Foreword
This standard was drafted in accordance with the rules given in GB/T 1.1-2009.
This standard replaces YY 0174-2005 "Surgical Blade".
The main changes in this standard compared with YY 0174-2005 are as follows.
--- Revised the scope of application (see Chapter 1, Chapter 1 of the.2005 edition);
--- Revised manufacturing materials (see 3.3, version 3.2 of.2005);
--- Increased blade identification requirements (see 3.4);
--- Revised the hardness requirements (see 4.4, 4.4.1 of the.2005 edition);
--- Increased anti-rust performance requirements (see 4.6);
--- Increased ethylene oxide residue requirements (see 4.8);
--- Added packaging label and specification requirements (see 4.9);
--- Revised the surface roughness test method (see 5.2.1, 5.2.1 of the.2005 edition);
--- Revised the blade sharpness test method (see 5.3,.2005 edition 5.3);
--- Revised type inspection (see Chapter 6, Chapter 6 of the.2005 edition);
--- Revised the label and specification requirements (see Chapter 7, Chapter 7 of the.2005 edition);
--- Revised the packaging, transportation, storage requirements (see Chapter 8, Chapter 8 of the.2005 edition).
Please note that some of the contents of this document may involve patents, and the issuing organization of this document is not responsible for identifying these patents.
This standard was proposed by the State Drug Administration.
This standard is under the jurisdiction of the National Technical Committee for Standardization of Surgical Devices (SAC/TC94).
This standard was drafted. Shanghai Pudong Jinhuan Medical Supplies Co., Ltd., Shanghai Medical Device Testing Institute, Huaiyin Medical Devices
Limited company.
The main drafters of this standard. Zhang Yanqing, Wang Zezhen, Gao Bai, Wang Fengcai, Huang Shuze, Lu Guangheng, Lu Lidong.
The previous versions of the standards replaced by this standard are.
---WS2/Z45~WS2/Z46-1982;
---GB n210-1983;
---GB 2544-1988;
---YY/T 0174-1994, YY 0293-1997;
---YY 0174-2005.
Surgical blade
1 Scope
This standard specifies the classification and identification of surgical blades, requirements, test methods, type inspection, labels and instructions, packaging, transportation, storage
And expiration date.
This standard is applicable to surgical blades (hereinafter referred to as blades) for cutting soft tissues mounted on the surgical handle.
2 Normative references
The following documents are indispensable for the application of this document. For dated references, only dated versions apply to this article.
Pieces. For undated references, the latest edition (including all amendments) applies to this document.
GB/T 191 packaging storage and transportation icon
GB/T 1299 tool steel
GB/T 4340.1 Metallic materials - Vickers hardness test - Part 1. Test method
GB 8662 surgical blade and surgical tool handle fit size
GB/T 9969 General guidelines for the use of industrial products
GB/T 14233.1 Medical infusion, blood transfusion, and injecting machines - Test methods - Part 1
YY 0167-2005 Non-absorbable surgical suture
YY/T 0294.1 Surgical instruments, metallic materials - Part 1. Stainless steel
YY/T 0466.1 Medical devices for the labeling, marking and information of medical devices - Part 1. General requirements
YY/T 1052 surgical instrument sign
Pharmacopoeia of the People's Republic of China (2015 edition · four)
3 Classification and identification
3.1 Delivery status
The blades are available in both sterile and non-sterile delivery conditions (hereinafter referred to as sterile blades and non-sterile blades).
3.2 Specifications
Refer to Appendix A for the specification and dimensions of the insert and the assembly specifications for the insert.
3.3 Materials
The manufacturing material of the blade shall be made of non-alloyed tool steel meeting the requirements of GB/T 1299 or martensite complying with the requirements of YY/T 0294.1.
Stainless steel, or other suitable metal materials that meet the requirements of Chapter 4.
3.4 Identification requirements
According to YY/T 1052, the surface of the blade shall be marked with at least the manufacturer code, material code (non-alloy tool steel, default) and regulations.
The grid location is shown in Figure 1.
YY 0174-2019
Scalpel blade
ICS 11.040.30
C31
People's Republic of China Pharmaceutical Industry Standard
Replacing YY 0174-2005
Surgical blade
Published on.2019-05-31
2020-06-01 implementation
State Drug Administration issued
Foreword
This standard was drafted in accordance with the rules given in GB/T 1.1-2009.
This standard replaces YY 0174-2005 "Surgical Blade".
The main changes in this standard compared with YY 0174-2005 are as follows.
--- Revised the scope of application (see Chapter 1, Chapter 1 of the.2005 edition);
--- Revised manufacturing materials (see 3.3, version 3.2 of.2005);
--- Increased blade identification requirements (see 3.4);
--- Revised the hardness requirements (see 4.4, 4.4.1 of the.2005 edition);
--- Increased anti-rust performance requirements (see 4.6);
--- Increased ethylene oxide residue requirements (see 4.8);
--- Added packaging label and specification requirements (see 4.9);
--- Revised the surface roughness test method (see 5.2.1, 5.2.1 of the.2005 edition);
--- Revised the blade sharpness test method (see 5.3,.2005 edition 5.3);
--- Revised type inspection (see Chapter 6, Chapter 6 of the.2005 edition);
--- Revised the label and specification requirements (see Chapter 7, Chapter 7 of the.2005 edition);
--- Revised the packaging, transportation, storage requirements (see Chapter 8, Chapter 8 of the.2005 edition).
Please note that some of the contents of this document may involve patents, and the issuing organization of this document is not responsible for identifying these patents.
This standard was proposed by the State Drug Administration.
This standard is under the jurisdiction of the National Technical Committee for Standardization of Surgical Devices (SAC/TC94).
This standard was drafted. Shanghai Pudong Jinhuan Medical Supplies Co., Ltd., Shanghai Medical Device Testing Institute, Huaiyin Medical Devices
Limited company.
The main drafters of this standard. Zhang Yanqing, Wang Zezhen, Gao Bai, Wang Fengcai, Huang Shuze, Lu Guangheng, Lu Lidong.
The previous versions of the standards replaced by this standard are.
---WS2/Z45~WS2/Z46-1982;
---GB n210-1983;
---GB 2544-1988;
---YY/T 0174-1994, YY 0293-1997;
---YY 0174-2005.
Surgical blade
1 Scope
This standard specifies the classification and identification of surgical blades, requirements, test methods, type inspection, labels and instructions, packaging, transportation, storage
And expiration date.
This standard is applicable to surgical blades (hereinafter referred to as blades) for cutting soft tissues mounted on the surgical handle.
2 Normative references
The following documents are indispensable for the application of this document. For dated references, only dated versions apply to this article.
Pieces. For undated references, the latest edition (including all amendments) applies to this document.
GB/T 191 packaging storage and transportation icon
GB/T 1299 tool steel
GB/T 4340.1 Metallic materials - Vickers hardness test - Part 1. Test method
GB 8662 surgical blade and surgical tool handle fit size
GB/T 9969 General guidelines for the use of industrial products
GB/T 14233.1 Medical infusion, blood transfusion, and injecting machines - Test methods - Part 1
YY 0167-2005 Non-absorbable surgical suture
YY/T 0294.1 Surgical instruments, metallic materials - Part 1. Stainless steel
YY/T 0466.1 Medical devices for the labeling, marking and information of medical devices - Part 1. General requirements
YY/T 1052 surgical instrument sign
Pharmacopoeia of the People's Republic of China (2015 edition · four)
3 Classification and identification
3.1 Delivery status
The blades are available in both sterile and non-sterile delivery conditions (hereinafter referred to as sterile blades and non-sterile blades).
3.2 Specifications
Refer to Appendix A for the specification and dimensions of the insert and the assembly specifications for the insert.
3.3 Materials
The manufacturing material of the blade shall be made of non-alloyed tool steel meeting the requirements of GB/T 1299 or martensite complying with the requirements of YY/T 0294.1.
Stainless steel, or other suitable metal materials that meet the requirements of Chapter 4.
3.4 Identification requirements
According to YY/T 1052, the surface of the blade shall be marked with at least the manufacturer code, material code (non-alloy tool steel, default) and regulations.
The grid location is shown in Figure 1.
Related standard:   YY/T 0681.15-2019  YY/T 0681.17-2019
Related PDF sample:   YY 0167-2005  YY/T 0681.14-2018
   
 
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