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Position: Chinese Standard in English/YY 0174-2019
YY 0174-2019   Scalpel blade (English Version)
Standard No.: YY 0174-2019 Status:valid remind me the status change

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Language:English File Format:PDF
Word Count: 7500 words Price(USD):225.0 remind me the price change

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Implemented on:2020-6-1 Delivery: via email in 1 business day
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Standard No.: YY 0174-2019
English Name: Scalpel blade
Chinese Name: 手术刀片
Chinese Classification: C31    General and microsurgical devices
Professional Classification: YY    Professional Standard - Pharmaceutics
ICS Classification: 11.040.30 11.040.30    Surgical instruments and materials 11.040.30
Issued by: National Medical Products Adminstration
Issued on: 2019-05-31
Implemented on: 2020-6-1
Status: valid
Superseding:YY 0174-2005 Scalpel blade
Language: English
File Format: PDF
Word Count: 7500 words
Price(USD): 225.0
Delivery: via email in 1 business day
Codeofchina.com is in charge of this English translation. In case of any doubt about the English translation, the Chinese original shall be considered authoritative. This standard is developed in accordance with the rules given in GB/T 1.1-2009. This standard replaces YY 0174-2005 Scalpel blade. The following main changes have been made with respect to YY 0174-2005: ——application scope is revised (see Clause 1 hereof; Clause 1 of 2005 Edition); ——manufacturing materials are revised (see 3.3 hereof; 3.2 of 2005 Edition); ——requirements for the blade identification are added (see 3.4); ——requirements for hardness are revised (see 4.4 hereof; 4.4.1 of 2005 Edition); ——requirements for anticorrosion performance are added (see 4.6); ——requirements for residual quantity of ethylene oxide are added (see 4.8); ——requirements for packaging label and instruction are added (see 4.9); ——test methods for surface roughness are revised (see 5.2.1 hereof; 5.2.1 of 2005 Edition); ——test methods for cutting edge sharpness are revised (see 5.3 hereof; 5.3 of 2005 Edition); ——type test is revised (see Clause 6 hereof; Clause 6 of 2005 Edition); ——requirements for labels and instructions are revised (see Clause 7 hereof, Clause 7 of the 2005 Edition); ——requirements for packaging, transportation and storage are revised (see Clause 8 hereof; Clause 8 of 2005 Edition). Attention is drawn to the possibility that some of the elements of this document may be the subject of patent rights. The issuing body of this document shall not be held responsible for identifying any or all such patent rights. This standard was proposed by State Drug Administration (SDA). This standard is under the jurisdiction of National Technical Committee 94 on Chirurgicum Apparatus of Standardization Administration of China (SAC/TC 94). The previous editions replaced by this standard are as follows: ——WS2/Z45~WS2/Z46-1982; ——GBn 210-1983; ——GB 2544-1988; ——YY/T 0174-1994, YY 0293-1997; ——YY 0174-2005. Scalpel blade 1 Scope This standard specifies the classification and identification, requirements, test methods, type inspection, label and instruction, packaging, transportation and storage and validity period of scalpel blade. This standard is applicable to surgical blades installed on the scalpel handle for cutting soft tissues (hereinafter referred to as blades). 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 (including any amendments) applies. GB/T 191 Packaging—Pictorial marking for handling of goods GB/T 1299 Tool and mould steels GB/T 4340.1 Metallic materials—Vickers hardness—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 equipments for medical use - Part 1: Chemical analysis methods 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—Symbols to be used with medical device labels, labelling and information to be supplied—Part 1: General requirements YY/T 1052 Marking requirements for surgical instruments Pharmacopoeia of the People's Republic of China (Edition 2015, Volume IV) 3 Classification and identification 3.1 Delivery status Blades are delivered in either sterile or non-sterile states (hereinafter referred to as sterile blades and non-sterile blades). 3.2 Specifications and types Refer to Annex A for the specifications, types and overall dimensions of the blade and the assembly specifications of the blade handle. 3.3 Material The blade shall be made of non-alloy tool steel conforming to GB/T 1299 or martensitic stainless steel conforming to YY/T 0294.1, or other applicable metal materials conforming to Clause 4. 3.4 Identification requirements According to YY/T 1052, the blade surface shall at least be marked with the manufacturer's code, material code (non-alloy tool steel and identification default) and specification, and the identification position is shown in Figure 1. keys: L——lengths; B——breadths (widths); α, δ, b, b1, L1, L2——assembly dimensions with handles. Figure 1 Identification location of materials and specifications 4 Requirements 4.1 Dimensions The assembly dimensions α, δ, b, b1, L1 and L2 of the blade, as shown in Figure 1, shall meet the requirements specified in GB 8662. 4.2 Appearance 4.2.1 The value of blade surface roughness Ra shall not be greater than 0.4 μm, and the value of cutting edge surface roughness Ra shall not be greater than 0.8 μm. 4.2.2 The blade edge shall be free of nicks, naked blade, wire edge, cracks, etc. 4.2.3 The width of both sides of the blade cutting edge shall be similar and the surface shall be free of focal spots. 4.2.4 The blade shall be smooth and free from cracks, sharp edges, burrs and obvious pitting. 4.3 Sharpness of cutting edge The cutting edge of the blade shall be sharp and its cutting force shall not be greater than 0.80 N. 4.4 Hardness The blade shall be heat treated with a hardness of not less than 650 HV10. 4.5 Elasticity The blade shall be well flexible without fracture or obvious deformation after test. 4.6 Anti-corrosion performance The blade shall have good anti-corrosion performance and free from rust spots on the surface. 4.7 Sterility If it is a sterile blade, it shall be sterilized by a confirmed sterilization process, and the blade shall be sterile. 4.8 Residual quantity of ethylene oxide If the blade is sterilized with ethylene oxide, the residual quantity of ethylene oxide shall be not greater than 10 μg/g. 4.9 Packaging labels and instructions The packaging label shall be clear and conform to the provisions of Clause 7. Instructions shall specify detailed sterilization or disinfection methods.
Foreword i 1 Scope 2 Normative references 3 Classification and identification 4 Requirements 5 Test methods 6 Type inspection 7 Labels and instructions 8 Packaging, transportation, storage and validity period Annex A (Informative) Specifications and types of blades Annex B (Normative) Test method for sharpness of cutting edge of surgical blade Annex C (Normative) Test method for elasticity
Referred in YY 0174-2019:
*GB/T 191-2008 Packaging - Pictorial Marking for Handling of Goods
*GB/T 1299-2014 Tool and mould steels
*GB/T 4340.1-2009 Metallic materials—Vickers hardness test—Part 1:Test method
*GB 8662-2006 Fitting dimension between scalpel blades and handles
*GB/T 9969-2008 General Principles for Preparation of Instructions for Use of Industrial Products
*GB/T 14233.1-2022 Test methods for infusion,transfusion,injection equipments for medical use―Part 1:Chemical analysis methods
*YY 0167-2005 Non-absorbable surgical suture
*YY/T 0294.1-2016 Surgical instruments—Metallic materials—Part 1:Stainless steel
*YY/T 0466.1-2016 Medical devices - Symbols to be used with medical device labels, labelling and information to be supplied - Part 1: General requirements
*YY/T 1052-2004 Marking requirements for surgical instruments
Code of China
Standard
YY 0174-2019  Scalpel blade (English Version)
Standard No.YY 0174-2019
Statusvalid
LanguageEnglish
File FormatPDF
Word Count7500 words
Price(USD)225.0
Implemented on2020-6-1
Deliveryvia email in 1 business day
Detail of YY 0174-2019
Standard No.
YY 0174-2019
English Name
Scalpel blade
Chinese Name
手术刀片
Chinese Classification
C31
Professional Classification
YY
ICS Classification
Issued by
National Medical Products Adminstration
Issued on
2019-05-31
Implemented on
2020-6-1
Status
valid
Superseded by
Superseded on
Abolished on
Superseding
YY 0174-2005 Scalpel blade
Language
English
File Format
PDF
Word Count
7500 words
Price(USD)
225.0
Keywords
YY 0174-2019, YY/T 0174-2019, YYT 0174-2019, YY0174-2019, YY 0174, YY0174, YY/T0174-2019, YY/T 0174, YY/T0174, YYT0174-2019, YYT 0174, YYT0174
Introduction of YY 0174-2019
Codeofchina.com is in charge of this English translation. In case of any doubt about the English translation, the Chinese original shall be considered authoritative. This standard is developed in accordance with the rules given in GB/T 1.1-2009. This standard replaces YY 0174-2005 Scalpel blade. The following main changes have been made with respect to YY 0174-2005: ——application scope is revised (see Clause 1 hereof; Clause 1 of 2005 Edition); ——manufacturing materials are revised (see 3.3 hereof; 3.2 of 2005 Edition); ——requirements for the blade identification are added (see 3.4); ——requirements for hardness are revised (see 4.4 hereof; 4.4.1 of 2005 Edition); ——requirements for anticorrosion performance are added (see 4.6); ——requirements for residual quantity of ethylene oxide are added (see 4.8); ——requirements for packaging label and instruction are added (see 4.9); ——test methods for surface roughness are revised (see 5.2.1 hereof; 5.2.1 of 2005 Edition); ——test methods for cutting edge sharpness are revised (see 5.3 hereof; 5.3 of 2005 Edition); ——type test is revised (see Clause 6 hereof; Clause 6 of 2005 Edition); ——requirements for labels and instructions are revised (see Clause 7 hereof, Clause 7 of the 2005 Edition); ——requirements for packaging, transportation and storage are revised (see Clause 8 hereof; Clause 8 of 2005 Edition). Attention is drawn to the possibility that some of the elements of this document may be the subject of patent rights. The issuing body of this document shall not be held responsible for identifying any or all such patent rights. This standard was proposed by State Drug Administration (SDA). This standard is under the jurisdiction of National Technical Committee 94 on Chirurgicum Apparatus of Standardization Administration of China (SAC/TC 94). The previous editions replaced by this standard are as follows: ——WS2/Z45~WS2/Z46-1982; ——GBn 210-1983; ——GB 2544-1988; ——YY/T 0174-1994, YY 0293-1997; ——YY 0174-2005. Scalpel blade 1 Scope This standard specifies the classification and identification, requirements, test methods, type inspection, label and instruction, packaging, transportation and storage and validity period of scalpel blade. This standard is applicable to surgical blades installed on the scalpel handle for cutting soft tissues (hereinafter referred to as blades). 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 (including any amendments) applies. GB/T 191 Packaging—Pictorial marking for handling of goods GB/T 1299 Tool and mould steels GB/T 4340.1 Metallic materials—Vickers hardness—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 equipments for medical use - Part 1: Chemical analysis methods 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—Symbols to be used with medical device labels, labelling and information to be supplied—Part 1: General requirements YY/T 1052 Marking requirements for surgical instruments Pharmacopoeia of the People's Republic of China (Edition 2015, Volume IV) 3 Classification and identification 3.1 Delivery status Blades are delivered in either sterile or non-sterile states (hereinafter referred to as sterile blades and non-sterile blades). 3.2 Specifications and types Refer to Annex A for the specifications, types and overall dimensions of the blade and the assembly specifications of the blade handle. 3.3 Material The blade shall be made of non-alloy tool steel conforming to GB/T 1299 or martensitic stainless steel conforming to YY/T 0294.1, or other applicable metal materials conforming to Clause 4. 3.4 Identification requirements According to YY/T 1052, the blade surface shall at least be marked with the manufacturer's code, material code (non-alloy tool steel and identification default) and specification, and the identification position is shown in Figure 1. keys: L——lengths; B——breadths (widths); α, δ, b, b1, L1, L2——assembly dimensions with handles. Figure 1 Identification location of materials and specifications 4 Requirements 4.1 Dimensions The assembly dimensions α, δ, b, b1, L1 and L2 of the blade, as shown in Figure 1, shall meet the requirements specified in GB 8662. 4.2 Appearance 4.2.1 The value of blade surface roughness Ra shall not be greater than 0.4 μm, and the value of cutting edge surface roughness Ra shall not be greater than 0.8 μm. 4.2.2 The blade edge shall be free of nicks, naked blade, wire edge, cracks, etc. 4.2.3 The width of both sides of the blade cutting edge shall be similar and the surface shall be free of focal spots. 4.2.4 The blade shall be smooth and free from cracks, sharp edges, burrs and obvious pitting. 4.3 Sharpness of cutting edge The cutting edge of the blade shall be sharp and its cutting force shall not be greater than 0.80 N. 4.4 Hardness The blade shall be heat treated with a hardness of not less than 650 HV10. 4.5 Elasticity The blade shall be well flexible without fracture or obvious deformation after test. 4.6 Anti-corrosion performance The blade shall have good anti-corrosion performance and free from rust spots on the surface. 4.7 Sterility If it is a sterile blade, it shall be sterilized by a confirmed sterilization process, and the blade shall be sterile. 4.8 Residual quantity of ethylene oxide If the blade is sterilized with ethylene oxide, the residual quantity of ethylene oxide shall be not greater than 10 μg/g. 4.9 Packaging labels and instructions The packaging label shall be clear and conform to the provisions of Clause 7. Instructions shall specify detailed sterilization or disinfection methods.
Contents of YY 0174-2019
Foreword i 1 Scope 2 Normative references 3 Classification and identification 4 Requirements 5 Test methods 6 Type inspection 7 Labels and instructions 8 Packaging, transportation, storage and validity period Annex A (Informative) Specifications and types of blades Annex B (Normative) Test method for sharpness of cutting edge of surgical blade Annex C (Normative) Test method for elasticity
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Keywords:
YY 0174-2019, YY/T 0174-2019, YYT 0174-2019, YY0174-2019, YY 0174, YY0174, YY/T0174-2019, YY/T 0174, YY/T0174, YYT0174-2019, YYT 0174, YYT0174