YY/T 0174-2019 English PDF

Standard ID	USD	BUY PDF	Lead-Days	Standard Title (Description)	Status
YY/T 0174-2019	230	Add to Cart	Auto, < 3 mins	Scalpel blade	Valid
YY 0174-2019	230	Add to Cart	Auto, < 3 mins	[YY/T 0174-2019] Scalpel blade	Obsolete
YY 0174-2005	479	Add to Cart	3 days	Scalpel blade	Obsolete
YY/T 0174-1994	279	Add to Cart	3 days	(Surgical blades)	Obsolete

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YY 0167   YY/T 0245   YY/T 0242   YY 0329   

Basic data

Standard ID: YY/T 0174-2019 (YY/T0174-2019)
Description (Translated English): Scalpel blade
Sector / Industry: Medical Device & Pharmaceutical Industry Standard (Recommended)
Classification of Chinese Standard: C31
Classification of International Standard: 11.040.30
Word Count Estimation: 14,16
Date of Issue: 2019-05-31
Date of Implementation: 2020-06-01
Issuing agency(ies): State Drug Administration
Summary: This standard specifies the classification and identification, requirements, test methods, type inspection, labels and instructions, packaging, transportation, storage and expiration date of surgical blades. This standard is applicable to surgical blades (hereinafter referred to as blades) installed on scalpel handles for cutting soft tissues.

YY/T 0174-2019: Scalpel blade

---This is a DRAFT version for illustration, not a final translation. Full copy of true-PDF in English version (including equations, symbols, images, flow-chart, tables, and figures etc.) will be manually/carefully translated upon your order.
ICS 11:040:30 C31 Pharmaceutical Industry Standard of the People's Republic of China YY 0174-2019 Replace YY 0174-2005 scalpel blade According to the State Drug Administration medical device industry Standard Announcement (No: 76 of 2022), this standard is from From September 7, 2022, it will be converted into a recommended standard, no Enforce it again: Released on:2019-05-31 and implemented on 2020-06-01 Released by the State Drug Administration

foreword

This standard is drafted in accordance with the rules given in GB/T 1:1-2009: This standard replaces YY 0174-2005 "Scalpel": Compared with YY 0174-2005, the main changes of this standard are as follows: --- Revised the scope of application (see Chapter 1, Chapter 1 of the:2005 edition); --- Revised the manufacturing materials (see 3:3, 3:2 of the:2005 edition); --- Increased blade identification requirements (see 3:4); --- Revised hardness requirements (see 4:4, 4:4:1 of the:2005 edition); --- Increased anti-rust performance requirements (see 4:6); --- Added ethylene oxide residue requirements (see 4:8); --- Increased packaging label and instructions requirements (see 4:9); --- Revised the surface roughness test method (see 5:2:1, 5:2:1 of the:2005 edition); --- Revised the test method for edge sharpness (see 5:3, 5:3 of the:2005 edition); --- Revised the type inspection (see Chapter 6, Chapter 6 of the:2005 edition); ---Revised labeling and instructions requirements (see Chapter 7, Chapter 7 of the:2005 edition); --- Revised packaging, transportation, storage requirements (see Chapter 8, Chapter 8 of the:2005 edition): Please note that some content of this document may involve patents, and the issuing organization of this document does not undertake the responsibility for identifying these patents: This standard was proposed by the State Drug Administration: This standard is under the jurisdiction of the National Surgical Instruments Standardization Technical Committee (SAC/TC94): This standard was drafted by: Shanghai Pudong Jinhuan Medical Supplies Co:, Ltd:, Shanghai Medical Device Testing Institute, Huaiyin Medical Device Co:, Ltd: Ltd: The main drafters of this standard: Zhang Yanqing, Wang Zewei, Gao Bai, Wang Fengcai, Huang Shuze, Lu Guangheng, Lu Lidong: The previous releases of the standards replaced by this standard are as follows: ---WS2/Z45~WS2/Z46-1982; ---GB n210-1983; ---GB 2544-1988; ---YY/T 0174-1994, YY 0293-1997; ---YY 0174-2005: YY 0174-2019 scalpel blade

1 Scope

This standard specifies the classification and identification, requirements, test methods, type inspection, labels and instructions, packaging, transportation and storage of surgical blades: and expiration date: This standard applies to surgical blades installed on scalpel handles for cutting soft tissues (hereinafter referred to as blades):

2 Normative references

The following documents are indispensable for the application of this document: For dated references, only the dated version applies to this document pieces: For undated references, the latest version (including all amendments) applies to this document: GB/T 191 Packaging, storage and transportation icon marks GB/T 1299 tool steel GB/T 4340:1 Vickers hardness test for metallic materials - Part 1: Test method Matching dimensions of GB 8662 surgical blades and surgical knife handles GB/T 9969 General Rules for Instructions for Use of Industrial Products GB/T 14233:1 Test methods for medical infusion, blood transfusion and injection equipment - Part 1: Chemical analysis methods YY 0167-2005 Non-absorbable surgical suture YY/T 0294:1 Metal materials for surgical instruments Part 1: Stainless steel YY/T 0466:1 Symbols for Medical Device Labeling, Marking and Information Provision for Medical Devices Part 1: General Requirements YY/T 1052 Surgical Instrument Marking Pharmacopoeia of the People's Republic of China (2015 Edition, Volume Four)

3 Classification and identification

3:1 Delivery status Blades are available in two delivery states, sterile and non-sterile (hereinafter referred to as sterile blades and non-sterile blades): 3:2 Specification type Please refer to Appendix A for the specifications, types and dimensions of the blade, and the specifications for assembling it with the handle: 3:3 Materials The manufacturing material of the blade should be non-alloy tool steel meeting the requirements of GB/T 1299 or martensite meeting the requirements of YY/T 0294:1 Stainless steel, or other applicable metallic materials meeting the requirements of Chapter 4: 3:4 Labeling requirements According to the provisions of YY/T 1052, the surface of the blade should at least be marked with the manufacturer code, material code (non-alloy tool steel, default mark) and specification: grid, see Figure 1 for the location of the mark: YY 0174-2019 ......

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