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YY/T 0105-2020 English PDF

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YY/T 0105-2020: Intradermal needles
Status: Valid

YY/T 0105: Evolution and historical versions

Standard IDContents [version]USDSTEP2[PDF] delivered inStandard Title (Description)StatusPDF
YY/T 0105-2020English299 Add to Cart 4 days [Need to translate] Intradermal needles Valid YY/T 0105-2020
YY 0105-1993English199 Add to Cart 2 days [Need to translate] press-needle Obsolete YY 0105-1993

PDF similar to YY/T 0105-2020


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Basic data

Standard ID YY/T 0105-2020 (YY/T0105-2020)
Description (Translated English) Intradermal needles
Sector / Industry Medical Device & Pharmaceutical Industry Standard (Recommended)
Classification of Chinese Standard C42
Classification of International Standard 11.040.60
Word Count Estimation 16,164
Date of Issue 2020-09-27
Date of Implementation 2021-09-01
Older Standard (superseded by this standard) YY 0105-1993
Regulation (derived from) Announcement No. 108 (2020) of the National Medical Products Administration
Issuing agency(ies) State Drug Administration

YY/T 0105-2020: Intradermal needles

---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.
Intradermal needles ICS 11.040.60C42 People's Republic of China Pharmaceutical Industry Standards YY/T 0105-2020 replaces YY 05-1993 Released on 2020-09-27 Implementation of 2021-09-01 Issued by the National Medical Products Administration 1 Scope 1 2 Normative references 1 3 Terms and definitions 1 4 Structure, classification and specifications 2 5 Requirements 3 6 Test method 6 7 Packaging 7 8 Mark 7 9 Transportation and storage 8 Appendix A (informative appendix) Guide to materials 9 Appendix B (Normative Appendix) The firmness of the needle body and the needle handle 10 Reference 13

Foreword

This standard was drafted in accordance with the rules given in GB/T 1.1-2009. This standard replaces YY 0105-1993 "Push Needle" and amends the name to "Intradermal Needle". Compared with YY 0105-1993, except for editorial revisions The main technical changes of the external change are as follows. ---Modified the scope of application (see Chapter 1, Chapter 1 of the.1993 edition); ---Modified the content of normative references (see Chapter 2, Chapter 2 of the.1993 edition); ---Added the content of terms and definitions (see Chapter 3, Chapter 3 of the.1993 edition); ---The type of granular intradermal needle has been added. (See 3.2); ---The size requirements for intradermal needles have been revised (see 5.1, 4.2 of the.1993 edition); ---The requirements and test methods for the strength and sharpness of the needle tip have been revised (see 5.2, 6.3, 4.4, 5.4.1 of the.1993 edition); ---The requirements and test methods of needle body hardness have been revised (see 5.3, 6.4, 4.5 and 5.4.2 of the.1993 edition); ---The requirements and test methods for the firmness of the needle body and the needle handle have been added (see 5.6 and 6.7); ---Added sterility requirements and test methods (see 5.7, 6.8); ---Added the requirements and test methods for biocompatibility (see 5.8, 6.9); ---Modified the requirements of appearance (see 5.9, 4.4, 4.6, 4.8 of the.1993 edition); ---Modified packaging, marking and storage requirements (see Chapters 7 and 8, Chapter 7 of the.1993 edition); ---Deleted the requirements for the materials used to manufacture intradermal needles (4.3 of the.1993 edition); ---Deleted the content of the inspection rules (Chapter 6 of the.1993 edition). Please note that some of the contents of this document may involve patents. The issuing agency 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 Physiotherapy Equipment Subcommittee (SAC/TC10/SC4) of the National Medical Electrical Appliance Standardization Technical Committee. Drafting organizations of this standard. Tianjin Medical Device Quality Supervision and Inspection Center, Suzhou Medical Products Factory Co., Ltd. The main drafters of this standard. Yang Guojuan, Zhang Lu, Gao Xianghui, Zhang Longfei, Chen Cheng, Xu Aimin. The previous editions of the standard replaced by this standard are as follows. Intradermal needle

1 Scope

This standard specifies the structure, classification and specifications, requirements, test methods, packaging, marking, transportation and storage of intradermal needles. This standard applies to intradermal needles used for intradermal acupuncture therapy in traditional Chinese medicine. This standard applies to the needle body material that meets the skin of 06Cr19Ni10 or other austenitic stainless steel specified in GB/T 4240-2019. Inner needle.

2 Normative references

The following documents are indispensable for the application of this document. For dated reference documents, only the dated version applies to this article Pieces. For undated reference documents, the latest version (including all amendments) is applicable to this document. GB/T 191 Graphical signs for packaging, storage and transportation GB 2024-2016 Acupuncture needles GB/T 4240-2019 stainless steel wire GB/T 4340.1 Vickers Hardness Test of Metallic Materials Part 1.Test Method GB/T 14233.2-2005 Medical transfusion, blood transfusion, injection equipment inspection methods Part 2.Biological test methods GB/T 16886.1-2011 Biological Evaluation of Medical Devices Part 1.Evaluation and Testing in the Process of Risk Management YY/T 0149-2006 Stainless steel medical equipment corrosion resistance test method YY/T 04666.1 Medical devices used for medical device labeling, marking and information symbols. Part 1.General requirements

3 Terms and definitions

3.1 Subcutaneously embedded small acupuncture tool. Note. There are two types of intradermal needles. one is a granular intradermal needle, and the other is a snap-type intradermal needle (punch needle). 3.6 4 Structure, classification and specifications 4.1 Structure The typical structure of the intradermal needle and the names of its components are shown in Figure 1, Figure 2, and Figure 3. 4.2 Classification According to whether it is sterile or not, intradermal needles can be divided into two types. sterile and non-sterile. According to the method of use, snap-type intradermal needles (punch needles) can be divided into non-electric acupuncture needles and electro-acupuncture needles. According to the combination of the needle tip and the needle handle, intradermal needles can be divided into two types. one-piece type and non-one-piece type. 4.3 Specifications and materials The specifications of intradermal needles are expressed as needle diameter×needle length. Example. Φ0.25×2mm. See Appendix A for the materials used to make intradermal needles.

5 requirements

5.1 Dimensions 5.1.1 The basic dimensions and tolerances of typical granular intradermal needles should meet the requirements of Table 1. a If the size of the intradermal needle is not within the scope of Table 1, the manufacturer shall specify the relevant size and tolerance. 5.1.2 The basic dimensions and tolerances of a typical snap-type intradermal needle (snap needle) should meet the requirements of Table 2. 5.2 Needle tip strength and sharpness After the needle tip is applied with the force specified in Table 3 to contact the steel block, its piercing force should not be greater than that specified in Table 3. 5.3 Needle body hardness The hardness of the needle body should meet the requirements of Table 4. 5.4 Surface roughness The maximum value of the surface roughness parameter R A of the needle body and the needle tip should be 0.4 μm. 5.5 Corrosion resistance Intradermal needles should have good corrosion resistance. 5.6 The firmness of the needle body and the needle handle The connection between the needle body and the needle handle of the non-integrated intradermal needle should be firm. When the static tension specified in Table 5 is applied to the center axis of the needle When facing the time, the needle body and the needle handle are not separated. 5.7 Sterile Sterile intradermal needles should be sterilized through a confirmed sterilization process to ensure the sterility of the product. Note. For suitable sterilization methods, please refer to the confirmation and routine control of the sterilization process of medical devices specified in the documents GB 18278.1, GB 18279 and GB 18280. System requirements. 5.8 Biocompatibility The part expected to be in contact with the patient’s skin should be evaluated and shaped according to the guidelines and principles given in Appendix A of GB 168886.1-2011 Into a file. 5.9 Appearance 5.9.1 The needle tip should be sharp, round and right, free of burrs, hooks and other defects. 5.9.2 There should be no scars, bends and pits on the surface of the needle. 5.9.3 For the needle handles of the integrally formed intradermal needles, the spiral loops should be round and straight, arranged closely, and there should be no obvious separation. Non-integrated intradermal needle The plane of the needle body and the connected needle handle should be perpendicular. The circular plane of the needle body of the snap-type intradermal needle (punch needle) and the connected needle handle should be perpendicular. Granule The needle body of the type intradermal needle should be parallel to the plane of the connected needle handle, and there should be no obvious deviation.

6 Test method

6.1 General Except for sterility and biocompatibility tests, no less than 3 samples are taken for other items for testing. 6.2 Dimensions The use of general measuring tools or special measuring tools should meet the requirements of 5.1. 6.3 Point strength and sharpness According to the method of 5.3.2 in GB 2024-2016, it should meet the requirements of 5.2. Note. A typical granular intradermal needle with the needle body and the needle handle at the same cross-section. If the needle body length is less than 5mm, the raw material needle blank can be used (the exposed part of the clamp is not larger than the standard Weigh the length of the needle body for the test; the needle body and the needle handle are not at the same cross-section of the intradermal needle (punch needle), if the needle body length is less than 7mm, the raw material needle blank (holding The exposed part shall not be greater than the nominal length of the needle body) for the test. 6.4 Needle body hardness The test is carried out according to the method of GB/T 4340.1 and should meet the requirements of 5.3. Note. Needle body length < 25mm can use raw material needle blanks for testing. 6.5 Surface roughness Use a 10x magnifying glass to compare with the standard surface roughness sample block, and it should meet the requirements of 5.4. 6.6 Corrosion resistance Carry out according to the method of citric acid solution test method in Chapter 7 of YY/T 0149-2006, check the corrosion marks on the surface of the test piece, and its corrosion The degree should be free of any corrosion (level a) and meet the requirements of 5.5. 6.7 The firmness of needle body and needle handle When the length of the needle body L2≥2.5mm, the test shall be carried out in accordance with the method in Appendix B or an equivalent method, and the result shall meet the requirements of 5.6.needle When the body length L2< 2.5mm, insert the entire length of the needle body of the intradermal needle into the simulated skin model, and then pull it out. After repeating 10 times, check the needle The connection between the body and the needle handle should be firm. The recommended simulated skin model should meet the following requirements. a) Material. Addition molding silicone rubber; b) Thickness. ≥2.5mm;...

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