HOME   Cart(0)   Quotation   About-Us Policy PDFs Standard-List
www.ChineseStandard.net Database: 189760 (18 Oct 2025)

YY/T 1031-2016 PDF English

US$230.00 · In stock · Download in 9 seconds
YY/T 1031-2016: Needle holders
Delivery: 9 seconds. True-PDF full-copy in English & invoice will be downloaded + auto-delivered via email. See step-by-step procedure
Status: Valid

YY/T 1031: Evolution and historical versions

Standard IDContents [version]USDSTEP2[PDF] deliveryName of Chinese StandardStatus
YY/T 1031-2016English230 Add to Cart 0-9 seconds. Auto-delivery Needle holders Valid
YY/T 1031-2004English479 Add to Cart 3 days Needle holders Obsolete

Excerpted PDFs (Download full copy in 9 seconds upon purchase)

PDF Preview: YY/T 1031-2016
      

Similar standards

YY 1001   YY/T 0981   YY 1001.1   YY/T 1148   

YY/T 1031-2016: Needle holders

---This is an excerpt. Full copy of true-PDF in English version (including equations, symbols, images, flow-chart, tables, and figures etc.), auto-downloaded/delivered in 9 seconds, can be purchased online: https://www.ChineseStandard.net/PDF.aspx/YYT1031-2016
YY PHARMACEUTICAL INDUSTRY STANDARD OF THE PEOPLE’S REPUBLIC OF CHINA ICS 11.040.30 C 31 Replacing YY/T 1031-2004 Needle Holders 持针钳 ISSUED ON: MARCH 23, 2016 IMPLEMENTED ON: JANUARY 1, 2017 Issued by: China Food and Drug Administration

Table of Contents

Foreword ... 3 1 Scope ... 5 2 Normative References ... 5 3 Classification ... 5 4 Requirements ... 9 5 Test Methods ... 11 6 Marking ... 13 7 Packaging and Storage ... 13 Appendix A (normative) Determination Method for Oscillating Quantity of Head End of Needle Holders ... 14 Appendix B (normative) Type Inspection ... 18 Needle Holders

1 Scope

This Standard specifies the classification, requirements, test methods, marking, packaging, storage and inspection rules of needle holders. This Standard is applicable to needle holders for holding suture needles for suturing skin, microvessels or tissues, etc.

2 Normative References

The following documents are indispensable to the application of this document. In terms of references with a specified date, only versions with a specified date are applicable to this document. In terms of references without a specified date, the latest version (including all the modifications) is applicable to this document. GB/T 230.1-2009 Metallic Materials - Rockwell Hardness Test - Part 1: Test Method (scales A, B, C, D, E, F, G, H, K, N, T) GB/T 1220-2007 Stainless Steel Bars GB/T 4340.1-2009 Metallic Materials - Vickers Hardness Test - Part 1: Test Method YY/T 0149-2006 Medical Instruments of Stainless Steel - Test Methods of Corrosion Resistance YY 0167-2005 Non-absorbable Surgical Suture YY/T 0171-2008 Surgical Instruments - Packaging, Marking and Instructions YY/T 0173-2010 Surgical Instruments - Gill Shaft, Bolt and Rivet YY/T 0173.4-2005 Surgical Instruments - Teeth, Serration, Ratchet and Ellipsoid Ring YY/T 0294.1-2005 Surgical Instruments - Metallic Materials - Part 1: Stainless Steel YY/T 1052-2004 Marking Requirements for Surgical Instruments JJ G 34 Dial Gauges (dial and digital)

3 Classification

3.1 The needle holders are divided into: general needle holders, insert needle holders and microvascular needle holders. the handle of the needle holders without cemented carbide inserts shall not be golden yellow. 4.3 Surface Roughness The surface of the needle holders can be made with gloss or without gloss, and the value of the surface roughness parameter Ra shall not be greater than: with gloss: 0.4 m, without gloss: 0.8 m. 4.4 Elasticity and Firmness 4.4.1 The needle holders shall have good elasticity and firmness. 4.4.2 The connection between the cemented carbide inserts and the base of the insert needle holders shall be firm. 4.5 Clamping Performance The needle holders shall have good clamping performance. 4.6 Tooth Contact When the finger rings of the needle holders bump against each other, or when the locking teeth are all locked, no less than three-fifths of the tooth surface of the head serration shall be in contact. 4.7 Gill Flexibility The opening and closing of the gill joints of the needle holders shall be flexible, and with appropriate tightness. 4.8 Oscillating Quantity Disengage the locking teeth of the needle holders, and the head ends are separated by 1 mm. The oscillating quantity of the head end generated by the oscillating force applied to the ring part of the needle holders shall be not greater than that specified in Table 2. Table 2 -- Oscillating Quantity at the Head End Unit: millimeter 4.9 Dimensions The dimensions of the needle holders shall comply with the stipulations of 1 and 2 in Table 1. Total Length of Needle Holder L Oscillating Quantity 4.10 Hardness 4.10.1 The needle holders shall be subjected to thermal treatment, and their hardness shall comply with the stipulations of Table 3. 4.10.2 The hardness of the cemented carbide insert shall not be less than 923HV0.5; the difference between two pieces shall not be greater than 50HV0.5. 4.11 Corrosion Resistance The corrosion resistance of the appearance of the needle holders shall not be lower than the stipulations of Grade-b in the boiling water test method in YY/T 0149-2006.

5 Test Methods

5.1 Appearance Use normal or corrected vision to examine it and use hands to touch and feel it, which shall comply with the stipulations of 4.1.1 and 4.1.2. 5.2 Color Scale of the Handle Use normal or corrected vision to examine it, which shall comply with the stipulations of 4.2. 5.3 Surface Roughness The surface roughness of the needle holder shall be examined by the sample piece comparison method. Under the condition of magnification by 5 ~ 10 times, compare it with the sample piece, and use normal or corrected vision to examine it, which shall comply with the stipulations of 4.3. 5.4 Elasticity and Firmness 5.4.1 Place a stainless steel wire that complies with the stipulations of Table 4 on the front end of the head of the needle holder. The needle holder is completely closed, then loosened; repeat 3 times; observe the body of the instrument, which shall comply with the stipulations of 4.4.1. 5.4.2 After the insert needle holder is subjected to the elasticity and firmness test (5.4.1), observe the insert, which shall comply with the stipulations of 4.4.2. 5.5 Clamping Performance At one third of the front end of the head of the needle holder, clamp the 3-0 Class I uncoated medical suture specified in YY 0167-2005; pull it hard, until the suture breaks; observe the clamped suture, which shall comply with the stipulations of 4.5. 5.6 Tooth Contact Imitate the action of use, which shall comply with the requirements of 4.6. 5.7 Gill Flexibility Imitate the action of use, which shall comply with the stipulations of 4.7. 5.8 Oscillating Quantity Perform the test in accordance with the method specified in Appendix A, which shall comply with the stipulations of 4.8. 5.9 Dimensions Use a general measuring instrument to measure them, which shall comply with the stipulations of 4.9. 5.10 Hardness 5.10.1 In accordance with the stipulations of GB/T 230.1-2009, determine the hardness. Respectively measure three points on each of the two pieces of the needle holder (except for the cemented carbide insert); respectively calculate the arithmetic mean, which shall comply with the stipulations of 4.10.1. 5.10.2 In accordance with the stipulations of GB/T 4340.1-2009, determine the hardness. Respectively measure three points on each of the two cemented carbide inserts; respectively calculate the arithmetic mean, which shall comply with the stipulations of 4.10.2. 5.11 Corrosion Resistance

Appendix A

(normative) Determination Method for Oscillating Quantity of Head End of Needle Holders A.1 Terms A.1.1 Oscillating quantity of head end The head ends of the two pieces are separated by a specified position, and under the action of a specified force, the two pieces are oscillated relative to each other. Oscillating quantity of head end refers to the maximum displacement generated between the head ends of the two pieces. A.1.2 Fixing piece The female piece of the needle holder. A.1.3 Oscillating piece The male piece of the needle holder. A.1.4 Downward oscillating force The force applied at the head end of the oscillating piece to oscillate the head end downward. A.1.5 Upward oscillating force The force applied in the tooth socket of the ratchet of the oscillating piece (or near the root of the ring) to oscillate the head end upward. A.2 Instrument Requirements A.2.1 The measuring instrument for the oscillating quantity of the head end is composed of a dial indicator, a clamp for fixing the needle holder, a gill shaft supporting element, a measuring tool for the opening distance of the two head ends and an oscillating force element (see Figure A.1). ......
Source: Above contents are excerpted from the full-copy PDF -- translated/reviewed by: www.ChineseStandard.net / Wayne Zheng et al.


      

Tips & Frequently Asked Questions

Question 1: How long will the true-PDF of English version of YY/T 1031-2016 be delivered?

Answer: The full copy PDF of English version of YY/T 1031-2016 can be downloaded in 9 seconds, and it will also be emailed to you in 9 seconds (double mechanisms to ensure the delivery reliably), with PDF-invoice.

Question 2: Can I share the purchased PDF of YY/T 1031-2016_English with my colleagues?

Answer: Yes. The purchased PDF of YY/T 1031-2016_English will be deemed to be sold to your employer/organization who actually paid for it, including your colleagues and your employer's intranet.

Question 3: Does the price include tax/VAT?

Answer: Yes. Our tax invoice, downloaded/delivered in 9 seconds, includes all tax/VAT and complies with 100+ countries' tax regulations (tax exempted in 100+ countries) -- See Avoidance of Double Taxation Agreements (DTAs): List of DTAs signed between Singapore and 100+ countries

Question 4: Do you accept my currency other than USD?

Answer: Yes. www.ChineseStandard.us -- YY/T 1031-2016 -- Click this link and select your country/currency to pay, the exact amount in your currency will be printed on the invoice. Full PDF will also be downloaded/emailed in 9 seconds.

Question 5: Should I purchase the latest version YY/T 1031-2016?

Answer: Yes. Unless special scenarios such as technical constraints or academic study, you should always prioritize to purchase the latest version YY/T 1031-2016 even if the enforcement date is in future. Complying with the latest version means that, by default, it also complies with all the earlier versions, technically.

How to buy and download a true PDF of English version of YY/T 1031-2016?

A step-by-step guide to download PDF of YY/T 1031-2016_EnglishStep 1: Visit website https://www.ChineseStandard.net (Pay in USD), or https://www.ChineseStandard.us (Pay in any currencies such as Euro, KRW, JPY, AUD).
Step 2: Search keyword "YY/T 1031-2016".
Step 3: Click "Add to Cart". If multiple PDFs are required, repeat steps 2 and 3 to add up to 12 PDFs to cart.
Step 4: Select payment option (Via payment agents Stripe or PayPal).
Step 5: Customize Tax Invoice -- Fill up your email etc.
Step 6: Click "Checkout".
Step 7: Make payment by credit card, PayPal, Google Pay etc. After the payment is completed and in 9 seconds, you will receive 2 emails attached with the purchased PDFs and PDF-invoice, respectively.
Step 8: Optional -- Go to download PDF.
Step 9: Optional -- Click Open/Download PDF to download PDFs and invoice.
See screenshots for above steps: Steps 1~3    Steps 4~6    Step 7    Step 8    Step 9