YY/T 0956-2014Implants for surgery - Staples with parallel legs for orthopaedic use - General requirements (English PDF)
外科植入物 矫形用U型钉 通用要求
This is a limited preview
Buy now to download the full PDF (15 pages)
Need quotation for your management?
Get a formal quotation for YY/T 0956-2014 in 30 minutes.
Issued by
NMPA
Level / Type
Industry · Recommended
Issue date
June 17, 2014
Implementation date
July 1, 2015
Scope
YY/T 0956-2014 is the English-translated version of 外科植入物 矫形用U型钉 通用要求.
YY/T 0956-2014 is the Chinese pharmaceutical industry standard that sets the general requirements, the dimensions and the tolerances for the orthopaedic staple with parallel legs.
An informative annex gives guidance on choosing and using such staples without forming part of the requirements, and the standard covers the material, the form and the dimensions of the bridge and the legs, the surface finish and the marking. Issued on 17 June 2014, it has applied since 1 July 2015.
Found what you need?
Document preview — YY/T 0956-2014
National Standard of the People's Republic of China
- ICS
- 11.040.40
- Classification
- C 35
- Replacing
- YY 0119-2002
Issued by: National Medical Products Administration of the People's Republic of China
Contents
- Foreword
- 1 Scope
- 2 Normative references
- 3 Design
- 4 Dimension
Foreword
This standard was drafted in accordance with GB/T 1.1-2009 given rules.
This standard uses the translation method identical with ISO 8827 "orthopedic surgical implants with U-shaped staples General requirements." Correspondence between the consistency of the standards of international documents and normative references of the following documents.
--- GB 4234-2003 surgical implants made of stainless steel (ISO 5823-1:1997, MOD)
--- YY/T 0605.5-2007 surgical implants of metallic materials - Part 5. Wrought cobalt - chromium - tungsten - nickel alloys (ISO 5832-5. 2005, IDT)
--- GB/T 228.1-2010 tensile testing of metallic materials - Part 1. room temperature test methods (ISO 6892-1:2009, MOD)
--- YY/T 0640-2008 active surgical implants General requirements (ISO 14630:2005, IDT)
This standard and ISO 8827. 1988 as compared, differences are as follows. Normative documents with YY/T 0640 instead of ISO 6018.
Note: ISO 6018 has been annulled, the content is covered by ISO 14630, YY/T 0640 equivalent conversion ISO 14630.
This standard replaces YY 0119-2002 "metal orthopedic implants osteosynthesis with nails" on the part of the U-shaped staples.
1 Scope
This standard specifies the Orthopedic U-shaped staples General requirements and dimensions and tolerancing.
Note: Appendix A gives the U-shaped staples selection and use of guidelines, but do not form an integral part of this standard.
2 Normative references
The following documents for the application of this document is essential. For dated references, only the dated version suitable for use herein Member. For undated references, the latest edition (including any amendments) applies to this document.
GB/T 228.1 tensile testing of metallic materials - Part 1. room temperature test methods (GB/T 228.1-2010, ISO 6892-1. 2009, MOD)
GB 4234 stainless steel surgical implants (GB 4234-2003, ISO 5832-1:1997, MOD)
YY/T 0605.5 surgical implants of metallic materials - Part 5. Wrought cobalt - chromium - tungsten - nickel alloy (YY/T 0605.5-2007, ISO 5832-5:2005, IDT)
YY/T 0640 General requirements for passive surgical implants (YY/T 0640-2008, ISO 14630:2005, IDT)
ISO 5832-3 Implants for surgery - Metallic materials - Part 3. Forged Titanium 6Al vanadium alloy (Implantsforsurgery- Metalicmaterials-Part 3. Wroughttitanium6-aluminium4-vanadiumaloy)
ISO 5832-4 Implants for surgery - Metallic materials - Part 4. Cast cobalt - chromium - molybdenum alloy (Implantsforsurgery- Metalicmaterials-Part 4. Cobalt-chromium-molybdenumcastingaloy)
3 Design
3.1 Radius of curvature
U-shaped staples selected wire manufacturing, within a radius of curvature of not less than 2mm and not smaller than the diameter of the wire, bend shape should be smooth.
3.2 Tip
U-shaped nail tip may be conical, three prism, spear-shaped or a flat shape.
3.3 Nail leg
Nail the legs should be parallel.
Note 1. Orthopedic shown in Figure 1 with the typical form of U-shaped nails. Figure 1 shows a U-shaped staples names and dimensions, its purpose is not specified U-shaped
Nail design requirements, this standard does not constitute a U-shaped staple Requirements section.
Note 2. Although there are other forms of cross-section of U-shaped nails, but generally circular, oval and rectangular cross-section class. If the manufacturer U-shaped nails with wire, general mining
Wire with a diameter of 2.5mm. Elliptical cross section can achieve greater strength, generally specifications for 4mm × 2mm, or by strengthening the curved screen angle Song at the strength [Fig. 1b)]. Nail the legs may be flat, barbed or other forms.
4 Dimension
U-shaped nail size should be the effective length (l), the effective width (b), the diameter (d) are labeled (Figure 1), in millimeters, for example,
......
This preview omits tables, figures, formulas and parts of the technical clauses. The complete document — 15 pages — is available in the English PDF.
Referenced standards
Normative references
- GB/T 228.1Metallic Materials — Tensile Testing — Part 1: Method of Test at Room Temperature
- YY/T 0605.5Implants for surgery - Metallic materials - Part 5: Wrought cobalt-chromium-tungsten-nickel alloy
- YY/T 0640Non-active surgical implants - General requirements
GB 4234 · ISO 5832-3 · ISO 5832-4
Similar standards
Editions of YY/T 0956
| Edition | Title | Revision | Status |
|---|---|---|---|
| YY/T 0956-2014 | Implants for surgery - Staples with parallel legs for orthopaedic use - General requirements | current edition | Current |
| YY 0119-2002 | Implants for surgery - Staples with parallel legs for orthopaedic use - General requirements | previous edition | Superseded |
This page sells the current edition, YY/T 0956-2014. Earlier editions are listed for reference only.
How to Download YY/T 0956-2014
- 1
Add to cart
Click "Download PDF" on this page and choose "Buy this standard". You can add more standards before checkout.
- 2
Checkout
Enter your email and billing details. Payment is processed securely by Stripe (cards or bank transfer). Prefer bank details? Request a quotation (min. order $300).
- 3
Instant delivery (0–9 sec)
Delivery is automatic: within seconds of payment you'll receive an email with a secure download link. The link stays valid for 72 hours.
- 4
Invoice included
A tax invoice is attached to the confirmation email. Need a custom invoice? Contact us.
Related Standards
GB 4234.1-2017 — Implants for surgery—Metallic materials—Part 1: Wrought stainless steel
GB 4234.1-2026 — Implants for surgery - Metallic materials - Part 1: Wrought stainless steel
GB 4234.11-2025 — Implants for surgery - Metallic materials - Part 11: Wrought titanium 6-aluminium 7-niobium alloy
Secure payment via Stripe
Payments accepted
YY/T 0956-2014
$125.00