YY/T 0345.1-2020 PDF English
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YY/T 0345.1: Historical versions
| Standard ID | USD | BUY PDF | Delivery | Standard Title (Description) | Status |
| YY/T 0345.1-2020 | 110 | Add to Cart | Auto, 9 seconds. | Implants for surgery - Metallic skeletal pins and wires - Part 1: General requirements | Valid |
| YY/T 0345.1-2011 | 199 | Add to Cart | 2 days | Implants for surgery. Skeletal pins and wires. Part 1: Material and mechanical requirements | Obsolete |
| YY 0345-2002 | 319 | Add to Cart | 3 days | Implants for osteosynthesis. Metal bone pins | Obsolete |
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YY/T 0345.1-2020: Implants for surgery - Metallic skeletal pins and wires - Part 1: General requirements
---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/YYT0345.1-2020
YY PHARMACEUTICAL INDUSTRY STANDARD ICS 11.040.40 C 35 Replacing YY/T 0345.1-2011 Implants for Surgery - Metallic Skeletal Pins and Wires - Part 1.General Requirements (ISO 5838-1.2013, MOD) Issued on: JUNE 30, 2020 Implemented on: JUNE 1, 2021 Issued by. National Medical Products Administration
Table of Contents
Foreword... 3 1 Scope... 6 2 Normative References... 6 3 Materials... 7 4 Mechanical Properties... 7 5 Manufacturing Method... 8 6 Surface Quality... 8 7 Sterilization... 8 8 Packaging... 8 9 Information Provided by the Manufacturer... 8Foreword
YY/T 0345 Implants for Surgery - Metallic Skeletal Pins and Wires is divided into the following 3 parts. ---Part 1.General Requirements; ---Part 2.Steinmann Skeletal Pins - Dimensions; ---Part 3.Kirschner Skeletal Wires. This is Part 1 of YY/T 0345. This Part was drafted in accordance with the rules provided in GB/T 1.1-2009. This document serves as a replacement for YY/T 0345.1-2011 Implants for Surgery - Skeletal Pins and Wires - Part 1.Material and Mechanical Requirements. In comparison with YY/T 0345.1-2011, apart from editorial modifications, the main technical changes are as follows. ---The title of the Standard is modified from “Implants for Surgery - Skeletal Pins and Wires - Part 1.Material and Mechanical Requirements” into “Implants for Surgery - Metallic Skeletal Pins and Wires - Part 1.General Requirements”; ---The requirements of YY 0605.9, YY 0605.12 and ISO 5832-14 are added to the material section (see Chapter 3); ---The requirements for tensile strength of super-hard stainless steel materials 8mm are added to the mechanical properties (see Chapter 4); ---The requirements for manufacturing methods (see Chapter 5), surface quality (see Chapter 6), sterilization (see Chapter 7), packaging (see Chapter 8) and information provided by the manufacturer (see Chapter 9) are added. This Part uses the re-drafting method in the modification and adoption of ISO 5838-1.2013.In comparison with ISO 5838.1-2013, there are the following technical differences. ---Regarding normative references, this Standard has made adjustments with technical differences to adapt to the technical conditions of China. The adjustments are intensively reflected in Chapter 2 “Normative References”. The specific adjustments are as follows. GB/T 228.1, which modifies and adopts international standard is used to replace ISO 6892-1; GB 4234, which modifies and adopts international standard is used to replace ISO 5832-1; Implants for Surgery - Metallic Skeletal Pins and Wires - Part 1.General Requirements1 Scope
This Part of YY/T 0345 specifies the general requirements for metallic skeletal pins and wires used for orthopedic surgery. This Part applies to metallic skeletal pins and wires used for orthopedic surgery, but not to bundled and wound metal wires.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 228.1 Metallic Materials - Tensile Testing - Part 1.Method of Test at Room Temperature (GB/T 228.1-2010, ISO 6892-1.2009, MOD) GB 4234.1 Implants for Surgery - Metallic Materials - Part 1.Wrought Stainless Steel (GB 4234.1-2017, ISO 5832-1.2007, MOD) GB/T 4334 Corrosion of Metals and Alloys - Test Methods for Intergranular Corrosion of Stainless Steels (GB/T 4334-2008, ISO 3651-1.1998 & ISO 3651-2.1998, MOD) GB/T 13810 Wrought Titanium and Titanium Alloy for Surgical Implants GB 23102 Implants for Surgery - Metallic Materials - Wrought Titanium-6aluminium- 7niobium Alloy (GB 23102-2008, ISO 5832-11.1994, IDT) YY/T 0605.5 Implants for Surgery - Metallic Materials - Part 5.Wrought Cobalt-chromium- tungsten-nickel Alloy (YY/T 0605.5-2007, ISO 5832-5.2005, IDT) YY/T 0605.6 Implants for Surgery - Metallic Materials - Part 6.Wrought Cobalt-nickel- chromium-molybdenum Alloy (YY/T 0605.6-2007, ISO 5832-6.1997, IDT) YY/T 0605.7 Implants for Surgery - Metallic Materials - Part 7.Forgeable and Cold-formed Cobalt-chromium-nickel-molybdenum-iron Alloy (YY/T 0605.7-2007, ISO 5832-7.1994, IDT) YY/T 0605.8 Implants for Surgery - Metallic Materials - Part 8.Wrought Cobalt-nickel- chromium-molybdenum-tungsten-iron Alloy (YY/T 0605.8-2007, ISO 5832-8.1997, IDT) ......Source: Above contents are excerpted from the full-copy PDF -- translated/reviewed by: www.ChineseStandard.net / Wayne Zheng et al.
