YY/T 0345.1-2020 English PDF (YY/T0345.1-2020)

YY/T 0345.1-2020: Implants for surgery - Metallic skeletal pins and wires - Part 1: General requirements
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YY/T 0345.1-2020
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... 8
Foreword
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 Requirements
1 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 and 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)
YY/T 0345.1-2020
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... 8
Foreword
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 Requirements
1 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 and 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)