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外科植入物 金属材料第1部分：锻造不锈钢
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GB 4234.1-2017
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标准编号: GB 4234.1-2017 (GB4234.1-2017)
中文名称: 外科植入物 金属材料第1部分：锻造不锈钢
英文名称: Implants for surgery -- Metallic materials -- Part 1: Wrought stainless steel
行业: 国家标准
中标分类: H40
国际标准分类: 11.040.40
字数估计: 10,180
发布日期: 2017-12-29
实施日期: 2019-07-01
起草单位: 国家食品药品监督管理局天津医疗器械质量监督检验中心
归口单位: 国家食品药品监督管理总局
提出机构: 国家食品药品监督管理总局
发布机构: 中华人民共和国国家质量监督检验检疫总局、中国国家标准化管理委员会
GB 4234.1-2017: 外科植入物 金属材料第1部分：锻造不锈钢
GB 4234.1-2017 英文名称: Implants for surgery -- Metallic materials -- Part 1: Wrought stainless steel
1 范围
《外科植入物 金属材料》的本部分规定了外科植入物用锻造不锈钢的特征及相应的试验方法。
本部分适用于外科植入物用锻造不锈钢。
注1:取自成品的试样,其力学性能可不必遵循本部分的规定。
注2:本部分中描述的合金对应于 ASTM F138[1]/ASTM F139[2]中 UNS编号 S31673的合金及已废止的DIN17443[3]中材料号为1.4441的合金。
2 规范性引用文件
下列文件对于本文件的应用是必不可少的。凡是注日期的引用文件,仅注日期的版本适用于本文
件。凡是不注日期的引用文件,其最新版本(包括所有的修改单)适用于本文件。
GB/T 228.1 金属材料 拉伸试验 第1部分:室温试验方法(GB/T 228.1-2010,ISO 6892-1:
2009,MOD)
GB/T 2975 钢及钢制品 力学性能试验取样位置及试样制备(GB/T 2975-1998,eqvISO 377:
1997)
GB/T 10561-2005 钢中非金属夹杂物含量的测定 标准评级图显微检验法(ISO 4967:1998,
IDT)
GB/T 17505 钢及钢产品 交货一般技术要求(GB/T 17505-2016,ISO 404:2013,MOD)
ISO 437 钢和铸铁 全碳量的测定 燃烧重量分析法
ISO 439 钢和铸铁 全硅量的测定 重量分析法
ISO 629 钢和铸铁 锰含量的测定 分光光度法
ISO 643 钢 表面晶粒度的显微测定法
ISO 671 钢和铸铁 硫含量的测定 燃烧滴定法
ISO 10714 钢和铸铁 磷含量的测定 磷钒钼酸盐分光光度法
3 化学成分
3.1 试样
分析用试样的选取应符合GB/T 2975的规定。
3.2 熔炼分析
按第6章规定的方法进行钢的熔炼分析,其化学成分应符合表1的规定。
铬(Cr)含量和钼(Mo)含量按下式得出的计算结果(c值)应不小于26。
4 完全退火状态下的显微组织
4.1 晶粒度
按第6章规定的方法测定奥氏体的晶粒度,其结果应不粗于5级。
4.2 显微组织
按第6章规定的方法测定,钢材组织中不应存在δ铁素体、χ相和σ相。
4.3 夹杂物含量
按第6章规定的方法测定,完成热轧处理后的钢材中非金属夹杂物含量不应超过表2中给出的
数值。
注:可能需要采用特殊的加工技术,如真空熔炼或电渣熔炼,以便生产出符合纯净度要求的钢材。
5 力学性能
5.1 试样
拉伸试验的试样选取与试样制备应符合GB/T 2975的规定。
5.2 拉伸试验
按第6章的方法试验时,棒材、丝材、板材和带材的力学性能应分别符合表3、表4和表5的规定。
如果有任一试样不符合要求或在标距范围之外断裂,则应按GB/T 17505的规定重新进行试验。
5.3 标距长度
应符合GB/T 228.1的规定。
6 试验方法
用于测定本部分要求的试验方法见表6。
GB 4234.1-2017
GB
NATIONAL STANDARD OF THE
PEOPLE’S REPUBLIC OF CHINA
ICS 11.040.40
H 40
Replacing GB 4234-2003
Implants for surgery - Metallic materials –
Part 1. Wrought stainless steel
(ISO 5832-1.2007, MOD)
ISSUED ON. DECEMBER 29, 2017
IMPLEMENTED ON. JULY 1, 2019
Issued by. General Administration of Quality Supervision, Inspection and
Quarantine;
Standardization Administration Committee.
Table of Contents
Foreword ... 3
1 Scope ... 6
2 Normative references ... 6
3 Chemical composition ... 7
4 Microstructure in the fully annealed condition ... 8
5 Mechanical properties ... 8
6 Test methods ... 9
Bibliography ... 11
Foreword
All technical content of this Part is mandatory.
"Implants for surgery - Metallic materials" is expected to divide into 14 parts.
- Part 1. Wrought stainless steel;
- Part 2. Pure titanium;
- Part 3. Forged titanium 6 aluminum 4 vanadium alloy;
- Part 4. Cast cobalt-chromium-molybdenum alloy;
- Part 5. Forged cobalt-chromium-tungsten-nickel alloy;
- Part 6. Forged cobalt-nickel-chromium-molybdenum alloy;
- Part 7. Wrought and cold worked cobalt-chromium-nickel-molybdenum-
iron alloy;
- Part 8. Forged cobalt-nickel-chromium-molybdenum-tungsten-iron alloy;
- Part 9. Forged high nitrogen stainless steel;
- Part 10. (preserved);
- Part 11. Forged titanium-6 aluminum-7 thallium alloy;
- Part 12. Forged cobalt-chromium-molybdenum alloy;
- Part 13. (preserved);
- Part 14. Forged titanium 15 molybdenum 5 zirconium 3 aluminum alloy.
This Part is Part 1 of "Implants for surgery - Metallic materials".
This Part was drafted in accordance with the rules given in GB/T 1.1-2009.
This Part replaces GB 4234-2003 "Stainless steel for surgical implants".
Compared with GB 4234-2003, in addition to the editorial modifications, the
main technical changes are as follows.
- deleted the order content, the contents of classification, size, shape,
weight and allowable deviation, inspection rules, packaging, marks and
quality certificate (Clause 3, Clause 4, Clause 5, Clause 8, Clause 9 of
Edition 2003);
- deleted the contents of smelting method, delivery status, surface quality,
special requirements (6.2, 6.3, 6.6, 6.7 of Edition 2003);
- deleted the contents of chemical composition of which the designation is
00Cr18Ni15Mo3N as well as corresponding contents of mechanical
properties (6.1.1, 6.4.1, 6.4.2, 6.4.3 of Edition 2003);
- modified the chemical composition of molybdenum (Mo) (see Table 1 of
this Edition, Table 1 of Edition 2003);
- modified the mechanical properties of bars (see Table 3 of this Edition,
Table 2 of Edition 2003);
- modified the mechanical properties of strip and sheet (see Table 5 of this
Edition, Table 4 of Edition 2003);
- deleted the contents of Annex A, Annex B, Annex C (Annex A, Annex B
and Annex C of Edition 2003).
NOTE. This Part seeks to be consistent with international standards to the greatest extent as
possible. It deleted the contents that are suitable for order contract in Edition 2003.
This Part uses redrafting method to modify and adopt ISO 5832-1.2007
"Implants for surgery - Metallic materials - Part 1. Wrought stainless steel" and
Amendment 1 issued in 2008.
Compared with ISO 5832-1.2007, the main differences in this Part are as
- for the normative references, this Part made adjustments with technical
differences to meet the technical conditions in China; the adjustments are
centrally reflected in Clause 2 "Normative References", as follows.
• replaced ISO 6892 with GB/T 228.1 whose modification used
International standards;
• replaced ISO 377 with GB/T 2975 whose modification used
International standards;
• replaced ISO 404 with GB/T 17505 whose modification used
International standards.
GB/T 228.1, so as to facilitate the standard user in China.
This Part made the following editorial modifications.
- made editorial modifications to the description methods of "specified non-
proportional extension strength" and "elongation after fracture" in Table 3;
Implants for surgery - Metallic materials -
Part 1. Wrought stainless steel
1 Scope
This part of "Implants for surgery - Metallic materials" specifies the
characteristics of, and corresponding test methods for wrought stainless steel
This Part is applicable to wrought stainless steel for use in the manufacture of
surgical implants.
NOTE 1 The mechanical properties of a sample obtained from a finished product made of this
alloy can differ from those specified in this Part.
NOTE 2 The alloy described in this Part corresponds to UNS S31673 referred to in ASTM F
138 [1]/ASTM F 139 [2] and to alloy code 1.4441 given in the withdrawn DIN 17443 [3].
2 Normative references
The following referenced documents are indispensable for the application of
this document. For dated references, only the edition cited applies. For undated
amendments) applies.
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/T 2975, Steel and Steel Products - Location and Preparation of Test
Pieces for Mechanical Testing (GB/T 2975-1998, eqv ISO 377.1997)
GB/T 10561-2005, Steel - Determination of Content of Nonmetallic
Inclusions - Micrographic Method Using Standards Diagrams (ISO
4967.1998, IDT)
GB/T 17505, Steel and steel products General technical delivery
ISO 437, Steel and cast iron - Determination of total carbon content -
Combustion gravimetric method
ISO 439, Steel and iron - Determination of total silicon content - Gravimetric
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