GB 4234.1-2017 (GB4234.1-2017) & related versions
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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
follows.
- 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.
- replaced the description of 5.3 "Gauge length" in ISO 5832-1.2007 with
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
for use in the manufacture of surgical implants.
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
references, the latest edition of the referenced document (including any
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
requirements (GB/T 17505-2016, ISO 404.2013, MOD)
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
......
| Standard ID | GB 4234.1-2017 (GB4234.1-2017) | | Description (Translated English) | Implants for surgery -- Metallic materials -- Part 1: Wrought stainless steel | | Sector / Industry | National Standard | | Classification of Chinese Standard | H40 | | Classification of International Standard | 11.040.40 | | Word Count Estimation | 10,179 | | Date of Issue | 2017-12-29 | | Date of Implementation | 2019-07-01 | | Drafting Organization | State Food and Drug Administration Tianjin Medical Device Quality Supervision and Inspection Center | | Administrative Organization | China Food and Drug Administration | | Proposing organization | State Food and Drug Administration | | Issuing agency(ies) | People's Republic of China General Administration of Quality Supervision, Inspection and Quarantine, China National Standardization Administration |
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