GB 4234.1-2017Implants for surgery—Metallic materials—Part 1: Wrought stainless steel (English PDF)

Foreword

This document was drafted in accordance with the provisions of GB/T 1.1-2020

Directives for standardization - Part 1.Rules for the structure and drafting of

standardizing documents.

This document is Part 1 of GB 4234 Implants for surgery - Metallic materials. GB 4234

has already published the following parts.

-- Part 1.Wrought stainless steel;

-- Part 2.Unalloyed titanium;

-- Part 3.Wrought titanium 6-aluminum 4-vanadium alloy;

-- Part 4.Cobalt-chromium-molybdenum casting alloy;

-- Part 7.Forgeable and cold-formed cobalt-chromium-nickel-molybdenum-iron

alloy;

-- Part 9.Wrought high nitrogen stainless steel;

-- Part 11.Wrought titanium 6-aluminium 7-niobium alloy;

-- Part 12.Wrought cobalt-chromium-molybdenum alloy.

This document replaces GB 4234.1-2017 Implants for surgery - Metallic materials -

Part 1.Wrought stainless steel. Compared with GB 4234.1-2017, apart from structural

adjustments and editorial changes, the main technical changes are as follows.

-- The chapter "Terms and definitions" has been added (see Chapter 3);

-- The requirements for silicon (Si) in the chemical composition have been changed,

and the requirements for cobalt (Co) have been added (see Table 1; see Table 1

in the 2017 edition);

-- The requirements for the mechanical properties of the wire have been changed

(see Table 4; see Table 4 in the 2017 edition);

-- The requirements for gauge length of mechanical properties have been changed

(see 6.3; see 5.3 in the 2017 edition);

-- The test methods for carbon (C), silicon (Si), manganese (Mn), sulfur (S), and

phosphorus (P) have been changed (see Table 6; see Table 6 in the 2017 edition).

Implants for surgery - Metallic materials - Part 1.Wrought

stainless steel

1 Scope

This document specifies the performance requirements for wrought stainless steel used

in surgical implants and describes the corresponding test methods.

This document applies to the testing and evaluation of wrought stainless steel materials

used in surgical implants.

NOTE. The alloys described in this document correspond to alloys with UNS number S31673 in ASTM

F138/ASTM F139.

2 Normative references

The provisions of the following documents constitute the essential clauses of this

document through normative references in this text. Among them, for any dated

reference, only the version corresponding to that date applies to this document; for any

undated reference, the latest version (including all amendments) applies to this

document.

GB/T 223(all parts) Iron, steel and alloy

GB/T 228.1-2021 Metallic materials - Tensile testing - Part 1.Method of test at

room temperature (ISO 6892-1.2019, MOD)

NOTE. The content referenced from GB/T 228.1-2021 is not technically different from the content

referenced from ISO 6892-1.2019.

GB/T 2975 Steel and steel products - Location and preparation of samples and test

pieces for mechanical testing (GB/T 2975-2018, ISO 377.2017, MOD)

GB/T 6394 Determination of estimating the average grain size of metal

GB/T 10561-2023 Determination of content of nonmetallic inclusions in steel -

Micrographic method using standard diagrams (ISO 4967.2013, MOD)

GB/T 17505 Steel and steel products - General technical delivery requirements

(GB/T 17505-2016, ISO 404.2013, MOD)

ISO 643 Steel - Micrographic determination of the apparent grain size

3 Terms and definitions

For the purposes of this document, the terms and definitions given in GB/T 228.1-2021

apply.

4 Chemical composition