Specification

NF S94-080-1

January 1997

AFNOR
Association Française de Normalisation
www.afnor.fr

S94-080-1

Surgical implants
Titanium alloy TA6V

Part 1: bars and rods

Any total or partial reproduction or Printed by the AFNOR on the

representation by any means of the 8 March 2002
pages published in this document,
made without the authorisation of for
the editor is illegal and a
BOSTON SCIENTIFIC INTERNATIONAL
counterfeit. Only the following is
authorised: reproductions destined
for the sole private use of the copier with the authorisation of the Editor
and not destined for a collective use,
and also analyses and short citations
justified by the scientific character
or information of the work in which
they are incorporated (French Law
dated 1st July 1992 – art. L 122-4
and L 122-5 and Penal code art.
425).
 NF S 94-080-1
January 1997
French specifications
Classification index: S 94-080-1

ICS: 11.040.40

Surgical implants
Titanium alloy TA6V

Part 1: Bars and rods

E: Surgical implants – Titanium alloy Ti 6 Al 4v – Part 1: Bars and rods

D: Chirurgische Implantate – Ti/Al-6/V-4-Titanlegierung – Teil 1_ Stäbe
und Stangen

French specification homologated

by decision of the General Director of the AFNOR on the 5 December 1996

to take effect on the 5 January 1997.

Replaces the experimental specification with the same index dated October
1994.

Cross reference

At the date of publication of this document, there is no European or

international works on the same subject.

Analysis This document defines the characteristics of bars and rods in titanium alloy
for surgical implant.

Describers Thesaurus International Technique: surgical implant, metal product,

titanium alloy, metal bar, metal rod, characteristic, chemical composition,
size, size tolerance, surface condition, control tests, assay, ultrasound control
test.

Modifications Relative to the document replaced, change of status, editorial modifications

and addition of paragraph 6.3 Ultrasound control test.

Corrections

Edited and distributed by the Association Française de Normalisation (AFNOR), Tour Europe 92049 Paris La Défense Cedex
Tel.: 01 42 91 55 55 – International tel.: +33 1 42 91 55 55

1st print 97-01-F

Metal materials for surgical implants

AFNOR S93Q

Members of the normalisation commission

President: Mrs. Duclerget

Secretariat: Mrs. De Grandis – AFNOR

MR. AURELLE SERF

MR. BENHAMOUDA LNE
MR. BERMOND GROUPE LEPINE
MR. BLANQUAERT LES LABORATOIRES OSTEAL MEDICAL
MR. CARENTZ DIMSO STRYKER FRANCE SARL
MR. DEPOISER LABORATOIRES BOUDET ET DUSSAIX
MRS. DUCLERGET LNE
MR. DUFLOS TECHPY
MS. GRZEGORCZYK CRITT MDTS
MS. GUERARD BENOIT GIRAD ET CIE
MRS. HANNAIRE SNITEM
MR. LASSALLE MAURICE MARLE SA
MR. MALLARD CEDIOR
MR. MALOCHET WICHARD SA
MR. MARGERIT TORNIER
MR. PEROT AUBERT & DUVAL SA
MR. RAILLE SMITH AND NEPHEW RICHARDS FRANCE
MS. SIFFERLEN SOFAMOR DANEK SNC
MR. SOUMIREU FORECREU SA
 1 Field of application

This document specifies the characteristics and test methods corresponding to the products to be
forged or machined in titanium alloy, elaborated in the form of bars or rods (alloy TA6V), used for the
manufacture of surgical implants.

2 Specification references

This document includes by dated or non dated reference provisions from other publications. These
specification references are cited in the appropriate sections in the text and the publications are listed
below. For the dated references, later amendments or reviews of any of these publications only apply
to this document if they have been incorporated by amendment or review. For the non dated
references, the last edition of the publication referred to applies.

NF EN 10002-1 Metal materials – Traction test – Part 1: Test method (at room temperature)
(classification index: A 03-001).
NF A 06-931 Steel and cast iron – Total carbon assay – Infrared absorption method after
combustion in an induction oven.
NF A 06-650 Titanium and titanium alloys chemical analysis – Hydrogen assay.
NF A 06-651 Titanium and titanium alloys chemical analysis – Oxygen assay.
NF A 06-652 Titanium and titanium alloys chemical analysis – Aluminium in Ti-Al-V alloys
assay – Volumetric EDTA method.
NF A 06-653 Titanium and titanium alloys chemical analysis – Iron assay – Molecular
absorption spectrometry method.
NF A 06-654 Titanium and titanium alloys chemical analysis – Nitrogen assay – Volumetric
method.
NF A 06-656 Titanium and titanium alloys chemical analysis – Vanadium in Ti-Al-V alloys
assay – Volumetric method.
NF A 08-650 Titanium and titanium alloys chemical analysis – Aluminium, vanadium and iron
elements in TA6Vgrade alloys – Flame Atomic absorption spectrometry or plasma
emission spectrometry method.
E 05-015 State of the surface of the products – Prescriptions – Part 1: Generalities,
terminology, and definitions.
ETTC 2 Standard microstructures for titanium  +  alloys – European Titanium Producers
Technical Commission.
ETTC 5 Definition of a standard aeronautic quality (STQ) and the quality disks (DQ) for
titanium alloys - European Titanium Producers Technical Commission.
ETTC 6 Titanium and titanium alloy scraps treated for recycling – European Titanium
Producers Technical Commission.
ETTC 7 Regulations for the ultrasound control testing of titanium and titanium allow half-
products – European Titanium Producers Technical Commission.
ETTC 8 Titanium and titanium alloy metallography –European Titanium Producers
Technical Commission.

3 Definitions

For the requirements of this document, the following definitions apply:

3.1 bars

Products with a diameter less than or equal to 100 mm.

3.2 rods

Products with a diameter greater than 100 mm.

 4 Raw materials

The sponge, master alloys, addition elements and recycling materials sources must be certified by the
ingot manufacturer. The recycling of scraps and chips is authorised in accordance with document
ETTC 6.

5 Elaboration of the material

The elaboration of the material must comply with the requirements of document ETTC 5, standard
quality.

6 Reception characteristics

The reception characteristics must comply with table 1.

NOTE: The specifications of the ISO 5832-3 specifications comply with the corresponding
specifications in table 1.

Table 1

1 Raw materials and elaboration (see articles 4 and 5)

2 Chemical compositions Element (%) Al C Fe H 1) N O V Ti
min 5.5 3.5 Balance
max 6.75 0.08 0.3 0.015 2) 0.05 0.2 4.5
3 Shape Products for forging Products for machining
4 Dimensions   100 mm   100 mm  > 100 mm
5 Normal delivery condition Hot-rolled or forged, machined, dipped Hot-rolled or Forged, machined,
forged, dipped
machined,
dipped
6 Tests and examinations to be carried out on Normal delivery condition
7 Micrograph ETTC 2 A1  A9 A1  A9 B1  B15
Absence of visible inclusions at x 200
8 Room temperature traction
Sample longitudinal direction longitudinal cross direction
direction
At half radius when the diameter of the product allows it
Characteristics
Rm > 860 MPa
Re0.2% > 780 Mpa
A% > 10 %
Z > 25 %
9  transformation point Metallographic method (article 4 of ETTC 8) or DTA method (Differential thermal
analysis) or calculation formula
10 Dimensional control See paragraph 6.1
11 Surface examination See paragraph 6.2
12 Ultrasound control test See paragraph 6.3
1) On finished product, at 5 mm of the surface when the diameter of the product allows it.
2) Except for rods, for which the maximum hydrogen content must be 0.01%
6.1 Dimension control tests

The following control tests must be carried, unless there are special indications on the order:

a) Diameter tolerance

They must comply with table 2.

Table 2

Dimensions in millimetres

Diameter Tolerance
9 <   18 + 0.2
0
18 <   30 + 0.2
0
30 <   50 + 0.6
0
50 <   80 + 0.7
0
80 <   120 + 0.9
0
120 <   250 +1
0
250   +4
0

b) Tolerance on the length

For the products ordered in unit or multiple lengths, the tolerance must be stated on the order.

c) Dressing-off tolerances

The maximum slag must be less than 2 mm per meter of the bar and less than 0.12 % of the total
length of the bar.

d) Shape tolerance

Local retouching is authorised on conditional that the depth does not exceed 3 % of the diameter. The
retouching must be open ended in shape, length 10 times to 20 times the depth of the retouched zone.
6.2 Examination of the surface for the products destined for forging

The average roughness values measured must comply with table 3.

Table 3

Diameter Ra Rt
(mm) (m) (m)
  50 Ra  1.6 Rt  12.5
50 <   100 Ra  3.2 Rt  16
 > 100 Ra  6.4 Rt  32

6.3 Ultrasound control test

The ultrasound control test must be carried out according to the instructions in document ETTC 7, and
in accordance with the client for products of a thickness less than or equal to 12 mm.

7 Test methods

The test methods to be used for the determination of the compliance with the specifications of this
document must be those given in table 4.

Table 4

Specification Article concerned Test method

Raw materials 4 ETTC 6
Elaboration 5 ETTC 5
Chemical composition Table 1.2 Al: NF A 08-650 or NF A 06-652
Fe: NF A 08-650 or NF A 06-653
H: NF A 08-650
N: NF A 08-654
O: NF A 08-651
V: NF A 08-650 or NF A 06-656

NOTE: Concerning the element C, a specification is being

written; in the meantime the methodology of specification NF A
06-391 may be used
Micrograph Table 1.7 ETTC 2
Traction Table 1.8 NF EN 10002-1

 transformation point Table 1.9 ETTC 8

Surface examination Table 1.11 E 05-015

Ultrasound control test Table 1.12 ETTC 7