ASTM F56-82

Specification for Stainless Steel Sheet and Strip for Surgical Implants (Withdrawn 1989)

General Information

• Status: Withdrawn
• Withdrawal Date: 23-Nov-1989
• ICS: 11.040.40 - Implants for surgery, prosthetics and orthotics
• ICS: 77.140.20 - Stainless steels
• Technical Committee: F04 - Medical and Surgical Materials and Devices
• Drafting Committee: F04.02 - Division II - Orthopaedic Devices

Standards Content (Sample)

ASTM F5b 82 m 0757510 0652433 T m
Designation: F 56 - 82
4cTb
.
AMERICAN SOCIETY FOR TESTING AND MATERIALC
1916 Race St.,Philadelphia, Pa. 19103
Reprinted from the Annual Book of ASFM Standards, Copyright ASTM
if not listed in the current combined index, will appear in the next edition.
Standard Specification for
STAINLESS STEEL SHEET AND STRIP FOR SURGICAL
IMPLANTS'
This standard is issued under the fixed designatiorrF 56; the number immediately following the designationindicatesthe year
of original adoption or, in the we of revision, the year of last revision. A number in parentheses indicates the year of last
reapproval. A superscript epsilon (E) indicatu an editorid change since the las: revision or reapprova1.
4. Ordering information
1. scope
4.1 Inquiries and orders for material under
€.l This specification covers the require-
this specification shall include the following
ments for two compositions of stainless steel
sheet and strip used for the manufacture of information:
4.1.1 Quantity (weight or number of pieces),
surgical implants.
4.1.2 Grade (1 or 2),
NOTE 1-Exposure to temperatures above 8ûû°F
(425OC) during fabrication may impair corrosionre- 4.1.3 ASTM designation,
sistance unless such exposure is followed by a soh-
4.1.4 Form (sheet or strip),
tion-annealing treatment.
4.1.5 Condition (see 5. i),
1.2 The values stated in inch-pound units 4.1.6 Mechanical properties (if applicable,
are to be regarded as the standard. for special conditions),
4.1.7 Finish (see 5.2),
2. Applicable Documents
4.1.8 Applicable dimensions including size,
2.1 ASTM Standards: thickness, width, and length (exact, random,
A 262 Recommended Practices for Detecting multiples) or print number, and
Susceptibility in Intergranular Attack in 4.1.9 Special requirements.
steel'
5. Manufacture
A480 Specification for Genera1 Require-
ments for Deliveryof Flat-Rolled Stainless 5.1 Condition-Sheet and strip shall be fur-
and Heat-Resisting Steel Plate, Sheet, and nished to the implant manufacturer, as speci-
fied, in the annealed or cold-worked condition
Strip2
A 75 1 Methods, Practices, and Definitions (see Table 1).
for Chemical Analysis of Steel Products2 . 5.2 Finish-Types of finish available in sheet
and strip are dull cold-rolled, bright cold-
E 112 Estimating the Average Grain Size of
Metals3 roiled, intermediate polished, general-purpose
2.2 American Society for Quality Control polished, dull satin finish, high luster finish,
mirror fuiish, or as specified in the implant
(ASQC) Standard
Cl-1968 Specifications of General Require- manufacturer's purchase order.
ments for a Quality Program4
' This specification is under the jurisdiction of ASTM
Committee F-4 on Medical and Surgical Materials and De-
3. General Requirements for Delivery
vicesand is the direct responsibiiityof SubcommitteeFO4.02
3.1 In addition to the requirements of this on Resources.
Current editionapprovedMarch 26,1982. PublishedMay
specification, all requirements of the current
1982. ûrighallypublishedas F 56 - 66. Last previous edifion
edition of Specification A 480 shall apply.
F 5: - 16.
Annual Book of ASTM Siandarrls, Part 3.
3.2 In the case where a conflict exists be-
:Annual Book of ASTM Standards, Part 1 I.
tween this standard and those listed in 2. l and
Available from American Society for Quality Control,
2.2, this standard shall take precedence. 161 W. Wisconsin Ave., Milwaukee, Wis. 53203.

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F 56
6. Chemical Requirements Practice E.
9.2 The grain size shall be five or finer when
6.1 The heat analysis shali conform to the
I tested in accordance with Methods E 112.
requirements as to chemical composition spec-
9.2.1 It ise preferred that samples for grain
ified in Table 2.
size determination be selected after the find
6.2 Methods and practices relating to chem-
annealing operation and prior to a final cold-
ical analysis required by this specification shall
working operation. .
be in accordance with Methods A 75 1,
..
9.2.2 If samples are selected after a final
7. MetaUurgical Requirements cold-working operation, transverse specimens
shall be prepared. . ~
7.1 Material shall contain no free ferrite
9.3 Any other special requirements shall be
phase when it is examined metallographically
specified on the purchase order.
at 1ûûX magnification.
10. Certification
8. Mechauical Requirements
10.1 The manufacturer‘s cert5catio.n that
8.1 Material shall conform to the appropri-
the material was manufactured and tested in
ate requirements as to mechanical properties
accordance with this specification togetherwith
specified in Table 1, or shall be specified in the
a report of the test results shall be furnished at
implant manufacturer’s purchase order.
the time of shipment.
8.2 When desired, Rockwell hardness, A
scale (HRA), Rockwell hardness, B scale
11. Quaiity Program Requirements
(HRB) or Rock
...