ASTM F899 - 23

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Designation: F899 −23
Standard Speciﬁcation for
Wrought Stainless Steels for Surgical Instruments
1
This standard is issued under the ﬁxed designation F899; the number immediately following the designation indicates the year of original
adoption or, in the case of revision, the year of last revision. A number in parentheses indicates the year of last reapproval. A superscript
epsilon (´) indicates an editorial change since the last revision or reapproval.
This standard has been approved for use by agencies of the U.S. Department of Defense.
1. Scope*
1.1 This speciﬁcation covers the chemistry requirements for
wrought stainless steels used for the manufacture of surgical
instruments. The data contained in Tables 1-4 of this
speciﬁcation, including typical hardness values, common heat
treating cycles, and examples of selected stainless steels that
have been used for surgical instruments, is provided for
reference only. Mechanical property requirements, heat treat-
ing requirements, hardness requirements, and all other require-
ments except chemistry are governed by the appropriate
material standards as referenced below or as agreed upon
between the purchaser and supplier.
1.2 The SI units in this standard are the primary units. The
values stated in either primary SI units or secondary inch-
pound units are to be regarded separately as standard. The
values stated in each system may not be exact equivalents;
therefore, each system shall be used independently of each
other. Combining values from the two systems may result in
nonconformance with the standard.
1.3 This international standard was developed in accor-
dance with internationally recognized principles on standard-
ization established in the Decision on Principles for the
Development of International Standards, Guides and Recom-
mendations issued by the World Trade Organization Technical
Barriers to Trade (TBT) Committee.
2. Referenced Documents
2.1 ASTM Standards:
2
A276/A276M Speciﬁcation for Stainless Steel Bars and
Shapes
A313/A313M Speciﬁcation for Stainless Steel Spring Wire
A314 Speciﬁcation for Stainless Steel Billets and Bars for
Forging
A480/A480M Speciﬁcation for General Requirements for
Flat-Rolled Stainless and Heat-Resisting Steel Plate,
Sheet, and Strip
A484/A484M Speciﬁcation for General Requirements for
Stainless Steel Bars, Billets, Shapes, and Forgings
A555/A555M Speciﬁcation for General Requirements for
Stainless Steel Wire and Wire Rods
A564/A564M Speciﬁcation for Hot-Rolled and Cold-
Finished Age-Hardening Stainless Steel Bars and Shapes
A582/A582M Speciﬁcation for Free-Machining Stainless
Steel Bars
A751 Test Methods and Practices for Chemical Analysis of
Steel Products
2.2 ISO Standards:
3
ISO 7153-1 Surgical Instruments—Materials—Part 1: Met-
als
ISO 9001 Quality Management Systems—Requirements
3. Classiﬁcation and Type
3.1 Classes—Stainless steel material requirements for sur-
gical instruments shall conform to one of the following classes,
as speciﬁed:
3.1.1 Class 3—Austenitic Stainless Steel.
3.1.2 Class 4—Martensitic Stainless Steel.
3.1.3 Class 5—Precipitation Hardening Stainless Steel.
3.1.4 Class 6—Ferritic Stainless Steel.
3.2 Type—Where applicable, the commercially recognized
type of stainless steel is included in Tables 5 and 6.
4. Ordering Information
4.1 Inquiries and orders for material under this speciﬁcation
shall include the following information as agreed upon by the
purchaser and supplier:
4.1.1 Quantity (weight or number of pieces),
4.1.2 Classiﬁcation, optional,
4.1.3 Type,
4.1.4 Form,
4.1.5 Condition (see 5.1),
4.1.6 Finish (see 5.3),
1
This speciﬁcation is under the jurisdiction of ASTM Committee F04 on
Medical and Surgical Materials and Devices and is the direct responsibility of
Subcommittee F04.12 on Metallurgical Materials.
Current edition approved Nov. 1, 2023. Published November 2023. Originally
approved in 1984. Last previous edition approved in 2020 as F899 – 20. DOI:
10.1520/F0899-23.
2
For referenced ASTM standards, visit the ASTM website, www.astm.org, or
contact ASTM Customer Service at service@astm.org. For Annual Book of ASTM
Standards volume information, refer to the standard’s Document Summary page on
the ASTM website.
3
Available from American National Standards Institute (ANSI), 25 W. 43rd St.,
4th Floor, New York, NY 10036, http://www.ansi.org.
*A Summary of Changes section appears at the end of this standard
Copyright © ASTM International, 100 Barr Harbor Drive, PO Box C700, West Conshohocken, PA 19428-2959. United States
This international standard was developed in accordance with internationally recognized principles on standardization established in the Decision on Principles for the
Development of International Standards, Guides and Recommendations issued by the World Trade Organization Technical Barriers to Trade (TBT) Committee.
1

4.1.7 Mechanical properties or hardness, and
4.1.8 Applicable dimensions, including size, thickness,
width, and length (exact, random, or multiples) or drawing
number.
5. Manufacture
5.1 Condition—Stainless steels shall be furnished to the
purchaser, as speciﬁed, in the hot-ﬁnished, cold-ﬁnished,
annealed, solution-treated, solution-treated and aged, quench-
hardened and tempered, or as speciﬁed by the purchaser. (Note
that highly hardenable martensitic stainless billets and bars
such as Types 420A, 420B, 420C, 420 Mod, 420F, 420F Mod,
440A, 440A Mod, 440B, and 440C intended for forging are
commonly annealed prior to shipment and so speciﬁed in order
to avoid the possibility of thermal cracking. Other hardenable
martensitic grades such as Types 403, 410, 416, 416 Mod, and
431, which also may require annealing, depending on their
composition and size, are furnished suitable for cold cutting
when so speciﬁed on the purchase order.) Type 302PH
(S17710) may be furnished as hot-rolled or hot-formed, cold
drawn or cold drawn, and age-hardened.
5.2 Conditioning—Billet and bar intended for forging may
be conditioned by chipping, grinding, or other suitable means
to remove injurious surface defects.
5.3 Finish—Types of ﬁnish available for bar and wire
products are cold-drawn, pickled, ground, ground and polished,
or as speciﬁed in the purchase order.
6. General Requirements for Delivery
6.1 In addition to the chemistry requirements of this
speciﬁcation, all requirements of the current editions of Speci-
ﬁcations A276/A276M,A313/A313M,A314,A480/A480M,
A484/A484M,A555/A555M,A564/A564M,A582/A582M,
and Test Methods and Practices A751 shall apply where
applicable, as agreed upon between the purchaser and supplier.
6.2 This speciﬁcation complements the applicable ISO
document covering stainless steel for surgical instruments and,
by reference, includes all of the stainless grades in ISO 7153-1.
7. Chemical Requirements
7.1 The heat analysis shall conform to the requirements as
to chemical composition speciﬁed in Tables 5-8.
7.2 Uniﬁed Numbering System (UNS) designations have
been added to Tables 5-8 to provide an easy cross reference to
a common numbering system. In order to ensure consistency in
the materials used for the manufacture of surgical instruments,
compositional limits tighter than typical UNS limits have been
established for certain elements (as denoted by an asterisk). For
example, more restrictive carbon and sulfur limits are speciﬁed
in Table 7.
7.3 The chemical composition requirements for Types 301,
303, 304, 316, 410, 420A, 420B, 420C, and 430F also meet the
composition requirements in ISO 7153-1.
7.4 Methods and practices relating to chemical analysis
required by this speciﬁcation shall be in accordance with Test
Methods and Practices A751.
7.5 The cobalt content of the heat analysis shall be indicated
for information only on the certiﬁcate issued by the manufac-
turer for the materials listed in Tables 5-8.
8. Mechanical Requirements
8.1 Material shall conform to the mechanical property
requirements cited in the appropriate ASTM standards (see 2.1)
or shall meet the mechanical property requirements speciﬁed
by the purchaser.
8.2 When desired, Brinell hardness number (HB), Rockwell
hardness B scale (HRB), or Rockwell hardness C scale (HRC)
limits may be speciﬁed. Typical hardness values for selected
Class 4 martensitic stainless steels in the annealed condition
are listed in Table 1. These typical hardness values are
provided for reference only.
9. Heat Treatment
9.1 Material shall be heat treated per the applicable refer-
enced ASTM standard (see 2.1) for the selected stainless steel.
9.2 Typical hardness values for selected Class 4 martensitic
stainless steels are listed in Table 2 and are provided for
reference only.
9.3 Heat treating guidelines for Class 5 precipitation hard-
ening stainless steels are included in Speciﬁcation A564/
A564M.
9.4 Specifying a hardness requirement appropriate for the
selected alloy and intended application is the responsibility of
the purchaser.
10. Special Information
10.1 Some examples of selected stainless steels that have
been used for various surgical instrument applications are
listed in Table 3 and Table 4 for information purposes.
NOTE 1—Re-sulphurized free-machining grades can exhibit lower
TABLE 1 Typical Maximum Hardness for Selected Class 4
Martensitic Stainless Steels in the Annealed Condition
A
UNS or Type Typical Maximum
Brinell Hardness
B
410 210
410X 220
416 262
416 Mod 262
420A 220
420B 235
420 Mod 255
420X 262
420C 262
420F 262
420F Mod 262
UNS S42027 255
431 285
440A 285
440A Mod 285
440B 285
440C 285
440F 285
UNS S42026 260
UNS S42010 235
UNS S44027 285
A
Excludes billets and bars for forging.
B
Or equivalent Rockwell hardness.
F899 − 23
2

TABLE 2 Typical Heat Treating Cycles and Resultant Hardness Values for Selected Class 4 Martensitic Stainless Steels

UNS or Type Typical Hardening

Temperature

Typical Hardness at Indicated Tempering

Temperature

UNS or Type Typical Hardening

Temperature

Typical Hardness at Indicated

Tempering Temperature

°C °F (HRC) °C °F (HRC)

410 1010 °C [1850 °F] 260 500 43 420F 1038 °C [1900 °F] 149 300 52

371 700 43 204 400 52

482 900

42 260 500 50

538 1000

30 315 600 50

593 1100 24 371 700 49

410X 1024 °C [1875 °F] 260 500 46 427 800

371 700 46/47 420F Mod 1038 °C [1900 °F] 149 300 53

482 900

48 204 400 50

538 1000

44 260 500 48

593 1100 31 315 600 48

416 Mod 982 °C [1800 °F] 149 300 38 371 700 48

260 500 37 427 800

371 700 37 UNS S42026 1050 °C [1920 °F] 204 400 56

482 900

35 260 500 54/55

538 1000

30 315 600 53/54

593 1100 22 431 1038 °C [1900 °F] 260 500 42

416 982 °C [1800 °F] 149 300 41 371 700 42

260 500 39 482 900

371 700 41 593 1100

482 900

36 440A 1038 °C [1900 °F] 149 300 56/57

538 1000

31 204 400 56

593 1100 26 260 500 54

420A 1010 °C [1850 °F] 149 300 53 315 600 51/52

204 400 50 371 700 51

260 500 48 427 800

315 600 48 440A Mod 1080 °C [1976 °F] 149 300 58

371 700 48 204 400 54

427 800

48 260 500 53/54

420B 1038 °C [1900 °F] 149 300 52 315 600 53

204 400 52 371 700 53

260 500 50 427 800

315 600 50 440B 1038 °C [1900 °F] 149 300 58/59

371 700 49 204 400 56/57

427 800

49 260 500 53/54

420 Mod 1010 °C [1850 °F] 177 350 56/57 315 600 53

204 400 55 371 700 54

260 500 54 427 800

420X 1038 °C [1900 °F] 315 600 53 440C 1038 °C [1900 °F] 149 300 60

149 300 52 204 400 59

204 400 52 260 500 57

260 500 50 315 600 56

315 600 50 371 700 56

371 700 49 427 800

427 800

49 440F 1038 °C [1900 °F] 149 300 60

S42010 1038 °C [1900 °F] 204 400 50 204 400 59

260 500 47 260 500 57

316 600

47 315 600 56

371 700 48 371 700 56

454 850 48 427 800

420C 1038 °C [1900 °F] 149 300 58 S42027 1010 °C [1850 °F] 149 300 58/59

204 400 55/56 204 400 57/58

260 500 53/54 260 500 57/58

315 600 53/54 315 600 56/57

371 700 54/55 UNS S44027 1038 °C [1900 °F] 149 300 58

427 800

55 204 400 57

260 500 54

315 600 53

371 700 53

427 800

The temperatures listed are intended to be guides with the ﬁnal heat treat cycle determined by the designer or heat treatment engineer, or both, to meet the intended

use of the device. Time at temperature depends on section size. It is recommended that a controlled heat treating atmosphere be used in accordance with good commercial

practice. Heat treat cycles may use air, oil, or gas for quench.

Temper at least 1 h at the indicated temperature and air cool. Large section sizes require longer times at temperature.

Tempering in the range of 399/566 °C [750 ⁄1050 °F] results in decreased impact strength and reduced corrosion resistance.

Tempering over 427 °C [800 °F] results in reduced corrosion resistance.

Tempering above 316 °C [600 °F] results in reduced toughness.

F899 − 23

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摘要：

ASTM F899-23 是当前最新版的外科器械用不锈钢标准规范，由美国材料与试验协会发布，用于替代旧版本。该标准全面修订了外科植入物、手术器械及医疗器械制造中常用的不锈钢材料（包括马氏体、奥氏体、沉淀硬化型及铁素体不锈钢）的化学成分、力学性能、热处理要求以及供货状态。ASTM F899-23 强调了材料的生物相容性、耐腐蚀性以及加工工艺的稳定性，对医疗设备制造商、原材料供应商及检测机构具有关键指导意义。该标准明确了 17-4 PH、316L、420 等常见牌号的规范要求，并增加了对材料微观洁净

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