ASTM F899-20
(Specification)Standard Specification for Wrought Stainless Steels for Surgical Instruments
Standard Specification for Wrought Stainless Steels for Surgical Instruments
ABSTRACT
This specification covers the chemical requirements for wrought stainless steels used for the manufacture of surgical instruments. Classes of stainless steels covered here are Class 3 (austenitic stainless steel), Class 4 (martensitic stainless steel), Class 5 (precipitation hardening stainless steel), and Class 6 (ferritic stainless steel). The data contained in this specification, such as typical hardness values, common heat treating cycles, and examples of selected stainless steels that have been used for surgical instruments, are provided for reference only. Mechanical property, heat treatment, hardness, and all other requirements except for chemical composition, are governed by the appropriate material standards as specified or as agreed upon between purchaser and supplier.
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 treating requirements, hardness requirements, and all other requirements 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 non-conformance with the standard.
1.3 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.
General Information
Relations
Buy Standard
Standards Content (Sample)
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.
Designation:F899 −20
Standard Specification for
1
Wrought Stainless Steels for Surgical Instruments
ThisstandardisissuedunderthefixeddesignationF899;thenumberimmediatelyfollowingthedesignationindicatestheyearoforiginal
adoption or, in the case of revision, the year of last revision.Anumber in parentheses indicates the year of last reapproval.Asuperscript
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* A480/A480M Specification for General Requirements for
Flat-Rolled Stainless and Heat-Resisting Steel Plate,
1.1 This specification covers the chemistry requirements for
Sheet, and Strip
wrought stainless steels used for the manufacture of surgical
A484/A484M Specification for General Requirements for
instruments. The data contained in Tables 1-4 of this
Stainless Steel Bars, Billets, and Forgings
specification, including typical hardness values, common heat
A555/A555M Specification for General Requirements for
treating cycles, and examples of selected stainless steels that
Stainless Steel Wire and Wire Rods
have been used for surgical instruments, is provided for
A564/A564M Specification for Hot-Rolled and Cold-
reference only. Mechanical property requirements, heat treat-
Finished Age-Hardening Stainless Steel Bars and Shapes
ing requirements, hardness requirements, and all other require-
A582/A582M Specification for Free-Machining Stainless
ments except chemistry are governed by the appropriate
Steel Bars
material standards as referenced below or as agreed upon
A751 Test Methods, Practices, and Terminology for Chemi-
between the purchaser and supplier.
cal Analysis of Steel Products
1.2 The SI units in this standard are the primary units. The 3
2.2 ISO Standards:
values stated in either primary SI units or secondary inch-
ISO 7153-1 Surgical Instruments – Materials – Part 1: Met-
pound units are to be regarded separately as standard. The
als
values stated in each system may not be exact equivalents;
ISO 9001 Quality Management Systems—Requirements
therefore, each system shall be used independently of each
other. Combining values from the two systems may result in
3. Classification and Type
non-conformance with the standard.
3.1 Classes—Stainless steel material requirements for sur-
1.3 This international standard was developed in accor-
gicalinstrumentsshallconformtooneofthefollowingclasses,
dance with internationally recognized principles on standard-
as specified:
ization established in the Decision on Principles for the
3.1.1 Class 3—Austenitic Stainless Steel.
Development of International Standards, Guides and Recom-
3.1.2 Class 4—Martensitic Stainless Steel.
mendations issued by the World Trade Organization Technical
3.1.3 Class 5—Precipitation Hardening Stainless Steel.
Barriers to Trade (TBT) Committee.
3.1.4 Class 6—Ferritic Stainless Steel.
3.2 Type—Where applicable, the commercially recognized
2. Referenced Documents
type of stainless steel is included in Tables 5 and 6.
2
2.1 ASTM Standards:
A276 Specification for Stainless Steel Bars and Shapes
4. Ordering Information
A313/A313M Specification for Stainless Steel Spring Wire
4.1 Inquiries and orders for material under this specification
A314 Specification for Stainless Steel Billets and Bars for
shall include the following information as agreed upon by the
Forging
purchaser and supplier:
4.1.1 Quantity (weight or number of pieces),
4.1.2 Classification, optional,
1
This specification is under the jurisdiction of ASTM Committee F04 on
4.1.3 Type,
Medical and Surgical Materials and Devices and is the direct responsibility of
Subcommittee F04.12 on Metallurgical Materials.
4.1.4 Form,
Current edition approved Feb. 1, 2020. Published March 2020. Originally
4.1.5 Condition (see 5.1),
approved in 1984. Last previous edition approved in 2019 as F899 – 19. DOI:
4.1.6 Finish (see 5.3),
10.1520/F0899-20.
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
3
Standards volume information, refer to the standard’s Document Summary page on Available fromAmerican National Standards Institute (ANSI), 25 W. 43rd St.,
the ASTM website. 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
1
---------------------- Page: 1 ----------------------
F899−20
TABLE 1 Typical Maximum Hardness for Selected Class 4
7. Chemical Requirements
A
Martensitic Stainless Steels in The
...
This document is not an ASTM standard and is intended only to provide the user of an ASTM standard an indication of what changes have been made to the previous version. Because
it may not be technically possible to adequately depict all changes accurately, ASTM recommends that users consult prior editions as appropriate. In all cases only the current version
of the standard as published by ASTM is to be considered the official document.
Designation: F899 − 19 F899 − 20
Standard Specification for
1
Wrought Stainless Steels for Surgical Instruments
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 treating requirements, hardness requirements, and all other requirements 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 non-conformance with the
standard.
1.3 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.
2. Referenced Documents
2
2.1 ASTM Standards:
A276 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, 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, Practices, and Terminology for Chemical Analysis of Steel Products
3
2.2 ISO Standards:
ISO 7153-1 Surgical instrumentsInstruments – Materials – Part 1: Metals
ISO 9001 Quality Management Systems—Requirements
3. Classification and Type
3.1 Classes—Stainless steel material requirements for surgical 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.
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 Sept. 15, 2019Feb. 1, 2020. Published October 2019March 2020. Originally approved in 1984. Last previous edition approved in 20122019 as
F899 – 12b.F899 – 19. DOI: 10.1520/F0899-19.10.1520/F0899-20.
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
1
---------------------- Page: 1 ----------------------
F899 − 20
TABLE 1 Typical Maximum Hardness for Selected Class 4
A
Martensitic Stainless Steels in The Annealed Condition
Typical Maximum
Type
B
Brinell Hardness
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
A
Exclude
...
NOTICE: This standard has either been superseded and replaced by a new version or withdrawn.
Contact ASTM International (www.astm.org) for the latest information
Designation: F899 − 20
Standard Specification for
1
Wrought Stainless Steels for Surgical Instruments
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* A480/A480M Specification for General Requirements for
Flat-Rolled Stainless and Heat-Resisting Steel Plate,
1.1 This specification covers the chemistry requirements for
Sheet, and Strip
wrought stainless steels used for the manufacture of surgical
A484/A484M Specification for General Requirements for
instruments. The data contained in Tables 1-4 of this
Stainless Steel Bars, Billets, and Forgings
specification, including typical hardness values, common heat
A555/A555M Specification for General Requirements for
treating cycles, and examples of selected stainless steels that
Stainless Steel Wire and Wire Rods
have been used for surgical instruments, is provided for
A564/A564M Specification for Hot-Rolled and Cold-
reference only. Mechanical property requirements, heat treat-
Finished Age-Hardening Stainless Steel Bars and Shapes
ing requirements, hardness requirements, and all other require-
A582/A582M Specification for Free-Machining Stainless
ments except chemistry are governed by the appropriate
Steel Bars
material standards as referenced below or as agreed upon
A751 Test Methods, Practices, and Terminology for Chemi-
between the purchaser and supplier.
cal Analysis of Steel Products
1.2 The SI units in this standard are the primary units. The 3
2.2 ISO Standards:
values stated in either primary SI units or secondary inch-
ISO 7153-1 Surgical Instruments – Materials – Part 1: Met-
pound units are to be regarded separately as standard. The
als
values stated in each system may not be exact equivalents;
ISO 9001 Quality Management Systems—Requirements
therefore, each system shall be used independently of each
other. Combining values from the two systems may result in
3. Classification and Type
non-conformance with the standard.
3.1 Classes—Stainless steel material requirements for sur-
1.3 This international standard was developed in accor-
gical instruments shall conform to one of the following classes,
dance with internationally recognized principles on standard-
as specified:
ization established in the Decision on Principles for the
3.1.1 Class 3—Austenitic Stainless Steel.
Development of International Standards, Guides and Recom-
3.1.2 Class 4—Martensitic Stainless Steel.
mendations issued by the World Trade Organization Technical
3.1.3 Class 5—Precipitation Hardening Stainless Steel.
Barriers to Trade (TBT) Committee.
3.1.4 Class 6—Ferritic Stainless Steel.
3.2 Type—Where applicable, the commercially recognized
2. Referenced Documents
type of stainless steel is included in Tables 5 and 6.
2
2.1 ASTM Standards:
A276 Specification for Stainless Steel Bars and Shapes
4. Ordering Information
A313/A313M Specification for Stainless Steel Spring Wire
4.1 Inquiries and orders for material under this specification
A314 Specification for Stainless Steel Billets and Bars for
shall include the following information as agreed upon by the
Forging
purchaser and supplier:
4.1.1 Quantity (weight or number of pieces),
4.1.2 Classification, optional,
1
This specification is under the jurisdiction of ASTM Committee F04 on
4.1.3 Type,
Medical and Surgical Materials and Devices and is the direct responsibility of
Subcommittee F04.12 on Metallurgical Materials.
4.1.4 Form,
Current edition approved Feb. 1, 2020. Published March 2020. Originally
4.1.5 Condition (see 5.1),
approved in 1984. Last previous edition approved in 2019 as F899 – 19. DOI:
4.1.6 Finish (see 5.3),
10.1520/F0899-20.
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
3
Standards volume information, refer to the standard’s Document Summary page on Available from American National Standards Institute (ANSI), 25 W. 43rd St.,
the ASTM website. 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
1
---------------------- Page: 1 ----------------------
F899 − 20
TABLE 1 Typical Maximum Hardness for Selected Class 4
7. Chemical Requirements
A
Martensitic Stainless Steels in The Annealed Condition
7.1 The heat analysis shall conform to the requirements as
Typical Maximum
Type
B
t
...
Questions, Comments and Discussion
Ask us and Technical Secretary will try to provide an answer. You can facilitate discussion about the standard in here.