ASTM F1026-86(2014)

Standard Specification for General Workmanship and Performance Measurements of Hemostatic Forceps

ABSTRACT
This specification covers general workmanship aspects of hemostatic forceps fabricated from stainless steel and intended for reuse in surgery. All of the component parts of the instruments shall be made of martensitic stainless steel of Type 410, 410X, 416, 416MOD, 420A, or 420B. Materials shall be tested and the individual grades shall conform to physical requirements such as heat treatment, hardness, and passivation; performance requirements such as finger rings, jaw serrations and teeth, box lock, clearance, ratchets, jaw and rachet setting, elasticity, and corrosion resistance. Workmanship, finish, and appearance, are also detailed.
SCOPE
1.1 This specification covers general workmanship aspects of hemostatic forceps fabricated from stainless steel and intended for reuse in surgery.

General Information

• Status: Historical
• Publication Date: 30-Sep-2014
• ICS: 11.040.30 - Surgical instruments and materials
• Technical Committee: F04 - Medical and Surgical Materials and Devices
• Drafting Committee: F04.33 - Medical/Surgical Instruments

Standards Content (Sample)

NOTICE: This standard has either been superseded and replaced by a new version or withdrawn.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:F1026 −86 (Reapproved 2014)
Standard Specification for
General Workmanship and Performance Measurements of
1
Hemostatic Forceps
This standard is issued under the fixed designation F1026; 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.
1. Scope 5.1.1 The component parts of the instruments shall be heat
treated under conditions recommended for the material used.
1.1 This specification covers general workmanship aspects
Typical heat treating guidelines and hardness values are given
of hemostatic forceps fabricated from stainless steel and
in Specification F899.
intended for reuse in surgery.
5.1.2 The hardness of all opposing parts of the same
instrument shall not vary in hardness by more than 4 units on
2. Referenced Documents
the Rockwell Hardness C scale (HRC) or equivalent. (See Test
2
2.1 ASTM Standards:
Methods E18.)
E18 Test Methods for Rockwell Hardness of Metallic Ma-
5.2 Passivation—Instruments and instrument components
terials
shall be passivated after completion of all fabricating and
E92 Test Method for Vickers Hardness of Metallic Materials
3
finishing operations.
(Withdrawn 2010)
E140 Hardness Conversion Tables for Metals Relationship
6. Performance Requirements
Among Brinell Hardness, Vickers Hardness, Rockwell
Hardness, Superficial Hardness, Knoop Hardness, Sclero-
6.1 FingerRings—Insidesurfacesshallbewellroundedand
scope Hardness, and Leeb Hardness
polished and shall comply with the requirements in 7.1.
F899 Specification for Wrought Stainless Steels for Surgical
6.2 Jaw Serrations and Teeth—The serrations and teeth
Instruments
shall be of uniform depth and height and well defined to
F921 Terminology Relating to Hemostatic Forceps
provide effective gripping. The serrations and teeth shall
interdigitate. The edges of the serrations shall be chamfered.
3. Terminology
6.3 Box Lock—The hemostatic forceps shall be of box lock
3.1 Definitions applicable to hemostatic forceps shall be in
construction, as defined in Definitions F921. The pin, or other
accordance with Definitions F921.
fastening component, shall be permanently secured. The joint
performance of the box lock shall be smooth, of equal
4. Material
resistance, and non-binding when opening or closing the
4.1 All of the component parts of the instruments shall be
forceps to an included angle of 90 6 5° (the lock may be
made of martensitic stainless steel of Type 410, 410X, 416,
lubricated).
416MOD, 420A, or 420B of Specification F899.
6.4 Clearance—The maximum clearance between the male
5. Physical Requirements
and female members of the forceps in the lock area shall be 0.4
mm (0.015 in.). The clearance is the visible gap that exists
5.1 Heat Treatment and Hardness for Component Parts:
when the instrument is viewed from both the front and side
profile or end view of the instrument (excluding bevel) (see
1 Fig. 1).
This specification is under the jurisdiction of ASTM Committee F04 on
Medical and Surgical Materials and Devices and is the direct responsibility of
6.5 Ratchets—Ratchetsshallsecurelyengageateachratchet
Subcommittee F04.33 on Medical/Surgical Instruments.
position in a smooth and progressive manner.
Current edition approved Oct. 1, 2014. Published November 2014. Originally
ε1
approved in 1986. Last previous edition approved in 2008 as F1026 – 86 (2008) .
6.6 Jaw and Ratchet Setting—The jaw tips shall close and
DOI: 10.1520/F1026-86R14.
2
interdigitate when the first ratchet position is engaged, and
For referenced ASTM standards, visit the ASTM website, www.astm.org, or
contact ASTM Customer Service at [e-mail]. For Annual Book of ASTM
there shall be no visible misalignment of the jaws. The jaws
Standards volume information, refer to the standard’s Document Summary page on
shall progressively tighten with each succeeding ratchet en-
the ASTM website.
3
gagement. Each ratchet position shall hold firmly and release
The last approved version of this historical standard is referenced on
www.astm.org. easily. The jaws shall be fully closed and the serrations
Copyright © ASTM International, 100 Barr Harbor Drive, PO Box C700, West Conshohocken, PA 19428-2959. United States
1

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F1026−86 (2014)
8. Test Methods
8.1 Hardness—Hardness shall be determined in accordance
with Test Methods E18 or Test Method E92. Conversion of
Vickers hardness values to Rockwell values shall be in
accordance with the Conversion Tables in E140.
8.2 Elasticity—The instrument shall have a segment of
basswood, leather strap, or stainless steel wire test material
placed between the jaws at the tip. Th
...

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.
´1
Designation: F1026 − 86 (Reapproved 2008) F1026 − 86 (Reapproved 2014)
Standard Specification for
General Workmanship and Performance Measurements of
1
Hemostatic Forceps
This standard is issued under the fixed designation F1026; 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.
1
ε NOTE—Editorial changes were made throughout in June 2008.
1. Scope
1.1 This specification covers general workmanship aspects of hemostatic forceps fabricated from stainless steel and intended
for reuse in surgery.
2. Referenced Documents
2
2.1 ASTM Standards:
E18 Test Methods for Rockwell Hardness of Metallic Materials
3
E92 Test Method for Vickers Hardness of Metallic Materials (Withdrawn 2010)
E140 Hardness Conversion Tables for Metals Relationship Among Brinell Hardness, Vickers Hardness, Rockwell Hardness,
Superficial Hardness, Knoop Hardness, Scleroscope Hardness, and Leeb Hardness
F899 Specification for Wrought Stainless Steels for Surgical Instruments
F921 Terminology Relating to Hemostatic Forceps
3. Terminology
3.1 Definitions applicable to hemostatic forceps shall be in accordance with Definitions F921.
4. Material
4.1 All of the component parts of the instruments shall be made of martensitic stainless steel of Type 410, 410X, 416, 416MOD,
420A, or 420B of Specification F899.
5. Physical Requirements
5.1 Heat Treatment and Hardness for Component Parts:
5.1.1 The component parts of the instruments shall be heat treated under conditions recommended for the material used. Typical
heat treating guidelines and hardness values are given in Specification F899.
5.1.2 The hardness of all opposing parts of the same instrument shall not vary in hardness by more than 4 units on the Rockwell
Hardness C scale (HRC) or equivalent. (See Test Methods E18.)
5.2 Passivation—Instruments and instrument components shall be passivated after completion of all fabricating and finishing
operations.
6. Performance Requirements
6.1 Finger Rings—Inside surfaces shall be well rounded and polished and shall comply with the requirements in 7.1.
6.2 Jaw Serrations and Teeth—The serrations and teeth shall be of uniform depth and height and well defined to provide
effective gripping. The serrations and teeth shall interdigitate. The edges of the serrations shall be chamfered.
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
F04.33 on Medical/Surgical Instruments.
Current edition approved Feb. 1, 2008Oct. 1, 2014. Published March 2008November 2014. Originally approved in 1986. Last previous edition approved in 20022008 as
ε1
F1026 – 86 (2002).(2008) . DOI: 10.1520/F1026-86R08E01.10.1520/F1026-86R14.
2
For referenced ASTM standards, visit the ASTM website, www.astm.org, or contact ASTM Customer Service at [e-mail]. For Annual Book of ASTM Standards
volume information, refer to the standard’s Document Summary page on the ASTM website.
3
The last approved version of this historical standard is referenced on www.astm.org.
Copyright © ASTM International, 100 Barr Harbor Drive, PO Box C700, West Conshohocken, PA 19428-2959. United States
1

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F1026 − 86 (2014)
6.3 Box Lock—The hemostatic forceps shall be of box lock construction, as defined in Definitions F921. The pin, or other
fastening component, shall be permanently secured. The joint performance of the box lock shall be smooth, of equal resistance,
and non-binding when opening or closing the forceps to an included angle of 90 6 5° (the lock may be lubricated).
6.4 Clearance—The maximum clearance between the male and female members of the forceps in the lock area shall be 0.4 mm
(0.015 in.). The clearance is the visible gap that exists when the instrument is viewed from both the front and side profile or end
view of the instrument (excluding bevel) (see Fig. 1).
6.5 Ratchets—Ratchets shall securely engage at each ratchet position in a smooth and progressive manner.
6.6 Jaw and Ratchet Setting—The jaw tips shall close and interdigitate when the first ratchet position is engaged, and there shall
be no visible misalignment of the jaws. The jaws shall progressively tighten with each succeeding ratchet engagement. Each ratchet
position shall hold firmly and release eas
...