iTeh StandardsiTeh Standards
EURUSD
Your shopping cart is empty.
ASTM

ASTM F1613-95(2008)e1

(Specification)

Standard Specification for Surgical Tissue/Dressing/Pick-Up Forceps (Thumb Type)

Standard Specification for Surgical Tissue/Dressing/Pick-Up Forceps (Thumb Type)

ABSTRACT
This specification covers general workmanship requirements of spring-action, surgical tissue, dressing, or pick-up forceps (thumb type) for use in the retraction, grasping, or dissection of tissue during surgical procedures. However, this specification does not cover delicate tissue forceps such as employed in microsurgery or neurosurgery. The forceps and all component parts shall be manufactured from Class 4 martensitic stainless steel (heat treated), while modified working ends may be manufactured from stellite, tungsten carbide, or other suitable material. The forcep halves shall be symmetrical, with the teeth well formed, uniform in depth and spacing, and mesh without binding, and the surfaces uniformly finished and free of burrs, sharp edges, cracks, coarse marks, and processing materials. In addition, the forceps shall have handle serrations that are uniform in depth and spacing. Tests for hardness and corrosion resistance shall be performed and shall conform to the requirements specified.
SCOPE
1.1 This specification covers general workmanship aspects of spring-action, tissue, dressing, or pick-up forceps (thumb-type) intended for the retraction, grasping, or dissection of tissue during surgical procedures.
1.2 The values stated in inch-pound units are to be regarded as the standard. The values given in parentheses are for information only.

General Information

Status
Historical
Publication Date
31-Jan-2008
ICS
11.040.30 - Surgical instruments and materials
Technical Committee
F04 - Medical and Surgical Materials and Devices
Drafting Committee
F04.33 - Medical/Surgical Instruments
Current Stage
Ref Project

Relations

Replaces
ASTM F1613-95(2008) - Standard Specification for Surgical Tissue/Dressing/Pick-Up Forceps (Thumb Type)
Effective Date
01-Feb-2008

Buy Standard

ASTM F1613-95(2008)e1 - Standard Specification for Surgical Tissue/Dressing/Pick-Up Forceps (Thumb Type)ASTM F1613-95(2008)e1 - Standard Specification for Surgical Tissue/Dressing/Pick-Up Forceps (Thumb Type)
PreviousNext
Technical specification
ASTM F1613-95(2008)e1 - Standard Specification for Surgical Tissue/Dressing/Pick-Up Forceps (Thumb Type)
English language
2 pages
sale 15% off
Preview
sale 15% off
Preview

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
´1
Designation: F1613 −95 (Reapproved2008)
Standard Specification for
Surgical Tissue/Dressing/Pick-Up Forceps (Thumb Type)
This standard is issued under the fixed designation F1613; 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.
´ NOTE—Editorial changes were made throughout in June 2008.
1. Scope 3.1.1 Definitions shall be in accordance with Terminology
F1638.
1.1 This specification covers general workmanship aspects
3.1.2 modified working ends—working surfaces possessing
of spring-action, tissue, dressing, or pick-up forceps (thumb-
superior hardness characteristics that are the result of either
type) intended for the retraction, grasping, or dissection of
depositing various materials on the base metal or securing an
tissue during surgical procedures.
insert permanently (such as by brazing) to the base metal (see
1.2 The values stated in inch-pound units are to be regarded
Note 3).
as the standard. The values given in parentheses are for
information only.
4. Material
4.1 All component parts of the instrument shall be fabri-
2. Referenced Documents
cated from Class 4 martensitic stainless steel in accordance
2.1 ASTM Standards:
with Specification F899.The modified working ends may be of
E18 Test Methods for Rockwell Hardness of Metallic Ma-
stellite, tungsten carbide, or other suitable material.
terials
E92 Test Method forVickers Hardness of Metallic Materials
5. Requirements
(Withdrawn 2010)
E140 Hardness Conversion Tables for Metals Relationship 5.1 Heat Treatment and Hardness for Component Parts:
Among Brinell Hardness, Vickers Hardness, Rockwell 5.1.1 The stainless steel component parts shall be heat
Hardness, Superficial Hardness, Knoop Hardness, and treated under conditions recommended for the material used.
Scleroscope Hardness 5.1.2 The Rockwell hardness (HRC) of the instrument with
F899 Specification for Wrought Stainless Steels for Surgical the working end not modified shall be 40–49 HRC (see Test
Instruments Methods E18) after appropriate processing. Instruments in
F921 Terminology Relating to Hemostatic Forceps which the working end has been modified shall have an HRC
F1026 Specification for General Workmanship and Perfor- of A77.
mance Measurements of Hemostatic Forceps
5.2 Corrosion Resistance—Instrumentsshallbesubjectedto
F1089 Test Method for Corrosion of Surgical Instruments
corrosion tests as specified in Test Method F1089.
F1638 Terminology for Surgical Tissue/Dressing/Pick-Up
5.3 Finish:
Forceps (Thumb-Type)
5.3.1 Surfaces—Surfaces of the instruments shall be uni-
formly finished and free of burrs, sharp edges, cracks, coarse
3. Terminology
marks, and processing materials.
3.1 Definitions:
5.3.2 Type—The finish shall be one of the types specified in
Definitions F921 or as specified by the purchaser.
This specification is under the jurisdiction of ASTM Committee F04 on
5.4 Workmanship:
Medical and Surgical Materials and Devices and is the direct responsibility of
5.4.1 Symmetry—Excluding functional differences, both
Subcommittee F04.33 on Medical/Surgical Instruments.
forceps halves shall be symmetrical.
Current edition approved Feb. 1, 2008. Published March 2008. Originally
approved in 1995. Last previous edition approved in 2002 as F1613 – 95 (2002).
5.4.2 Teeth—Teeth shall be well formed
...

Questions, Comments and Discussion

Ask us and Technical Secretary will try to provide an answer. You can facilitate discussion about the standard in here.

This May Also Interest You

ASTM
ASTM F899-23(Specification)
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 nonconformance 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.

  • Technical specification
    8 pages
    English language
    sale 15% off
  • Technical specification
    8 pages
    English language
    sale 15% off
ASTM
ASTM F2026-23(Specification)
Standard Specification for Polyetheretherketone (PEEK) Polymers for Surgical Implant Applications

ABSTRACT
This specification covers polyetheretherketone (PEEK) polymer in virgin forms as pellets, powder, and so forth. It provides requirements and associated test methods for these thermoplastics when they are to be used in the manufacture of intracorporeal devices such as surgical implants or components of surgical or dental devices. The PEEK polymer in the scope of this specification is a pure semicrystalline homopolymer consisting of phenylene rings connected by ether (E) and carbonyl (or ketone, K) groups along the polymer chain. Its polymeric structure is defined by the repeating unit EEK. As with any material, some characteristics may be altered by the processing techniques (molding, extrusion, machining, assembly, sterilization, and so forth) required for the production of a specific part or device. Therefore, properties of fabricated forms of these polymers shall be evaluated using appropriate test methods such as US Pharmacopeia test (infrared spectroscopy, viscosity measurements, and total heavy metal content (as lead)), and differential scanning calorimetry. Fabricated forms, material or forms containing colorants, fillers, processing aids, or other additives, as well as polymer blends which contain PEEK, or reclaimed materials, are not covered by this specification. The properties which shall be evaluated are the following: density, tensile strength, elongation, flexural strength, flexural modulus, and impact strength. The biocompatibility of PEEK polymers is also detailed.
SCOPE
1.1 This specification covers polyetheretherketone (PEEK) polymer in virgin forms (for example, pellets, granules, powder, filaments used in additive manufacturing) and fabricated forms. It provides requirements and associated test methods for these thermoplastics when they are to be used in the manufacture of intracorporeal devices such as surgical implants or components of surgical or dental devices.  
1.2 The properties included in this specification are those applicable for PEEK polymers only. Indicated properties are for fabricated forms. Materials or forms containing colorants, fillers, processing aids, or other additives, as well as polymer blends which contain PEEK, or reclaimed materials, are not covered by this specification.  
1.3 This specification is designed to recommend physical, chemical, and biological test methods to establish a reasonable level of confidence concerning the performance of virgin PEEK polymers for use in medical implant devices.  
1.4 The values stated in SI units are to be regarded as standard. No other units of measurement are included in this standard.  
1.5 When evaluating material in accordance with this specification, hazardous materials, operations, and equipment may be involved. This standard does not purport to address all of the safety concerns, if any, associated with its use. It is the responsibility of the user of this standard to establish appropriate safety, health, and environmental practices and determine the applicability of regulatory limitations prior to use.  
1.6 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.

  • Technical specification
    5 pages
    English language
    sale 15% off
  • Technical specification
    5 pages
    English language
    sale 15% off
ASTM
ASTM F2066-23(Specification)
Standard Specification for Wrought Titanium-15 Molybdenum Alloy for Surgical Implant Applications (UNS R58150)

ABSTRACT
This specification covers the chemical, mechanical, and metallurgical requirements for wrought titanium-15 molybdenum alloy to be used in the manufacture of surgical implants. The product shall be classified as: strip; sheet; plate; bar; or wire. The heat analysis shall conform to the chemical composition prescribed. Material shall be furnished in the beta annealed condition. Bend tests and tension tests shall be performed to conform to the specified requirements.
SCOPE
1.1 This specification covers the chemical, mechanical, and metallurgical requirements for wrought titanium-15 molybdenum alloy to be used in the manufacture of surgical implants (1).2  
1.2 The values stated in either SI units or inch-pound units are to be regarded separately as standard. The values stated in each system are not necessarily exact equivalents; therefore, to ensure conformance with the standard, each system shall be used independently of each other, and values from the two systems shall not be combined.  
1.3 This standard does not purport to address all of the safety concerns, if any, associated with its use. It is the responsibility of the user of this standard to establish appropriate safety, health, and environmental practices and determine the applicability of regulatory limitations prior to use.  
1.4 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.

  • Technical specification
    6 pages
    English language
    sale 15% off
  • Technical specification
    6 pages
    English language
    sale 15% off
ASTM
ASTM F1325-91(2023)(Specification)
Standard Specification for Stainless Steel Suture Needle Holders—General Workmanship Requirements and Corresponding Test Methods

ABSTRACT
This specification covers general workmanship and test method requirements of stainless steel suture needle holders intended for reuse in surgery. Materials of all component parts shall be fabricated from martensitic stainless steel type 410, 410X, 416, 420A, 420B, 420C, 420F, 420F Mod, and 440B. The material shall be heat treated and shall conform to the specified hardness, corrosion resistance, workmanship, finish, and appearance.
SCOPE
1.1 This specification covers general workmanship aspects of stainless steel suture needle holders intended for reuse in surgery.  
1.2 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.

  • Technical specification
    2 pages
    English language
    sale 15% off
ASTM
ASTM F1840-10(2023)(Terminology)
Standard Terminology for Surgical Suture Needles

ABSTRACT
This terminology covers the general definitions of terms specific to stainless steel surgical suture needles.
SCOPE
1.1 This terminology covers general definitions for surgical needles.  
1.2 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.

  • Standard
    3 pages
    English language
    sale 15% off
ASTM
ASTM F1613-95(2023)(Specification)
Standard Specification for Surgical Tissue/Dressing/Pick-Up Forceps (Thumb Type)

ABSTRACT
This specification covers general workmanship requirements of spring-action, surgical tissue, dressing, or pick-up forceps (thumb type) for use in the retraction, grasping, or dissection of tissue during surgical procedures. However, this specification does not cover delicate tissue forceps such as employed in microsurgery or neurosurgery. The forceps and all component parts shall be manufactured from Class 4 martensitic stainless steel (heat treated), while modified working ends may be manufactured from stellite, tungsten carbide, or other suitable material. The forcep halves shall be symmetrical, with the teeth well formed, uniform in depth and spacing, and mesh without binding, and the surfaces uniformly finished and free of burrs, sharp edges, cracks, coarse marks, and processing materials. In addition, the forceps shall have handle serrations that are uniform in depth and spacing. Tests for hardness and corrosion resistance shall be performed and shall conform to the requirements specified.
SCOPE
1.1 This specification covers general workmanship aspects of spring-action, tissue, dressing, or pick-up forceps (thumb-type) intended for the retraction, grasping, or dissection of tissue during surgical procedures.  
1.2 The values stated in inch-pound units are to be regarded as the standard. The values given in parentheses are for information only.  
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.

  • Technical specification
    2 pages
    English language
    sale 15% off
ASTM
ASTM F3212-16(2023)(Test Method)
Standard Test Method for Coring Testing of Huber Needles

SIGNIFICANCE AND USE
5.1 This test method determines whether Huber needles are designed and manufactured such that they will not produce a core during simulated implantable port access.  
5.2 If a needle produces a core during actual use, leaking of the implantable port may occur. Also, the core may be flushed into the port’s reservoir and subsequently into the patient’s body.
SCOPE
1.1 This test method covers the qualitative measurement of Huber-type needles’ potential to remove septum material during implantable port access (1).2  
1.2 This test method does not address other issues that may include, but are not limited to, force measurement during the perforation/withdrawal, septum integrity, and any safety issues.  
1.3 This standard does not purport to address all of the safety concerns, if any, associated with its use. It is the responsibility of the user of this standard to establish appropriate safety, health, and environmental practices and determine the applicability of regulatory limitations prior to use.  
1.4 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.

  • Standard
    10 pages
    English language
    sale 15% off
ASTM
ASTM F700-93(2022)(Practice)
Standard Practice for Care and Handling of Intracranial Aneurysm Clips and Instruments

SCOPE
1.1 This practice covers recommended procedures for handling of neurosurgical intracranial aneurysm clips and the clip appliers (instruments).  
1.2 This practice is intended to inform hospital receiving personnel, central supply personnel, operating room personnel, and other individuals who will handle intracranial aneurysm clips and the instruments related thereto of recommended care and handling procedures to prevent damage of intracranial aneurysm clips and instruments.  
1.3 Handling and packaging procedures for the product are not a part of this practice and are covered in other practices.  
1.4 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.

  • Standard
    2 pages
    English language
    sale 15% off
ASTM
ASTM F1079-87(2022)(Specification)
Standard Specification for Inserted and Noninserted Surgical Scissors

ABSTRACT
This specification covers the general workmanship aspects of inserted and noninserted 410, 410K, 416, 420, 420A, and 420B martensitic stainless steel scissors intended for reuse in surgery. Inserts should be made of stellite, tungsten carbide, or other suitable materials. The instruments should conform to the required values of corrosion resistance cutting ability, Rockwell hardness, and physical properties after passivation and heat treatment. The products should also have finger rings, joints, cutting edges, pivot screws, and finish that are of the required quality.
SCOPE
1.1 This specification covers general workmanship aspects of inserted and noninserted stainless steel scissors fabricated from stainless steel and intended for reuse in surgery.  
1.2 The following safety hazards caveat pertains only to the test method described in this specification: This standard does not purport to address all of the safety concerns, if any, associated with its use. It is the responsibility of the user of this standard to establish appropriate safety, health, and environmental practices and determine the applicability of regulatory limitations prior to use.  
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.

  • Technical specification
    2 pages
    English language
    sale 15% off
ASTM
ASTM F1026-86(2022)(Specification)
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.  
1.2 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.

  • Technical specification
    2 pages
    English language
    sale 15% off