ASTM F1078-10(2018)
(Terminology)Standard Terminology for Surgical Scissors—Inserted and Non-Inserted Blades
Standard Terminology for Surgical Scissors—Inserted and Non-Inserted Blades
SCOPE
1.1 This terminology defines basic terms and considerations for the components of scissors with either inserted or non-inserted blades (see Fig. 1). Instruments in this terminology are limited to those fabricated having scissor blades made from stainless steel and used for surgical procedures.
FIG. 1 Components of a Scissors (Inserted and Non-Inserted)
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.
General Information
- Status
- Published
- Publication Date
- 30-Sep-2018
- Technical Committee
- F04 - Medical and Surgical Materials and Devices
- Drafting Committee
- F04.33 - Medical/Surgical Instruments
Relations
- Effective Date
- 01-Oct-2018
- Effective Date
- 01-Nov-2023
- Effective Date
- 01-Feb-2020
- Effective Date
- 15-Sep-2019
- Effective Date
- 01-Dec-2012
- Effective Date
- 01-Nov-2012
- Effective Date
- 01-Jun-2012
- Effective Date
- 01-Mar-2011
- Effective Date
- 01-Dec-2010
- Effective Date
- 01-Feb-2009
- Effective Date
- 01-Feb-2009
- Effective Date
- 01-Feb-2008
- Effective Date
- 01-Feb-2008
- Effective Date
- 01-Feb-2007
- Effective Date
- 10-Apr-2002
Overview
ASTM F1078-10(2018), Standard Terminology for Surgical Scissors-Inserted and Non-Inserted Blades, establishes clear terminology for the components and characteristics of surgical scissors designed with either inserted or non-inserted blades. These instruments are fabricated from stainless steel and are intended exclusively for use in surgical procedures.
This terminology standard, developed by ASTM International, provides a framework to ensure consistency and clarity in the design, specification, manufacturing, and procurement of surgical scissors. It supports the global harmonization of medical instrument terminology, contributing to quality, safety, and regulatory compliance.
Key Topics
- Component Definitions: Provides standardized terms for key parts of surgical scissors, including blade, shank, joint, finger rings, proximal and distal ends, as well as top and bottom scissor halves.
- Blade Types: Covers both inserted and non-inserted blade configurations, detailing the differences and components involved.
- Physical Properties: Defines characteristics such as hardness, finish (bright/mirror, satin/matte/black), corrosion, passivation, and blade alignment.
- Critical Features: Explains construction elements like the screw (fastener for joining scissor halves), ride, ride relief, serrations, and chamfer.
- Material Specifications: Specifies the use of stainless steel per ASTM F899, ensuring corrosion resistance and durability in surgical environments.
- Use-Related Considerations: Addresses terms related to performance, such as set (blade positioning for proper cutting action) and tip match-up.
Applications
The ASTM F1078-10(2018) standard holds significant value for the medical device industry, particularly in the design, manufacturing, and quality assurance of surgical scissors. Practical applications include:
- Manufacturing Consistency: Ensures uniformity across surgical scissor designs and eases communication between manufacturers and healthcare providers.
- Procurement and Specification: Assists hospitals, surgical centers, and procurement professionals in identifying and sourcing the appropriate scissors for specific surgical procedures, based on standardized terms.
- Regulatory Compliance: Supports compliance with international medical device regulations by aligning terminology with recognized standards.
- Education and Training: Provides a foundation for training healthcare professionals, instrument technicians, and students on the key components and attributes of surgical scissors.
- Innovation Enablement: While providing defined terminology, the standard does not restrict technological advancements or new product features, fostering continued innovation in surgical instrument design.
Related Standards
For further guidance on surgical instruments and associated materials, consider these related standards:
- ASTM F899: Specification for Wrought Stainless Steels for Surgical Instruments - outlines material requirements for the stainless steel used in medical devices.
- ASTM F1079: Specification for Inserted and Noninserted Surgical Scissors - provides further technical requirements and testing protocols for these instruments.
- ISO 7741: Instruments for Surgery-Scissors and Shears-General Requirements and Testing - an international standard guiding the general requirements and evaluation of surgical scissors.
These documents collectively contribute to the high standards of quality, safety, and interoperability expected in medical and surgical instrument manufacturing.
Keywords: ASTM F1078-10, surgical scissors terminology, inserted blades, non-inserted blades, stainless steel surgical instruments, ASTM medical standards, scissor blade definitions, surgical instrument components, compliance, medical device manufacturing
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Frequently Asked Questions
ASTM F1078-10(2018) is a standard published by ASTM International. Its full title is "Standard Terminology for Surgical Scissors—Inserted and Non-Inserted Blades". This standard covers: SCOPE 1.1 This terminology defines basic terms and considerations for the components of scissors with either inserted or non-inserted blades (see Fig. 1). Instruments in this terminology are limited to those fabricated having scissor blades made from stainless steel and used for surgical procedures. FIG. 1 Components of a Scissors (Inserted and Non-Inserted) 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.
SCOPE 1.1 This terminology defines basic terms and considerations for the components of scissors with either inserted or non-inserted blades (see Fig. 1). Instruments in this terminology are limited to those fabricated having scissor blades made from stainless steel and used for surgical procedures. FIG. 1 Components of a Scissors (Inserted and Non-Inserted) 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.
ASTM F1078-10(2018) is classified under the following ICS (International Classification for Standards) categories: 01.040.11 - Health care technology (Vocabularies); 11.040.30 - Surgical instruments and materials. The ICS classification helps identify the subject area and facilitates finding related standards.
ASTM F1078-10(2018) has the following relationships with other standards: It is inter standard links to ASTM F1078-10(2011), ASTM F899-23, ASTM F899-20, ASTM F899-19, ASTM F899-12b, ASTM F899-12a, ASTM F899-12, ASTM F899-11, ASTM F899-10, ASTM F899-09e1, ASTM F899-09, ASTM F1079-87(2008), ASTM F1079-87(2008)e1, ASTM F899-07, ASTM F899-95. Understanding these relationships helps ensure you are using the most current and applicable version of the standard.
ASTM F1078-10(2018) is available in PDF format for immediate download after purchase. The document can be added to your cart and obtained through the secure checkout process. Digital delivery ensures instant access to the complete standard document.
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: F1078 − 10 (Reapproved 2018)
Standard Terminology for
Surgical Scissors—Inserted and Non-Inserted Blades
This standard is issued under the fixed designation F1078; 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 finger rings—the feature of the scissors that forms the grip-
ping surface for the surgeon (commonly classified as the
1.1 This terminology defines basic terms and considerations
ring-handled feature).
for the components of scissors with either inserted or non-
inserted blades (see Fig. 1). Instruments in this terminology are
joint—the junction where the scissor blades are secured by a
limited to those fabricated having scissor blades made from
screw, allowing the instrument to pivot.
stainless steel and used for surgical procedures.
proximal end—that portion of the instrument that is closest to
1.2 This international standard was developed in accor-
the surgeon when in use.
dance with internationally recognized principles on standard-
ization established in the Decision on Principles for the
ride—the edge which acts as a cam.
Development of International Standards, Guides and Recom-
ride relief—the contoured area between the shank and ride
mendations issued by the World Trade Organization Technical
Barriers to Trade (TBT) Committee.
rounded blade—a blade having a radius on its outer surface
which forms a transition between the outer edge and the
2. Referenced Documents
cutting edges.
2.1 ASTM Standards:
screw—the fastener which joins the scissor halves
F899 Specification for Wrought Stainless Steels for Surgical
Instruments
serrations—corrugations in the cutting edge of the blades.
F1079 Specification for Inserted and Noninserted Surgical
Scissors shank—(1) the part of either scissor half that yields
2.2 ISO Standard: configuration,length,andleverage;(2)thepartofthescissor
ISO 7741 Instruments for Surgery—Scissors and Shears half between the finger ring and joint.
General Requirements, Testing
surgical scissors with inserts—a stainless steel instrument,
available in various sizes and configurations, and used in
3. Terminology
surgical procedures for cutting body tissue, gauze, and
DEFINITIONS OF THE INSTRUMENTS
suture. An instrument of this type has tungsten carbide,
stellite, or other inserts.
blade—the segment that contains the cutting edge which may
be with or without serrations.
top scissor half—the component which contains the screw
head at assembly.
bottom scissor half—the component which contains the
threaded end of the screw.
DEFINITIONS OF PHYSICAL PROPERTIES
OF THE INSTRUMENT
distal end—the working end, comprised of two blades, that is
furthest from the surgeon when in use.
blade alignment—thepositioningofthebladeswithrespectto
tip match-up and blade setting.
ThisterminologyisunderthejurisdictionofASTMCommitteeF04o
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