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 a universal set of definitions for components and physical characteristics of surgical scissors constructed from stainless steel. Published and maintained by ASTM International, this standard supports consistent communication and quality in the medical device industry. It applies specifically to scissors used for surgical procedures, providing clarity for both inserted and non-inserted blade designs. The terminology is developed according to internationally recognized principles to align with global trade and regulatory requirements.
Key Topics
This standard focuses on terminology central to the manufacture, quality control, and selection of surgical scissors:
- Scissor Components: Defines parts such as blades, finger rings, shanks, joints, screws, proximal and distal ends, and ride features.
- Blade Types: Covers details for both inserted (with materials like tungsten carbide) and non-inserted blades, including features like serrations, rounded edges, and chamfered surfaces.
- Material Specifications: Specifies the exclusive use of stainless steel as per ASTM F899 for the manufacturing of these surgical instruments.
- Physical Properties: Includes definitions covering hardness, finish (bright/mirror, satin/matte, and black), corrosion, passivation, and blade alignment or set.
- Assembly Features: Differentiates between the top and bottom halves of scissors and explains joint and screw connections.
- Terminology Consistency: Enables uniform understanding between manufacturers, clinicians, and regulators.
Applications
ASTM F1078-10(2018) plays a vital role across several aspects of the medical and surgical instruments field:
- Product Design and Manufacturing: Provides manufacturers with clear definitions, ensuring that surgical scissors are produced with consistent component nomenclature and quality.
- Quality Assurance and Inspections: Used as a reference point during device inspection, allowing for uniform assessment of instrument properties and compliance with industry standards.
- Medical Procurement and Specification: Assists healthcare providers and purchasing departments in defining requirements and verifying product claims during procurement.
- Training and Education: Serves as a learning resource for surgical staff and technicians to ensure correct understanding of instrument features and terminology.
- Regulatory Compliance: Supports manufacturers in meeting global trade and compliance requirements as outlined by the World Trade Organization’s Technical Barriers to Trade (TBT) Committee.
- Innovation and Communication: Facilitates clear dialogue about new features or changes in scissor design without ambiguity.
Related Standards
Surgical scissors and related instruments often require compliance with additional ASTM and ISO standards:
- ASTM F899: Specification for Wrought Stainless Steels for Surgical Instruments - defines acceptable stainless steel grades for surgical tool fabrication.
- ASTM F1079: Specification for Inserted and Noninserted Surgical Scissors - covers performance and material requirements.
- ISO 7741: Instruments for Surgery-Scissors and Shears - General Requirements, Testing - provides international guidelines for the requirements and testing methods for surgical scissors.
- WTO TBT Principles: Ensures this terminology aligns with global standardization and regulatory expectations.
Practical Value
Adoption of ASTM F1078-10(2018) enhances product quality, patient safety, and international consistency in surgical scissor terminology and manufacturing. By standardizing definitions and material expectations, this document reduces misunderstandings, accelerates product development cycles, and supports the safe, effective use of surgical tools worldwide.
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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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