ASTM F1079-87(2022)
(Specification)Standard Specification for Inserted and Noninserted Surgical Scissors
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.
General Information
- Status
- Published
- Publication Date
- 31-Jan-2022
- Technical Committee
- F04 - Medical and Surgical Materials and Devices
- Drafting Committee
- F04.33 - Medical/Surgical Instruments
Relations
- Effective Date
- 01-Nov-2023
- Effective Date
- 01-Feb-2020
- Effective Date
- 15-Sep-2019
- Effective Date
- 01-Oct-2018
- Effective Date
- 01-Jul-2018
- Effective Date
- 01-Feb-2018
- Effective Date
- 01-Jul-2017
- Effective Date
- 01-Dec-2012
- Effective Date
- 01-Dec-2012
- Effective Date
- 01-Nov-2012
- Effective Date
- 01-Jun-2012
- Effective Date
- 01-Nov-2011
- Effective Date
- 01-Jun-2011
- Effective Date
- 01-Mar-2011
- Effective Date
- 01-Dec-2010
Overview
ASTM F1079-87(2022): Standard Specification for Inserted and Noninserted Surgical Scissors defines the general workmanship and performance criteria for reusable surgical scissors fabricated from martensitic stainless steels. This international standard, developed by ASTM International, ensures that both inserted and noninserted surgical scissors meet stringent requirements for quality, durability, and safety. The specification applies to instruments made from types 410, 410K, 416, 420, 420A, and 420B stainless steels, covering essential properties such as corrosion resistance, hardness, and cutting ability after appropriate manufacturing processes like passivation and heat treatment.
Key Topics
Materials and Construction
- Scissors must be manufactured from specific types of martensitic stainless steels, ensuring consistent mechanical and physical characteristics suitable for surgical applications.
- Inserts, if present, should be made from durable materials such as stellite or tungsten carbide for enhanced cutting performance and longevity.
Mechanical Properties
- Strict Rockwell hardness ranges are defined to ensure durability and maintain sharp edges.
- Components require uniform hardness to guarantee balanced performance and robustness.
Corrosion Resistance
- Stainless steel surgical scissors must undergo corrosion tests and passivation, supporting reusable applications by safeguarding against rust and contamination.
Workmanship and Finish
- Specifications cover precise construction elements, including well-rounded finger rings, smooth joints, uniform cutting edges, and securely set pivot screws.
- All surfaces must be uniformly finished, free from burrs, cracks, and other manufacturing defects.
Performance Testing
- Scissors are subject to rigorous cutting ability tests using specified materials that reflect their intended surgical use.
Applications
ASTM F1079-87(2022) is a critical standard for manufacturers and procurement specialists in the medical device industry, particularly those focusing on surgical instruments. Key applications include:
- Manufacturing Compliance: Provides a benchmark for producing high-quality, reusable surgical scissors that meet international expectations for safety and performance.
- Quality Assurance: Assists hospitals, clinics, and surgical instrument suppliers in sourcing instruments with proven durability and corrosion resistance.
- Regulatory Reference: Acts as a document for inspection and certification bodies to assess whether surgical scissors conform to essential international safety and workmanship criteria.
- Research and Development: Guides the development of new scissor models or material upgrades by defining baseline material properties and durability expectations.
Related Standards
For comprehensive compliance and quality in surgical instruments, users of ASTM F1079-87(2022) should also reference the following related standards:
- ASTM F899: Specification for Wrought Stainless Steels for Surgical Instruments - details material requirements for surgical-grade stainless steel.
- ASTM F1078: Terminology for Surgical Scissors-Inserted and Non-Inserted Blades - provides relevant definitions and descriptive terms used in surgical scissors.
- ASTM F1089: Test Method for Corrosion of Surgical Instruments - contains procedures for evaluating corrosion resistance.
- ASTM E18: Test Methods for Rockwell Hardness of Metallic Materials - specifies procedures for hardness testing.
- ASTM A380: Practice for Cleaning, Descaling, and Passivation of Stainless Steel Parts - outlines processes for ensuring the cleanliness and corrosion resistance of stainless steel instruments.
By adhering to ASTM F1079-87(2022) and its related standards, manufacturers and healthcare providers can ensure the safety, reliability, and repeatable performance of surgical scissors, supporting excellent patient outcomes and long-term instrument value.
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Frequently Asked Questions
ASTM F1079-87(2022) is a technical specification published by ASTM International. Its full title is "Standard Specification for Inserted and Noninserted Surgical Scissors". This standard covers: 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.
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.
ASTM F1079-87(2022) is classified under the following ICS (International Classification for Standards) categories: 11.040.30 - Surgical instruments and materials. The ICS classification helps identify the subject area and facilitates finding related standards.
ASTM F1079-87(2022) has the following relationships with other standards: It is inter standard links to ASTM F899-23, ASTM F899-20, ASTM F899-19, ASTM F1078-10(2018), ASTM E18-18, ASTM F1089-18, ASTM E18-17, ASTM E18-12, ASTM F899-12b, ASTM F899-12a, ASTM F899-12, ASTM E18-11, ASTM F1078-10(2011), ASTM F899-11, ASTM F899-10. Understanding these relationships helps ensure you are using the most current and applicable version of the standard.
ASTM F1079-87(2022) 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:F1079 −87 (Reapproved 2022)
Standard Specification for
Inserted and Noninserted Surgical Scissors
This standard is issued under the fixed designation F1079; 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 F1089 Test Method for Corrosion of Surgical Instruments
1.1 This specification covers general workmanship aspects
3. Terminology
of inserted and noninserted stainless steel scissors fabricated
from stainless steel and intended for reuse in surgery.
3.1 Definitions applicable to surgical scissors shall be in
accordance with Terminology F1078.
1.2 The following safety hazards caveat pertains only to the
test method described in this specification: This standard does
4. Material
not purport to address all of the safety concerns, if any,
associatedwithitsuse.Itistheresponsibilityoftheuserofthis
4.1 All the component parts of the instrument shall be made
standard to establish appropriate safety, health, and environ-
of martensitic stainless steel type 410, 410K, 416, 420, 420A,
mental practices and determine the applicability of regulatory
and 420B in accordance with Specification F899. Inserts shall
limitations prior to use.
be made of stellite or tungsten carbide or other suitable
1.3 This international standard was developed in accor-
material.
dance with internationally recognized principles on standard-
ization established in the Decision on Principles for the
5. Physical Properties
Development of International Standards, Guides and Recom-
5.1 Rockwell Hardness—The Rockwell hardness of the
mendations issued by the World Trade Organization Technical
scissor halves and inserts shall be within the range of 40 HRC
Barriers to Trade (TBT) Committee.
and 58 HRC (approximately equivalent to Vickers hardness
2. Referenced Documents
530 HV and 670 HV). (See Test Methods E18.) Opposite
halves and inserts shall not vary in hardness by more than four
2.1 ASTM Standards:
points on the Rockwell hardness scale (HRC) or equivalent.
A380 Practice for Cleaning, Descaling, and Passivation of
Stainless Steel Parts, Equipment, and Systems
5.2 Passivation—Instruments and instrument components
E18 Test Methods for Rockwell Hardness of Metallic Ma-
shall be passivated after completion of all fabricating and
terials
finishing operations as specified in Practice A380.
E92 Test Methods for Vickers Hardness and Knoop Hard-
5.3 Heat Treatment—The component parts of the instru-
ness of Metallic Materials
ments shall be heat treated under conditions recommended for
E140 Hardness Conversion Tables for Metals Relationship
the material used. Typical heat treatment guidelines and
Among Brinell Hardness, Vickers Hardness, Rockwell
hardness values are given in Specification F899.
Hardness, Superficial Hardness, Knoop Hardness, Sclero-
scope Hardness, and Leeb Hardness
6. Performance Requirements
F899 Specification for Wrought Stainless Steels for Surgical
Instruments
6.1 Corrosion Resistance—Instruments or instrument com-
F1078 Terminology for Surgical Scissors—Inserted and
ponents shall be subject to corrosion tests specified in Test
Non-Inserted Blades
Method F1089.
6.2 CuttingAbility—The test material shall comply with the
This specification is under the jurisdiction of ASTM Committee F04 on
materialspecifiedinTable1,Table2,orTable3.Cleanscissors
Medical and Surgical Materials and Devices and is the direct responsibility of
tobetestedpriortotesting.Performthreeseparate,consecutive
Subcommittee F04.33 on Medical/Surgical Instruments.
tests with each scissors. Each test shall consist of a nonstop cut
Current edition approved Feb. 1, 2022. Published February 2022. Originally
along the distal two-thirds of the blade length using the test
approved in 1987. Last previous edition approved in 2014 as F1079 – 87 (2014).
DOI: 10.1520/F1079-87R22.
material at right angles to the threads (if present) of the
For referenced ASTM standards, visit the ASTM website, w
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