ISO 10334-1994 PDF

Full title and description

ISO 10334:1994 — Implants for surgery — Malleable wires for use as sutures and other surgical applications. The standard specifies nominal dimensions, required mechanical properties and the test methods to verify those properties for malleable wires intended for surgical implant use.

Abstract

This International Standard defines dimensions and mechanical property requirements (tensile strength, elongation, resistance to damage in bending and in torsion) for malleable implant wires used as sutures and in other surgical applications, and gives the test methods to be used. Surface finish is explicitly not covered by the document.

General information

• Status: Published (International Standard — confirmed in ISO systematic review).
• Publication date: August 1994 (Edition 1, 1994-08).
• Publisher: International Organization for Standardization (ISO).
• ICS / categories: 11.040.40 (Implants for surgery, prosthetics and orthotics).
• Edition / version: Edition 1 (1994).
• Number of pages: 4 pages.

Key bibliographic and status details above are taken from the ISO bibliographic record for ISO 10334:1994 (the publication was last reviewed and confirmed in 2022).

Scope

ISO 10334:1994 applies to malleable metallic wires intended for implantation and for use as sutures or in similar surgical applications. It specifies nominal sizes and dimensional tolerances where applicable, defines required mechanical properties (tensile strength, elongation) and criteria for resistance to damage from bending and torsion, and gives the corresponding test methods to assess compliance. Surface finish and detailed finished-device design requirements are outside the scope.

Key topics and requirements

• Specified nominal dimensions and dimensional tolerances for malleable implant wires.
• Mechanical property requirements: tensile strength and elongation limits.
• Requirements and acceptance criteria for resistance to damage when subjected to bending and to torsion.
• Standardized test methods to determine tensile properties and to assess bending/torsion damage resistance.
• Notes on exclusions: surface finish and finished-device design are not covered by this standard.

Typical use and users

Manufacturers and suppliers of implantable malleable wire (suture-wire manufacturers), medical-device designers, surgical-device manufacturers, independent testing and quality laboratories, and regulatory or conformity-assessment bodies consult ISO 10334 when specifying or verifying mechanical characteristics of implant wires used in surgical applications.

Related standards

ISO 10334 is part of the ISO/TC 150 (Implants for surgery) body of work; it is complementary to other standards that cover implant metallic materials and device-level requirements (for example, the ISO 5832 series on metallic materials for surgical implants). For device-level quality and regulatory processes, standards such as ISO 13485 (medical device quality management) and ISO 14971 (medical device risk management) are commonly used alongside material/type standards.

Keywords

ISO 10334, malleable wire, suture wire, implant wire, implants for surgery, tensile strength, elongation, bending resistance, torsion resistance, test methods, ISO/TC 150.

FAQ

Q: What is this standard?

A: ISO 10334:1994 is an International Standard titled "Implants for surgery — Malleable wires for use as sutures and other surgical applications" that sets dimensional and mechanical-property requirements and associated test methods for implantable malleable wires.

Q: What does it cover?

A: It covers nominal dimensions, tensile strength and elongation requirements, and resistance to damage in bending and torsion, together with prescribed test methods. It does not cover surface finish or finished-device design.

Q: Who typically uses it?

A: Suture- and implant-wire manufacturers, medical-device designers, testing laboratories, purchasers of implantable wire products, and regulators or conformity-assessment bodies use it to specify and verify material and mechanical requirements for malleable implant wires.

Q: Is it current or superseded?

A: The ISO bibliographic record shows ISO 10334:1994 as published in August 1994 and the publication was reviewed and confirmed in ISO's systematic review process in 2022, so this edition remains the current (confirmed) version in ISO's catalogue. Users should check national adoption or amendment notices for local status if required.

Q: Is it part of a series?

A: It is part of ISO's work on "Implants for surgery" (ISO/TC 150). Related documents addressing implant materials include the ISO 5832 series (metallic materials for surgical implants); ISO 10334 itself is a narrow, product-specific standard within that broader technical committee scope.

Q: What are the key keywords?

A: Malleable wire, implant wire, suture, tensile strength, elongation, bending resistance, torsion, test method, implants for surgery, ISO 10334.