ASTM F2063-18 PDF

Full title and description

ASTM F2063-18 — Standard Specification for Wrought Nickel‑Titanium Shape Memory Alloys for Medical Devices and Surgical Implants. This specification defines the chemical, physical, mechanical and metallurgical requirements for wrought nickel‑titanium (NiTi, Nitinol) mill products — bar, flat rolled products and tubing — intended for use in the manufacture of medical devices and surgical implants.

Abstract

Specifies composition (nominally 54.5 to 57.0 wt% Ni), permitted impurity limits, required melting and processing controls (vacuum or inert‑atmosphere melting), acceptable mill product sizes and surface conditions, and required chemical and physical test methods. Because nickel/titanium contents alone do not guarantee shape‑memory or superelastic performance, the standard requires thermomechanical or calorimetric methods (e.g., transformation‑temperature testing) to verify functional alloy behavior; tensile and elongation properties are specified for annealed mill product.

General information

• Status: Active standard (F2063-18).
• Publication date: 2018 (designated -18; last updated/published in August 2018).
• Publisher: ASTM International (ASTM Committee F04 — Medical and Surgical Materials and Devices).
• ICS / categories: 11.040.30 — Surgical instruments and materials (implants and surgical materials).
• Edition / version: F2063-18 (current edition published 2018).
• Number of pages: 6 pages (compact specification).

Scope

The standard covers wrought nickel‑titanium mill products (bar, flat rolled products and tubing) with nominal nickel content of about 54.5–57.0 wt% intended for the manufacture of medical devices and surgical implants. Requirements apply to mill product sizes typically from approximately 5.50 mm to 94.0 mm (0.218 to 3.70 in.) in diameter or thickness; finished device shapes and final surface finishes are outside the mill‑product scope (finished cold‑worked tube is addressed separately under Specification F2633). The standard provides requirements in both SI and inch‑pound units and specifies recommended analysis and test methods for chemistry, gases and mechanical properties.

Key topics and requirements

• Chemical composition: nominal Ni 54.5–57.0 wt% with defined maximums for carbon, iron, cobalt, copper and other trace elements; titanium balance.
• Melting and cleanliness: vacuum or inert‑atmosphere melting to control metallurgy and chemistry (no intentional alloying additions other than Ni and Ti).
• Transformation / functional verification: because small composition differences affect transformation temperatures and superelastic/shape‑memory behavior, calorimetry or equivalent thermomechanical test methods are required to confirm transformation temperatures (Af, etc.).
• Mechanical properties: tensile strength and elongation requirements for annealed mill product with testing after annealing; different limits for larger cross sections.
• Surface condition and finish: allowable surface conditions include oxidized, descaled, pickled, blasted, machined, ground, mechanically polished or electropolished; surface condition requirements are noted for downstream device processing.
• Analytical/test methods: major elements by spectrometric methods (DCP, ICP, AAS, XRF, GDMS or equivalent); carbon by combustion, hydrogen by inert gas fusion or vacuum hot extraction, and nitrogen/oxygen by inert gas fusion.

Typical use and users

Used by medical device OEMs, implant designers, metal producers and suppliers of NiTi mill product, quality and process engineers, testing laboratories, and regulatory/quality organizations to specify acceptance criteria for NiTi mill stock used to manufacture stents, guidewires, shape‑memory components, and other implantable or surgical devices. It is commonly referenced in material procurement, inspection plans, device design input and supplier quality agreements.

Related standards

Standards commonly referenced with F2063 include ASTM F2633 (finished NiTi cold‑worked tubing specification), test methods for transformation temperature such as ASTM F2082 (thermomechanical/calorimetric methods), and medical device biocompatibility standards (for example, ISO 10993 series) and other ASTM material specifications used in implantable device manufacture. Users should consult the cited references and committee guidance for cross‑references and complementary requirements.

Keywords

NiTi, Nitinol, nickel‑titanium, shape memory alloy, superelastic, medical grade, implantable, mill product, tubing, bar, flat rolled, transformation temperature, Af, calorimetry, ASTM F2063-18.

FAQ

Q: What is this standard?

A: ASTM F2063-18 is a material specification that defines chemical, physical, mechanical and metallurgical requirements for wrought nickel‑titanium mill products used in medical devices and surgical implants.

Q: What does it cover?

A: It covers wrought NiTi bar, flat rolled products and tubing (mill product), including composition limits, impurity controls, melting/processing controls, surface conditions, required analytical and mechanical tests, and procedures to verify transformation behavior. Finished device geometry and final device surface finishes are typically outside the mill‑product scope; finished cold‑worked tube is addressed in F2633.

Q: Who typically uses it?

A: Medical device manufacturers, implant designers, NiTi material suppliers, procurement and quality teams, test laboratories and regulatory reviewers use this specification to ensure consistent, qualifying mill stock for implantable and surgical components.

Q: Is it current or superseded?

A: The -18 edition (F2063-18) is the current ASTM edition published in 2018 and listed as active. Revision activity has been initiated in committee work at times; users should confirm the edition and any recent amendments before procurement or regulatory submission.

Q: Is it part of a series?

A: It is one of several ASTM materials specifications used for implantable/surgical metals and is related to other NiTi and implant material standards (for example ASTM F2633 for finished tubing and test standards for transformation‑temperature measurement). It sits in the ASTM F04 committee portfolio dealing with medical and surgical materials and devices.

Q: What are the key keywords?

A: Nitinol, NiTi, nickel‑titanium, shape memory, superelastic, Af temperature, transformation temperature, medical grade, implant, tubing, bar, flat rolled, ASTM F2063.