AS 2320.4-2003 PDF

St AS 2320.4-2003

Name in English:
St AS 2320.4-2003

Name in Russian:
Ст AS 2320.4-2003

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Original standard AS 2320.4-2003 in PDF full version. Additional info + preview on request

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Оригинальный стандарт AS 2320.4-2003 в PDF полная версия. Дополнительная инфо + превью по запросу
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Full title and description

AS 2320.4-2003 — Implants for surgery — Metallic materials — Cobalt-chromium-molybdenum casting alloy. Specifies the required characteristics and corresponding test methods for cobalt‑chromium‑molybdenum casting alloy intended for use in the manufacture of surgical implants. This Australian adoption is identical to ISO 5832‑4:1996.

Abstract

AS 2320.4-2003 defines the material specification and test procedures for a cobalt‑chromium‑molybdenum casting alloy used in surgical implants. The standard sets compositional and performance criteria and references appropriate mechanical and metallurgical test methods to ensure suitability and safety of cast implant components.

General information

  • Status: Published (Australian adoption of the ISO text).
  • Publication date: 01 January 2003.
  • Publisher: Standards Australia.
  • ICS / categories: Implants for surgery / medical metallic materials — ICS 11.040.40 (surgical implants/metallic biomaterials).
  • Edition / version: 2nd edition (AS adoption of ISO 5832‑4:1996).
  • Number of pages: 2 pages (concise technical specification).

Key bibliographic facts above are drawn from the Standards Australia product record and the corresponding ISO entry for the original text.

Scope

This standard applies to cobalt‑chromium‑molybdenum casting alloy intended for surgical implant manufacturing. It specifies the chemical and physical characteristics required of the alloy and the test methods to demonstrate conformity (for example metallurgical examination, mechanical testing and relevant chemical analyses). The scope text follows the ISO adoption used for the Australian standard.

Key topics and requirements

  • Definition and designation of the cobalt‑chromium‑molybdenum casting alloy for implants.
  • Mandatory chemical composition limits and permissible tolerances for alloying elements and impurities.
  • Required mechanical properties and how to measure them (representative test methods for cast material).
  • Microstructure and metallurgical examination criteria relevant to cast implant performance.
  • Corrosion resistance and biocompatibility-related acceptance checks (as applicable to metallic implant materials).
  • Specified sample preparation and testing procedures to verify conformity of production material.

Typical use and users

Primary users are medical device manufacturers (orthopaedic and dental implant producers), materials engineers, metallurgical testing laboratories, regulatory compliance teams, and purchasing/procurement specialists responsible for selecting implant-grade alloys. The standard is used to qualify incoming cast alloy batches and to demonstrate that materials used in implant manufacture meet internationally recognized criteria.

Related standards

AS 2320.4-2003 is the Australian adoption of ISO 5832‑4 (1996). The ISO 5832 series covers metallic materials for surgical implants (other parts address stainless steels, titanium alloys, etc.). ISO 5832‑4 has been revised at the international level (subsequent ISO editions were published after 1996, most recently in 2024), so users should be aware of newer ISO editions when seeking the current international text. National equivalents and related documents (for example other parts of ISO 5832 and corresponding national adoptions) provide complementary material specifications and test methods.

Keywords

AS 2320.4-2003, implants for surgery, cobalt‑chromium‑molybdenum, Co‑Cr‑Mo, casting alloy, metallic biomaterials, implant material specification, test methods, Standards Australia, ISO 5832‑4.

FAQ

Q: What is this standard?

A: AS 2320.4-2003 is an Australian standard that adopts the ISO specification for cobalt‑chromium‑molybdenum casting alloy intended for surgical implants; it specifies composition, mechanical and metallurgical requirements and test methods.

Q: What does it cover?

A: It covers the definition and required properties of the Co‑Cr‑Mo casting alloy for implants, including chemical composition limits, required tests to verify mechanical and metallurgical characteristics, and acceptance criteria for material used in implant manufacture.

Q: Who typically uses it?

A: Medical device manufacturers (orthopaedics, dental implants), materials and quality engineers, testing laboratories, and regulatory/compliance personnel use this standard to specify and verify implant‑grade casting alloy.

Q: Is it current or superseded?

A: AS 2320.4-2003 records the Australian adoption of ISO 5832‑4:1996 (published 2003 as the AS adoption). At the international level ISO 5832‑4 has been revised since 1996 (later editions were published, including a 2024 edition), so users seeking the most up‑to‑date international requirements should consult the latest ISO edition; the Australian document remains a published adoption from 2003.

Q: Is it part of a series?

A: Yes — it is part of the ISO/AS family of standards covering metallic materials for surgical implants (the ISO 5832 series). Other parts of the series cover different implant metals (stainless steels, titanium alloys, wrought cobalt‑chromium alloys, etc.).

Q: What are the key keywords?

A: Cobalt‑chromium‑molybdenum, Co‑Cr‑Mo, casting alloy, surgical implants, implant materials, test methods, AS 2320.4, ISO 5832‑4.