EN ISO 5832-6:2022 PDF

Name: EN ISO 5832-6:2022 — Implants for surgery - Metallic materials - Part 6: Wrought cobalt-nickel-chromium-molybdenum alloy (ISO 5832-6:2022)
SKU: EN ISO 5832-6:2022
Price: 51.9 EUR
Availability: InStock

Implants for surgery - Metallic materials - Part 6: Wrought cobalt-nickel-chromium-molybdenum alloy (ISO 5832-6:2022)

Название (английский):

EN ISO 5832-6:2022

Implants for surgery - Metallic materials - Part 6: Wrought cobalt-nickel-chromium-molybdenum alloy (ISO 5832-6:2022)

Статус документа:: Действующий
Формат:: Электронный (PDF)
Количество страниц:: 11
Дата публикации:: 30 марта 2022 г.
Издание:: CEN EN 5832 edition 2 version 1
ICS:: 11.040.40

Тип поставки:

Full version165 €Read online 24h10 €Read online 72h15 €

Язык документа:

ruen

Срок поставки:2 раб. дн. (перевод)

Цена:165 €

Описание (английский):

This document specifies the characteristics of, and corresponding test methods for, wrought cobalt-nickel chromium-molybdenum alloy for use in the manufacture of surgical implants. NOTE The tensile properties of a sample obtained from a finished product made of this alloy do not necessarily comply with those specified in this document.

Abstract

Похожие стандарты

Стандарты, упомянутые в описании

Overview

EN ISO 5832-6:2022 - "Implants for surgery - Metallic materials - Part 6: Wrought cobalt‑nickel‑chromium‑molybdenum alloy" specifies the required chemical composition, microstructure, tensile properties and corresponding test methods for wrought Co–Ni–Cr–Mo alloys used as raw material in the manufacture of surgical implants. Published by CEN/ISO, this standard applies to the base material (not finished devices) and is part of the ISO 5832 series for implant metallic materials.

Key topics and technical requirements

Chemical composition (heat analysis): the alloy composition limits include, for example:

Nickel: 33.0–37.0%
Chromium: 19.0–21.0%
Molybdenum: 9.0–10.5%
Boron: ≤ 0.015% and limits for Fe, Ti, Mn, Si, C, P, S; Cobalt as balance.

Microstructure

Microstructure must be uniform.
Grain size in the annealed condition shall be not coarser than grain size No. 4 (per ISO 643).

Tensile properties (tested per ISO 6892‑1): specified minimum values by condition:

Annealed: Tensile strength Rm ≥ 793 MPa, Proof/Yield Rp0.2 ≥ 300 MPa, Elongation A ≥ 50%
Medium hard: Rm ≥ 1 000 MPa, Rp0.2 ≥ 655 MPa, A ≥ 20%
Hard: Rm ≥ 1 207 MPa, Rp0.2 ≥ 1 000 MPa, A ≥ 10%
Note: tensile properties can be altered by cold‑working and ageing; tensile results from finished product samples may not reflect these raw‑material values.

Test methods & conformity

Chemical analysis, grain size (ISO 643) and tensile testing (ISO 6892‑1) are referenced.
Retest and failure handling procedures are defined for conformity assessment.

Applications and practical value

Material specification for manufacturers of orthopaedic and trauma implants, dental implants, and other non‑active surgical implants where Co–Ni–Cr–Mo alloys are chosen for strength and corrosion resistance.

Used by material suppliers, medical device OEMs, quality/acceptance laboratories, and regulatory/standards teams to:

Verify raw‑material compliance before device fabrication.
Define procurement specifications and supplier contracts.
Support regulatory submissions and technical documentation.

Related standards

ISO 5832 series (other metallic implant materials)

ISO 643 - Micrographic determination of apparent grain size

ISO 6892‑1 - Tensile testing of metallic materials

This standard provides authoritative, testable requirements for wrought Co–Ni–Cr–Mo implant alloy supply and acceptance, helping ensure material consistency, safety, and traceability in surgical implant manufacturing.

EN ISO 5832-6:2022 PDF

Abstract

Похожие стандарты

Overview

Key topics and technical requirements

Applications and practical value

Who should use this standard

Related standards

Технические детали

ISO 5832-6:2022

Implants for surgery — Metallic materials — Part 6: Wrought cobalt-nickel-chromium-molybdenum alloy

ISO 5832-11:2024

Implants for surgery — Metallic materials — Part 11: Wrought titanium 6-aluminium 7-niobium alloy

ISO 6435:2024

Stainless steel bars for the reinforcement of concrete

SIST EN ISO 6892-1:2020

Metallic materials - Tensile testing - Part 1: Method of test at room temperature (ISO 6892-1:2019)