ISO 5832-9:2019
Implants for surgery — Metallic materials — Part 9: Wrought high nitrogen stainless steel
Implants for surgery — Metallic materials — Part 9: Wrought high nitrogen stainless steel
- Статус документа:
- Действующий
- Формат:
- Электронный (PDF)
- Количество страниц:
- 5
- Дата публикации:
- 8 февраля 2019 г.
- Издание:
- ISO IS 5832 edition 3 version 1
- ICS:
- 11.040.40
This document specifies the characteristics of, and corresponding test methods for, wrought stainless steel containing a mass fraction of 0,25 % to 0,50 % nitrogen for use in the manufacture of surgical implants for which high levels of strength and corrosion resistance are required. NOTE 1 The mechanical properties of a sample obtained from a finished product made of this alloy can differ from those specified in this document. NOTE 2 Requirements for other stainless steels for implants for surgery can be found in ISO 5832-1.
Abstract
Overview
ISO 5832-9:2019 - Implants for surgery: Wrought high nitrogen stainless steel specifies the chemical, microstructural, corrosion and mechanical requirements, and associated test methods, for wrought stainless steel containing 0.25 % to 0.50 % nitrogen used in the manufacture of surgical implants that require high strength and corrosion resistance. This third edition updates previous versions and is part of the ISO 5832 series for metallic implant materials.
Key topics and requirements
- Chemical composition: Defined cast analysis limits for major elements (typical ranges):
- Nitrogen: 0.25 % – 0.50 %
- Chromium: 19.5 % – 22.0 %; Nickel: 9.0 % – 11.0 %
- Molybdenum: 2.0 % – 3.0 %; Niobium: 0.25 % – 0.80 %
- Carbon, silicon, manganese, sulfur, phosphorus and residuals constrained to maximum values.
- Microstructure: Austenitic grain size no coarser than No. 5; absence of delta ferrite, chi and sigma phases; controlled non‑metallic inclusion limits (cleanliness often achieved by electroslag remelting).
- Corrosion resistance: Must pass the Monypenny–Strauss intergranular corrosion test after heat treatment at 675 °C for 1 h, followed by air cooling (per ISO 3651‑2).
- Mechanical properties: Tensile strength, yield/proof strength and elongation specified for bars, wires, rods, sheet and strip across annealed, medium‑hard and hard conditions. Examples:
- Annealed bars (≤80 mm): tensile ≥ 740 MPa, yield ≥ 430 MPa, elongation ≥ 35 %
- Medium‑hard bars (≤20 mm): tensile ≥ 1 000 MPa, yield ≥ 700 MPa, elongation ≥ 20 %
- High‑strength wires/rods: tensile values may reach ~1 800 MPa for small diameters (see standard tables).
- Test methods and sampling: Methods referenced include ISO 377 (sampling), ISO 643 (grain size), ISO 4967 (inclusions), ISO 3651‑2 (intergranular corrosion) and ISO 6892‑1 (tensile testing).
Note: Mechanical properties of finished components can differ from raw-alloy test samples.
Applications
ISO 5832-9:2019 applies to the specification of wrought high‑nitrogen stainless steel for surgical implants where enhanced load-bearing performance and corrosion resistance are critical. Typical users select this material for implants and components that demand high strength and biocompatible corrosion behavior.
Who should use this standard
- Implant manufacturers and material engineers
- Raw‑material suppliers and steel producers
- Quality assurance and testing laboratories
- Regulatory and procurement professionals specifying implant materials
Related standards
- ISO 5832‑1 (other stainless steels for implants)
- ISO 377, ISO 404, ISO 643, ISO 3651‑2, ISO 4967, ISO 6892‑1 (referenced test and sampling methods)
Keywords: ISO 5832-9:2019, wrought high nitrogen stainless steel, implants for surgery, surgical implants, corrosion resistance, tensile strength, chemical composition, intergranular corrosion, medical implant materials.
Технические детали
- Технический комитет
- ISO/TC 150/SC 1 - Materials
- SKU
- ISO 5832-9:2019
Похожие стандарты
Стандарты, упомянутые в описании
ISO 5832-3:2021
ДействующийImplants for surgery — Metallic materials — Part 3: Wrought titanium 6-aluminium 4-vanadium alloy
Overview ISO 5832-3:2021 - "Implants for surgery - Metallic materials - Part 3: Wrought titanium 6‑aluminium 4‑vanadium alloy (Ti‑6Al‑4V)" - specifies the chemical, microstructural and mechanical cha…
ISO 3651-2:1976
ОтменёнAustenitic stainless steels — Determination of resistance to intergranular corrosion — Part 2: Corrosion test…
ISO 3774:1988
ДействующийCinematography — 35 mm motion-picture film perforated 8 mm Type S (1-3-5-7-0) and (1-0) — Cutting and perfora…
Overview ISO 3774:1988 is an international standard published by ISO that specifies critical dimensions for cutting and perforating 35 mm motion-picture film, particularly with 8 mm Type S perforatio…
ISO 6431:1992
ОтменёнPneumatic fluid power — Single rod cylinders, 1 000 kPa (10 bar) series, with detachable mountings, bores fro…
ISO 4967:2013
ОтменёнSteel — Determination of content of non-metallic inclusions — Micrographic method using standard diagrams
Overview ISO 4967:2013 - Steel: Determination of content of non‑metallic inclusions - micrographic method using standard diagrams - defines a standardized metallographic procedure to assess non‑metal…
ISO 6892-1:2019
ДействующийMetallic materials — Tensile testing — Part 1: Method of test at room temperature
Overview ISO 6892-1:2019 - "Metallic materials - Tensile testing - Part 1: Method of test at room temperature" specifies a standardized method for performing tensile tests on metallic materials at ro…
ISO 5832-1:2016
ОтменёнImplants for surgery — Metallic materials — Part 1: Wrought stainless steel
ISO 4048:2018
ДействующийLeather — Chemical tests — Determination of matter soluble in dichloromethane and free fatty acid content
Overview ISO 4048:2018 - Leather - Chemical tests - Determination of matter soluble in dichloromethane and free fatty acid content - specifies a standardized laboratory method to measure substances i…