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EVS-EN ISO 5832-1:2024

Implants for surgery - Metallic materials - Part 1: Wrought stainless steel (ISO 5832-1:2024)

General information

Valid from 02.05.2024
Base Documents
ISO 5832-1:2024; EN ISO 5832-1:2024
ICS Groups
11.040.40 Implants for surgery, prosthetics and orthotics
Directives or regulations
None

Standard history

Status
Date
Type
Name
02.05.2024
Main
EVS-EN ISO 5832-1:2024
15.10.2019
Main
EVS-EN ISO 5832-1:2019

ISO 5832-1 specifies the characteristics of, and corresponding test methods for, wrought stainless steel for use in the manufacture of surgical implants.

While no known surgical implant material has ever been shown to cause absolutely no adverse reactions in the human body, long-term clinical experience with the material referred to in ISO 5832-1 has shown that an acceptable level of biological response can be expected when the material is used in appropriate applications.

However, this standard covers the raw material and not finished medical devices, where the design and fabrication of the device can impact biological response.

ISO 5832-1:2024 text has been approved in Europe as EN ISO 5832-1:2024 without any changes.

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Standard monitoring
English (PDF 524 KB)

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EVS-EN ISO 14630:2012

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Newest version Valid from 04.01.2013
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EVS-EN ISO 16061:2021

Instruments for use in association with non-active surgical implants - General requirements (ISO 16061:2021)
Newest version Valid from 15.04.2021
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EVS-EN ISO 15001:2011

Anaesthetic and respiratory equipment - Compatibility with oxygen (ISO 15001:2010)
Newest version Valid from 02.11.2011
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EVS-EN ISO 25539-1:2017

Cardiovascular implants - Endovascular devices - Part 1: Endovascular prostheses (ISO 25539-1:2017)
Newest version Valid from 04.04.2017

Standards designation

EVS Estonian standard
EN European standard (published by an CEN or CENELEC)
EN ISO International standard adopted as an European standard
ISO International Organization for Standardization’s standard
IEC International Electrotechnical Commission’s standard
HD CENELEC’s harmonisation document
   
EVS-EN European standard implemented in Estonia
EVS-EN ISO International standard adopted in Europe and implemented in Estonia
EVS-EN ISO/IEC International standard/International electrotechnical standard adopted in Europe and implemented in Estonia
EVS-IEC International electrotechnical standard implemented in Estonia
EVS-ISO International standard implemented in Estonia
   
A, AMD amedment
+A a full standard plus the amendment
/A only amendment
COR, AC corrigendum
+COR a full standard plus the corrigendum
NA national annex
+NA a full standard plus the national annex
/NA only national annex
TS technical specification
TR technical report
CWA agreement, developed by a CEN or CENELEC
prEVS-EN (etc) draft standard
   
et the standard is in Estonian only
en the standard is in English only
et-en the standard is in Parallel text Estonian-English