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EVS-EN ISO 21536:2009

Non-active surgical implants - Joint replacement implants - Specific requirements for knee-joint replacement implants

General information

Valid from 03.12.2009
Base Documents
ISO 21536:2007; EN ISO 21536:2009
ICS Groups
11.040.40 Implants for surgery, prosthetics and orthotics
Directives or regulations
93/42/EEC Medical devices (MDD)

Standard history

Status
Date
Type
Name
Main
prEN ISO 21536
01.04.2014
Amendment
EVS-EN ISO 21536:2009/A1:2014
03.12.2009
Main
EVS-EN ISO 21536:2009
Main
EVS-EN ISO 21536:2007
This International Standard provides specific requirements for knee joint replacement implants. With regard to safety, this International Standard specifies requirements for intended performance, design attributes, materials, design evaluation, manufacture, sterilization, packaging, information supplied by the manufacturer and methods of test

Required fields are indicated with *

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Standard monitoring
English (PDF 256 KB)

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Amendment

EVS-EN ISO 21536:2009/A1:2014

Non-active surgical implants - Joint replacement implants - Specific requirements for knee-joint replacement implants - Amendment 1 (ISO 21536:2007/Amd 1:2014)
Newest version Valid from 01.04.2014
Main

EVS-EN ISO 14630:2012

Non-active surgical implants - General requirements (ISO 14630:2012)
Newest version Valid from 04.01.2013
Main

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
Main

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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Amendment

EVS-EN ISO 21536:2009/A1:2014

Non-active surgical implants - Joint replacement implants - Specific requirements for knee-joint replacement implants - Amendment 1 (ISO 21536:2007/Amd 1:2014)
Newest version Valid from 01.04.2014
Main

ISO 14879-1:2000

Implants for surgery -- Total knee-joint prostheses -- Part 1: Determination of endurance properties of knee tibial trays
Withdrawn from 20.07.2020
Main

EVS-EN 556-2:2015

Sterilization of medical devices - Requirements for medical devices to be designated ''STERILE" - Part 2: Requirements for aseptically processed medical devices
Newest version Valid from 06.10.2015
Main

EVS-EN ISO 15798:2013

Ophthalmic implants - Ophthalmic viscosurgical devices (ISO 15798:2013)
Withdrawn from 01.03.2022

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