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EVS-EN ISO 10993-1:2011

Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process (ISO 10993-1:2009)

General information

Withdrawn from 31.12.2020
Base Documents
ISO 10993-1:2009; EN ISO 10993-1:2009
ICS Groups
11.100.20 Biological evaluation of medical devices
Directives or regulations
None

Standard history

Status
Date
Type
Name
31.12.2020
Main
EVS-EN ISO 10993-1:2020
03.02.2011
Main
EVS-EN ISO 10993-1:2011
06.09.2010
Corrigendum
EVS-EN ISO 10993-1:2009/AC:2010
Main
EVS-EN ISO 10993-1:2009
This part of ISO 10993 describes: - the general principles governing the biological evaluation of medical devices within a risk management process; - the general categorization of devices based on the nature and duration of their contact with the body; - the evaluation of existing relevant data from all sources; - the identification of gaps in the available data set on the basis of a risk analysis; - the identification of additional data sets necessary to analyse the biological safety of the medical device; - the assessment of the biological safety of the medical device. This part of ISO 10993 does not cover testing of materials and devices that do not come into direct or indirect contact with the patient's body, nor does it cover biological hazards arising from any mechanical failure. Other parts of ISO 10993 cover specific tests, as indicated in the Foreword.

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Standard monitoring
English (PDF 371 KB)

Related products

Main

EVS-EN ISO 10993-1:2020

Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process (ISO 10993-1:2018, including corrected version 2018-10)
Newest version Valid from 31.12.2020
Corrigendum

EVS-EN ISO 10993-1:2009/AC:2010

Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process - Technical Corrigendum 1
Withdrawn from 31.12.2020
Main

EVS-EN ISO 14155:2020

Clinical investigation of medical devices for human subjects - Good clinical practice (ISO 14155:2020)
Newest version Valid from 02.10.2020
Main

EVS-EN ISO 10993-18:2020

Biological evaluation of medical devices - Part 18: Chemical characterization of medical device materials within a risk management process (ISO 10993-18:2020)
Valid from 15.06.2020

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EVS-EN ISO 15223-1:2016

Medical devices - Symbols to be used with medical device labels, labelling and information to be supplied - Part 1: General requirements (ISO 15223-1:2016, Corrected version 2017-03)
Withdrawn from 01.10.2021
Main + corrigendum

EVS-EN ISO 13485:2016

Medical devices - Quality management systems - Requirements for regulatory purposes (ISO 13485:2016)
Valid from 02.03.2016
Main

EVS-EN ISO 10993-10:2013

Biological evaluation of medical devices - Part 10: Tests for irritation and skin sensitization (ISO 10993-10:2010)
Withdrawn from 01.03.2023
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EVS-EN 1041:2008+A1:2013

Information supplied by the manufacturer of medical devices
Withdrawn from 17.05.2021

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