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EVS-EN ISO 10993-7:2008/A1:2022

Biological evaluation of medical devices - Part 7: Ethylene oxide sterilization residuals - Amendment 1: Applicability of allowable limits for neonates and infants (ISO 10993-7:2008/Amd 1:2019)

General information

Valid from 01.02.2022
Base Documents
ISO 10993-7:2008/Amd 1:2019; EN ISO 10993-7:2008/A1:2022
ICS Groups
11.100.20 Biological evaluation of medical devices
Directives or regulations
None

Standard history

Status
Date
Type
Name
Main
prEN ISO 10993-7
01.02.2022
Amendment
EVS-EN ISO 10993-7:2008/A1:2022
01.02.2022
Main + amendment
EVS-EN ISO 10993-7:2008+A1:2022
09.01.2009
Main
EVS-EN ISO 10993-7:2008
Amendment to EN ISO 10993-7:2008

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Standard monitoring

Related products

Main + amendment

EVS-EN ISO 10993-7:2008+A1:2022

Biological evaluation of medical devices - Part 7: Ethylene oxide sterilization residuals (ISO 10993-7:2008 + ISO 10993-7:2008/Amd 1:2019)
Newest version Valid from 01.02.2022
Main

EVS-EN ISO 10993-7:2008

Biological evaluation of medical devices - Part 7: Ethylene oxide sterilization residuals
Valid from 09.01.2009
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 10993-1:2020

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

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EVS-EN ISO 15223-1:2021

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EVS-EN ISO 11135:2014/A1:2019

Sterilization of health-care products - Ethylene oxide - Requirements for the development, validation and routine control of a sterilization process for medical devices - Amendment 1: Revision of Annex E, Single batch release (ISO 11135:2014/Amd 1:2018)
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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
Amendment

EVS-EN ISO 13485:2016/A11:2021

Medical devices - Quality management systems - Requirements for regulatory purposes (ISO 13485:2016)
Valid from 16.09.2021

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