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UNE - Spanish national standards
Page 126
UNE-EN ISO 10993-3:2015 (06/05/2015)
Biological evaluation of medical devices - Part 3: Tests for genotoxicity, carcinogenicity and reproductive toxicity (ISO 10993-3:2014)
Available languages: English, Spanish
Available design: electronic design (pdf), Print design
from 93.10 EUR more info
UNE-EN ISO 10993-4:2018 (24/01/2018)
Biological evaluation of medical devices - Part 4: Selection of tests for interactions with blood (ISO 10993-4:2017)
Available languages: English, Spanish
Available design: electronic design (pdf), Print design
from 133.30 EUR more info
UNE-EN ISO 10993-4:2018/A1:2025 (22/10/2025) Change
Biological evaluation of medical devices - Part 4: Selection of tests for interactions with blood - Amendment 1 (ISO 10993-4:2017/Amd 1:2025, Corrected version 2025-04)
Available languages: English, Spanish
Available design: electronic design (pdf), Print design
from 63.70 EUR more info
UNE-EN ISO 10993-5:2009 (09/12/2009)
Biological evaluation of medical devices - Part 5: Tests for in vitro cytotoxicity (ISO 10993-5:2009)
Available languages: English, Spanish
Available design: electronic design (pdf), Print design
from 91.10 EUR more info
UNE-EN ISO 10993-5:2009/A11:2025 (22/10/2025) Change
Biological evaluation of medical devices - Part 5: Tests for in vitro cytotoxicity
Available languages: English, Spanish
Available design: electronic design (pdf), Print design
from 40.20 EUR more info
UNE-EN ISO 10993-6:2017 (25/10/2017)
Biological evaluation of medical devices - Part 6: Tests for local effects after implantation (ISO 10993-6:2016)
Available languages: English, Spanish
Available design: electronic design (pdf), Print design
from 94.10 EUR more info
UNE-EN ISO 10993-7:2009 (03/06/2009)
Biological evaluation of medical devices - Part 7: Ethylene oxide sterilization residuals (ISO 10993-7:2008)
Available languages: English, Spanish
Available design: electronic design (pdf), Print design
from 132.30 EUR more info
UNE-EN ISO 10993-7:2009/A1:2022 (27/07/2022) Change
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)
Available languages: English, Spanish
Available design: electronic design (pdf), Print design
from 52.90 EUR more info
UNE-EN ISO 10993-7:2009/AC:2010 (24/02/2010) Change
Biological evaluation of medical devices - Part 7: Ethylene oxide sterilization residuals - Technical Corrigendum 1 (ISO 10993-7:2008/Cor 1:2009)
Available languages: English, Spanish
Available design: electronic design (pdf)
from 1.00 EUR more info
UNE-EN ISO 10993-9:2022 (25/05/2022)
Biological evaluation of medical devices - Part 9: Framework for identification and quantification of potential degradation products (ISO 10993-9:2019)
Available languages: English, Spanish
Available design: electronic design (pdf), Print design
from 67.60 EUR more info
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