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ÖNORM - Austrian standards
Page 95
ÖNORM EN ISO 10993-11 (15/10/2018)
Biological evaluation of medical devices - Part 11: Tests for systemic toxicity (ISO 10993-11:2017)
Available languages: English, German
Available design: electronic design (pdf), Print design
from 156.20 USD more info
ÖNORM EN ISO 10993-12 (15/09/2021)
Biological evaluation of medical devices - Part 12: Sample preparation and reference materials (ISO 10993-12:2021)
Available languages: English, German
Available design: electronic design (pdf), Print design
from 134.30 USD more info
ÖNORM EN ISO 10993-12/A1 (01/02/2026) Change
Biological evaluation of medical devices - Part 12: Sample preparation and reference materials - Amendment 1 (ISO 10993-12:2021/Amd 1:2025)
Available languages: English, German
Available design: electronic design (pdf), Print design
from 93.90 USD more info
ÖNORM EN ISO 10993-13 (01/10/2010)
Biological evaluation of medical devices - Part 13: Identification and quantification of degradation products from polymeric medical devices (ISO 10993-13:2010)
Available languages: English, German
Available design: electronic design (pdf), Print design
from 95.90 USD more info
ÖNORM EN ISO 10993-14 (15/09/2009)
Biological evaluation of medical devices - Part 14: Identification and quantification of degradation products from ceramics (ISO 10993-14:2001)
Available languages: English, German
Available design: electronic design (pdf), Print design
from 95.90 USD more info
ÖNORM EN ISO 10993-15 (15/08/2023)
Biological evaluation of medical devices - Part 15: Identification and quantification of degradation products from metals and alloys (ISO 10993-15:2019)
Available languages: English, German
Available design: electronic design (pdf), Print design
from 112.00 USD more info
ÖNORM EN ISO 10993-16 (15/01/2018)
Biological evaluation of medical devices - Part 16: Toxicokinetic study design for degradation products and leachables (ISO 10993-16:2017)
Available languages: English, German
Available design: electronic design (pdf), Print design
from 113.90 USD more info
ÖNORM EN ISO 10993-17 (15/02/2024)
Biological evaluation of medical devices - Part 17: Toxicological risk assessment of medical device constituents (ISO 10993-17:2023)
Available languages: English, German
Available design: electronic design (pdf), Print design
from 259.70 USD more info
ÖNORM EN ISO 10993-17/A1 (01/04/2026) Change
Biological evaluation of medical devices - Part 17: Toxicological risk assessment of medical device constituents - Amendment 1 (ISO 10993-17:2023/Amd 1:2025)
Available languages: English, German
Available design: electronic design (pdf), Print design
from 106.10 USD more info
ÖNORM EN ISO 10993-18 (15/02/2021)
Biological evaluation of medical devices - Part 18: Chemical characterization of medical device materials within a risk management process (ISO 10993-18:2020)
Available languages: English, German
Available design: electronic design (pdf), Print design
from 240.00 USD more info
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