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Standard [CURRENT] 2018-09

DIN EN ISO 10993-11:2018-09
Biological evaluation of medical devices - Part 11: Tests for systemic toxicity (ISO 10993-11:2017); German version EN ISO 10993-11:2018
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Standard [CURRENT] 2023-07

DIN EN ISO 10993-15:2023-07
Biological evaluation of medical devices - Part 15: Identification and quantification of degradation products from metals and alloys (ISO 10993-15:2019); German version EN ISO 10993-15:2023
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Standard [CURRENT] 2024-02

DIN EN ISO 10993-17:2024-02
Biological evaluation of medical devices - Part 17: Toxicological risk assessment of medical device constituents (ISO 10993-17:2023); German version EN ISO 10993-17:2023
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Standard [CURRENT] 2023-11

DIN EN ISO 10993-18:2023-11
Biological evaluation of medical devices - Part 18: Chemical characterization of medical device materials within a risk management process (ISO 10993-18:2020 + Amd 1:2022); German version EN ISO 10993-18:2020 + A1:2023
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This document also features in an online service. Online services not only give you electronic access to collections of standards, they contain lots of extra information too (such as directives, legal texts, commentaries, etc.). There are automatic updates on a regular basis – and online services also give you large savings compared with the cost of purchasing standards individually.

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Standard [CURRENT] 2023-03

DIN EN ISO 15189:2023-03
Medical laboratories - Requirements for quality and competence (ISO 15189:2022); German version EN ISO 15189:2022
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This document also features in an online service. Online services not only give you electronic access to collections of standards, they contain lots of extra information too (such as directives, legal texts, commentaries, etc.). There are automatic updates on a regular basis – and online services also give you large savings compared with the cost of purchasing standards individually.

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from 175.20 EUR VAT included

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Draft standard 2024-02

DIN EN ISO 15193:2024-02 - Draft
In vitro diagnostic medical devices - Requirements for reference measurement procedures (ISO/DIS 15193:2023); German and English version prEN ISO 15193:2023

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Draft standard 2024-02

DIN EN ISO 15194:2024-02 - Draft
In vitro diagnostic medical devices - Requirements for certified reference materials and the content of supporting documentation (ISO/DIS 15194:2023); German and English version prEN ISO 15194:2023

from 112.30 EUR VAT included

from 104.95 EUR VAT excluded

Standard [CURRENT] 2022-08

DIN EN ISO 24443:2022-08
Cosmetics - Determination of sunscreen UVA photoprotection in vitro (ISO 24443:2021, Corrected version 2022-02); German version EN ISO 24443:2021

Corrected document: Customers who purchased the previous document DIN EN ISO 24443:2022-03 received free of charge

from 135.10 EUR VAT included

from 126.26 EUR VAT excluded

Draft standard 2023-03

DIN ISO 4802-1:2023-03 - Draft
Glassware - Hydrolytic resistance of the interior surfaces of glass containers - Part 1: Determination by titration method and classification (ISO/DIS 4802-1:2022); Text in German and English

from 85.30 EUR VAT included

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Draft standard 2023-03

DIN ISO 4802-2:2023-03 - Draft
Glassware - Hydrolytic resistance of the interior surfaces of glass containers - Part 2: Determination by flame spectrometry and classification (ISO/DIS 4802-2:2022); Text in German and English

from 85.30 EUR VAT included

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