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Medizintechnik

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Pre-standard 2023-03

DIN CEN ISO/TS 5798:2023-03
In vitro diagnostic test systems - Requirements and recommendations for detection of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) by nucleic acid amplification methods (ISO/TS 5798:2022); German version CEN ISO/TS 5798:2022
Procedure : Pre-Standard
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from 117.10 EUR VAT included

from 109.44 EUR VAT excluded

Draft standard 2024-04

DIN EN ISO 7405:2024-04 - Draft
Dentistry - Evaluation of biocompatibility of medical devices used in dentistry (ISO/DIS 7405:2024); German and English version prEN ISO 7405:2024

from 175.20 EUR VAT included

from 163.74 EUR VAT excluded

Standard [CURRENT] 2021-05

DIN EN ISO 10993-1:2021-05
Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process (ISO 10993-1:2018, including corrected version 2018-10); German version EN ISO 10993-1:2020
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from 141.20 EUR VAT included

from 131.96 EUR VAT excluded

Standard [CURRENT] 2023-02

DIN EN ISO 10993-2:2023-02
Biological evaluation of medical devices - Part 2: Animal welfare requirements (ISO 10993-2:2022); German version EN ISO 10993-2:2022
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from 85.30 EUR VAT included

from 79.72 EUR VAT excluded

Draft standard 2024-04

DIN EN ISO 10993-4/A1:2024-04 - Draft
Biological evaluation of medical devices - Part 4: Selection of tests for interactions with blood - Amendment 1 (ISO 10993-4:2017/DAM 1:2024); German and English version EN ISO 10993-4:2017/prA1:2024

from 63.80 EUR VAT included

from 59.63 EUR VAT excluded

Standard [CURRENT] 2009-10

DIN EN ISO 10993-5:2009-10
Biological evaluation of medical devices - Part 5: Tests for in vitro cytotoxicity (ISO 10993-5:2009); German version EN ISO 10993-5:2009
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Suitable online services

from 123.40 EUR VAT included

from 115.33 EUR VAT excluded

Draft standard [PRE-ORDER] 2024-06

DIN EN ISO 10993-6:2024-06 - Draft
Biological evaluation of medical devices - Part 6: Tests for local effects after implantation (ISO/DIS 10993-6:2024); German and English version prEN ISO 10993-6:2024

from 141.20 EUR VAT included

from 131.96 EUR VAT excluded

Standard [CURRENT] 2017-09

DIN EN ISO 10993-6:2017-09
Biological evaluation of medical devices - Part 6: Tests for local effects after implantation (ISO 10993-6:2016); German version EN ISO 10993-6:2016
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from 123.40 EUR VAT included

from 115.33 EUR VAT excluded

Standard [CURRENT] 2022-09

DIN EN ISO 10993-7:2022-09
Biological evaluation of medical devices - Part 7: Ethylene oxide sterilization residuals (ISO 10993-7:2008 + Cor 1:2009 + Amd 1:2019); German version EN ISO 10993-7:2008 + AC:2009 + A1:2022
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from 197.50 EUR VAT included

from 184.58 EUR VAT excluded

Standard [CURRENT] 2023-04

DIN EN ISO 10993-10:2023-04
Biological evaluation of medical devices - Part 10: Tests for skin sensitization (ISO 10993-10:2021); German version EN ISO 10993-10:2023
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from 151.90 EUR VAT included

from 141.96 EUR VAT excluded

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