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Standards Worldwide
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Medizintechnik

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Standard [CURRENT] 2024-09

DIN EN 556-1:2024-09
Sterilization of medical devices - Requirements for medical devices to be designated "STERILE" - Part 1: Requirements for terminally sterilized medical devices; German version EN 556-1:2024

from 70.50 EUR VAT included

from 65.89 EUR VAT excluded

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Standard [AVAILABLE PRE-PUBLICATION] 2025-01

DIN EN 556-2:2025-01
Sterilization of medical devices - Requirements for medical devices to be designated "STERILE" - Part 2: Requirements for aseptically processed medical devices; German version EN 556-2:2024

And replaced by 2025-01 for: DIN EN 556-2:2015-11 , DIN EN 556-2:2023-02

from 85.30 EUR VAT included

from 79.72 EUR VAT excluded

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Draft standard 2023-02

DIN EN 556-2:2023-02 - Draft
Sterilization of medical devices - Requirements for medical devices to be designated "STERILE" - Part 2: requirements for aseptically processed medical devices; German and English version prEN 556-2:2023

DIN EN 556-2:2025-01

from 85.30 EUR VAT included

from 79.72 EUR VAT excluded

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Draft standard 2024-04

DIN EN ISO 11135:2024-04 - Draft
Sterilization of health care products - Ethylene oxide - Requirements for the development, validation and routine control of a sterilization process for medical devices (ISO/DIS 11135.2:2024); German and English version prEN ISO 11135:2024

from 231.40 EUR VAT included

from 216.26 EUR VAT excluded

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Standard [CURRENT] 2023-08

DIN EN ISO 11137-2:2023-08
Sterilization of health care products - Radiation - Part 2: Establishing the sterilization dose (ISO 11137-2:2013 + Amd 1:2022); German version EN ISO 11137-2:2015 + A1:2023

from 197.50 EUR VAT included

from 184.58 EUR VAT excluded

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Standard [CURRENT] 2017-11

DIN EN ISO 11137-3:2017-11
Sterilization of health care products - Radiation - Part 3: Guidance on dosimetric aspects of development, validation and routine control (ISO 11137-3:2017); German version EN ISO 11137-3:2017

An integral part of radiation sterilization is the ability to measure dose. Dose is measured during all stages of development, validation and routine monitoring of the sterilization process.

from 135.10 EUR VAT included

from 126.26 EUR VAT excluded

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Pre-standard 2023-10

DIN CEN ISO/TS 11137-4:2023-10
Sterilization of health care products - Radiation - Part 4: Guidance on process control (ISO/TS 11137-4:2020); German version CEN ISO/TS 11137-4:2023
Procedure : Pre-Standard

from 130.70 EUR VAT included

from 122.15 EUR VAT excluded

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Standard [CURRENT] 2024-06

DIN EN ISO 11139:2024-06
Sterilization of health care products - Vocabulary of terms used in sterilization and related equipment and process standards (ISO 11139:2018 + Amd 1:2024); German and English version EN ISO 11139:2018 + A1:2024

from 216.10 EUR VAT included

from 201.96 EUR VAT excluded

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Standard [CURRENT] 2023-10

DIN EN ISO 13004:2023-10
Sterilization of health care products - Radiation - Substantiation of selected sterilization dose: Method VDₘₐₓSD (ISO 13004:2022); German version EN ISO 13004:2023

from 163.40 EUR VAT included

from 152.71 EUR VAT excluded

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Standard [CURRENT] 2024-09

DIN EN ISO 13408-1:2024-09
Aseptic processing of health care products - Part 1: General requirements (ISO 13408-1:2023); German version EN ISO 13408-1:2024

from 197.50 EUR VAT included

from 184.58 EUR VAT excluded

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