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Standards Worldwide
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

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Standard [NEW] 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

from 87.90 EUR VAT included

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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

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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 203.40 EUR VAT included

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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.

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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

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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 222.60 EUR VAT included

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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 168.30 EUR VAT included

from 157.29 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 203.40 EUR VAT included

from 190.09 EUR VAT excluded

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Standard [CURRENT] 2021-11

DIN EN ISO 17664-1:2021-11
Processing of health care products - Information to be provided by the medical device manufacturer for the processing of medical devices - Part 1: Critical and semi-critical medical devices (ISO 17664-1:2021); German version EN ISO 17664-1:2021

from 115.70 EUR VAT included

from 108.13 EUR VAT excluded

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