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Standards [CURRENT]

SN EN ISO 11140-1

Sterilization of health care products - Chemical indicators - Part 1: General requirements (ISO 11140-1:2014)
Edition 2015-01

Standards [CURRENT]

SN EN ISO 11140-3

Sterilization of health care products - Chemical indicators - Part 3: Class 2 indicator systems for use in the Bowie and Dick-type steam penetration test (ISO 11140-3:2007, including Cor 1:2007)
Edition 2009-10

Standards [CURRENT]

SN EN ISO 11137-2

Sterilization of health care products - Radiation - Part 2: Establishing the sterilization dose (ISO 11137-2:2013)
Edition 2015-12

Standards [CURRENT]

SN EN ISO 11137-2/A1

Sterilization of health care products - Radiation - Part 2: Establishing the sterilization dose (ISO 11137-2:2013/Amd 1:2022); Amendment A1
Edition 2023-04

Standards [CURRENT]

DIN EN ISO 80601-2-56

Medical electrical equipment - Part 2-56: Particular requirements for basic safety and essential performance of clinical thermometers for body temperature measurement (ISO 80601-2-56:2017 + Amd1:2018); German version EN ISO 80601-2-56:2017 + A1:2020
Edition 2020-08

Standards [CURRENT]

SN EN ISO 8536-14

Infusion equipment for medical use - Part 14: Clamps and flow regulators for transfusion and infusion equipment without fluid contact (ISO 8536-14:2016)
Edition 2018-08

Draft standard

DIN EN ISO 5362

Anaesthetic and respiratory equipment - Anaesthetic reservoir bags (ISO/DIS 5362:2023); German and English version prEN ISO 5362:2023
Edition 2023-02

Standards [CURRENT]

DIN EN 1422

Sterilizers for medical purposes - Ethylene oxide sterilizers - Requirements and test methods; German version EN 1422:2014
Edition 2014-08

Standards [CURRENT]

DIN EN 302510

Short Range Devices (SRD) - Ultra Low Power Active Medical Membrane Implants (ULP-AMI-M) and Peripherals (ULP-AMI-M-P) operating in the frequency range 30 MHz to 37,5 MHz - Harmonised Standard covering the essential requirements of article 3.2 of the Directive 2014/53/EU (Endorsement of the English version EN 302 510 V2.1.1 (2017-01) as German standard)
Edition 2017-05

Technical Specification

DIN CEN ISO/TS 20440

Health informatics - Identification of medicinal products - Implementation guidelines for ISO 11239 data elements and structures for the unique identification and exchange of regulated information on pharmaceutical dose forms, units of presentation, routes of administration and packaging (ISO/TS 20440:2023); German version CEN ISO/TS 20440:2023
Edition 2023-09

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