11 : Health care technology
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DIN EN ISO 11199-2/A1:2024-04
Assistive products for walking manipulated by both arms - Requirements and test methods - Part 2: Rollators - Amendment 1: Eliminate brake requirements in 6.5 Structure requirements (ISO 11199-2:2021/DAM 1:2024), German and English version EN ISO 11199-2:2021/prA1:2024
4/1/2024 - PDF - English, German -
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DIN EN ISO 10993-4/A1:2024-04
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
4/1/2024 - PDF - English, German -
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PR NF EN ISO 10993-4/A1, S99-501-4/A1PR (04/2024)
Évaluation biologique des dispositifs médicaux - Partie 4 : Choix des essais pour les interactions avec le sang - Amendement 1
4/1/2024 - Paper - English, French -
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DIN EN ISO 5840-3/A1:2024-03
Cardiovascular implants - Cardiac valve prostheses - Part 3: Heart valve substitutes implanted by transcatheter techniques - Amendment 1 (ISO 5840-3:2021/DAM 1:2024), German and English version EN ISO 5840-3:2021/prA1:2024
3/1/2024 - PDF - English, German -
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DIN EN ISO 5840-1/A1:2024-03
Cardiovascular implants - Cardiac valve prostheses - Part 1: General requirements - Amendment 1 (ISO 5840-1:2021/DAM 1:2024), German and English version EN ISO 5840-1:2021/prA1:2024
3/1/2024 - PDF - English, German -
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PR NF EN ISO 7711-1/A1, S91-115/A1PR (03/2024)
Médecine bucco-dentaire - Instruments rotatifs diamantés - Partie 1 : Exigences générales - Amendement 1
3/1/2024 - Paper - English, French -
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DIN EN ISO 5840-2/A1:2024-03
Cardiovascular implants - Cardiac valve prostheses - Part 2: Surgically implanted heart valve substitutes - Amendment 1 (ISO 5840-2:2021/DAM 1:2024), German and English version EN ISO 5840-2:2021/prA1:2024
3/1/2024 - PDF - English, German -
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DIN EN ISO 7711-1/A1:2024-02
Dentistry - Diamond rotary instruments - Part 1: General requirements - AMENDMENT 1 (ISO 7711-1:2021/DAM 1:2024), German and English version EN ISO 7711-1:2021/prA1:2024
2/1/2024 - PDF - English, German -
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DIN EN 17272/A1:2023-12
Chemical disinfectants and antiseptics - Methods of airborne room disinfection by automated process - Determination of bactericidal, mycobactericidal, sporicidal, fungicidal, yeasticidal, virucidal and phagocidal activities, German and English version EN 17272:2020/prA1:2023
12/1/2023 - PDF - English, German -
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PR NF EN IEC 60601-2-68/A1, C74-068/A1PR (10/2023)
Amendement 1 - Appareils électromédicaux - Partie 2-68: Exigences particulières pour la sécurité de base et les performances essentielles des appareils de radiothérapie à rayonnement X assistée par imagerie médicale, destinés à être utilisés avec les accélérateurs d'électrons, les appareils de thérapie par faisceau d'ions légers et les appareils de thérapie par faisceau de radionucléides
10/1/2023 - Paper - English, French -
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PR NF EN ISO 81060-2/A2, S97-101-2/A2PR (05/2023)
Sphygmomanomètres non invasifs - Partie 2 : Investigation clinique pour type ponctuel à mesurage automatique - Amendement 2
5/1/2023 - Paper - English, French -
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DIN EN ISO 81060-2/A2:2023-04
Non-invasive sphygmomanometers - Part 2: Clinical investigation of intermittent automated measurement type - Amendment 2 (ISO 81060-2:2018/DAM 2:2023), German and English version EN ISO 81060-2:2019/prA2:2023
4/1/2023 - PDF - English, German -
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PR NF EN 17122/A1, T72-205/A1PR (04/2023)
Antiseptiques et désinfectants chimiques - Essai quantitatif de surfaces non poreuses pour l'évaluation de l'activité virucide des désinfectants et antiseptiques chimiques utilisés dans le domaine vétérinaire - Méthode d'essai et prescriptions - Phase 2,
4/1/2023 - Paper - English, French -
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PR NF EN 1789/A1, S64-021/A1PR (03/2023)
Véhicules de transport sanitaire et leurs équipements - Ambulances routières
3/1/2023 - Paper - English, French -
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PR NF EN 455-1+A1/A2, S97-001-1/A2PR (03/2023)
Gants médicaux non réutilisables - Partie1 : exigences et essais pour la détection de l'absence de trous
3/1/2023 - Paper - English, French -
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DIN EN ISO 80601-2-55/A1:2023-03
Medical electrical equipment - Part 2-55: Particular requirements for the basic safety and essential performance of respiratory gas monitors - Amendment 1 (ISO 80601-2-55:2018/DAM 1:2023), German and English version EN ISO 80601-2-55:2018/prA1:2023
3/1/2023 - PDF - English, German -
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DIN EN ISO 11139/A1:2023-03
Sterilization of health care products - Vocabulary of terms used in sterilization and related equipment and process standards - Amendment 1 (ISO 11139:2018/DAM 1:2023), German and English version EN ISO 11139:2018/prA1:2023
3/1/2023 - PDF - English, German -
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DIN EN 17122/A1:2023-03
Chemical disinfectants and antiseptics - Quantitative non-porous surface test for the evaluation of virucidal activity of chemical disinfectants and antiseptics used in the veterinary area - Test method and requirements - Phase 2, step 2, German and English version EN 17122:2019/prA1:2023
3/1/2023 - PDF - English, German -
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DIN EN 1789/A1:2023-01
Medical vehicles and their equipment - Road ambulances, German and English version EN 1789:2020/prA1:2023
1/1/2023 - PDF - English, German -
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PR NF EN IEC 80601-2-49/A1, C74-380/A1PR (01/2023)
Amendement 1 - Appareils électromédicaux - Partie 2-49 : exigences particulières pour la sécurité de base et les performances essentielles des moniteurs multifonctions des patients
1/1/2023 - Paper - English, French -
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DIN EN 455-1/A2:2023-01
Medical gloves for single use - Part 1: Requirements and testing for freedom of holes, German and English version EN 455-1:2020+A1:2022/prA2:2023
1/1/2023 - PDF - English, German -
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PR NF EN 60601-2-45/A2, C74-124/A2PR (04/2022)
Amendement 2 - Appareils électromédicaux - Partie 2-45 : Exigences particulières pour la sécurite de base et les performances essentielles des appareils de mammographie à rayonnement X et des appareils mammographiques steréotaxiques
4/1/2022 - Paper - English, French -
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PR NF EN IEC 60601-2-83/A1, C74-283/A1PR (04/2022)
Amendement 1 - Appareils électromédicaux - Partie 2-83 : Exigences particulières pour la sécurité de base et les performances essentielles des appareils de luminothérapie à domicile
4/1/2022 - Paper - English, French -
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PR NF EN IEC 80601-2-78/A1, C74-398/A1PR (11/2021)
Amendement 1 - Appareils électromédicaux - Partie 2-78: Exigences particulières pour la sécurité de base et les performances essentielles des robots médicaux dédiés à la rééducation, l'évaluation, la compensation ou l'atténuation
11/1/2021 - Paper - English, French -
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PR NF EN IEC 60601-2-75/A1, C74-275/A1PR (08/2021)
Amendment 1 - Medical electrical equipment - Part 2-75 : Particular requirements for the basic safety and essential performance of photodynamic therapy and photodynamic diagnosis equipment
8/1/2021 - Paper - English, French -
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PR NF EN IEC 60601-2-3/A2, C74-370/A2PR (08/2021)
Amendment 2 - Medical electrical equipment - Part 2-3 : Particular requirements for the basic safety and essential performance of short-wave therapy equipment
8/1/2021 - Paper - English, French -
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PR NF EN IEC 60601-2-10/A2, C74-313/A2PR (07/2021)
Amendment 2 - Medical electrical equipment - Part 2-10 : Particular requirements for the basic safety and essential performance of nerve and muscle stimulators
7/1/2021 - Paper - English, French -
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DIN EN 62563-1/A2:2021-06
Medical electrical equipment - Medical image display systems - Part 1: Evaluation methods - Amendment 2 (IEC 62563-1:2009/AMD 2:2020), German and English version EN 62563-1:2010/prA2:2021
6/1/2021 - PDF - English, German -
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PR NF D11-201/A1, D11-201/A1PR (02/2021)
Household management - Conditions of assembly and installation of wash basins for accomodating handicapped persons
2/1/2021 - Paper - French -
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PR NF EN ISO 15002/A2, S95-169/A2PR (03/2020)
Flow-metering devices for connection to terminal units of medical gas pipeline systems - Amendment 2
3/1/2020 - Paper - English, French -
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DIN EN 60601-1-11/A1 VDE 0750-1-11/A1:2018-11
Medical electrical equipment - Part 1-11: General requirements for basic safety and essential performance - Collateral Standard: Requirements for medical electrical equipment and medical electrical systems used in the home healthcare environment (IEC 62A/1239/CD:2018), Text in German and English
11/1/2018 - Paper - German -
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DIN EN 60601-1-8/A2 VDE 0750-1-8/A2:2018-09
Medical electrical equipment - Part 1-8: General requirements for basic safety and essential performance - Collateral Standard: General requirements, tests and guidance for alarm systems in medical electrical equipment and medical electrical systems (IEC 62A/1241/CD:2018), Text in German and English
9/1/2018 - Paper - German -
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DIN EN 60601-1/A2 VDE 0750-1/A2:2018-09
Medical electrical equipment - Part 1: General requirements for basic safety and essential performance (IEC 62A/1237/CD:2018), Text in German and English
9/1/2018 - Paper - German -
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DIN EN 60601-2-43/A2 VDE 0750-2-43/A2:2018-09
Medical electrical equipment - Part 2-43: Particular requirements for the basic safety and essential performance of X-ray equipment for interventional procedures (IEC 62B/1074/CDV:2018), German and English version EN 60601-2-43:2010/prA2:2018
9/1/2018 - Paper - German -
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DIN EN 60601-1-6/A2 VDE 0750-1-6/A2:2018-07
Medical electrical equipment - Part 1-6: General requirements for basic safety and essential performance - Collateral standard: Usability (IEC 62A/1204/CD:2017), Text in German and English
7/1/2018 - Paper - German -
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DIN EN 60601-1-10/A2 VDE 0750-1-10/A2:2018-07
Medical electrical equipment - Part 1-10: General requirements for basic safety and essential performance - Collateral Standard: Requirements for the development of physiologic closed-loop controllers (IEC 62A/1208/CD:2017), Text in German and English
7/1/2018 - Paper - German -
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DIN EN 60601-2-54/A2 VDE 0750-2-54/A2:2017-11
Medical electrical equipment - Part 2-54: Particular requirements for the basic safety and essential performance of X-ray equipment for radiography and radioscopy (IEC 62B/1047/CDV:2017), German version EN 60601-2-54:2009/prA2:2017
11/1/2017 - Paper - German -
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DIN EN 60601-1-2/A1 VDE 0750-1-2/A1:2017-11
Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral Standard: Electromagnetic disturbances - Requirements and tests (IEC 62A/1202/CD:2017)
11/1/2017 - Paper - German -
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DIN EN 60601-2-65/A1 VDE 0750-2-65/A1:2017-02
Medical electrical equipment - Part 2-65: Particular requirements for the basic safety and essential performance of dental intra-oral X-ray equipment (IEC 62B/1006/CDV:2016), German version EN 60601-2-65:2013/prA1:2016
2/1/2017 - Paper - German -
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DIN EN 60601-2-4/A1 VDE 0750-2-4/A1:2017-02
Medical Electrical Equipment - Part 2-4: Particular requirements for the basic safety and essential performance of cardiac defibrillators (IEC 62D/1344/CDV:2016), German version EN 60601-2-4:2011/FprA1:2016
2/1/2017 - Paper - German -
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DIN EN 60601-2-63/A1 VDE 0750-2-63/A1:2017-02
Medical electrical equipment - Part 2-63: Particular requirements for the basic safety and essential performance of dental extra-oral X-ray equipment (IEC 62B/1004/CDV:2016), German version EN 60601-2-63:2015/prA1:2016
2/1/2017 - Paper - German -
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DIN EN 62563-1/A1:2016-05
Medical electrical equipment - Medical image display systems - Part 1: Evaluation methods (IEC 62B/983/CDV:2015), German and English version EN 62563-1:2010/FprA1:2015
5/1/2016 - PDF - English, German -
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DIN EN 80601-2-58/A1 VDE 0750-2-58/A1:2016-03
Medical Electrical Equipment - Part 2-58: Particular requirements for the basic safety and essential performance of lens removal and vitrectomy devices for ophthalmic surgery (IEC 62D/1258/CDV:2015), German version EN 80601-2-58:2015/FprA1:2015
3/1/2016 - Paper - German -
Learn More€20.45
