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DIN EN ISO 80601-2-61 rev
Medical electrical equipment - Part 2-61: Particular requirements for basic safety and essential performance of pulse oximeter equipment (ISO 80601-2-61:2017, Corrected version 2018-02)
DIN EN ISO 5649
Medical laboratories - Concepts and specifications for the design, development, implementation, and use of laboratory-developed tests (ISO/DIS 5649:2023); German and English version prEN ISO 5649:2023
DIN EN ISO 12609-1
Eye and face protection against intense light sources used on humans and animals for cosmetic and medical applications - Part 1: Specification for products (ISO/FDIS 12609-1:2021); German version FprEN ISO 12609-1:2021
prEN 16615
Chemical disinfectants and antiseptics - Quantitative test method for the evaluation of bactericidal and yeasticidal and/or fungicidal and/or tuberculocidal and/or mycobactericidal activity on non-porous surfaces with mechanical action employing wipes or mops in the medical area (4- field test) - Test method and requirements (phase 2, step 2)
DIN EN IEC 61223-3-8
Evaluation and routine testing in medical imaging departments - Part 3-8: Acceptance and constancy tests - Radiography and radioscopy (IEC/CDV 61223-3-8:2022); German and English version prEN IEC 61223-3-8:2022
DIN EN ISO 23908
Sharps injury protection - Requirements and test methods - Sharps protection mechanisms for single-use needles, introducers for catheters and needles used for blood testing, monitoring, sampling and medical substance administration (ISO/DIS 23908:2023); German and English version prEN ISO 23908:2023
DIN EN ISO 11137-1
Sterilization of health care products - Radiation - Part 1: Requirements for the development, validation and routine control of a sterilization process for medical devices (ISO/FDIS 11137-1:2023); German and English version FprEN ISO 11137-1:2023
DIN EN ISO 10993-4/A1
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
prEN 868-3
Packaging for terminally sterilized medical devices - Part 3: Paper for use in the manufacture of paper bags (specified in EN 868-4) and in the manufacture of pouches and reels (specified in EN 868-5) - Requirements and test methods
DIN EN ISO/IEEE 11073-10700
Health informatics - Device interoperability - Part 10700: Point‐of‐care medical device communication - Standard for base requirements for participants in a service‐oriented device connectivity (SDC) system (ISO/IEEE FDIS 11073-10700:2024); English version prEN ISO IEEE 11073-10700:2024