Here is a list of all the updates for standards on health care technology for the first quarter this year. Follow us for more updates!
- AAMI/ISO-80369-1 (2019 Edition) – Small bore connectors for liquids and gases in healthcare applications – Part 1: General requirements.
- BS-EN-ISO-80601-2-13 (2012/A2 EDITION) – Medical electrical equipment
- DIN-EN-ISO-27427 (2020 EDITION) – Anaesthetic and respiratory equipment – Nebulizing systems and components (ISO 27427:2013); German version EN ISO 27427:2019
- DIN-EN-13544-1 (REPLACED) – Part 1: Nebulizing Systems and Their Components, Respiratory Therapy Equipment
- DIN-EN-ISO-5362 (2019 Edition) – Anaesthetic reservoir bags (ISO 5362:2006)
- DIN-EN-1820 (REPLACED) – Anaesthetic Reservoir Bags
- DIN-EN-ISO-80601-2-79 (2020 Edition) – Medical electrical equipment – Part 2-79: Particular requirements for basic safety and essential performance of ventilatory support equipment for ventilatory impairment (ISO 80601-2-79:2018)
- DIN-EN-ISO-10651-6 (REPLACED) – Part 6: Home-Care Ventilatory Support Devices, Lung Ventilators for Medical Use
- DIN-EN-ISO-80601-2-80 (2020 Edition) – Medical electrical equipment – Part 2-80: Particular requirements for basic safety and essential performance of ventilatory support equipment for ventilatory insufficiency (ISO 80601-2-80:2018)
- ISO-80601-2-12 (2nd Edition) – Medical electrical equipment – Part 2-12: Particular requirements for basic safety and essential performance of critical care ventilators
- ISO-81060-2 (3rd Edition) – Non-invasive sphygmomanometers – Part 2: Clinical investigation of intermittent automated measurement type
- ISO-81060-2-AM1 (3rd Ed. Amendment 1) – AMENDMENT 1, Part 2: Clinical investigation of intermittent automated measurement type, Non-invasive sphygmomanometers
- ISO-81060-5 (1st Edition) – Non-invasive sphygmomanometers – Part 5: Requirements for the repeatability and reproducibility of NIBP simulators for testing of automated non-invasive sphygmomanometers
- PD-ISO-81060-5 (2020 Edition) – Non-invasive sphygmomanometers
- SS-EN-17250 (2020 Edition) – Foodstuffs – Determination of ochratoxin A in spices, liquorice, cocoa and cocoa products by IAC clean-up and HPLC-FLD
- SS-EN-ISO-11117 (2019 Edition) – Gas cylinders – Valve protection caps and guards – Design, construction and tests (ISO 11117:2019)
- SS-EN-ISO-11197 (2019 Edition) – Medical supply units (ISO 11197:2019)
- SS-EN-ISO-17510 (2020 Edition) – Medical devices – Sleep apnea breathing therapy – Masks and application accessories (ISO 17510:2015)
- SS-EN-ISO-17510-2 (REPLACED) Sleep apnea breathing therapy – Part 2: Masks and application accessories (ISO 17510-2:2007)
- SS-EN-ISO-17510 (2020 Edition) – Medical devices – Sleep apnoea breathing therapy – Masks and application accessories (ISO 17510:2015)
- SS-EN-ISO-18562-1 (2020 Edition) – Biocompatibility evaluation of breathing gas pathways in healthcare applications – Part 1: Evaluation and testing within a risk management process (ISO 18562-1:2017)
- SS-EN-ISO-18562-2 (2020 Edition) – Biocompatibility evaluation of breathing gas pathways in healthcare applications – Part 2: Tests for emissions of particulate matter (ISO 18562-2:2017)
- SS-EN-ISO-18562-3 (2020 Edition) – Biocompatibility evaluation of breathing gas pathways in healthcare applications – Part 3: Tests for emissions of volatile organic compounds (VOCs) (ISO 18562-3:2017)
- SS-EN-ISO-18562-4 (2020 Edition) – Biocompatibility evaluation of breathing gas pathways in healthcare applications – Part 4: Tests for leachables in condensate (ISO 18562-4:2017)
- SS-EN-ISO-5356-2-AM1 (2012 Ed. Amendment 1) – Anaesthetic and respiratory equipment – Conical connectors – Part 2: Screw-threaded weight-bearing connectors – Amendment 1 (ISO 5356-2:2012/Amd 1:2019)
- SS-EN-ISO-80601-2-12 (2020 Edition) – Medical electrical equipment – Part 2-12: Particular requirements for basic safety and essential performance of critical care ventilators (ISO 80601-2-12:2020)
- SS-EN-ISO-80601-2-13-AM1 (2012 Ed. Amendment 1) – Medical electrical equipment – Part 2-13: Particular requirements for basic safety and essential performance of an anaesthetic workstation – Amendment 1 (ISO 80601-2-13:2011/Amd 1:2015)
- SS-EN-ISO-80601-2-13-AM2 (2012 Ed. Amendment 2) – Medical electrical equipment – Part 2-13: Particular requirements for basic safety and essential performance of an anaesthetic workstation – Amendment 1 (ISO 80601-2-13:2011/Amd 1:2015)
- SS-EN-ISO-80601-2-74 (2020 Edition) – Medical electrical equipment – Part 2-74: Particular requirements for basic safety and essential performance of respiratory humidifying equipment (ISO 80601-2-74:2017)
- SS-EN-ISO-81060-2 (2019 Edition) – Non-invasive sphygmomanometers – Part 2: Clinical investigation of intermittent automated measurement type (ISO 81060-2:2018)
- SS-EN-ISO-8185 (Cancelled) – Respiratory tract humidifiers for medical use – Particular requirements for respiratory humidification systems (ISO 8185:2007)
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