This is a list of all the standards that were updated in the first quarter of 2020. The list is alphabetical. Documents that have been replaced will link to its replacement. A complete list on the subject can be found here.
- AAMI/ISO-80369-1 (2019 Edition) – Small bore connectors for liquids and gases in healthcare applications – Part 1: General requirements.
- BS-EN-ISO-80601-2-12 (2020 Edition) – Medical electrical equipment
- BS-EN-ISO-80601-2-13 (2012/A2 Edition) – Medical electrical equipment
- DIN-EN-13544-1 (Replaced) – Part 1: Nebulizing Systems and Their Components, Respiratory Therapy Equipment
- DIN-EN-1820 (Replaced) – Anaesthetic Reservoir Bags
- DIN-EN-ISO-10651-6 (Replaced) – Part 6: Home-Care Ventilatory Support Devices, Lung Ventilators for Medical Use
- 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 Ed. Amendment 1) –
Non-invasive sphygmomanometers – Part 2: Clinical investigation of intermittent automated measurement type - 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
- SS-EN-ISO-17510 (2020 Edition) – Medical devices – Sleep apnoea breathing therapy – Masks and application accessories
- SS-EN-ISO-17510-2 (Replaced) – Sleep apnoea breathing therapy – Part 2: Masks and application accessories
- 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
- SS-EN-ISO-18562-2 (2020 Edition) – Biocompatibility evaluation of breathing gas pathways in healthcare applications – Part 2: Tests for emissions of particulate matter
- 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
- SS-EN-ISO-18562-4 (2020 Edition) – Biocompatibility evaluation of breathing gas pathways in healthcare applications – Part 4: Tests for leachables in condensate
- SS-EN-ISO-5356-2 (2012 Ed. Amendment 1) –
Anaesthetic and respiratory equipment – Conical connectors – Part 2: Screw-threaded weight-bearing connectors - 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
- SS-EN-ISO-80601-2-13 (2012 Ed. Amendment 1) –
Medical electrical equipment – Part 2-13: Particular requirements for basic safety and essential performance of an anaesthetic workstation - SS-EN-ISO-80601-2-13 (2012 Ed. Amendment 2) –
Medical electrical equipment – Part 2-13: Particular requirements for basic safety and essential performance of an anaesthetic workstation - 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
- SS-EN-ISO-81060-2 (2019 Edition) – Non-invasive sphygmomanometers – Part 2: Clinical investigation of intermittent automated measurement type
- SS-EN-ISO-8185 (Withdrawn) – Respiratory tract humidifiers for medical use – Particular requirements for respiratory humidification systems
Some of these standards are available for our subscription service. Documents purchased this way are uploaded to a personalized website so you and your team can access the standards you need anywhere. For more information, read here. For all our other services to help you keep compliant, check out a full list here.
To search up other standards by ICS subject check here.