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Medical device traceability enabled by unique device identification (UDI)
60.60 Standard published
Dentistry - Guidance on the classification of dental devices and accessories
60.60 Standard published
Medical gloves for single use - Guidance for selection
60.60 Standard published
Inhalational nitric oxide systems - Part 2: Supply systems
60.60 Standard published
General guidance on the equipment used for inhaled nitric oxide therapy
60.60 Standard published
Luer connectors - A report to CEN chef from the CEN forum task group "Luer fittings"
60.60 Standard published
Joint implants - Part 1: Novel methods for isolating wear particles from joint replacements and related devices
60.60 Standard published
Joint implants - Part 2: Tiered toolkit approach to evaluate the biological impact of wear particles from joint replacements and related devices
60.60 Standard published
Medical vehicles and their equipment - Air ambulances - Part 1: Requirements for medical devices used in air ambulances
40.60 Close of voting
Medical vehicles and their equipment - Air ambulances - Part 2: Operational and technical requirements for air ambulances
40.60 Close of voting
Lung ventilators - Part 1: Particular requirements for critical care ventilators
10.00 Proposal for new project registered
Medical electrical equipment - Part 1: Particular requirements for the safety of lung ventilators - Critical care ventilators (IEC 60601-2-12:2001)
10.00 Proposal for new project registered
Biological evaluation of medical devices - Part 23: Tests for irritation (ISO 10993-23:2021)
40.60 Close of voting
Packaging for terminally sterilized medical devices - Part 1: Requirements for materials, sterile barrier systems and packaging systems (ISO 11607-1:2019)
40.60 Close of voting
Packaging for terminally sterilized medical devices - Part 2: Validation requirements for forming, sealing and assembly processes (ISO 11607-2:2019)
40.60 Close of voting
Clinical investigation of medical devices for human subjects - Good clinical practice (ISO 14155:2020)
40.60 Close of voting
Medical devices utilizing animal tissues and their derivatives - Part 1: Application of risk management (ISO 22442-1:2020)
40.60 Close of voting
Medical devices utilizing animal tissues and their derivatives - Part 2: Controls on sourcing, collection and handling (ISO 22442-2:2020)
40.60 Close of voting
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