Healthcare

ISO/DIS 18192-3 - Implants for surgery — Wear of total intervertebral spinal disc prostheses — Part 3: Impingement-wear testing and corresponding environmental conditions for test of lumbar and cervical prostheses
Categories: Implants for surgery, prosthetics and orthotics
Committee: ISO/TC 150/SC 5 (Osteosynthesis and spinal devices)
Origin: ISO
Close date: 19 Sep 2024
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ISO 10993-17:2023/DAmd 1 - Biological evaluation of medical devices — Part 17: Toxicological risk assessment of medical device constituents — Amendment 1
Categories: Medical devices. Biological evaluation
Committee: ISO/TC 194 (Biological and clinical evaluation of medical devices)
Origin: ISO
Close date: 25 Sep 2024
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EN ISO 10993-17:2023/prA1 - Biological evaluation of medical devices - Part 17: Toxicological risk assessment of medical device constituents - Amendment 1 (ISO 10993-17:2023/DAmd 1:2024)
Categories: Medical devices. Biological evaluation
Committee: CEN/TC 206 (Biological and clinical evaluation of medical devices)
Origin: CEN
Close date: 25 Sep 2024
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prEN 455-5 - Medical gloves for single use - Part 5: Extractable chemical residues
Categories: Hospital equipment
Committee: CEN/TC 205 (Non-active medical devices)
Origin: CEN
Close date: 26 Sep 2024
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ISO 16840-12:2021/DAmd 1 - Wheelchair seating — Part 12: Envelopment and immersion characterization of seat cushions using a dual semispherical indenter — Amendment 1
Categories: Aids. Adaptation for moving
Committee: ISO/TC 173/SC 1 (Wheelchairs)
Origin: ISO
Close date: 09 Oct 2024
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ISO 16840-13:2021/DAmd 1 - Wheelchair seating — Part 13: Determination of the lateral stability property of a seat cushion — Amendment 1
Categories: Aids. Adaptation for moving
Committee: ISO/TC 173/SC 1 (Wheelchairs)
Origin: ISO
Close date: 09 Oct 2024
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ISO 7176-14:2022/DAmd 1 - Wheelchairs — Part 14: Power and control systems for electrically powered wheelchairs and scooters — Requirements and test methods — Amendment 1: Correction of referred standard
Categories: Aids. Adaptation for moving
Committee: ISO/TC 173/SC 1 (Wheelchairs)
Origin: ISO
Close date: 09 Oct 2024
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ISO 7176-25:2022/DAmd 1 - Wheelchairs — Part 25: Lead-acid batteries and chargers for powered wheelchairs — Requirements and test methods — Amendment 1: Range of charging voltage and range of the minimum and maximum rated DC output voltage for testing
Categories: Aids. Adaptation for moving
Committee: ISO/TC 173/SC 1 (Wheelchairs)
Origin: ISO
Close date: 09 Oct 2024
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ISO 7376:2020/DAmd 1 - Anaesthetic and respiratory equipment — Laryngoscopes for tracheal intubation — Amendment 1: Clarification about optical output and illumination requirements
Categories: Anaesthetic, respiratory and reanimation equipment
Committee: ISO/TC 121/SC 2 (Airways and related equipment)
Origin: ISO
Close date: 17 Oct 2024
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ISO/DIS 11979-4 - Ophthalmic implants — Intraocular lenses — Part 4: Labelling and information
Categories: Medical equipment. Ophthalmic
Committee: ISO/TC 172/SC 7 (Ophthalmic optics and instruments)
Origin: ISO
Close date: 23 Oct 2024
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ISO/DIS 8536-16 - Infusion equipment for medical use — Part 16: Infusion sets for single use with volumetric infusion controllers
Categories: Transfusion, infusion and injection equipment
Committee: ISO/TC 76 (Transfusion, infusion and injection, and blood processing equipment for medical and pharmaceutical use)
Origin: ISO
Close date: 23 Oct 2024
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prEN ISO 11979-4 - Ophthalmic implants - Intraocular lenses - Part 4: Labelling and information (ISO/DIS 11979-4:2024)
Categories: Medical equipment. Ophthalmic
Committee: CEN/TC 170 (Ophthalmic optics)
Origin: CEN
Close date: 23 Oct 2024
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prEN ISO 8536-16 - Infusion equipment for medical use - Part 16: Infusion sets for single use with volumetric infusion controllers (ISO/DIS 8536-16:2024)
Categories: Transfusion, infusion and injection equipment
Committee: CEN/TC 205 (Non-active medical devices)
Origin: CEN
Close date: 23 Oct 2024
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ISO/DIS 27186 - Active implantable medical devices — Four-pole connector system for implantable cardiac rhythm management devices — Dimensional and test requirements
Categories: Implants for surgery, prosthetics and orthotics
Committee: ISO/TC 150/SC 6 (Active implants)
Origin: ISO
Close date: 24 Oct 2024
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IEC 62083 ED3 - Medical device software - Requirements for the safety of radiotherapy treatment planning systems
Categories: Medical equipment.Therapy
Committee: IEC/TC 62 (Electrical equipment in medical practice)
Origin: IEC
Close date: 25 Oct 2024
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prEN IEC 62083:2024 - Medical device software - Requirements for the safety of radiotherapy treatment planning systems
Categories: Medical equipment.Therapy
Committee: CLC/TC 62 (error)
Origin: CENELEC
Close date: 25 Oct 2024
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ISO/DIS 7376-2 - Anaesthetic and respiratory equipment — Part 2: Video laryngoscopes
Categories: Anaesthetic, respiratory and reanimation equipment
Committee: ISO/TC 121/SC 2 (Airways and related equipment)
Origin: ISO
Close date: 28 Oct 2024
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ISO/DIS 80601-2-69 - Medical electrical equipment — Part 2-69: Particular requirements for the basic safety and essential performance of oxygen concentrator equipment
Categories: Anaesthetic, respiratory and reanimation equipment
Committee: ISO/TC 121/SC 3 (Respiratory devices and related equipment used for patient care)
Origin: ISO
Close date: 11 Nov 2024
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ISO/DIS 80601-2-67 - Medical electrical equipment — Part 2-67: Particular requirements for basic safety and essential performance of oxygen-conserving equipment
Categories: Anaesthetic, respiratory and reanimation equipment
Committee: ISO/TC 121/SC 3 (Respiratory devices and related equipment used for patient care)
Origin: ISO
Close date: 11 Nov 2024
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