Healthcare

EN 60601-2-68:2015/prA1:2023 - Amendment 1 - Medical electrical equipment - Part 2-68: Particular requirements for the basic safety and essential performance of X-ray-based image-guided radiotherapy equipment for use with electron accelerators, light ion beam therapy equipment and radionuclide beam therapy equipment
Categories: Medical equipment.Therapy
Committee: CLC/TC 62 (Electrical equipment in medical practice)
Origin: CENELEC
Close date: 29 Sep 2023
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IEC 60601-2-68/AMD1 ED1 - Amendment 1 - Medical electrical equipment - Part 2-68: Particular requirements for the basic safety and essential performance of X-ray-based image-guided radiotherapy equipment for use with electron accelerators, light ion beam therapy equipment and radionuclide beam therapy equipment
Categories: Medical equipment.Therapy
Committee: IEC/TC 62 (Electrical equipment in medical practice)
Origin: IEC
Close date: 29 Sep 2023
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ISO/DIS 14607 - Non-active surgical implants — Mammary implants — Specific requirements
Categories: Implants for surgery, prosthetics and orthotics
Committee: ISO/TC 150 (Implants for surgery)
Origin: ISO
Close date: 06 Oct 2023
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ISO/DIS 18190 - Anaesthetic and respiratory equipment — General requirements for airway devices and related equipment
Categories: Anaesthetic, respiratory and reanimation equipment
Committee: ISO/TC 121/SC 2 (Airways and related equipment)
Origin: ISO
Close date: 06 Oct 2023
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ISO/DIS 80369-6 - Small bore connectors for liquids and gases in healthcare applications — Part 6: Connectors for neural applications
Categories: Syringes, needles and catheters
Committee: ISO/TC 210 (Quality management and corresponding general aspects for medical devices)
Origin: ISO
Close date: 06 Oct 2023
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prEN ISO 14607 - Non-active surgical implants - Mammary implants - Particular requirements (ISO/DIS 14607:2023)
Categories: Implants for surgery, prosthetics and orthotics
Committee: CEN/TC 285 (Non-active surgical implants)
Origin: CEN
Close date: 06 Oct 2023
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prEN ISO 80369-6 - Small bore connectors for liquids and gases in healthcare applications - Part 6: Connectors for neural applications (ISO/DIS 80369-6:2023)
Categories: Syringes, needles and catheters
Committee: CEN/CLC/JTC 3 (Quality management and corresponding general aspects for medical devices)
Origin: CENELEC
Close date: 06 Oct 2023
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ISO 80369-6 ED2 - Small bore connectors for liquids and gases in healthcare applications - Part 6: Connectors for neuraxial applications
Categories: Syringes, needles and catheters
Committee: IEC/TC 62 (Electrical equipment in medical practice)
Origin: IEC
Close date: 06 Oct 2023
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ISO/DIS 10555-8 - Intravascular catheters — Sterile and single-use catheters — Part 8: Catheters for extracorporeal blood treatment
Categories: Syringes, needles and catheters
Committee: ISO/TC 84 (Devices for administration of medicinal products and catheters)
Origin: ISO
Close date: 11 Oct 2023
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prEN ISO 8536-13 - Infusion equipment for medical use - Part 13: Graduated flow regulators for single use with fluid contact (ISO/DIS 8536-13:2023)
Categories: Transfusion, infusion and injection equipment
Committee: CEN/TC 205 (Non-active medical devices)
Origin: CEN
Close date: 17 Oct 2023
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ISO/DIS 8536-13 - Infusion equipment for medical use — Part 13: Graduated flow regulators for single use with fluid contact
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: 17 Oct 2023
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prEN ISO 17664-2 - Processing of health care products - Information to be provided by the medical device manufacturer for the processing of medical devices - Part 2: Non-critical medical devices (ISO 17664-2:2021)
Categories: Sterilization and disinfection. General
Committee: CEN/TC 204 (Sterilization of medical devices)
Origin: CEN
Close date: 19 Oct 2023
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ISO/DIS 8362-2 - Injection containers and accessories — Part 2: Closures for injection vials
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 2023
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prEN ISO 8362-2 - Injection containers and accessories - Part 2: Closures for injection vials (ISO/DIS 8362-2:2023)
Categories: Transfusion, infusion and injection equipment
Committee: CEN/BT (Bureau Technique)
Origin: CEN
Close date: 23 Oct 2023
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prEN 13795-1 - Surgical clothing and drapes - Requirements and test methods - Part 1: Surgical drapes and gowns
Categories: Hospital equipment
Committee: CEN/TC 205 (Non-active medical devices)
Origin: CEN
Close date: 26 Oct 2023
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prEN 13795-2 - Surgical clothing and drapes - Requirements and test methods - Part 2: Clean air suits
Categories: Hospital equipment
Committee: CEN/TC 205 (Non-active medical devices)
Origin: CEN
Close date: 26 Oct 2023
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prEN 14683 - Medical face masks - Requirements and test methods
Categories: Hospital equipment
Committee: CEN/TC 205 (Non-active medical devices)
Origin: CEN
Close date: 26 Oct 2023
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prEN IEC 80601-2-71:2023 - Medical electrical equipment - Part 2-71: Particular requirements for the basic safety and essential performance of functional near-infrared spectroscopy (NIRS) equipment
Categories: Medical equipment. Diagnostic
Committee: CLC/TC 62 (Electrical equipment in medical practice)
Origin: CENELEC
Close date: 27 Oct 2023
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IEC 80601-2-71 ED2 - Medical electrical equipment - Part 2-71: Particular requirements for the basic safety and essential performance of functional near-infrared spectroscopy (NIRS) equipment
Categories: Medical equipment. Diagnostic
Committee: IEC/TC 62 (Electrical equipment in medical practice)
Origin: IEC
Close date: 27 Oct 2023
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ISO/DIS 13615 - Traditional Chinese Medicine — Atractylodes macrocephala rhizome
Categories: Medicaments
Committee: ISO/TC 249 (Traditional Chinese medicine)
Origin: ISO
Close date: 02 Nov 2023
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