Healthcare

prEN 14476 - Chemical disinfectants and antiseptics - Quantitative suspension test for the evaluation of virucidal activity in the medical area - Test method and requirements (Phase 2/Step 1)
Categories: Disinfectants and antiseptics
Committee: CEN/TC 216 (Chemical disinfectants and antiseptics)
Origin: CEN
Close date: 01 Aug 2024
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prEN IEC 80601-2-23:2024 - Medical electrical equipment - Part 2-23: Particular requirements for the basic safety and essential performance of transcutaneous partial pressure monitoring equipment
Categories: Medical equipment. Diagnostic
Committee: CLC/TC 62 (error)
Origin: CENELEC
Close date: 02 Aug 2024
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IEC 80601-2-23 ED1 - Medical electrical equipment - Part 2-23: Particular requirements for the basic safety and essential performance of transcutaneous partial pressure monitoring equipment
Categories: Medical equipment. Diagnostic
Committee: IEC/TC 62 (Electrical equipment in medical practice)
Origin: IEC
Close date: 02 Aug 2024
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IEC 60061-PR2024-1 ED3 - Lamp caps and holders together with gauges for the control of interchangeability and safety - Proposal for GJ6.6d-2-x fits with keys in IEC 60061-1 (7004-188) and IEC 60061-2 (7005-188)
Categories: Medical equipment. Diagnostic
Committee: IEC/TC 34 (Lighting)
Origin: IEC
Close date: 02 Aug 2024
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prEN ISO 10993-7 - Biological evaluation of medical devices - Part 7: Ethylene oxide sterilization residuals (ISO/DIS 10993-7:2024)
Categories: Medical devices. Biological evaluation
Committee: CEN/TC 206 (Biological and clinical evaluation of medical devices)
Origin: CEN
Close date: 12 Aug 2024
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ISO/DIS 10993-7 - Biological evaluation of medical devices — Part 7: Ethylene oxide sterilization residuals
Categories: Medical devices. Biological evaluation
Committee: ISO/TC 194 (Biological and clinical evaluation of medical devices)
Origin: ISO
Close date: 12 Aug 2024
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ISO/DIS 13504 - Dentistry — General requirements for instruments and related accessories used in dental implant placement and treatment
Categories: Dental instruments
Committee: ISO/TC 106/SC 4 (Dental instruments)
Origin: ISO
Close date: 13 Aug 2024
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prEN ISO 13504 - Dentistry - General requirements for instruments and related accessories used in dental implant placement and treatment (ISO/DIS 13504:2024)
Categories: Dental instruments
Committee: CEN/TC 55 (Dentistry)
Origin: CEN
Close date: 13 Aug 2024
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ISO/DIS 16671.2 - Ophthalmic implants — Irrigating solutions for ophthalmic surgery
Categories: Medical equipment. Ophthalmic
Committee: ISO/TC 172/SC 7 (Ophthalmic optics and instruments)
Origin: ISO
Close date: 14 Aug 2024
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prEN ISO 16671 - Ophthalmic implants - Irrigating solutions for ophthalmic surgery (ISO/DIS 16671.2:2024)
Categories: Medical equipment. Ophthalmic
Committee: CEN/TC 170 (Ophthalmic optics)
Origin: CEN
Close date: 14 Aug 2024
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EN ISO 10993-12:2021/prA1 - Biological evaluation of medical devices - Part 12: Sample preparation and reference materials - Amendment 1 (ISO 10993 12:2021/DAM 1:2024)
Categories: Medical devices. Biological evaluation
Committee: CEN/TC 206 (Biological and clinical evaluation of medical devices)
Origin: CEN
Close date: 14 Aug 2024
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ISO/DIS 4823 - Dentistry — Elastomeric impression and bite registration materials
Categories: Dental materials
Committee: ISO/TC 106/SC 2 (Prosthodontic materials)
Origin: ISO
Close date: 14 Aug 2024
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ISO 10993-12:2021/DAmd 1 - Biological evaluation of medical devices — Part 12: Sample preparation and reference materials — Amendment 1
Categories: Medical devices. Biological evaluation
Committee: ISO/TC 194 (Biological and clinical evaluation of medical devices)
Origin: ISO
Close date: 14 Aug 2024
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prEN ISO 4823 - Dentistry - Elastomeric impression and bite registration materials (ISO/DIS 4823:2024)
Categories: Dental materials
Committee: CEN/TC 55 (Dentistry)
Origin: CEN
Close date: 14 Aug 2024
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ISO/DIS 14155 - Clinical investigation of medical devices for human subjects — Good clinical practice
Categories: Medical devices. Biological evaluation
Committee: ISO/TC 194 (Biological and clinical evaluation of medical devices)
Origin: ISO
Close date: 15 Aug 2024
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prEN ISO 10993-1 - Biological evaluation of medical devices - Part 1: Requirements and general principles for the evaluation of biological safety within a risk management process (ISO/DIS 10993-1:2024)
Categories: Medical devices. Biological evaluation
Committee: CEN/TC 206 (Biological and clinical evaluation of medical devices)
Origin: CEN
Close date: 19 Aug 2024
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IEC 63489 ED1 - DB - Common data concepts for smart manufacturing
Categories: Medical equipment. General
Committee: IEC/TC 65 (Industrial-process measurement, control and automation)
Origin: IEC
Close date: 23 Aug 2024
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IEC 80601-2-31 ED1 - Medical electrical equipment - Part 2-31: Particular requirements for the basic safety and essential performance of external cardiac pacemakers with internal power source
Categories: Medical equipment. General
Committee: IEC/TC 62 (Electrical equipment in medical practice)
Origin: IEC
Close date: 23 Aug 2024
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prEN IEC 80601-2-31:2024 - Medical electrical equipment - Part 2-31: Particular requirements for the basic safety and essential performance of external cardiac pacemakers with internal power source
Categories: Medical equipment. General
Committee: CLC/TC 62 (error)
Origin: CENELEC
Close date: 23 Aug 2024
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ISO/DIS 11980 - Ophthalmic optics — Contact lenses and contact lens care products — Guidance for clinical investigations
Categories: Medical equipment. Ophthalmic
Committee: ISO/TC 172/SC 7 (Ophthalmic optics and instruments)
Origin: ISO
Close date: 26 Aug 2024
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