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New Medical Equipment Standards for the 2nd Quarter 2017

Kyle Bach

Document Center Inc. is pleased to announce that the following New Standards on Medical Equipment are now available:

  • IEC 60601-2-75, Edition 1.0, Medical electrical equipment – Part 2-75: Particular requirements for the basic safety and essential performance of photodynamic therapy and photodynamic diagnosis equipment
  • IEC 60601-4-1, Edition 1.0, Medical electrical equipment – Part 4-1: Guidance and interpretation – Medical electrical equipment and medical electrical systems employing a degree of autonomy
  • ISO 80002-2, 1st Edition, Medical device software – Part 2: Validation of software for medical device quality systems
  • PD IEC 60601-4-1, 2017 Edition, Medical electrical equipment. Guidance and interpretation. Medical electrical equipment and medical electrical systems employing a degree of autonomy
  • UNE EN ISO 15223-1, 2017 Edition, Medical devices – Symbols to be used with medical device labels, labelling and information to be supplied – Part 1: General requirements
  • DIN EN ISO 5366-1, Withdrawn and replace by DIN EN ISO 5366, Anaesthetic and respiratory equipment – Tracheostomy tubes – Part 1: Tubes and connectors for use in adults
  • ISO 80601-2-74, 1st Edition, Medical electrical equipment – Part 2-74: Particular requirements for basic safety and essential performance of respiratory humidifying equipment
  • BS EN 80369-5, 2016 Edition, Small-bore connectors for liquids and gases in healthcare applications. Connectors for limb cuff inflation applications 
  • ISO 7886-1, 2nd Edition, Sterile hypodermic syringes for single use – Part 1: Syringes for manual use
  • UNE EN ISO 7153-1, 2017 Edition, Surgical instruments – Materials – Part 1: Metals
  • IEC 60601-2-2, Edition 6.0, Medical electrical equipment – Part 2-2: Particular requirements for the basic safety and essential performance of high frequency surgical equipment and high frequency surgical accessories
  • IEC 60601-2-2-RL, Edition 6.0, Medical electrical equipment – Part 2-2: Particular requirements for the basic safety and essential performance of high frequency surgical equipment and high frequency surgical accessories
  • UNE EN ISO 7153-1, 2017 Edition, Surgical instruments – Materials – Part 1: Metals
  • ANSI/AAMI/ISO-7198, 2016 Edition, Cardiovascular implants – Tubular vascular prostheses
  • ANSI/AAMI/ISO-7199, 2016 Edition, Cardiovascular implants and artificial organs – Blood-gas exchangers (oxygenators)
  • ASTM F1828, 2017 Edition, Standard Specification for Ureteral Stents
  • ASTM F2064, 2017 Edition, Standard Guide for Characterization and Testing of Alginates as Starting Materials Intended for Use in Biomedical and Tissue Engineered Medical Product Applications
  • ASTM F2180, 2017 Edition, Standard Specification for Metallic Implantable Strands and Cables
  • ASTM F2706, 20107 Edition, Standard Test Methods for Occipital-Cervical and Occipital-Cervical-Thoracic Spinal Implant Constructs in a Vertebrectomy Model
  • ASTM F2902, 2016 Edition with Editorial Correction (E1), Standard Guide for Assessment of Absorbable Polymeric Implants
  • ASTM F384, 2017 Edition, Standard Specifications and Test Methods for Metallic Angled Orthopedic Fracture Fixation Devices
  • ASTM F543, 2017 Edition, Standard Specification and Test Methods for Metallic Medical Bone Screws
  • ASTM F67, 2013 Edition Reapproved in 2017, Standard Specification for Unalloyed Titanium, for Surgical Implant Applications (UNS R50250, UNS R50400, UNS R50550, UNS R50700)
  • BS ISO 18192-3, 2017 Edition, Implants for surgery. Wear of total intervertebral spinal disc prostheses. Impingement-wear testing and corresponding environmental conditions for test of lumbar prostheses under adverse kinematic conditions
  • BS ISO 19233-1, 2017 Edition, Implants for surgery. Orthopaedic joint prosthesis. Procedure for producing parametric 3D bone models from CT data of the knee
  • ISO 18192-3, 1st Edition, Implants for surgery – Wear of total intervertebral spinal disc prostheses – Part 3: Impingement-wear testing and corresponding environmental conditions for test of lumbar prostheses under adverse kinematic conditions
  • ISO 14708-3, 1st Edition, Implants for surgery – Orthopaedic joint prosthesis – Part 1: Procedure for producing parametric 3D bone models from CT data of the knee
  • ISO 11491, 1st Edition, Implants for surgery – Determination of impact resistance of ceramic femoral heads for hip joint prostheses
  • ISO 19233-1, 1st Edition, Implants for surgery – Orthopaedic joint prosthesis – Part 1: Procedure for producing parametric 3D bone models from CT data of the knee
  • IEC 60601-2-43-AM1, Edition 2.0 with Amendment 1, Amendment 1 – Medical electrical equipment – Part 2-43: Particular requirements for the basic safety and essential performance of X-ray equipment for interventional procedures
  • IEC 60601-2-65-AM1, Edition 1.0 with Amendment 1, Amendment 1 – Medical electrical equipment – Part 2-65: Particular requirements for the basic safety and essential performance of dental intra-oral X-ray equipment  
  • IEC 60601-2-28, Edition 3.0, Medical electrical equipment – Part 2-28: Particular requirements for the basic safety and essential performance of X-ray tube assemblies for medical diagnosis
  • IEC 60601-2-28-RL, Edition 1.0, Medical electrical equipment – Part 2-28: Particular requirements for the basic safety and essential performance of X-ray tube assemblies for medical diagnosis
  • ISO 19614, 1st Edition, Traditional Chinese medicine – Pulse graph force transducer
  • BS EN ISO 11979-8, 2017 Edition, Ophthalmic implants. Intraocular lenses. Fundamental requirements
  • EN ISO 11979-8, 2017 Edition – See BS or DIN Edition, Ophthalmic implants – Intraocular lenses – Part 8: Fundamental requirements
  • ISO 10939, 3rd Edition, Ophthalmic instruments – Slit-lamp microscopes
  • ISO 11979-8, 3rd Edition, Ophthalmic implants – Intraocular lenses – Part 8: Fundamental requirements
  • ISO 15798, 3rd Edition, Ophthalmic implants – Ophthalmic viscosurgical devices
  • ISO 15798-AM1, 3rd Edition with Amendment 1, AMENDMENT 1, Ophthalmic implants – Ophthalmic viscosurgical devices
  • ISO 18476, 1st Edition, Ophthalmic optics and instruments – Free form technology – Spectacle lenses and measurement
  • ISO 22979, 2nd Edition, Ophthalmic implants – Intraocular lenses – Guidance on assessment of the need for clinical investigation of intraocular lens design modifications
  • BS ISO 19611, 2017 Edition, Traditional Chinese medicine. Air extraction cupping device
  • DIN EN ISO 19054, 2017 Edition, Rail systems for supporting medical equipment
  • ISO 19611, 1st Edition, Traditional Chinese medicine – Air extraction cupping device
  • ISO 20308, 1st Edition, Traditional Chinese medicine – Gua Sha instruments
  • ISO 20498-2, 1st Edition, Traditional Chinese medicine – Computerized tongue image analysis system – Part 2: Light environment

For more standards like these, please refer to our Document Center List of Standards on Medical Equipment.