Apakah standard yang disyorkan semasa melakukan ujian prestasi? | What are the recommended standards used when conducting performance testing?

Bergantung kepada jenis peranti, laporan hendaklah dikemukakan mengikut standard yang disenaraikan di bawah : | Depending on the type of devices, the reports shall be submitted as per standards listed below :

  • ISO 594-1: Conical Fittings with 6% (Lure) Taper for Syringes, Needles and Certain Other Medical Equipment - Part 1: General Specifications
  • ISO 594-2: Conical Fittings with 6% (Lure) Taper for Syringes, Needles and Certain Other Medical Equipment - Part 1: Lock Fittings
  • ISO 720: 1985: Glass - Hydrolytic Resistance of Glass Grains a 121º C - Method of Test and Classification
  • ISO 7864: Sterile Hypodermic Needles for Single Use
  • ISO 7886-1: Sterile Hypodermic Syringes for Single Use - Part 1: Syringes for Manual Use
  • ISO 7886-2: First Edition 1996-05-15: Sterile Hypodermic syringes for Syringes for Single Use - Part 2: Syringes for use with power driven syringe pumps
  • ISO 7886-3: First Edition 1996-05-15: Sterile Hypodermic syringes for Syringes for Single Use - Part 3: Auto-disposable syringes for fixed-dose immunization
  • ISO 11040-4: Prefilled Syringes Part 4: Glass Barrel for Injectables
  • ISO 10993-1: Biological Evaluation of Medical Devices - Part 1: Evaluation and Testing
  • ISO 11608-1: Pen-Injectors for Medical Use – Part 1: Pen-injectors – Requirements and test methods
  • ISO 11608-2: Pen-Injectors for Medical Use – Part 2: Needles – Requirements and test methods
  • ISO 11608-3: Pen-Injectors for Medical Use – Part 3: Finished Cartridge – Requirements and test methods
  • ISO 11608-4: Pen-Injectors for Medical Use – Part 4: Requirements and test methods for electronic and electromechanical pen-injectors
  • ISO 21649: Needle-Free Injectors for Medical Use - Requirements and Test Methods.
  • ASTM D4169:, Standard Practice for Performance Testing of Shipping Containers and Systems
  • ANSI/AAMI/ISO 17665-1: 2006, Sterilization of Health Care Products – Moist Heat – Part 1: Requirements for the development, validation, and routine control of a sterilization process for medical devices
  • ANSI/AAMI/ISO 11135-1:2007,Sterilization of Health Care Products – Ethylene oxide – Part 1: Requirements for development, validation, and routine control of a sterilization process for medical device
  • USP 27:2004, Sterility, Biocompatibility, Biological Tests and Assays, Bacterial Endotoxin Test (LAL), Pyrogen Test (USP Rabbit Test), or other applicable tests related to the drug/biological product and delivery of the drug/biological product
  • AAMI/ANSI/ISO 11737-1:2006, Sterilization of medical devices-microbiological methods-Part 1: Determination of the population of microorganisms on product
  • ANSI/AAMI/ISO 11607:2006, Packaging for terminally sterilized medical devices The report of all tests mentioned above must include the objectives, methodology, results, analysis and manufacturer's conclusions.
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