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STANDARDS

EUROPEAN AND INTERNATIONAL STANDARDS
MAIN STANDARDS, GUIDELINES AND PHARMACOPOEIA THAT ARE APPLIED IN TIPROMED S.R.L.'S QUALITY SYSTEM.

standard
  • ISO 13485 Medical devices - Management systems for quality. Requirements for regulatory purposes
  • ISO 11135-1 Sterilisation of health care products - Ethylene oxide - Part 1: Requirements for development, validation and routine control of a sterilisation process for medical devices
  • ISO 11138-2 Sterilisation of health care products - Part 2: Biological indicators for ethylene oxide sterilisation
  • F.U.I. or F.U. Official Pharmacopoeia of the Italian Republic
  • Ph. Eur. European Pharmacopoeia
  • EN 556 Medical Devices' Sterilisation - Requirements for devices labeled "sterile"
  • ISO 14971 Medical devices - Application of risk management to medical devices
  • ISO 10993 - 1 Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process
  • ISO 10993 - 3 Biological evaluation of medical devices - Part 3: Tests for genotoxicity, carcinogenicity and reproductive toxicity
  • ISO 10993 - 4 Biological evaluation of medical devices - Part 4: Selection of tests related to blood interaction
  • ISO 10993 - 5 Biological evaluation of medical devices - Part 5: Tests for in vitro cytotoxicity
  • ISO 10993 - 6 Biological evaluation of medical devices - Part 6: Tests for local effects after implantation
  • ISO 10993 - 7 Biological evaluation of medical devices - Part 7: Ethylene oxide sterilisation residuals
  • ISO 10993 - 10 Biological evaluation of medical devices - Part 10: Tests for irritation and delayed-type hypersensitivity
  • ISO 10993 - 11 Biological evaluation of medical devices - Part 11: Tests for systemic toxicity
  • ISO 14644 - 1 Cleanrooms and associated controlled environments-Classification of air cleanliness
  • ISO 10555 - 1 Sterile single-use intravascular catheters - General requirements
  • ISO 10555 - 5 Sterile single-use intravascular catheters - Peripheral catheters with internal needle
  • ISO 2859-1 Sampling procedures for attributes
  • ISO 594 - 2 Conical fittings 6% (Luer) for syringe needles and other types of equipment - Luer Lock Connection
  • ISO 594 - 1 Conical fittings 6% (Luer) for syringe needles and other types of equipment - General requirements
  • ISO 15223 - 1 Symbols to be used with medical device labels, labeling and information to be provided
  • ASTM F640 Standard Test method for the determination of the radiopacity of plastic materials for medical use.
  • EN ISO 11607-1 Packaging for terminally sterilised medical devices - Part 1: Requirements for materials, sterile barrier systems and packaging systems
  • ISO 8536 - 4 Infusion equipment for medical use - Part 4: Disposable Infusion Set, fed by gravity
  • ISO 8536 - 9 Infusion equipment for medical use - Part 9: Tubes for fluids for use with pressure infusion equipment
  • ISO 8536 - 10 Infusione equipment for medical use - Part 10: Accessories for fluid tubes for use with pressure infusion equipment
  • ECC GMP Medicinal products for human and veterinary use: Good manufacturing practices (EudraLex Vol 4 - Annex 1) Manufacture of sterile medicinal products
  • UNI EN ISO 11607-2 Packaging for terminally sterilized medical devices - Part 2: Validation requirements for forming, sealing and assembly processes
  • ASTM F1980 Standard Guide for accelerated aging of the packaging of medical devices - Part 1: Requirements for materials, sterile barrier systems and packaging systems
  • Directive 93/42/EEC Medical Device Directive EEC and its amendments and additions (Dir. 2007/47/EEC).
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