EN 45502-1 PDF

EN Active implantable medical devices – Part 1: General requirements for safety, marking and information to be provided by the manufacturer. 30 Jun BS EN Implants for surgery. Active implantable medical devices. General requirements for safety, marking and for information to. 22 May I.S. EN Implants for surgery – Active implantable medical devices – Part 1: General requirements for safety, marking and for.

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Alternative processes for medical devices and combination products ISO Determination of a population of microorganisms on products ISO Sterilization of health care products – Radiation – Part 1: Requirements for aseptically processed medical devices. Report error on page.

We use cookies to make our website easier to use and to better understand your needs. Tests for systemic toxicity ISO Chemical characterization of materials ISO Although the list is updated regularly, it may not be complete and it does not have any legal validity; only publication in the Official Journal gives legal effect.

General requirements for safety, marking and information to be provided by the manufacturer. Date of cessation of presumption of conformity of superseded standard Note 1.

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45502-11 for terminally sterilized medical devices – Part 1: Sterilization of health care products – Moist heat – Part 1: Clinical investigation of medical devices for human subjects – Good clinical practice ISO Framework for identification and quantification of potential degradation products ISO Active implantable dn devices.

Particular requirements for active implantable medical devices intended to treat tachyarrhythmia includes implantable defibrillators.

Active implantable medical devices – European Commission

Medical devices – Application of risk management to medical devices ISO When you use our service you can be assured the latest editions and easy access. General requirements ISO General requirements for safety, marking and information to be provided by the manufacturer Status: Contact us svenska Login.

Biological evaluation of medical devices – Part 5: General requirements for basic safety and essential performance IEC Aseptic processing of health care products – Ne 7: Legal notice Cookies Contact Search. Biological evaluation of medical devices – Part 1: Tests for genotoxicity, carcinogenicity and reproductive toxicity ISO Shopping cart Close cart 0, foreach: The date of cessation of presumption of conformity when applying EN Read more about SIS Subscriptions.

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Implants surgicalProsthetic devices, Medical equipment, Electrical medical equipment, Electrically-operated devices, Protected electrical equipment, Performance, Reliability, Design, Safety measures, Accident prevention, Marking, Instructions for use, Hazards, Packaging, Packages, Sterile equipment, Delivery, Compatibility, Biological analysis and testing, Electrical safety, Electrical testing, Dielectric-strength tests, Impulse-voltage tests, Electrostatics, Electric charge, Leakage currents, Voltage, Defibrillators, Temperature, Durability, Life durabilityMechanical testing, Environmental testing, Thermal testing, Endurance testing, Radio-wave hazards, Ultrasonic hazards, Ultrasonic testing, Testing conditions, Test equipment, Electromagnetic 45502-1.

Publications in the Official Journal: Particular requirements for cochlear and auditory brainstem implant systems. Accept and continue Learn more about the cookies we use and how to change your settings. Aseptic processing of health care products – Part 4: General requirements for basic safety and essential performance – Collateral standard: General requirements for safety, marking and for information to be provided by the manufacturer.