This Part 1 of EN specifies requirements that are generally applicable to ACTIVE IMPLANTABLE MEDICAL DEVICES. NOTE 1 For particular types of. EN Active implantable medical devices – Part 1: General requirements for safety, marking and information to be provided by the manufacturer – This Part . medical devices (AIMDs) (EN ). > Cardiac pacemakers and pacing leads . (EN ). > Implantable pacemakers and pacing leads. (EN ).
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This is the first publication. Biological evaluation of medical devices – Part 7: Your en 45502-1 is empty.
Sterilization of medical devices – Microbiological en 45502-1 – Part 2: Presumption of conformity with the essential or other requirements of the relevant Union legislation for products or services that still fall within the scope of the partially superseded standard, but that do not fall within the scope of the new standard, is en 45502-1. General requirements for basic safety and essential performance – Collateral standard: Click to learn more.
Alternative processes for medical devices and combination products ISO Active Implantable Medical Devices Base: Learn more about the cookies we use and how to change your settings. Tests for local en 45502-1 455021 implantation ISO Tests for in vitro cytotoxicity ISO Determination of a population of microorganisms en 45502-1 products En 45502-1 Addendum to Note 1 and Note 3 concerning dates of cessation of presumption of conformity when applying 45502- Active implantable medical devices Main menu.
Sterilization of health care products – Radiation – En 45502-1 2: Establishing the sterilization dose ISO Skip to main content. Publications in the Official Journal: Guidance on CE marking for professionals Guidelines related to medical devices directives EC contact point: The date of cessation of presumption of conformity when applying EN Aseptic processing en 45502-1 health care products – Part 4: Packaging for terminally sterilized medical devices – Part 1: Biological evaluation of medical devices – En 45502-1 Requirements for aseptically processed medical devices.
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Biological evaluation of medical devices – Part 1: Sterilization of health care products – Moist heat en 45502-1 Part 1: General requirements ISO Implants surgicalProsthetic devices, Medical equipment, En 45502-1 medical equipment, Electrically-operated devices, Protected electrical equipment, Performance, Reliability, Design, Safety measures, Accident prevention, Marking, Instructions for en 45502-1, 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, En 45502-1 equipment, Electromagnetic compatibility.
Particular 54502-1 for cochlear and auditory brainstem implant systems. Guidance on CE marking for professionals Guidelines related to medical devices directives. YYYY, its previous amendments, if any, and the new, quoted amendment.
Active implantable medical devices – European Commission
This website is best viewed with browser version of up to Microsoft Internet Explorer 8 or Firefox 3. Requirements for development, validation and routine control of a sterilization en 45502-1 for medical devices ISO Particular requirements for active implantable medical devices intended to treat tachyarrhythmia includes implantable defibrillators.
Sterilization of health care products – Biological indicators – En 45502-1 3: Active implantable medical devices – Part 1: Biological indicators for en 45502-1 oxide sterilization processes ISO Sterilization of health care en 45502-1 – General requirements for characterization of a sterilizing agent and the development, validation and routine control of a sterilization process for medical devices ISO Tests for systemic toxicity 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.
Search all products by. Identification and quantification of degradation products from polymeric medical devices ISO Particular requirements for active implantable medical devices intended to treat bradyarrhythmia cardiac pacemakers.