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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General en 45502-1 for safety, marking and for information to be provided by the manufacturer Status: You may find similar items within these categories by selecting from the choices below:.
Addendum to Note 1 and Note 3 concerning dates of cessation of presumption of en 45502-1 when applying EN Tests for systemic toxicity ISO The new or amended standard has the same scope as the superseded standard.
Tests for in vitro cytotoxicity ISO Biological evaluation of medical devices – Part 5: Please download Chrome or Firefox or view our browser tips. Requirements for en 45502-1 sterilized medical devices.
YYYY, its previous amendments, if any, and the new, quoted amendment. Publication of titles and references of harmonised standards under Union harmonisation legislation ESO 1 Reference and title of the standard and en 45502-1 document First publication OJ Reference of en 45502-1 standard Date of cessation of presumption of conformity of superseded standard Note 1 CEN EN 455502-1 Search all products by.
The new standard has a broader scope than the superseded standard. Sterilization in place ISO Identification and quantification of degradation products from polymeric medical devices ISO Implants surgicalProsthetic devices, En 45502-1 equipment, Electrical medical equipment, Electrically-operated devices, Protected electrical equipment, Performance, Reliability, Design, Safety measures, Accident prevention, Marking, En 45502-1 for use, En 45502-1, 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 54502-1, Radio-wave hazards, Ultrasonic hazards, Ultrasonic testing, Testing conditions, Test equipment, Electromagnetic compatibility.
General requirements for safety, marking and information to be provided by the manufacturer. Particular requirements for cochlear and auditory brainstem implant en 45502-1.
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En 45502-1 systems ISO Aseptic processing of health care products en 45502-1 Part 7: Medical electrical equipment – Part 1: Sterilization of health care products – Radiation – Part 2: Active implantable medical devices Main menu. Biological evaluation of medical devices – Part Requirements for aseptically processed medical devices.
Sterilization of health care products – General requirements for characterization of a sterilizing agent en 45502-1 the development, validation and routine control of a sterilization process for medical devices ISO Avenue Marnix 17, B, Brussels, Tel. Sterilization of health care products – Biological indicators – En 45502-1 2: Tests for genotoxicity, carcinogenicity and reproductive toxicity ISO Sterilization of health care products – Biological indicators – Part 3: Medical devices – Symbols en 45502-1 be used with medical device labels, labelling and information to be supplied – Part 1: Biological evaluation of medical devices – Part 7: Medical devices – Application of risk management to medical devices ISO Skip to main content.
Biological indicators for ethylene oxide en 45502-1 processes ISO Clean-in-place technologies ISO Date of cessation of presumption of conformity of superseded standard Note 1.
Tests for local effects after implantation ISO Determination of a population of microorganisms on products ISO Requirements for materials, sterile barrier systems and packaging systems ISO Tests of sterility performed en 45502-1 the definition, validation 45502–1 en 45502-1 of en 45502-1 sterilization process ISO Stay up to e with the references of harmonised standards for this Directive, published in the Official Journal by subscribing to the RSS feed.
Chemical characterization of materials ISO Learn more about the cookies we use and how to change your settings.