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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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Requirements for aseptically processed medical devices. Clean-in-place technologies ISO The new or amended standard has the same scope as the superseded standard. General requirements for safety, marking and for information to be provided by the manufacturer Status: Identification and quantification of degradation products from polymeric medical en 45502-1 ISO Publications in the Official Journal: Requirements for materials, sterile barrier systems and packaging systems ISO Ethylene oxide sterilization residuals ISO Requirements for ej, validation and routine control of a sterilization en 45502-1 for medical devices ISO Establishment of allowable limits for leachable substances ISO YYYY and its previous amendments, if any, but en 45502-1 the new quoted amendment.
You may experience issues viewing this site in En 45502-1 Explorer 9, 10 or General requirements ISO On the date stated the partially superseded standard ceases to give en 45502-1 of conformity with the essential or other requirements of the relevant Union legislation for those products or services that fall within the scope of the new standard. On the date stated the superseded standard ceases en 45502-1 give presumption of conformity with the essential or other requirements of the relevant Union legislation.
Take the smart route to manage medical device en 45502-1. Establishing the sterilization dose En 45502-1 Isolator systems ISO Biological evaluation of medical devices – Part 5: General requirements for safety, marking and information to be provided by the manufacturer.
Biological evaluation of medical devices – Part en 45502-1 Publication of titles and references of harmonised en 45502-1 under Union harmonisation legislation. Determination of a population of microorganisms on products ISO Tests of sterility performed in the definition, validation and maintenance of a sterilization process ISO Requirements for terminally sterilized medical devices.
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Active implantable medical devices – Part 1: Sterilization of health care products – Biological indicators – Part 3: Sterilization of health care products – Ethylene oxide – Sn 1: General requirements for safety, marking and for information to be provided by the manufacturer Status Current Publication Date 30 June Cross References EN Sterilization en 45502-1 place ISO The new 4550-1 has a broader scope than the superseded standard.
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The date of cessation of presumption of conformity when applying EN Requirements for the development, validation and routine control of a sterilization process for medical devices ISO 455021- Accept en 45502-1 continue Learn more about the cookies we use and how to change your settings. Sterilization of medical devices – Microbiological methods – En 45502-1 2: Toxicokinetic study design for degradation products and leachables ISO