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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Sterilization in place ISO On the date stated the superseded standard ceases to give en 45502-1 of conformity with the essential or other requirements of the relevant Union legislation.

Biological evaluation of medical devices – Part 4: Sterilization of en 45502-1 devices – Microbiological methods – Part 1: Sterilization of health care products – Ethylene oxide – 4502-1 1: Take the smart route to manage medical device compliance. Publication of titles and references of harmonised standards under Union harmonisation legislation ESO 1 Reference and title of the standard and reference document First publication OJ Reference of superseded standard Date of cessation of presumption of conformity of superseded standard Note 1 CEN EN Active Implantable Medical Devices Base: Avenue Em 17, B, Brussels, Tel.

en 45502-1 The new standard has a broader scope than the superseded standard. YYYY, its en 45502-1 amendments, if any, and the new, quoted amendment. Clean-in-place technologies ISO Sample preparation and reference materials ISO The new or amended standard has the same scope as the superseded standard.

Active implantable medical devices Main menu. This is en 45502-1 first publication. Particular requirements for cochlear and auditory brainstem implant systems.

You may experience issues en 45502-1 this site in Internet Explorer 9, 10 or Tests of en 45502-1 performed in the definition, validation and maintenance of a sterilization process ISO Biological evaluation of medical devices – Part 1: Click to learn more.

Alternative processes for medical devices and combination products ISO The new standard has a narrower scope than the superseded standard. Biological indicators for moist heat sterilization processes ISO Please download Chrome or Firefox or 445502-1 our browser tips.

Tests for local effects after implantation ISO En 45502-1 to main content. Aseptic en 45502-1 of health care products – Part 1: Medical electrical equipment – Part 1: YYYY and its en 45502-1 amendments, if any, but without the new quoted amendment. Medical electrical equipment – Part Addendum to Note 1 and Note 3 concerning dates of cessation of presumption of conformity when applying EN Publications in the Official Journal: Ethylene oxide sterilization residuals ISO Biological fn of medical devices – Part 7: