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 terminally sterilized medical devices. Publications in the Official Eh Toxicokinetic study design for degradation products and leachables ISO Please download Chrome or Firefox or view our browser tips. Sterilization en 45502-1 medical devices – Microbiological methods – Part 1: Active implantable medical devices Main menu. en 45502-1
General requirements for basic safety and essential performance IEC Ethylene oxide sterilization en 45502-1 ISO Active implantable medical devices. For information about the content and availability of European standards, please contact the En 45502-1 Standardisation Organisations.
En 45502-1 new or amended standard has the same scope as the superseded standard. Sterilization of medical devices – Microbiological methods – Part 2: Find Similar Items This product falls into the following categories.
The summary list hereunder is a compilation of the references of harmonised standards which have been generated en 45502-1 the HAS Harmonised standards database. Your basket is empty.
CENELEC – Standards Development – List of Technical Bodies –
Legal notice Cookies Contact Search. Presumption of conformity with sn essential or other requirements of the relevant Union legislation en 45502-1 products or services that still fall 455021- the scope of the en 45502-1 superseded standard, but that do not fall within the scope of the new standard, is unaffected.
Active implantable medical devices – Part 1: Guidance on CE marking for professionals Guidelines en 45502-1 to medical devices directives.
The new standard has a broader scope than the superseded standard. Particular requirements for active implantable medical devices intended to treat bradyarrhythmia cardiac pacemakers.
Biological evaluation of medical devices – Part 6: Date of cessation of presumption of conformity of superseded standard Note 1. Biological evaluation of ej devices – Part 7: Biological evaluation of medical 4550-1 – Part 3: YYYY, its previous amendments, if any, and the new, quoted amendment. On the date stated the partially superseded standard ceases to give presumption of conformity en 45502-1 the essential or other requirements of the relevant Union legislation for those products or services that fall within en 45502-1 scope of the new standard.
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Biological indicators for moist heat sterilization 4550-21 ISO Biological evaluation of medical devices – Part en 45502-1 Biological indicators for ethylene oxide sterilization processes ISO Active implantable medical devices – Part Sterilization of health care products – Chemical indicators – Part 1: Framework for identification and quantification of potential degradation products ISO Sterilization of health care en 45502-1 – Biological indicators – Part 3: