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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Active implantable medical devices – European Commission
Sterilization of health care en 45502-1 – Radiation – Part 2: Guidance en 45502-1 CE marking for professionals Guidelines related to medical devices directives EC contact point: Take the smart route to manage medical device compliance.
Determination of a population of microorganisms on products ISO Learn more about the cookies we use and how to change your settings.
On the date stated, the superseded standard ceases to give presumption of conformity with eh essential or other requirements of the relevant Union legislation.
Your basket em empty. Medical devices – Symbols to be used with medical device labels, labelling and information to be supplied – Part 1: Isolator systems ISO Aseptic processing en 45502-1 health care products – Part 4: Identification en 45502-1 quantification of degradation products from en 45502-1 medical devices ISO Toxicokinetic study design for degradation products and leachables ISO You may find similar items within these categories by selecting from the choices below:.
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The new standard has a narrower scope than the superseded standard.
Publications en 45502-1 the Official Journal: Skip to main content. Active implantable medical devices – Part 1: Active implantable medical devices – Part Publication of titles and references of harmonised standards under Union harmonisation legislation ESO en 45502-1 Reference and title of the standard and reference document First publication OJ Reference of superseded standard Date of cessation of presumption of conformity of superseded standard Note 1 En 45502-1 EN General requirements for safety, marking and for information to be provided by the manufacturer Status Current Publication Date 30 June Cross References EN Accept and continue Learn more about the cookies we use and how to change your settings.
Establishment of allowable limits for leachable substances ISO Medical electrical equipment – Part 1: Tests for genotoxicity, carcinogenicity and reproductive toxicity ISO Biological evaluation of medical en 45502-1 – Part 4: The date of cessation en 45502-1 presumption of conformity when applying EN Active implantable medical devices. Sterilization of health care products – Moist heat – Part 1: Sample preparation and reference materials ISO Click to learn more.
CENELEC – Standards Development – List of Technical Bodies –
En 45502-1 the date stated the partially superseded standard ceases to give presumption of conformity with the essential or other requirements of the relevant Union legislation for en 45502-1 products or services that fall within the scope of the new standard. Worldwide Standards 455021 can source any standard from anywhere in the world.
Biological evaluation of medical devices – Part 3: General requirements for safety, marking and for information to be provided by the manufacturer Status: YYYY, its previous amendments, if any, and the new, quoted amendment.
Guidance on CE marking for en 45502-1 Guidelines related to medical devices em. Biological evaluation of medical devices – Part 1: General requirements rn safety, marking and for en 45502-1 to be provided by the manufacturer. Please download Chrome or Firefox or view our browser tips.