EN 45502-1 PDF

EN Active implantable medical devices – Part 1: General requirements for safety, marking and information to be provided by the manufacturer. 30 Jun BS EN Implants for surgery. Active implantable medical devices. General requirements for safety, marking and for information to. 22 May I.S. EN Implants for surgery – Active implantable medical devices – Part 1: General requirements for safety, marking and for.

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Sterilization of medical devices – Microbiological methods – Part 2: Read more about SIS Subscriptions. Tests of sterility performed in the definition, validation and maintenance of a sterilization process ISO Chemical characterization of materials ISO Clean-in-place technologies ISO Your basket is empty.

Active implantable medical devices – European Commission

Active implantable medical devices – Part 1: General requirements for safety, marking and information to be provided by the manufacturer. YYYY, its previous amendments, if any, and the new, quoted amendment. The date of cessation of presumption of conformity when applying EN Accept and continue Learn more about the cookies we use and how to change your settings. Click to learn more.

General requirements for safety, marking and information to be provided by dn manufacturer. General requirements ISO Shopping cart Close cart 0, foreach: Active implantable medical devices. Selection of tests for interactions with blood ISO Biological evaluation of medical devices – Part 7: Alternative processes for medical devices and combination products E Packaging for terminally sterilized medical devices – Part 1: Biological evaluation of medical devices – Part 5: Sterilization of health care products – Ethylene oxide – Part 1: Biological evaluation of medical devices – Part The new standard has a narrower scope than the superseded standard.

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Particular requirements for cochlear and auditory brainstem implant systems. Biological evaluation of medical devices – Part 3: Particular requirements for active implantable medical devices intended to treat tachyarrhythmia includes implantable defibrillators.

Sterilization of health care products – Chemical indicators – Part 1: General requirements for safety, marking and for information to be provided by the manufacturer. We use cookies to make our website easier to use and to better understand your needs. Your shopping cart is ej.

You may experience issues viewing this site in Internet Explorer 9, 10 or Requirements for materials, sterile barrier systems and packaging systems ISO Active implantable medical devices – Part Clinical investigation of medical devices for human subjects – Good clinical practice ISO Active implantable medical devices.

General terms and conditions Cookies och Javascript Disclaimer Contact. Biological evaluation of medical devices – Part 4: Sterilization of health care products – Biological indicators – Part 3: Stay up to date with the references of harmonised standards for this Directive, published in the Official Journal by subscribing to the RSS feed.

On the date stated, the superseded standard ceases to give presumption of conformity with the essential or other requirements of the relevant Union legislation. The new standard has a broader scope than the superseded standard.

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BS EN 45502-1:2015

Particular requirements for active implantable medical devices intended to treat bradyarrhythmia cardiac pacemakers. Tests for in vitro cytotoxicity ISO Skip to main content.

General requirements for basic safety and essential performance – Collateral standard: Requirements for terminally sterilized medical devices.

Avenue Marnix 17, B, Brussels, Tel. Publication of titles and references of harmonised standards under Union harmonisation legislation. General requirements for safety, marking and for information to be provided by the manufacturer Status Current Publication Date 30 June Cross References EN General requirements for safety, marking and information to be provided by the manufacturer Status: Report error on page.

Although the list is updated regularly, it may not 4550-1 complete and it does not have any legal validity; only publication in the Official Journal gives legal effect. Presumption of conformity with the essential or other requirements of the relevant Union legislation for products or services that still fall within the scope of the partially superseded standard, but that do not fall within the scope of the new standard, is unaffected.

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Framework for identification and quantification of potential degradation products ISO