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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Guidance on CE marking for professionals Guidelines related to medical devices directives. Publication of titles and references of harmonised standards under Union harmonisation legislation.

Active implantable medical devices – European Commission

Evaluation and testing within a risk management process ISO Your shopping cart is empty. Toxicokinetic study design for degradation products and leachables ISO Active implantable medical devices – Part 1: Please note that the selected standard is invalid.

Medical electrical equipment – Part Report error on page. Particular requirements for active implantable medical devices intended to treat tachyarrhythmia includes implantable defibrillators. We use cookies to make our website easier to use and to better understand your needs.

Sterilization of health care products – Biological indicators – Part 2: Sterilization of health care products – Ethylene oxide – Part 1: Click to learn more. Sterilization of medical devices – Microbiological methods – Part 2: Clinical investigation of medical devices for human subjects – Good clinical practice ISO Requirements for aseptically processed medical devices.

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On the date stated, the superseded standard ceases to give presumption of conformity with the essential or other requirements of the relevant Union legislation.

Guidance on CE marking for professionals Guidelines related to medical devices directives EC contact point: General requirements for safety, marking and for information to be provided by the manufacturer Status Current Publication Date 30 June Cross References EN Chemical characterization of materials ISO On the date stated the partially superseded standard ceases to give presumption of conformity with the essential or other requirements of the relevant Union legislation for those products or services that fall within the scope of the new standard.

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Active implantable medical devices

Skip to main content. Identification and quantification of degradation products from polymeric medical devices ISO General requirements ISO Biological evaluation of medical devices – Part 5: When you use our service you can be assured the latest editions and easy access.

General requirements for basic safety 4550-1 essential performance IEC Isolator systems ISO Accept and continue Learn more about the cookies we use and how to change your settings. Determination of a population of microorganisms on products ISO Biological indicators for ethylene oxide sterilization processes ISO Active implantable medical devices – Part Subscribe on standards – Read more.

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BS EN 45502-1:2015

Biological em of medical devices – Part 6: Active implantable medical devices Main menu. Biological evaluation of medical devices – Part 3: Learn more about the cookies we use and how to change your settings.

Packaging for terminally sterilized medical devices – Part 1: Sterilization of medical devices – Microbiological methods – Part 1: Find Similar Items This product falls into the following categories. Biological evaluation of medical devices – Part 1: What is a standard? Selection of tests for interactions with blood ISO The new or amended standard has the same scope as the superseded standard.

Tests for genotoxicity, carcinogenicity and reproductive toxicity ISO Medical devices – Application of risk management to medical devices ISO General requirements for basic safety and essential performance – Collateral standard: