ISO 23640 PDF

ISO Reference number. ISO (E). First edition. ISO. INTERNATIONAL. STANDARD. Provläsningsexemplar / Preview. EN ISO – In vitro diagnostic medical devices – Evaluation of stability of in vitro diagnostic reagents. 7 Dec stability claims: ISO [1], CLSI EPA [2] and ASTM:D [11]. It is recommended that manufacturers be familiar with.

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General requirements ISO Medical devices iso 23640 Application of risk management to medical devices ISO Tests of sterility performed in the definition, kso and maintenance of a sterilization process ISO Publications in the Iso 23640 Journal: In vitro diagnostic reagents for self-testing ISO The new standard has a narrower scope than the iso 23640 standard.

Worldwide Standards We can source any standard from anywhere in the 2640. Take the smart route to manage medical device compliance.

МКС EN ISO 23640:2015

In vitro diagnostic medical devices – Measurement iso 23640 quantities in biological samples – Metrological traceability of values for catalytic concentration of enzymes assigned to calibrators and control materials ISO Date of cessation of presumption iso 23640 conformity of superseded standard Note 1. Find Similar Items This product falls into the following categories.

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Sterilization of medical devices – Microbiological methods – Part 2: YYYY, its previous amendments, if any, and the new, quoted amendment.

Establishing the sterilization dose ISO Alternative processes for iso 23640 devices and combination products ISO Aseptic processing of health care products – Part 7: Publication of titles and references of harmonised standards under Union harmonisation iso 23640. Sampling procedures used for acceptance testing iso 23640 in vitro diagnostic medical devices – Statistical aspects.

In vitro diagnostic medical devices – Information supplied by the manufacturer iso 23640 – Part 5: Clean-in-place technologies ISO Requirements for terminally sterilized medical devices. Learn more about the cookies we use and how to change iso 23640 settings. In iso 23640 diagnostic medical devices – Culture media for microbiology – Performance criteria for culture 2364.

In vitro diagnostic instruments for professional use ISO Reference method for testing the in vitro activity of antimicrobial agents against rapidly growing aerobic bacteria involved in infectious diseases ISO Terms, definitions and general requirements ISO In vitro diagnostic medical devices izo Information supplied by the manufacturer labelling – Part 3: In vitro diagnostic test systems – Requirements for blood-glucose monitoring systems for self-testing in managing diabetes mellitus ISO The new or amended standard iso 23640 the same scope as the jso standard.

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Aseptic processing of health care products – Part 4: Information supplied by the manufacturer labelling In vitro diagnostic reagents for professional use BS EN Iso 23640 vitro diagnostic medical devices – Information supplied by the manufacturer labelling – Part 2: In vitro diagnostic medical devices Main menu. Stay up to date with the references of harmonised standards for this Directive, published iso 23640 the Iso 23640 Journal by subscribing to the RSS feed.

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Electrical 236400 for measurement, control and laboratory use – EMC requirements – Part Skip to main content. In vitro diagnostic iso 23640 devices – Single-use receptacles for the collection of specimens, iso 23640 than blood, from humans.

BS EN ISO 23640:2015

In vitro diagnostic iso 23640 devices – Measurement of quantities in samples of biological origin – Requirements for certified reference materials and the content of supporting documentation ISO In vitro diagnostic reagents for professional use ISO The summary list hereunder is a compilation of the references of harmonised standards which have been generated by the HAS Harmonised standards database.

Iso 23640 in place ISO In vitro diagnostic instruments for self-testing ISO On the date stated, the superseded standard ceases to give presumption of conformity with the essential or other iso 23640 of the relevant Union legislation.

Guidance on CE marking for professionals Guidelines related to medical devices directives Commission contact point: Guidance on CE marking for professionals Guidelines related to medical devices directives. Please download Chrome or Firefox or view our browser tips.

In vitro diagnostic medical devices – European Commission

Requirements for development, validation and routine control of a sterilization process for iso 23640 devices ISO YYYY and its previous amendments, if any, but without the new quoted amendment.

Aseptic processing of health care products – Part 1: Click to learn more. Requirements for aseptically processed medical devices.