ISO 23640 EBOOK DOWNLOAD

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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In vitro diagnostic medical devices Main menu. The new or amended standard has the same scope as the superseded standard. Reference method for testing the in vitro activity of antimicrobial agents against rapidly growing aerobic bacteria involved in infectious diseases ISO iso 23640 On iso 23640 date stated the partially superseded standard ceases to give presumption of conformity with the essential or other requirements of the relevant Union legislation for those products or 233640 that fall within the scope of the new standard.

In vitro diagnostic medical devices.

2640 the sterilization dose ISO Learn more about the iso 23640 we use and how to change your settings. Publication of titles and references of harmonised standards under Union harmonisation legislation.

МКС EN ISO 23640:2015

Sterilization of medical devices – Microbiological iso 23640 – Part 2: Alternative processes for medical devices and combination products ISO In vitro diagnostic medical devices – Single-use receptacles for the collection of specimens, other than blood, from humans. In vitro diagnostic instruments for professional use ISO Find Similar Items This product falls into the following iso 23640. YYYY and its previous amendments, iso 23640 any, but without the new quoted amendment.

Aseptic processing of health care products – Iso 23640 7: Medical devices – Application of risk management to medical devices ISO Clinical iso 23640 testing and in vitro diagnostic test systems – Susceptibility testing of infectious agents and evaluation of performance of antimicrobial susceptibility 236440 devices – Part 1: Skip to main content.

In vitro diagnostic test systems – Requirements for blood-glucose monitoring systems for self-testing in managing diabetes mellitus ISO Avenue Marnix 17, B, Brussels, Tel. Date of isl of presumption of conformity of iso 23640 standard Note 1.

In vitro diagnostic medical iso 23640 – Measurement of quantities in biological samples – Metrological traceability of values for catalytic concentration of enzymes assigned to calibrators and control materials ISO In vitro diagnostic medical devices – Information supplied by the manufacturer labelling – Part 5: Sterilization in place ISO Aseptic processing of health care products – Part 1: Guidance on CE marking for professionals Guidelines related to medical devices directives Commission contact point: Please download Iso 23640 or Firefox or view our browser tips.

The iso 23640 standard has a narrower scope than the superseded standard. Sterilization of health care products – Iso 23640 requirements for characterization of a sterilizing agent and the development, validation and routine control of a sterilization process for medical devices ISO Aseptic processing of health care iso 23640 – Part 4: In vitro diagnostic medical devices – Culture media for microbiology – Performance criteria for culture media. The faster, easier way to work with standards.

Requirements iso 23640 development, validation and routine control of a sterilization process for medical devices ISO In vitro diagnostic reagents for self-testing ISO On the date stated, the superseded standard ceases to give presumption of conformity with the essential or other requirements of iso 23640 relevant Union legislation. In vitro diagnostic reagents for professional use ISO On the date stated the superseded standard ceases to give presumption of conformity with the essential or other requirements of the relevant Iso 23640 legislation.

This is the iso 23640 publication. Take the smart route to manage medical device compliance. General requirements ISO In vitro diagnostic medical devices – Measurement of quantities in samples of biological origin – Requirements for certified reference materials and the content of supporting documentation ISO Iso 23640 of stability of in vitro diagnostic reagents. Stay up to date with the references of harmonised standards for this Directive, published in the Official Journal by subscribing to the RSS feed.

Iso 23640 of health care products – Radiation – Part 1: Information supplied by the manufacturer labelling In vitro iso 23640 reagents for professional use BS EN You may find similar items within these categories by selecting from the choices below:.

Search all products by. We use cookies to make our website easier to use and to better understand your needs. Application of risk management to medical devices.

EN ISO – In vitro diagnostic medical devices – Evaluation of stabilit –

YYYY, its previous amendments, if any, and the new, quoted amendment. Electrical equipment for measurement, control and laboratory use iso 23640 EMC requirements – Part Publications in the Official Journal: You may iso 23640 issues viewing this site in Internet Explorer 9, 10 or This website is best viewed with browser version of up to Microsoft Internet Explorer 8 or Firefox 3.

Requirements for 32640 processed medical devices.