11.100.99 – Other standards related to laboratory medicine – PDF Standards Store ?u= Tue, 05 Nov 2024 23:56:12 +0000 en-US hourly 1 https://wordpress.org/?v=6.7.1 ?u=/wp-content/uploads/2024/11/cropped-icon-150x150.png 11.100.99 – Other standards related to laboratory medicine – PDF Standards Store ?u= 32 32 ISO 7405:2008/Amd 1:2013 ?u=/product/publishers/iso/iso-74052008-amd-12013/ Tue, 05 Nov 2024 23:56:12 +0000 Dentistry — Evaluation of biocompatibility of medical devices used in dentistry — Amendment 1: Positive control material
Published By Publication Date Number of Pages
ISO 2013-07 6
]]> Dentistry — Evaluation of biocompatibility of medical devices used in dentistry — Amendment 1: Positive control material
Published By Publication Date Number of Pages
ISO 2013-07 6
]]> ISO 7405:2008 ?u=/product/publishers/iso/iso-74052008/ Tue, 05 Nov 2024 23:56:12 +0000 Dentistry — Evaluation of biocompatibility of medical devices used in dentistry
Published By Publication Date Number of Pages
ISO 2008-12 42
]]> ISO 7405:2008 specifies test methods for the evaluation of biological effects of medical devices used in dentistry. It includes testing of pharmacological agents that are an integral part of the device under test.

ISO 7405:2008 does not cover testing of materials and devices that do not come into direct or indirect contact with the patient's body.

]]> ISO 7405:2018 ?u=/product/publishers/iso/iso-74052018/ Tue, 05 Nov 2024 23:56:12 +0000 Dentistry — Evaluation of biocompatibility of medical devices used in dentistry
Published By Publication Date Number of Pages
ISO 2018-10 50
]]> This document specifies test methods for the evaluation of biological effects of medical devices used in dentistry. It includes testing of pharmacological agents that are an integral part of the device under test.

This document does not cover testing of materials and devices that do not come into direct or indirect contact with the patient's body.

]]> ISO 15195:2018 ?u=/product/publishers/iso/iso-151952018/ Tue, 05 Nov 2024 21:36:33 +0000 Laboratory medicine — Requirements for the competence of calibration laboratories using reference measurement procedures
Published By Publication Date Number of Pages
ISO 2018-12 16
]]> This document specifies the requirements for competence to carry out reference measurement procedures in laboratory medicine, using the requirements of ISO/IEC 17025:2017 as a normative reference and listing additional requirements for calibration laboratories to perform their tasks adequately.

The relationship between clauses in this document and ISO/IEC 17025:2017 are summarized in Annex A.

Examinations of properties with results reported on a nominal or ordinal scale are not included.

This document is not applicable to medical laboratories.

NOTE Requirements for medical laboratories are specified in ISO 15189[1].

]]> ISO 15195:2003 ?u=/product/publishers/iso/iso-151952003/ Tue, 05 Nov 2024 21:36:32 +0000 Laboratory medicine — Requirements for reference measurement laboratories
Published By Publication Date Number of Pages
ISO 2003-10 20
]]> ISO 15195:2003 gives the specific requirements for reference measurement laboratories in laboratory medicine. Examinations of properties with results reported on a nominal or ordinal scale are not included.

ISO 15195:2003 is not applicable to routine medical laboratories.

The general requirements for the competence of calibration laboratories are laid down in ISO/IEC 17025 for testing and calibration laboratories. ISO 15195:2003 refers to the specific aspects of calibration laboratories in the field of laboratory medicine where such "calibration laboratories" are usually denoted as "reference measurement laboratories".

ISO 15195:2003 may form a basis for the accreditation of a reference measurement laboratory that applies for official recognition of the performance of a reference measurement procedure. Reference measurement laboratories are usually accredited by national metrology institutes or national accrediting bodies.

]]> DIN ISO 4802-1:2017 Edition ?u=/product/publishers/din/din-iso-4802-1/ Tue, 05 Nov 2024 17:44:54 +0000 Glassware - Hydrolytic resistance of the interior surfaces of glass containers - Part 1: Determination by titration method and classification
Published By Publication Date Number of Pages
DIN 2017-02 19
]]> This part of ISO 4802 specifies: a) a method for determining the hydrolytic resistance of the interior surfaces of glass containers when subjected to attack by water at 121 °C ± 1 °C for 60 min ± 1 min. The resistance is measured by titration of a known aliquot portion of the extraction solution produced with hydrochloric acid solution, in which case the resistance is inversely proportional to the volume of acid required; b) a classification of glass containers according to the hydrolytic resistance of the interior surfaces determined by the methods specified in this part of ISO 4802.

]]> DIN ISO 4802-2:2017 Edition ?u=/product/publishers/din/din-iso-4802-2/ Tue, 05 Nov 2024 17:44:54 +0000 Glassware - Hydrolytic resistance of the interior surfaces of glass containers - Part 2: Determination by flame spectrometry and classification
Published By Publication Date Number of Pages
DIN 2017-02 19
]]> This part of ISO 4802 specifies: a) methods for determining the hydrolytic resistance of the interior surfaces of glass containers when subjected to attack by water at (121 ± 1) °C for (60 ± 1) min. The resistance is measured by determining the amount of sodium and other alkali metal or alkaline earth oxides in the extraction solution using flame atomic emission or absorption spectrometry (flame spectrometry); b) a classification of glass containers according to the hydrolytic resistance of the interior surfaces determined by the methods specified in this part of ISO 4802. The test method specified in this part of ISO 4802 might not be applicable to containers whose surfaces have been treated with silicon (e. g. containers that are ready for direct filling).

]]> DIN EN ISO 7405:2019 Edition ?u=/product/publishers/din/din-en-iso-7405/ Tue, 05 Nov 2024 17:31:21 +0000 Zahnheilkunde - Beurteilung der Biokompatibilität von in der Zahnheilkunde verwendeten Medizinprodukten
Published By Publication Date Number of Pages
DIN 2019-03 56
]]> Dieses Dokument legt Prüfverfahren zur Beurteilung der biologischen Wirkungen von in der Zahnheilkunde verwendeten Medizinprodukten fest. Enthalten sind auch Prüfungen von pharmakologischen Stoffen, die ein integraler Bestandteil des zu prüfenden Medizinproduktes sind. Dieses Dokument gilt nicht für die Prüfung von Materialien und Produkten, die weder direkt noch indirekt mit dem Körper des Patienten in Kontakt kommen.*Inhaltsverzeichnis

]]> DIN EN ISO 22442-3:2008 Edition ?u=/product/publishers/din/din-en-iso-22442-3/ Tue, 05 Nov 2024 17:17:33 +0000 Medical devices utilizing animal tissues and their derivatives - Part 3: Validation of the elimination and/or inactivation of viruses and transmissible spongiform encephalopathy (TSE) agents
Published By Publication Date Number of Pages
DIN 2008-03 29
]]> This Part of ISO 22442 specifies requirements for the validation of the elimination and/or inactivation of viruses and TSE agents during the manufacture of medical devices (excluding in-vitro diagnostic medical devices) utilizing animal tissue or products derived from animal tissue, which are non-viable or have been rendered non-viable. It does not cover other transmissible and non-transmissible agents.

]]> DIN EN ISO 15195:2019 Edition ?u=/product/publishers/din/din-en-iso-15195/ Tue, 05 Nov 2024 17:02:12 +0000 Laboratory medicine - Requirements for the competence of calibration laboratories using reference measurement procedures
Published By Publication Date Number of Pages
DIN 2019-07 17
]]> This International Standard specifies the requirements for competence to carry out reference measurement procedures in laboratory medicine, using the requirements of ISO/IEC 17025:2017 as a normative reference and listing additional requirements for calibration laboratories to perform their tasks adequately. Examinations of properties with results reported on a nominal or ordinal scale are not included. This International Standard is not applicable to routine medical laboratories.

]]>