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IEC 62321-3-4:2023 specifies procedures for the screening of di-isobutyl phthalate (DIBP), di-n-butyl phthalate (DBP), benzyl butyl phthalate (BBP), di-(2-ethylhexyl) phthalate (DEHP) in polymers of electrotechnical products by using high performance liquid chromatography with ultraviolet detector (HPLC-UV), thin layer chromatography (TLC) and thermal desorption mass spectrometry (TD-MS). High…

IEC 62321-3-4:2023 spécifie des modes opératoires pour le criblage du phtalate de di-isobutyle (DIBP), du phtalate de di-n-butyle (DBP), du phtalate de benzyle et de butyle (BBP), du phtalate de bis (2-éthylhexyle) (DEHP) dans les polymères de produits électrotechniques en utilisant la chromatographie liquide à haute performance avec détecteur ultraviolet (HPLC-UV), la chromatographie sur couche…

This document identifies data elements and metadata to represent the information about microsatellite instability (MSI) for reporting the value of the biomarker using clinical massive parallel DNA sequencing. This document covers information about the MSI test result and related data, such as used resources, data generation condition, and data processing information which are helpful to clinical…

This document specifies the form and meaning of programs written in Ada. Its purpose is to promote the portability of Ada programs to a variety of computing systems. This document specifies: —   The form of a program written in Ada; —   The effect of translating and executing such a program; —   The manner in which program units can be combined to form Ada programs; —   The language-defined…

This document specifies the form and meaning of programs written in Ada. Its purpose is to promote the portability of Ada programs to a variety of computing systems. This document specifies: — The form of a program written in Ada; — The effect of translating and executing such a program; — The manner in which program units can be combined to form Ada programs; — The language-defined…

1 Scope This document specifies requirements for the information to be provided by the medical device manufacturer for the processing of critical or semi-critical medical devices (i.e. a medical device that enters normally sterile parts of the human body or a medical device that comes into contact with mucous membranes or non-intact skin) or medical devices that are intended to be sterilized.…

1 Domaine d’application Le présent document spécifie les exigences relatives aux informations à fournir par le fabricant du dispositif médical pour le traitement des dispositifs médicaux critiques ou semi-critiques (c’est-à-dire un dispositif médical qui pénètre dans des sites normalement stériles du corps humain ou un dispositif médical qui entre en contact avec des muqueuses ou une peau lésée…

1 Scope This document specifies requirements for the information to be provided by the medical device manufacturer for the processing of non-critical medical devices not intended to be sterilized (i.e. a medical device that is intended to come into contact with intact skin only or a medical device not intended for direct patient contact). This includes information for processing prior to use or…

1 Domaine d’application Le présent document spécifie les exigences applicables aux informations relatives au traitement des dispositifs médicaux non critiques et non destinés à être stérilisés, à fournir par le fabricant du dispositif (c’est-à-dire un dispositif médical destiné à entrer en contact avec la peau intacte uniquement ou un dispositif médical qui n’est pas destiné à un contact direct…

1 Scope This document provides guidance for the application of the requirements contained in ISO 11607-1 and ISO 11607-2. It does not add to, or otherwise change, the requirements of ISO 11607-1 and ISO 11607-2. This is an informative document, not normative. It does not include requirements to be used as basis of regulatory inspection or certification assessment activities. The guidance can be…