Technical product documentation (TPD) — General principles of representation — Part 2: Basic convent...
This document establishes the types of lines used in technical drawings (e.g. diagrams, plans or maps), their designations and their configurations, as well as general rules for the draughting of lines. In addition, this document specifies general rules for the representation of leader and reference lines and their components as well as for the arrangement of instructions on or at leader lines in…
Documentation technique de produits (TPD) — Principes généraux de représentation — Partie 2: Convent...
Le présent document établit les types de traits utilisés dans les dessins techniques (par exemple schémas, plans ou cartes), leurs désignations et leurs configurations, ainsi que les règles générales pour le tracé de traits. De plus, le présent document spécifie des règles générales pour la représentation des lignes repères et traits de référence et leurs composants, ainsi que pour la disposition…
In vitro diagnostic medical devices — Information supplied by the manufacturer (labelling) — Part 4:...
This document specifies requirements for information supplied by the manufacturer of in vitro diagnostic (IVD) reagents, calibrators, and controls intended for self-testing.
This document can also be applicable to accessories.
This document is applicable to the labels for outer and immediate containers and to the instructions for use.
This document does not apply to:
a) IVD instruments or…
In vitro diagnostic medical devices — Information supplied by the manufacturer (labelling) — Part 3:...
This document specifies requirements for information supplied by the manufacturer of in vitro diagnostic (IVD) instruments intended for professional use.
This document also applies to apparatus and equipment intended to be used with IVD instruments for professional use.
This document can also be applicable to accessories.
This document does not apply to:
a) instructions for instrument servicing…
In vitro diagnostic medical devices — Information supplied by the manufacturer (labelling) — Part 1:...
This document defines concepts, establishes general principles, and specifies essential requirements for information supplied by the manufacturer of IVD medical devices.
This document does not address language requirements since that is the domain of national laws and regulations.
This document does not apply to:
a) IVD medical devices for performance evaluation (e.g. for investigational use only…
In vitro diagnostic medical devices — Information supplied by the manufacturer (labelling) — Part 2:...
This document specifies requirements for information supplied by the manufacturer of in vitro diagnostic (IVD) reagents, calibrators and controls intended for professional use.
This document can also be applicable to accessories.
This document is applicable to the labels for outer and immediate containers and to the instructions for use.
This document does not apply to:
a) IVD instruments or…
In vitro diagnostic medical devices — Information supplied by the manufacturer (labelling) — Part 5:...
This document specifies requirements for information supplied by the manufacturer of in vitro diagnostic (IVD) instruments intended for self-testing.
This document is also applicable to apparatus and equipment intended to be used with IVD instruments for self-testing.
This document can also be applicable to accessories.
This document does not apply to:
a) instructions for instrument servicing or…
Dispositifs médicaux de diagnostic in vitro — Informations fournies par le fabricant (étiquetage) — ...
Le présent document spécifie les exigences relatives aux informations fournies par le fabricant de réactifs de diagnostic in vitro (DIV), d’étalons et de matériaux de contrôle destinés aux autodiagnostics.
Le présent document peut aussi s’appliquer aux accessoires.
Le présent document est applicable aux étiquettes apposées sur l’emballage externe et le contenant primaire, ainsi qu’aux notices d’…
