M/384 - Medical devices
Standardization mandate to CEN concerning the development of European standards relating to colour coding systems intended for specimen receptacles used for in vitro diagnostic medical devices
Mandate M/384 directs CEN to develop European standards for colour coding systems used in specimen receptacles intended for in vitro diagnostic medical devices. The objective is to standardize colour coding to ensure clear identification and compatibility across medical settings, enhancing safety and usability. This mandate supports harmonization within the medical device sector and facilitates compliance with regulatory requirements. The resolution for this mandate is referenced as CEN/BT C044/2006.
Purpose
The mandate M/384 aims to develop European standards related to colour coding systems for specimen receptacles used in in vitro diagnostic (IVD) medical devices. The objective is to ensure harmonisation and clarity in the colour coding of specimen containers.
Standardisation request
The European Committee for Standardization (CEN) is requested to create standards establishing uniform colour coding systems. These systems will apply specifically to specimen receptacles utilized within IVD medical devices, facilitating consistency and interoperability across Europe.
Expected deliverables
The key deliverable is a set of European standards that define and regulate colour coding protocols for specimen receptacles. These standards will support manufacturers, laboratories, and healthcare providers in the standardized identification and handling of diagnostic samples.
Context
This mandate was subject to a decision under resolution reference CEN/BT C044/2006. It falls within the broader regulatory framework governing medical devices within the European Union, aiming to enhance safety and efficiency in medical diagnostics through standardisation. Uniform colour coding can reduce errors and improve communication between healthcare practitioners and diagnostic services.
The mandate covers the development of European standards related to colour coding systems for specimen receptacles used in in vitro diagnostic medical devices.
General Information
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Frequently Asked Questions
A European Standardization Mandate is a formal request from the European Commission to the European Standardization Organizations (CEN, CENELEC, and ETSI) to develop European standards (ENs) in support of EU legislation and policies. Mandates are issued under Regulation (EU) No 1025/2012 and help ensure that products and services meet the essential requirements set out in EU directives and regulations.
M/384 is a European Standardization Mandate titled "Standardization mandate to CEN concerning the development of European standards relating to colour coding systems intended for specimen receptacles used for in vitro diagnostic medical devices". Standardization mandate to CEN concerning the development of European standards relating to colour coding systems intended for specimen receptacles used for in vitro diagnostic medical devices There are 0 standards developed under this mandate.
Standards developed in response to a mandate and cited in the Official Journal of the European Union become "harmonized standards". Products manufactured in compliance with harmonized standards benefit from a presumption of conformity with the essential requirements of the corresponding EU directive or regulation, facilitating CE marking and market access across the European Economic Area.