M/342 - Medical devices
Standardization mandate to CEN/CENELEC concerning the development of European standards relating to medical devices (Subject: hyperbaric chambers for medical purposes)
Mandate M/342 concerns the development of European standards for medical devices, specifically focusing on hyperbaric chambers for medical purposes. It involves the standardisation mandate issued by the European Commission to the European Standardisation Organisations CEN and CENELEC. The mandate aims to guide the creation of harmonised standards to ensure safety, performance, and regulatory compliance of these medical devices within the European market. The decision related to this mandate includes the approval or disapproval of the standardisation request, as referenced in resolution CEN/BT C34/2004.
Purpose
The mandate M/342 is issued to request the development of European standards related to medical devices, specifically focusing on hyperbaric chambers used for medical purposes. The aim is to ensure harmonized standardization across Europe to support the safety, performance, and regulatory compliance of these medical devices.
Standardisation request
The mandate requests CEN (European Committee for Standardization) and CENELEC (European Committee for Electrotechnical Standardization) to develop specific European standards concerning hyperbaric chambers intended for medical use. These standards are to address relevant technical, safety, and performance requirements.
Expected deliverables
- European standards defining requirements for hyperbaric chambers for medical purposes.
- Guidelines supporting conformity assessment and regulatory compliance.
- Harmonized technical specifications that facilitate market access and ensure patient safety.
Context
The mandate M/342 was adopted as per the resolution reference CEN/BT C34/2004. It responds to the need for standardized requirements in the medical device sector within the European Union, helping implement relevant directives and regulations. Hyperbaric chambers are specialized medical devices used for therapeutic treatments, and harmonized standards contribute to their safe manufacture and use across member states.
This mandate covers the development of European standards related to medical devices, specifically focusing on hyperbaric chambers for medical purposes. It involves standardisation work within the medical sector, targeting equipment used for medical treatments under hyperbaric conditions.
General Information
This European Standard is applicable to the performance and safety requirements of fire extinguishing systems and their associated test methods for multi-place chambers designed for pressures in excess of ambient atmospheric pressure and employed in medical installations for therapeutic purposes, in the following referred to as chambers.
- Standard16 pagesEnglish languagee-Library read for1 day
This European Standard is applicable to the performance and safety requirements of fire extinguishing systems and their associated test methods for multi-place chambers designed for pressures in excess of ambient atmospheric pressure and employed in medical installations for therapeutic purposes, in the following referred to as chambers.
- Standard16 pagesEnglish languagee-Library read for1 day
This European Standard is applicable to the performance and safety requirements and their associated test methods for multi-place pressure chambers designed for pressures in excess of ambient atmospheric pressure and employed in medical installations for therapeutic purposes, in the following referred to as pressure chambers.
- Standard39 pagesEnglish languagee-Library read for1 day
This European Standard is applicable to the performance and safety requirements and their associated test methods for multi-place pressure chambers designed for pressures in excess of ambient atmospheric pressure and employed in medical installations for therapeutic purposes, in the following referred to as pressure chambers.
- Standard39 pagesEnglish languagee-Library read for1 day
This European Standard is applicable to the performance and safety requirements of fire extinguishing
systems and their associated test methods for multi-place chambers designed for pressures in excess of
ambient atmospheric pressure and employed in medical installations for therapeutic purposes, in the following
referred to as chambers.
- Standard16 pagesEnglish languagee-Library read for1 day
This European Standard is applicable to the performance and safety requirements of fire extinguishing
systems and their associated test methods for multi-place chambers designed for pressures in excess of
ambient atmospheric pressure and employed in medical installations for therapeutic purposes, in the following
referred to as chambers.
- Standard16 pagesEnglish languagee-Library read for1 day
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/342 is a European Standardization Mandate titled "Standardization mandate to CEN/CENELEC concerning the development of European standards relating to medical devices (Subject: hyperbaric chambers for medical purposes)". Standardization mandate to CEN/CENELEC concerning the development of European standards relating to medical devices (Subject: hyperbaric chambers for medical purposes) There are 6 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.