M/467 - Medical beds
Standardisation mandate addressed to CEN and CENELEC: modification and completion of EN 60601-2-52 to prevent entrapment of children and of adults with an atypical anatomy in medical beds and entrapment of children in medical cots
Mandate M/467 addresses CEN and CENELEC to modify and complete the standard EN 60601-2-52. The objective is to enhance safety requirements for medical beds by preventing entrapment of children and adults with atypical anatomy, as well as entrapment of children in medical cots. This mandate aims to reduce risks associated with medical bed design and use, ensuring improved protection for vulnerable users. It involves updating the existing standard to reflect these safety considerations. The resolution reference for this mandate is CEN/BT C108/2010.
Purpose
The mandate M/467 aims to modify and complete the existing standard EN 60601-2-52. The focus is on enhancing safety requirements to prevent entrapment incidents involving children and adults with atypical anatomies in medical beds, as well as preventing entrapment of children in medical cots. This reflects a safety-driven effort to address specific risks posed by current medical bed designs.
Standardisation request
The mandate requests CEN (European Committee for Standardization) and CENELEC (European Committee for Electrotechnical Standardization) to review, revise, and complete the EN 60601-2-52 standard. The revision should specifically incorporate measures to prevent entrapment hazards linked to both medical beds and medical cots. The modification aims to ensure the standard effectively mitigates these risks for all users, including vulnerable groups like children and adults with non-typical anatomies.
Expected deliverables
- An updated version of EN 60601-2-52 incorporating:
- Enhanced safety criteria and design requirements for medical beds.
- Specific provisions targeting prevention of entrapment for children and adults with an atypical anatomy.
- Additional clauses addressing entrapment risks in medical cots for children.
These deliverables will provide manufacturers and healthcare providers with robust technical guidelines to improve product safety and reduce entrapment incidents.
Context
This mandate follows safety concerns related to entrapment accidents occurring in medical environments, particularly affecting vulnerable populations such as children and adults with atypical anatomical features. EN 60601-2-52 is a product-specific standard referenced under the broader EN 60601 series addressing safety in medical electrical equipment. The mandate reflects the EU's commitment to continuous improvement of product safety standards through targeted standardisation efforts by CEN and CENELEC. The decision regarding this mandate is recorded under resolution CEN/BT C108/2010.
This mandate covers the modification and completion of the standard EN 60601-2-52 to enhance safety by preventing the entrapment of children and adults with atypical anatomy in medical beds, as well as the entrapment of children in medical cots. The focus is on medical beds and cots used in healthcare settings to ensure safety through improved standardisation.
General Information
There are no results that match your search criteria
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/467 is a European Standardization Mandate titled "Standardisation mandate addressed to CEN and CENELEC: modification and completion of EN 60601-2-52 to prevent entrapment of children and of adults with an atypical anatomy in medical beds and entrapment of children in medical cots". Standardisation mandate addressed to CEN and CENELEC: modification and completion of EN 60601-2-52 to prevent entrapment of children and of adults with an atypical anatomy in medical beds and entrapment of children in medical cots 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.