IEC 60601-1-11 ed1.0
Medical electrical equipment - Part 1-11: General requirements for basic safety and essential performance - Collateral Standard: Requirements for medical electrical equipment and medical electrical systems used in the home healthcare environment
Has been published (and can be acquired in this link: http://webstore.iec.ch/Webstore/webstore.nsf/Artnum_PK/43967
From the IEC webstore:
IEC 60601-1-11:2010 applies to the basic safety and essential performance of medical electrical equipment and medical electrical systems which are intended by their manufacturer for use in the home healthcare environment, regardless of whether the medical electrical equipment or medical electrical system is intended for use by a lay operator or by trained healthcare personnel. The object of IEC 60601-1-11:2010 is to specify general requirements that are in addition to those of the general standard IEC 60601-1:2005 and to serve as the basis for particular standards. It is the recommendation of the committee that the content of this publication be adopted for implementation nationally not earlier than 3 years from the date of publication.
As home healthcare has been a growing trend in the medical device area, i´m pretty sure this standard will have a big impact on the future. Also, i´ve accpmpanied the development of the standard and it was quite discussed during the draft stage.
As can be seen in the contets (there´s a preview on the webstore) the standard focus on some aspects that are problematic for equipment which does not rely on a professional operator, such as usability of IFU and mechanical hazards.
Let´s see how it will affect members which have home healthcare products.
Medical electrical equipment - Part 1-11: General requirements for basic safety and essential performance - Collateral Standard: Requirements for medical electrical equipment and medical electrical systems used in the home healthcare environment
Has been published (and can be acquired in this link: http://webstore.iec.ch/Webstore/webstore.nsf/Artnum_PK/43967
From the IEC webstore:
IEC 60601-1-11:2010 applies to the basic safety and essential performance of medical electrical equipment and medical electrical systems which are intended by their manufacturer for use in the home healthcare environment, regardless of whether the medical electrical equipment or medical electrical system is intended for use by a lay operator or by trained healthcare personnel. The object of IEC 60601-1-11:2010 is to specify general requirements that are in addition to those of the general standard IEC 60601-1:2005 and to serve as the basis for particular standards. It is the recommendation of the committee that the content of this publication be adopted for implementation nationally not earlier than 3 years from the date of publication.
As home healthcare has been a growing trend in the medical device area, i´m pretty sure this standard will have a big impact on the future. Also, i´ve accpmpanied the development of the standard and it was quite discussed during the draft stage.
As can be seen in the contets (there´s a preview on the webstore) the standard focus on some aspects that are problematic for equipment which does not rely on a professional operator, such as usability of IFU and mechanical hazards.
Let´s see how it will affect members which have home healthcare products.