IEC 60601-1-11, 1st edition, just published Apr 28, 2010. This is the Medical electrical equipment collateral Standard for Medical electrical equipment & systems used in home healthcare environments. If the manufacturer is currently using 3rd edition of IEC 60601-1 (2005) or EN 60601-1:2006 or other national versions that are based on the 3rd edition of IEC 60601-1 and your product is intended, by the manufacturer, to be used in a home healthcare environment by the lay operator or trained healthcare personnel you need to start thinking about how you will implement this standard as it is effective immediately for any IEC 60601-1, 3rd edition product safety submission. If you are looking at this standard for a Regulatory submission for a national approval (i.e. FDA, EU MDD, Health Canada, etc.) by a Regulatory Body the time frame will vary depending on the country based upon the adoption of the standard and transition into a required standard for that country.
IEC 60601-1-11, 1st ed. published Std for Med Elec Equip & Systems used in Home Healthcare Environ