ISO 60601-1: 2006, which is the European version of the third edition of IEC 60601-1, was listed in the Official Journal of the European Communities on 27 November 2008 as a harmonised standard under the Medical Devices Directive 93/42/EEC. This means that compliance with ISO 60601-1: 2006 now provides a presumption of conformity with the MDD.
The entry in the Official Journal does not include a date for the cessation of presumption of conformity of the superseded standard. This means that at present there is no indication of when the harmonised status of the 1990 version of the standard will be withdrawn. One estimate is two to three years unless there is an applicable Particular Standard (Part 2 standard) for a device, in which case the 1990 version of EN 60601-1 would continue to be valid until that Particular Standard is updated.
Please download the relevant edition of the Official Journal.
Also listed as harmonised are a number of updated Collateral and Particular Standards to align with EN 60601-1: 2006 as well as some other associated standards. Included amongst these standards are:
- EN 60601-1-2: 2007 (EMC)
- EN 60601-1-6: 2007 (Usability)
- EN 60601-1-8: 2007 (Alarms)
- EN 62304: 2006 (Medical device software - Software life cycle processes)
- EN 62366: 2008 (Application of usability engineering to medical devices)
- EN 62304 should be used in association with clause 14 of EN 60601-1: 2006, Programmable Electrical Medical Systems (PEMS), to cover the software lifecycle requirements of the revision to the MDD (2007/47/EC)
- EN 62366 should be used, in association with EN 60601-1-6 for Medical Electrical Equipment, to address the use error requirements (e.g. ER 1) of the revision to the MDD
Key changes in EN 60601-1: 2006 from the 1990 version include
- The standard has included the concept of Essential Performance in addition to Basic Safety. Essential Performance is the performance necessary to achieve freedom from unacceptable risk (i.e. the absence or degradation of this performance aspect would result in an unacceptable risk).
- The scope of the standard has been extended. The requirements now cover the basic safety and essential performance of both Medical Electrical Equipment and Medical Electrical Systems. Medical Electrical Systems were previously covered by EN 60601-1-1 but these requirements have not been Incorporated into the part 1 standard.
- The requirements for Programmable Electrical Medical Systems (previously addressed under EN 60601-1-4) are now included in clause 14.
- The definition of Medical Electrical Equipment has been expanded by removing the limitation of equipment used only "under medical supervision". It also now includes equipment used for compensation or alleviation of disease, injury or disability.
- Risk Management is the biggest change in the standard and is causing the biggest problem for test houses. Sub-clause 4.2 now requires that a risk management process complying with ISO 14971 shall be performed. The standard makes many references to compliance being checked by inspection of the risk management file. Therefore manufacturers will need to supply these to their chosen test house during testing of a device.
- The manufacturer will need to identify which functions of the equipment are Essential Performance (sub-clause 4.3).
- The expected service life (maximum period of useful life) of the equipment shall be stated in the Risk Management File (sub-clause 4.4).
- Electrical Safety requirements are grouped under clause 8 which introduces the terms "Means of Operator Protection (MOOP)" and "Means of Patient Protection (MOPP). A MOOP is a means of reducing the risk of electric shock for a user and the values in the standard are based on EN 60950 for IT equipment. A MOPP is a means of reducing the risk of electric shock for the patient and the values are based on the previous version of EN 60601-1. One MOOP/MOPP is equivalent to basic insulation and two MOOP/MOPPs are equivalent to double or reinforced insulation.
- Mechanical requirements have been significantly increased and are present in Clauses 9 and 15.
- Excessive temperatures and fire safety are covered under clause 11 and include consideration of the anticipated contact time with a part.
The above are just some of the highlights of the changes to the standard. Manufacturers should now be getting familiar with these new requirements and considering how and when they will be applied to their devices.
NB: BSI is likely to continue to accept EN 60601-1: 1990 with its Amendments whilst this standard is harmonised. However, consideration must also be given to the state of the art requirements of the MDD, updated particular standards and the manufacturers own risk management process.
Please contact us if we can be of assistance or provide you with further information at eu.medicaldevices@bsigroup.com.
