EN 60601-1
| European Standard | EN 60601-1 |
|---|---|
| National standards |
DIN EN 60601-1 ÖVE / ÖNORM EN 60601-1 |
| Area | Medical technology |
| Regulates | Medical electrical equipment; Part 1: General requirements for safety including the essential performance characteristics |
| Brief description | General requirements for the safety of medical electrical equipment |
| Latest edition | 2006 |
The European Standard EN 60601-1 Medical Electrical Equipment; Part 1: General requirements for safety including the essential performance characteristics is the identical European version of the international standard IEC 60601-1. The standard is classified as VDE 0750-1 within the framework of the VDE standards .
The German Institute for Standardization is the publisher of the DIN standard DIN EN 60601-1 . The publisher of ÖNORM ÖVE / ÖNORM EN 60601-1 is Austrian Standards International .
content
The EN 60601-1 standard defines general requirements for basic safety and the essential performance features of electrical systems with a connection to a supply network , which are intended for diagnosis, treatment or monitoring of patients in accordance with the manufacturer's instructions. This standard only applies to devices and systems that are in direct physical or electrical contact with the patient. As a result, it does not apply to pure software products that are placed on the market without hardware (such as the computers on which they are operated). This standard also does not apply to in vitro diagnostic devices or implantable parts of active implantable medical devices.
The EN 60601-1 family also includes around 10 collateral standards (EN 60601-1-x) and around 60 particular standards (EN 60601-2-y). EN 60601 provides an overview of the series of standards . A special medical product must comply with the general requirements of EN 60601-1 as well as the special requirements applicable to collateral and particulate standards.
The collateral standards define requirements for individual product classes, such as: B. EN 60601-1-3 , which defines the requirements for radiation protection in radiological diagnostics. The particular standards define requirements for individual products, e.g. B. EN 60601-2-33 for magnetic resonance imaging devices or EN 60601-2-45 for mammography devices .
The particular standards are of particular importance. Since they can cancel, change or supplement individual requirements of the collateral standards and the basic standard, their content determines the requirements to be met for a medical device. It is essential to note that the collateral and particulate standards applied to a medical device must refer to the same edition of the basic standard. The reference of a standard to the third edition can be recognized by the fact that the words "basic safety" and "essential performance characteristics" are included in the title.
Third edition
The third edition of the EN 60601-1 standard from 2006 is a complete revision of the second edition from 1988. With the publication of the third edition, the importance of risk management has been significantly increased. Risk management according to ISO 14971 is now an essential part of the safety concept of medical devices. In addition, the contents of EN 60601-1-1 and EN 60601-1-4 have been integrated into EN 60601-1. The third edition of the European standard from 2006 corresponds to the edition of the IEC from 2005.
Third edition valid
Must be applied to products for which no Partikulärstandards, could in the EU , both the requirements of the second and the third output to document the fulfillment of the essential requirements until 1 June 2012 on transitional Medical Device Directive are applied. The original plan was to replace the second edition with the third edition in September 2009. After the date was postponed by the CENELEC / TC62 working group to June 1, 2012, the second edition was no longer valid for documenting compliance with the essential requirements.
For products for which particular standards are applicable, their transition periods ultimately determine the applicability of EN 60601-1. For example, only the third edition has been valid for ultrasound devices in the EU since October 1, 2010, as the transition period for the relevant particulate standard EN 60601-2-37 had already expired on this date. The same applies to computed tomography devices ; the transition period for the relevant particulate standard EN 60601-2-44 expired on May 1, 2012.
Strictly speaking, the EN 60601-1 is not applied to a device for which a particulate standard is available, only the corresponding particulate standard. The normative references contained therein refer to the applicable edition of EN 60601-1 and the applicable collateral standards. As long as a particular standard applies, which refers to the second edition of EN 60601-1, the second edition can be used for this specific product.
In general, the application of standards is always voluntary. However, they document the current state of the art, which is relevant if someone is harmed by a medical device and a dispute arises. Harmonized standards such as EN 60601-1 can be used to demonstrate compliance with the basic requirements of the EU Medical Device Directive. In principle, this fulfillment can also be proven in another way, which is then demonstrably equivalent to the application of the standard.
Outside the EEA , the respective national regulations must be observed. This may result in other transition periods, some of which differ considerably from those applicable in the EU.
Amendment 1 to the third edition (edition 3.1)
When the third edition was published, it became apparent that some of the requirements contained therein had to be corrected. This work could not be done before the publication of the third edition because the time frame set by the IEC for the development of the standard would have been exceeded. These corrections were incorporated into the basic standard and published in August 2012 with the edition IEC 60601-1: 2005 + A1: 2012 (European equivalent: EN 60601-1: 2006 + A1: 2013). The main changes concern the elimination of problems that were identified through the application of the standard, the reduction of references to risk management and the clarification of the term "essential performance characteristics".
Edition 3.1 of EN 60601-1 can be used for some medical devices:
- All products for which no particular standard is applicable
- For products for which there is a particulate standard, it is only applicable if this special particulate standard explicitly refers to edition 3.1 (i.e. EN 60601-1 / A1: 2013). If, as an exception, a particular standard refers to an edition of EN 60601-1 without a date (so-called undated reference), edition 3.1 would be directly applicable.
The reason for this lies on the one hand in the ISO / IEC directives , from the perspective of which reference should be made expressly to issue 3.1. If an already published particular standard contains a reference to the third edition (i.e. a dated reference to EN 60601-1: 2006), this particular standard can only be used with precisely this specified edition, which does not include the addition 1.
In the Official Journal of the European Union it was announced on May 16, 2014 that the presumption of conformity of the EN 60601-1: 2006 standard will expire with effect from December 31, 2017. Edition 3.1 (A1: 2013) is then applicable as a harmonized standard.
MOOP and MOPP
The third edition of EN 60601-1 places greater emphasis on the safety of patients on the one hand and medical staff as users of electrical and electronic devices on the other. It contains detailed and complex requirements for electrical safety through insulation, air and creepage distances, components and earthing. The standard requires that medical equipment that can come into contact with patients is equipped with two mutually independent safety precautions (MOP, Means of Protection ), so that electrical safety is still guaranteed even if one of the precautions fails. These isolation levels are defined as requirements for the isolation of the device to protect the user (MOOP, Means of Operator Protection ) or the patient (MOPP, Means of Patient Protection ). Due to the increased risks for patients when they come into contact with electrical or electronic equipment, more stringent requirements must be placed on MOPP to protect patients than on MOOP to protect the user.
extra information
In 2009 a supplement entitled “Graphic symbols for electrical devices in medical applications” was published, which is to be used with the third edition of the standard. Mainly three graphic symbols were corrected. This supplement is a modified version of IEC / TR 60878: 2003 and contains graphic symbols from almost all areas of medical technology. Supplementary sheets are purely for informational purposes and are not normative. They provide information and help, but are not mandatory.
Individual evidence
- ↑ Med-Info: Third edition of IEC 60601-1: 2005 + A1: 2012, TÜV SÜD Product Service GmbH (ed.), Munich 2014
- ↑ Communication from the Commission as part of the implementation of Council Directive 93/42 / EEC of June 14, 1993 on medical devices . In: Official Journal of the European Union. C 149/3 of May 16, 2014.
- ^ Richard Wilson: Know your MOPPS from your MOOPS in medical power supply design. Electronics Weekly, November 13, 2013, accessed February 19, 2016 .
literature
- Jeff Schnabel: Power supply according to 60601-1 in medical technology. In: Elektronikpraxis. No. 9, May 2015, pp. 46–48.