EN 60601

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The EN 60601 series of standards defines safety requirements and ergonomic requirements for medical electrical equipment and in medical systems. It is published in Germany by the German Institute for Standardization as a DIN standard . The standard is based on the IEC version IEC 60601 .

In Germany there have been product-specific requirements for medical devices within the framework of the VDE standards as a series of standards VDE 0750 since 1957 . Internationalization has taken place since the early 1970s with the first edition of IEC 60601.

construction

The EN 60601 series of standards is divided into

  • the general standard EN 60601-1 "Medical electrical equipment - Part 1: General specifications for safety including the essential performance characteristics", also known as the basic standard
  • the supplementary standards EN 60601-1-x, sometimes also called collateral standards
  • the special specifications EN 60601-2-y, sometimes also called particulate standards.

Specifications in the particular standards have priority over specifications in supplementary standards or the general standard.

IEC 60601-1: 2005 + Cor .: 2006 + Cor .: 2007 + A1: 2012, also known as Edition 3.1, is currently valid.

Basic standard

The EN 60601-1 applies to the basic safety and the essential performance characteristics of medical electrical devices and medical electrical systems with exactly one connection to a supply network, which are intended for diagnosis, treatment or monitoring of a patient according to the manufacturer's specifications. These devices and systems transmit energy to or from the patient and are in physical or electrical contact with the patient. Here general requirements for the safety including the essential performance characteristics of medical electrical devices are specified.

The basic standard thus stipulates general requirements and serves as the basis for the special stipulations.

Supplementary norms

In addition to the basic standard EN 60601-1 , there are around ten supplementary standards that can each be applied to a subgroup of all medical devices. So is z. For example, EN 60601-1-3 can only be applied to products that use X-rays for diagnostic purposes.

Special stipulations

In the special stipulations, special safety requirements for individual medical devices are specified, e.g. B. EN 60601-2-41 "Medical electrical equipment - Part 2-41: Particular stipulations for the safety of operating lights and examination lights". Currently (as of April 2011) there are around 60 of these standards.

There are also standards with the designation EN 60601-3-X, which regulate the performance characteristics of medical electrical devices. Corresponding standards that belong to the 3rd edition of EN 60601-1 are currently not in preparation.

applicability

When using standards from the EN 60601 family for testing or developing a medical product, it must always be ensured that all supplementary standards and special stipulations used refer to the same edition of EN 60601-1. Due to the structure and the content structure, z. For example, it is not possible to use special stipulations that refer to EN 60601-1: 1990 together with EN 60601-1: 2006.

Currently (January 2013), the 2nd edition (i.e. EN 60601-1: 1990) may be used in the EU for fewer and fewer product categories for placing on the market. For products for which there is no special stipulation (e.g. PET), this has no longer been possible since June 1, 2012. In the EU Official Journal it is stipulated that, since this date, EN 60601-1: 1990 can no longer be used for such products to meet the so-called basic requirements of the Medical Devices Directive and thus for placing on the market, i.e. H. the application of this standard no longer triggers the so-called presumption of conformity. The presumption of conformity means in general that when a standard is applied, it is assumed that the product thus fulfills all applicable fundamental requirements. For products for which there are special stipulations that refer to the 3rd edition (i.e. EN 60601-1: 2006), the EU Official Journal specifies transition dates for how long products based on the 2nd edition will be placed on the market allowed to. These transition dates have not yet been set for all products.

New numbering

From 2009 there will be a change in the numbering of the series of standards. The standards, which are created jointly by ISO and IEC at international level, are numbered starting with "80". Some of the standards in this series are then EN 80601 . Standards that have appeared under the previous numbering (EN 60601) are not affected by this and will be continued under their existing numbering.

As part of this change, there may be duplicate designations. Example in Germany: Pulse oximetry (previously only DIN EN ISO 9919) was currently published in Germany as DIN EN ISO 9919 / VDE 0750-2-54: 2009. The current draft and the standard applicable for the near future will be referred to as DIN ISO 80601-2-61 / VDE 0750-2-61 . At the same time, a draft DIN EN 60601-2-54 / VDE0750-2-54 was published, but this deals with X-ray devices. Result: the pulse oximetry will be performed under XXXXX-2-61 and the X-ray standard under XXXXX-2-54. Until this has been clearly established, there may be confusion.

Overview of all parts

The overview does not claim to be complete and can, for example, be compared with the directory of standards published by Beuth-Verlag or Austrian Standards International . The standard titles are abbreviated and do not correspond to the original titles.

If a standard part appears with a new number, it is listed here as EN 80601 -...

Supplementary norms

Special stipulations

Performance characteristics

  • EN 60601-3-1 Essential performance requirements for transcutaneous oxygen and carbon dioxide partial pressure monitoring devices (withdrawn)

See also

Web links

Individual evidence

  1. ↑ DIN EN 60601-1 - 2013-12 - Beuth.de. Retrieved July 9, 2018 .