EN 60601-1-11
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DIN EN 60601-1-11 |
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| Area | Medical technology |
| title | Medical electrical equipment - Part 1-11: Particular requirements for safety including the essential performance characteristics - Collateral standard: Requirements for medical electrical equipment and medical electrical systems for medical care in a domestic environment |
| Latest edition | April 2016 |
| ISO | IEC 60601-1-11: 2015 |
The EN 60601-1-11 with the title "Medical electrical equipment - Part 1-11: Special stipulations for the safety including the essential performance characteristics - supplementary standard: Requirements for medical electrical equipment and medical electrical systems for medical care in a domestic environment" is Part of the EN 60601 series of standards .
The DIN standard DIN EN 60601-1-11 is published by the German Institute for Standardization .
The standard is based on the international version IEC 60601-1-11. Within the framework of the VDE standards, the standard is classified as VDE 0750-1-11 , see DIN-VDE standards part 7 .
This supplementary standard regulates general requirements for safety, tests and guidelines for medical electrical devices and medical electrical systems for medical care in the home environment.
validity
Current edition: DIN EN 60601-1-11: 2016-04
Previous edition: DIN EN 60601-1-11: 2011-03
scope of application
The standard applies to medical electrical equipment or systems that
- be used in a home environment.
- be used with or without professional supervision.
- are also intended for use in other environments, e.g. B. for the clinical setting.
- which are often used in places where the voltage and safety measures of the electrical installation are not reliable.
- supervised by non-nursing staff with different levels of training.
extra information
The following requirements are contained in EN 60601-1-11 (extract):
- harsh environment
- rough handling
- Dielectric strength
Patients and users of medical devices in the home environment can recognize the requirement of protection class II stipulated in the standard on the nameplate and in the instructions for use (symbol: two concentric square, black frames). Devices with electrical protection class I (symbol: black circle with an upside down T inside it with two other black lines running parallel to it below) no longer comply with the standard and are therefore not marketable.