EN 60601-2-16
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DIN EN 60601-2-16 |
|---|---|
| Area | Medical technology |
| title | Medical electrical equipment - Part 2-16: Particular requirements for the safety of hemodialysis, hemodiafiltration and hemofiltration devices |
| Latest edition | 2.1999 |
| ISO | IEC 60601-2-16: 1998 |
The EN 60601-2-16 with the title "Medical electrical devices - Part 2-16: Special requirements for the safety of hemodialysis, hemodiafiltration and hemofiltration devices" is part of the EN 60601 series of standards .
The DIN standard DIN EN 60601-2-16 is published by the German Institute for Standardization .
The standard is based on the international version IEC 60601-2-16. Within the framework of the VDE standards, the standard is classified as VDE 0750-2-16 , see DIN-VDE standards part 7 .
This supplementary standard regulates general requirements for the safety, tests and guidelines of hemodialysis, hemodiafiltration and hemofiltration devices .
validity
The German edition 2.1999 has been accepted as a German standard from the date of its publication .
- The current version (2.1999) is to be used in accordance with the 2nd edition of DIN EN 60601-1 .
- A draft for the 3rd edition of DIN EN 60601-1 was published in November 2006.
scope of application
These special stipulations establish the minimum requirements for the safety of hemodialysis, hemodiafiltration and hemofiltration devices for individual patients. The devices are intended to be used either by medical personnel or under medical supervision, including hemodialysis, hemodiafiltration and hemofiltration devices used by the patient. These special provisions do not apply to:
- Extracorporeal circuits
- Dialyzers
- Dialysis fluid concentrates
- Water treatment devices
- Devices for peritoneal dialysis (see EN 60601-2-39 ).
extra information
The following changed requirements are contained in EN 60601-2-16 (extract):
- Accuracy of the operating data
- Protection against dangerous output values