IEC 60601-2-16:2008/COR1:2008

Corrigendum 1 - Medical electrical equipment - Part 2-16: Particular requirements for basic safety and essential performance of haemodialysis, haemodiafiltration and haemofiltration equipment

Applies to film integrated circuits and to hybrid film integrated circuits both passive and active. Applies also to partly-completed F and HFICs supplied to customers for subsequent processing as well as to chip carrier circuits having more than one chip, provided that they have been interconnected by film interconnection techniques. This specification defines the quality assessment procedures and the methods for electrical, climatic, mechanical and endurance tests. It outlines the requirements which shall be applied to the release of circuits using either qualification approval procedures or capability approval procedures.

General Information

• Status: Published
• Publication Date: 07-Oct-2008
• ICS: 11.040.20 - Transfusion, infusion and injection equipment
• ICS: 31.200 - Integrated circuits. Microelectronics
• Technical Committee: SC 62D - Particular medical equipment, software, and systems
• Current Stage: DELPUB - Deleted Publication
• Completion Date: 08-Mar-2012

Relations

• Corrects: IEC 60601-2-16:2008 - Medical electrical equipment - Part 2-16: Particular requirements for basic safety and essential performance of haemodialysis, haemodiafiltration and haemofiltration equipment
• Effective Date: 05-Sep-2023
• Revised: IEC 60601-2-16:2012 - Medical electrical equipment - Part 2-16: Particular requirements for basic safety and essential performance of haemodialysis, haemodiafiltration and haemofiltration equipment
• Effective Date: 05-Sep-2023

Standards Content (Sample)

IEC 60601-2-16
(Third edition – 2008)
Medical electrical equipment –
Part 2-16: Particular requirements for basic safety and essential performance
of haemodialysis, haemodiafiltration and haemofiltration equipment

CORRIGENDUM 1
Page 17
201.7.9.2.5 ME EQUIPMENT description
In the sixth dashed item, instead of:
“.PHYSIOLOGICAL CLOSED LOOP CONTROLLER.”
read:
“.PHYSIOLOGIC CLOSED-LOOP CONTROLLER…”
Page 26
201.12.4.4.105 * Air infusion
In item b), on page 27, in the first and seventh dashed items of the bullet point
entitled “Continuous air infusion”, instead of:
“.g cannula.”
read:
“.gauge cannula.”
In item b), on page 28, in the first dashed item of the bullet point entitled “Bolus air infusion”,
instead of:
“Set up the HAEMODIALYSIS EQUIPMENT with a DIALYSER with a standard capillary DIALYSER with
2 2
a surface area between 1 m and 1,5 m , the recommended EXTRACORPOREAL CIRCUIT and 16
g cannulas.”
read:
“Set up the HAEMODIALYSIS EQUIPMENT with a standard capillary DIALYSER with a surface area
2 2
between 1 m and 1,5 m , the recommended EXTRACORPOREAL CIRCUIT and 16 gauge
cannulas.”
In Note 7, following the second dashed item of the bullet point entitled “Bolus air infusion”,
instead of:
“.If degassed dialysate is.”
read:
“.If degassed DIALYSING FLUID is.”
October 2008
Page 34
208.6.3.3.2 Volume of auditory ALAR
...