IEC 60601-2-16:2008/COR1:2008
(Corrigendum)Corrigendum 1 - Medical electrical equipment - Part 2-16: Particular requirements for basic safety and essential performance of haemodialysis, haemodiafiltration and haemofiltration equipment
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
- Technical Committee
- SC 62D - Particular medical equipment, software, and systems
- Current Stage
- DELPUB - Deleted Publication
- Start Date
- 08-Mar-2012
- Completion Date
- 14-Feb-2026
Relations
- Effective Date
- 05-Sep-2023
- Effective Date
- 05-Sep-2023
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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 Released:10/8/2008
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Frequently Asked Questions
IEC 60601-2-16:2008/COR1:2008 is a standard published by the International Electrotechnical Commission (IEC). Its full title is "Corrigendum 1 - Medical electrical equipment - Part 2-16: Particular requirements for basic safety and essential performance of haemodialysis, haemodiafiltration and haemofiltration equipment". This standard covers: 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.
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.
IEC 60601-2-16:2008/COR1:2008 is classified under the following ICS (International Classification for Standards) categories: 11.040.20 - Transfusion, infusion and injection equipment; 31.200 - Integrated circuits. Microelectronics. The ICS classification helps identify the subject area and facilitates finding related standards.
IEC 60601-2-16:2008/COR1:2008 has the following relationships with other standards: It is inter standard links to IEC 60601-2-16:2008, IEC 60601-2-16:2012. Understanding these relationships helps ensure you are using the most current and applicable version of the standard.
IEC 60601-2-16:2008/COR1:2008 is available in PDF format for immediate download after purchase. The document can be added to your cart and obtained through the secure checkout process. Digital delivery ensures instant access to the complete standard document.
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
...
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