Medical Devices

Medical Devices Directive

The Medical Device Directive applies to medical devices and their accessories. For the purposes of this Directive, accessories are treated as medical devices in their own right. Medical devices are divided in classes which are treated in a different ways as defined by the Directive. The Directive defines essential requirements as well as requirements regarding design and construction.

DARE!! Consultancy is accredited for the Standard for medical devices (EN 60601) for both EMC and safety issues.
Experienced engineers conduct tests and examinations in accordance with this standard.

DARE!! Consultancy distinguishes itself because of the short waiting times and flexible scheduling of tests and examinations.
Our efficient working method allows us to offer services at interesting prices and hence for a good
quality price ratio.
This is why many manufacturers of reputation are carrying out the tests using the services of DARE!! Consultancy.

Technical Competence

Standard	Description	Date
EN 60601-1	Medical electrical equipment. Part 1: General requirements for safety - IEC 601-1:1988	1990
Amendment A1 to EN 60601-1	Medical electrical equipment. Part 1: General requirements for safety - IEC 601-1:1988/A1:1991	1992
Amendment A2 to EN 60601-1	Medical electrical equipment. Part 1: General requirements for safety - IEC 601-1:1988/A2:1995 + corrigendum June 1995	1995
Amendment A13 to EN 60601-1	Medical electrical equipment. Part 1: General requirements for safety	1995
EN 60601-1-1	Medical electrical equipment. Part 1: General requirements for safety - 1. Collateral standard: Safety requirements for medical electrical systems - IEC 601-1-1:1992	1993
Amendment A1 to EN 60601-1-1	Medical electrical equipment. Part 1: General requirements for safety - 1. Collateral standard: Safety requirements for medical electrical systems IEC 601-1-1:1992/A1:1995	1995
EN 60601-1-2	Medical electrical equipment - Part 1: General requirements for safety - 2. Collateral standard: Electromagnetic compatibility - Requirements and tests IEC 601-1-2: 1993	1993
EN 60601-1-3	Medical electrical equipment. Part 1: General requirements for safety - 3: Collateral standard: General requirements for radiation protection in diagnostic X-ray equipment. IEC 601-1-3:1994	1994
EN 60601-1-4	Medical electrical equipment - Part 1: General requirements for safety - 4. Collateral standard: Programmable electrical medical systems - IEC 60601-1-4:1996	1996
EN 60601-2-2	Medical electrical equipment. Part 2: Particular requirements for the safety of high frequency surgical equipment - IEC 601-2-2:1991	1992
EN 60601-2-3	Medical electrical equipment. Part 2: Particular requirements for the safety of short-wave therapy equipment - IEC 601-2-3:1991	1992
EN 60601-2-7	Medical electrical equipment -- Part 2-7: Particular requirements for the safety of high-voltage generators of diagnostic X-ray generators (IEC 60601-2-7:1998) Amendment A1:1997 to EN 60601-2-8:1997 (IEC 60601-2-8:1987 /A1:1997)	1998
EN 60601-2-9	Medical electrical equipment -- Part 2: Particular requirements for the safety of patient contact dosimeters used in radiotherapy with electrically connected radiation detectors (IEC 60601-2-9:1996)	1996
EN 60601-2-11	Medical electrical equipment -- Part 2: Particular requirements for the safety of gamma beam therapy equipment (IEC 60601-2-11:1997)	1997
EN 60601-2-16	Medical electrical equipment -- Part 2-16: Particular requirements for the safety of haemodialysis, haemodiafiltration an haemofiltration equipment (IEC 60601-2-16: 1998)	1998
EN 60601-2-17	Medical electrical equipment. Part 2: Particular requirements for the safety of remote-controlled automatically-driven gamma-ray after-loading equipment IEC 601-2-17:1989	1996
Amendment A1 to EN 60601-2-17	Medical electrical equipment. Part 2: Particular requirements for the safety of remote-controlled automatically-driven gamma-ray after-loading equipment. IEC 601-2-17:1989/A1:1996	1996
EN 60601-2-18	Medical electrical equipment -- Part 2: Particular requirements for the safety of endoscopic equipment (IEC 60601-2-18:1996)	1996
EN 60601-2-19	Medical electrical equipment -- Part 2: Particular requirements for the safety of baby incubators (IEC 60601-2-19:1990) Amendment A1:1996 to EN 60601-2-19:1996 (IEC 60601-2-19:1990/A1:1996)	1996
EN 60601-2-20	Medical electrical equipment -- Part 2: Particular requirements for the safety of transport incubators (IEC 60601-2-20:1990 + A1:1996)	1996
EN 60601-2-21	Medical electrical equipment -- Part 2: Particular requirements for the safety of infant radiant warmers (IEC 601-2-21:1994) Amendment A1:1996 to EN 60601-2-21:1994 (IEC 60601-2-21:1994/A1:1996)	1994
EN 60601-2-22	Medical electrical equipment. Part 2: Particular requirements for the safety of diagnostic and therapeutic laser equipment. IEC 601-2-22:1995	1995
EN 60601-2-23	Medical electrical equipment -- Part 2: Particular requirements for the safety of transcutaneous partial pressure monitoring equipment (IEC 60601-2-23:1993)	1997
EN 60601-2-24	Medical electrical equipment -- Part 2: Particular requirements for the safety of infusion pumps and controllers (IEC 60601-2-24:1998)	1998
EN 60601-2-25	Medical electrical equipment. Part 2: Particular requirements for the safety of electrocardiographs. IEC 601-2-25:1993	1995
EN 60601-2-26	Medical electrical equipment. Part 2: Particular requirements for the safety of electroencephalographs. IEC 601-2-26:1994	1994
EN 60601-2-27	Medical electrical equipment. Part 2: Particular requirements for the safety of electrocardiographic monitoring equipment - IEC 601-2-27:1994	1994
EN 60601-2-28	Medical electrical equipment. Part 2: Particular requirements for the safety of X-ray source assemblies and X-ray tube assemblies for medical diagnosis. IEC 601-2-28:1993	1993
EN 60601-2-29	Medical electrical equipment -- Part 2: Particular requirements for the safety of radiotherapy simulators (IEC 60601-2-29:1993) Amendment A1:1996 to EN 60601-2-29:1995 (IEC60601-2-29:1993/A1:1996)	1995
EN 60601-2-30	Medical electrical equipment. Part 2: Particular requirements for the safety of automatic cycling indirect blood pressure monitoring equipment. IEC 601-2-30:1995	1995
EN 60601-2-31	Medical electrical equipment. Part 2: Particular requirements for the safety of external cardiac pacemakers with internal power source. IEC 601-2-31:1994	1994
EN 60601-2-32	Medical electrical equipment. Part 2: Particular requirements for the safety of associated equipment of X-ray equipment - IEC 601-2-32:1994	1994
EN 60601-2-33	Medical electrical equipment. Part 2: Particular requirements for the safety of magnetic resonance equipment for medical diagnosis. IEC 601-2-33:1995	1995
EN 60601-2-34	Medical electrical equipment. Part 2: Particular requirements for the safety of direct blood-pressure monitoring equipment - IEC 601-2-34:1994	1995
EN 60601-2-35	Medical electrical equipment -- Part 2: Particular requirements for the safety of blankets, pads and mattresses, intended for heating in medical use (IEC 60601-2-35:1996)	1996
EN 60601-2-36	Medical electrical equipment -- Part 2: Particular requirements for the safety of equipment for extracorporeally induced lithotripsy (IEC 60601-2-36:1997)	1997
EN 60601-2-38	Medical electrical equipment -- Part 2-38: Particular requirements for the safety of electrically operated hospital beds (IEC 60601-2-38:1996)	1996
EN 60601-2-40	Medical electrical equipment -- Part 2-40: Particular requirements for the safety of electromyographs and evoked response equipment (IEC 60601-2-40:1998)	1998

References

DARE!! Consultancy performs tests and examinations in accordance to the Medical Device Directive for many manufacturers among which:

BurnCare
OMRON Health Care
DORC

For more information about the Medical Device Directive please use our contact form.

You can also call or email. See the contact information above.

D.A.R.E!! Consultancy
Vijzelmolenlaan 7
3447 GX Woerden - The Netherlands
Tel.: + 31 348 430 979
Fax.: + 31 348 430 645
e-mail: consultancy@dare.nl