Medical Devices

Medical Devices Directive

The Medical Devices 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.

Medical Devices Directive

DARE!! Measurements 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!! Measurements 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!! Measurements.

Parts of the EN60601

Standard Description Date

EN 60601-1

Medical electrical equipment. Part 1: General requirements for the base product safety and essential performance characteristics ( IEC 60601-1:2005) ( This and the standard below coexist untill July 2012)

2006

EN 60601-1

Medical electrical equipment. Part 1: General requirements product safety - IEC60601-1:1988

1980

Amendment A1 to EN 60601-1

Medical electrical equipment. Part 1: General requirements product safety - IEC60601-1:1998/A1:1991

1992

Amendment A2 to EN 60601-1

Medical electrical equipment. Part 1: General requirements for -IEC601-1: 1988 / A2: 1995 + corrections in June 1995

1995

Amendment A13 to EN 60601-1

Medical electrical equipment. Part 1: requirements for product safety

1995

EN 60601-1-1

Medical electrical equipment. Part 1: General requirements for product safety - IEC 601-1-1. Additional standard: Safety requirements for medical devices - IEC601-1-1: 1992

1993

Amendment A1 to EN 60601-1-1

Medical electrical equipment. Part 1: General requirements for product safety - IEC 601-1-1. 1. Additional standard: Safety requirements for medical devices - IEC601-1-1: 1992 / A1: 1995

1995

EN 60601-1-2

Medical electrical equipment. Part 1: General requirements for product safety - 2. Additional standard: Electromagnetic Compatibility - Requirements and testing - IEC 601-1-2: 1993

1993

EN 60601-1-3

Medical electrical equipment. Part 1: General requirements for product safety - 3: Supplementary standard: General requirements for radiation safety in diagnostics. X-ray equipment - IEC 601-1-3: 1994

1994

EN 60601-1-4

Medical electrical equipment. Part 1: General requirements for product safety - 4. Additional standard: Programmable electrical medical devices - IEC601-1-4: 1996

1996

EN 60601-2-2

Medical electrical equipment. Part 2-2: Particular requirements for safety of high frequency surgical equipment - IEC601-2-2: 1991

1992

EN 60601-2-3

Medical electrical equipment. Part 2-2: Particular requirements for safety of high frequency surgical equipment - IEC601-2-2: 1991...

1992

EN 60601-2-7

Medical electrical equipment. Part 2-7: Particular requirements for safety of high-voltage generators for diagnostics. X-ray Equipment - 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 2-9: Particular requirements for safety of patient contact dosimeter for use in radiotherapy with electrically connected radiation detectors - IEC 60601-2-9: 1996

1996

EN 60601-2-11

Medical electrical equipment - Part 2-11: Specific 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!! Measurements performs tests and examinations in accordance to the Medical Devices Directive for many manufacturers among which:

  • BurnCare
  • OMRON Health Care
  • DORC

For more information about The Medical Devices Directive please fill out our contact form below.

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