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

The Dutch ministry of Health, Welfare and Sport has designated DARE!! Medical Certifications as Notified Body to carry out conformity assessments according to the Medical Devices Directive 93/42/EEC. See theĀ publication in Netherlands Government Gazette for the decision of the ministry to designate DARE!! Medical Certifications.

In addition, DARE!! Medical Certifications is accredited (C447) for the certification of active (electronic) medical devices.

DARE!! Measurements is also accredited for testing conform the standard for Medical Electrical Equipment (EN 60601) for EMC and safety aspects. Experienced engineers perform the tests and examinations conform this standard.

DARE!! Medical Certifications distinguishes itself by short waiting times and flexible planning of tests, examinations, conformity assessments and certification. Our efficient working method allows us to offer these services for attractive prices and, therefore, ensuring an excellent price-quality ratio. This is why many high reputable companies make use of the services of DARE!! Medical Certifications.

Please note, in some cases of MDD conformity assessment, a manufacturer is obliged to submit clinical research with patients prior to the start of the research to the Health Care Inspectorate (IGZ).

Scope

DARE!! Medical Certifications is designated to perform conformity assessments of Active Medical Devices (class Imeas, IIa and IIb) that fall within the following scope:

  • MD 1101 Devices for extra-corporal circulation, infusion and haemopheresis
  • MD 1102 Respiratory devices, devices including hyperbaric chambers for oxygen therapy, inhalation anesthesia
  • MD 1103 Devices for stimulation or inhibition
  • MD 1104 Active surgical devices
  • MD 1108 Active rehabilitation devices and active prostheses
  • MD 1109 Active devices for patient positioning and transport
  • MD 1202 Imaging devices utilizing non-ionizing radiation
  • MD 1301 Monitoring devices of non-vital physiological parameters
  • MD 1302 Monitoring devices of vital physiological parameters
  • MD 1402 Devices utilizing non-ionizing radiation
  • MD S7004 Medical devices referencing the Directive 2006/42/EC on machinery
  • MD 7010 Medical devices incorporating software / utilizing software / controlled by software

The designation encompasses medical devices that:

  • are categorized as class I devices and have a measuring function
  • fall under the MD 1101 code and have an infusion utilization

DARE!! Medical Certifications is an independent operational company realising its profit completely with services to customers.

Leaflet

Download the Medical CertificationsĀ® leafletĀ here in pdf format.

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!! Medical Certifications performs conformity assessments conform the Medical Devices Directive for many manufacturers, such as:

  • Meditop
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