Cranage EMC and Safety (Medical Testing)
Cranage EMC &
Safety offers one of the most comprehensive testing and evaluation services for
both highly sophisticated medical equipment and manual and electrical equipment,
from ECG monitors, mass spectrometers, baby breathing monitors through to
patient trolleys, hoists, ventilators, wheelchairs and autoclaves.
Medical
Device EMC Testing - what are
the regulations?
Within the EU, the
Medical Device Regulation (EU) 2017/745 (MDR)
has replaced the Medical Device Directive and the Active Implantable Medical
Device Directive. The term 'medical device' covers a broad range of items, and
is defined in the Medical Devices Regulation (EU) 2017/745 as 'instruments,
apparatus, appliances, materials or other articles intended by the manufacturer
to be used, alone or in combination, for human beings, for the purpose,
prevention, monitoring, treatment or alleviation of diseases, injuries or
handicaps, replacement or modification of the anatomy or physiological
processes'. This definition means that simple devices, such as medical
thermometers, to complex, life sustaining devices such as programmable
pacemakers, are considered medical devices. The MDR (EU) 2017/745 contains 22
rules for classification, which is an increase on the previous MDD, and these
are based on risk, technical design and manufacture.
The MDR 2017/745 details the essential requirements manufacturers must meet in
order to gain
CE marking and sell their device within Europe,
with the conformity assessment being conducted based on the risk class of the
device. Within the MDR, medical devices are categorised into 4, based on their
risk.
- Class I - considered to be the lowest risk.
- Class IIa - usually low to medium risk & not used for
long periods of time, for example tracheotomy tubes.
- Class IIb - medium to high risk and may be used for longer
than 30 days, such as ventilators.
- Class III - these are the highest risk, an example being
pacemakers.
There have been some changes to classifications within the new MDR, and
therefore changes to the process of assessing conformity. It is imperative that
manufacturers review these and classify their products appropriately.
Most manufacturers of Class I devices (unless sterile or those with a
measurement function) may self-declare their product confirms with the MDR.
Class IIa, Class IIb and Class III must have the involvement of a Medical
Notified Body to approve their Declaration of Conformity (DOC). That is where Cranage EMC and
Safety come in, with our vast range of Medical Device EMC Testing experience in the field, and our test
results form part of the assessment by the appropriate Notified Body. All
manufacturers must produce a Technical File to show compliance and the level of
detail required has changed in the new MDR. If you require Medical Device EMC
Testing then Cranage are on hand to help, our highly experience team are the
best in the industry, providing a second to none Medical Device EMC Testing
service.
Therapeutic
and Medical Equipment Safety Testing
Cranage is UKAS accredited for the main medical standards that are used to
achieve compliance for worldwide market entry, IEC 60601-1 and IEC 60601-1-2.
IEC 60601-1 outlines the general safety and essential performance requirements
of medical electrical equipment, and IEC 60601-1-2 determines the requirements
for electromagnetic compatibility. At Cranage, we specialise in the assessment
of Class I, II and IIb medical electrical equipment with type B, BF and CF
applied parts, and have extensive experience that covers a vast range of items.
Our comprehensive UKAS schedule also covers the following particular
requirements:
- IEC 60601-1-11 Requirements for medical electrical equipment and medical
electrical systems used in the home
healthcare environment.
- IEC 60601-2-10 Requirements for the basic safety and essential
performance of nerve and muscle stimulators.
- IEC 61010-2-101 Requirements for in vitro diagnostic (IVD) medical
equipment.
Medical Electrical Equipment
Testing
Medical electrical devices must be tested for the relevant product safety and EMC standards
to ensure they are safe to use. The most common standards are
IEC/EN 60601-1 and IEC/EN 60601-1-2, covering the basic safety and essential performance of medical
electrical equipment. Cranage EMC and Safety is a UKAS accredited test
laboratory for these standards and our team of experienced engineers can test a
vast range of medical devices, with our previous tests including hospital beds,
prosthetic limbs, blood pressure monitors, ultrasound devices and pulse oximetry.
Safety
Testing
Our testing facilities for product safety include:
- Flammability, Needle Flame and Glow wire
- Drop testing
- Tumble barrel
- EMF testing and surveys
- Mechanical and electrical testing
- Comparative Tracking Index
How much does CE Marking for
Medical Devices cost?
Testing is product specific, due to the range of medical devices and therefore
the cost of testing varies. We are UKAS accredited for the standards
IEC/EN
60601-1 and IEC/EN 60601-1-2, showing we have been assessed as technically
competent for these standards. Get in touch with our team to discuss the cost of
testing your medical device
How do I
get my medical device CE marked?
CE marking is the responsibility of the manufacturer and is used to confirm the
medical device meets the essential requirements of the MDD. A CE mark cannot be
applied on Class IIa, Class IIb or Class III devices until a certificate has
been issued by a Notified Body.
Manufacturers must also register their device with the relevant Competent
Authority, which is the Medicine and Healthcare products Regulatory Agency (MHRA)
in the UK.
Accredited
laboratory
Using state of the art equipment to test your medical equipment Cranage EMC &
Safety is here to ensure all of your testing and evaluation needs are met in
full.
IEC 60601
testing
Our engineers also have a vast experience in testing and evaluating equipment
for compensation or alleviation of injury, disease or disability.
Cranage has core competency in all areas of MDD and IVD and constantly strives
to provide absolute testing certainty, accurately and reliably, so whether your
needs are for testing blood sampling equipment, gas pressure monitoring
equipment or a simple weighing machine we offer a service you can trust.
Medical Products and Equipment include but not limited to:
| - Medical Electrical Simulator for IVF - Blood Sampling Equipment - Gas Pressure Monitoring Equipment - Baby Breathing Monitors - Mass Spectrometers - Wheelchairs and Stair Lifts - Weighing Machines - Ventilators - ECG Monitors - Ultrasound Machines - PET Scanners - Infusion Pumps - Surgical Machines |
- Cardio Respiratory - ECG Monitors - Hospital Beds - Patient Trolleys - Hoists - Autoclaves - Syringe Pumps - X-ray Equipment - Dental Machines - MRI Machines - CT Scanners - Medical Lasers - Life Support Equipment |
Get in touch with our team to discuss how we can help you with your medical
device testing.
Areas CoveredWe offer medical device EMC testing, medical device safety testing and the testing of electrical medical equipment to the following locations and the rest of the UK: |
Opening Hours
Key Personnel
Reviews
Cranage EMC and Safety (Medical Testing)
01630 658568
Wallace Way, Tern Valley Business Park Market Drayton Shropshire, UK
TF9 3AG 5
We have always found Cranage to be professional and flexible, willing to respond at short notice to changing scenarios and able to provide positive contributions when developing compliant solutions.
Products and Services
Associations, Memberships
Conformities
Events & Shows
-
MedTech Innovation Expo 2020
MedTech is the UK and Ireland's leading medical design and manufacturing event. Our Marketing Ma
From: 29 June 2021 09:30 am To: 30 June 2021 16:00 pm Details
Our News & PR
-
Cranage EMC and Safety Spring Newsletter
Brighter times are ahead and we are looking forward to our exciting expansion, which has just got underway!
Details -
Cranage EMC and Safety UKAS accredited medical device testing
We are proud to have added IEC/EN 60601-1 and IEC/EN 60601-1-2 to our comprehensive UKAS schedule
Details -
CRANAGE EMC & SAFETY:CHRISTMAS NEWSLETTER
We’re sure there are a lot of people who are pleased to see 2020 drawing to a close, however, we wanted to take some time to review the positives this year.
Details -
Cranage EMC & Safety Announcement
We are delighted to announce that our Irish subsidiary company, Cranage Veritas, has this week been appointed as a Notified Body against the 2014/30/EU Electromagnetic Compatibility Directive.
Details