Modular Adapter rated above 100Kg (220lbs)
Jamie Gillespie Mr
Description
Collection
Title:
Modular Adapter rated above 100Kg (220lbs)
Creator:
Jamie Gillespie Mr
Date:
1/17/2003
Text:
Dear Ozan,
In response to your recent question regarding CE marking and testing of
modular adapters rated higher than 100Kg:
Most prosthetic products are a class I medical device. For a class I
product the manufacturer declares conformity with the medical directive by
self-declaration.
To be able to have CE marking on class I devices according to medical
directive, appropriate standards have to be used to test the products. If
they are not available, which in most cases they aren't a competent
manufacturer has to develop his own method to ensure safety. The
situation in standardization for prosthetic products is such that the
standards are in most cases unsatisfactory.
For all new products a responsible manufacturer like Össur does his risk
assessment and finds the appropriate way to test the product. He would
always use the available standards but in our case we do even more.
For the standard adapter range we have two weight limits. 100 kg
(220lbs)/normal use and 166 kg (365lbs)/ normal use. For the 100 kg
patients Össur decided to exceed the ISO 10328 standard Load level A100 by
8-20% because the 100 load level has showed to be weak for 80-90 kg active
patients. For the 166 kg patients we came to the conclusion that using
ISO 10328 A100 *1.66 would be sufficient.
If we would have to wait until the ISO technical committee would make a
standard for people weighing above 100 kg it might take 10 years until 130
kg patients would get a CE market prosthetic leg. That is not what the CE
declaration is about.
The manufacture is responsible for his action. If an ISO standard is bad
the manufacturer is still responsible and he will have to exceed the
standard.
If you have further questions don’t hesitate to ask,
Hekla Arnardóttir,
Test manager
Össur
Iceland
Jamie Gillespie
Technical Support Prosthetist
Össur Prosthetics
In response to your recent question regarding CE marking and testing of
modular adapters rated higher than 100Kg:
Most prosthetic products are a class I medical device. For a class I
product the manufacturer declares conformity with the medical directive by
self-declaration.
To be able to have CE marking on class I devices according to medical
directive, appropriate standards have to be used to test the products. If
they are not available, which in most cases they aren't a competent
manufacturer has to develop his own method to ensure safety. The
situation in standardization for prosthetic products is such that the
standards are in most cases unsatisfactory.
For all new products a responsible manufacturer like Össur does his risk
assessment and finds the appropriate way to test the product. He would
always use the available standards but in our case we do even more.
For the standard adapter range we have two weight limits. 100 kg
(220lbs)/normal use and 166 kg (365lbs)/ normal use. For the 100 kg
patients Össur decided to exceed the ISO 10328 standard Load level A100 by
8-20% because the 100 load level has showed to be weak for 80-90 kg active
patients. For the 166 kg patients we came to the conclusion that using
ISO 10328 A100 *1.66 would be sufficient.
If we would have to wait until the ISO technical committee would make a
standard for people weighing above 100 kg it might take 10 years until 130
kg patients would get a CE market prosthetic leg. That is not what the CE
declaration is about.
The manufacture is responsible for his action. If an ISO standard is bad
the manufacturer is still responsible and he will have to exceed the
standard.
If you have further questions don’t hesitate to ask,
Hekla Arnardóttir,
Test manager
Össur
Iceland
Jamie Gillespie
Technical Support Prosthetist
Össur Prosthetics
Citation
Jamie Gillespie Mr, “Modular Adapter rated above 100Kg (220lbs),” Digital Resource Foundation for Orthotics and Prosthetics, accessed November 5, 2024, https://library.drfop.org/items/show/220413.
