Smithers Extends Scope of UKAS Accreditation for Medical Device Testing in Shawbury, UK
Published: 7/26/2017
The United Kingdom Accreditation Service (UKAS) accreditation covers Smithers dedicated facility for medical device testing at Shawbury, UK for a range of commonly performed tests. Accreditation by UKAS to ISO/IEC 17025:2005 officially recognizes Smithers competence, impartiality and reliability in its ability to deliver results.
With the tests for vials, prefilled syringes, needle-based injection systems and syringes accredited, Smithers can apply the UKAS and International Laboratory Accreditation Cooperation (ILAC) stamp to reports which cover testing performed to these standards.
The tests are core components of Smithers’ testing program in its Shawbury facility, where it offers a broad range of medical device testing services.
Chris Berry, Manager of Medical Device Testing at Smithers, says “Updating our accredited scope demonstrates our commitment to quality assurance and our willingness to comply with client requests”.
Smithers Extended UKAS Scope of Accreditation
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Vials |
Container closure seal integrity |
BS EN ISO 8871-5:2016 (Annex D) |
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Prefilled syringes |
Breakloose and glide force |
BS ISO 11040-4:2015 (Annex E) BS ISO 11040-8:2016 |
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Dye solution tightness test |
BS ISO 11040-4:2015 (Annex H) |
|
|
Needle-based injection systems |
Dose accuracy |
BS EN ISO 11608-1:2015 |
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Syringes |
Plunger operation force |
BS EN ISO 7886-1:1997 (Annex G) |
The facility opened in December 2016 expands on existing capabilities and focuses on high-volume routine medical device tests ranging from product development to post-market surveillance, in line with the new compliance requirements related to European legislation for drug delivery devices.
Find out more about our medical device testing.