Smithers expanding UKAS accredited testing at Shawbury Medical Device Testing Laboratory
Published: 3/3/2017
Last week Smithers Medical Device Testing Laboratory in Shawbury were successfully assessed by UKAS auditors for an extension to our scope of accreditation.
The assessments were all successful and covered a range of commonly performed tests. Consequently, once the paperwork is completed we expect to have the following tests methods included to our accredited scope allowing us to apply the ILAC stamp to reports which cover testing performed to these standards:
Medical Device Testing
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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)
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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)
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These 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”.
Find out more about our medical device testing.