Smithers expanding UKAS accredited testing at Shawbury Medical Device Testing Laboratory

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

Vials

Container closure seal integrity

BS EN ISO 8871-5:2016 (Annex D)

Prefilled syringes

Breakloose and glide force

BS ISO 11040-4:2015 (Annex E)

BS ISO 11040-8:2016

 

 

Dye solution tightness test

BS ISO 11040-4:2015 (Annex H)

 

Needle-based injection systems

Dose accuracy

BS EN ISO 11608-1:2015

 

Syringes

Plunger operation force

BS EN ISO 7886-1:1997 (Annex G)

 

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.