Smithers Extends Scope of UKAS Accreditation for Medical Device Testing in Shawbury, UK

Smithers announced today an extension to its ISO/IEC 17025:2005 scope of accreditation for medical devices.

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 recognises 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 programme 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

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)

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.

To enquire about booking a laboratory visit please contact us 

Contact Chris Berry

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