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Industry Product Tested Test Type Test Standard
  1. Home
  2. standard
  3. bs iso 11040 4

BS ISO 11040-4Pre-filled Syringes - Part 4: Glass barrels for injectables and sterilized subassembled syringes ready for filling

This part of ISO 11040 applies to — tubing-glass barrels (single-chamber design) for injection preparations, and — sterilized subassembled syringes ready for filling. It specifies materials, dimensions, quality, and performance requirements, as well as relevant test methods. Relevant mechanical strength testing methods include: Syringe Barrel tests (C.1 Flange Breakage Resistance C.2 Luer Cone Breakage Resistance), E.1 Glide Force Test to evaluate syringe lubrication, F.1 Needle Penetration Test, G.1 Needle Pull-out Force, G.2 Closure system Liquid Leakage Test using compression tester, G.3 Luer-lock Adaptor Collar Pull-off Force and G.4 Torque Resistance, G.5 Luer-lock rigid tip cap Unscrewing Torque, G.6 Pull-off force of the tip cap or the needle shield

Test types
Pull-off / Pull-out
Compressive shear
compressive strength
needle penetration
Torque to turn
Industries
Medical & Medical Device
Pharmaceuticals

Some of our customers

Featured case studies

Syringe needle penetration test to ISO 11040-4 Annex F through simulated skin film
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Syringe testing to ISO 11040-4 Annex F needle penetration and drag

Glass pre-filled syringe closure leakage test to ISO11040-4 Annex G2
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Syringe testing to ISO 11040-4 Annex G2 closure leakage

ISO 11040 Annex C2 Luer break resistance test using universal fixture to locate the glass barrel horizontally and apply the cantilever force to the nose section via a notched probe
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Syringe testing to ISO 11040-4 Annex C2 Luer cone break resistance

Dual-action vice grip and syringe holder sleeve fixtures to apply tension to pull-off the tip cap
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Syringe testing to ISO 11040-4 Annex G6 needle shield pull-off force

Three sizes of syringe for plunger break-loose and glide force testing
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BD Medical logo

Automated syringe break-loose and glide force system

Break-loose and Sustainability Force Test
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Break-loose and sustaining force tests of pre-filled drug cartridges to ISO 11608-3

+44 (0)1403 799979
info@mecmesin.com

PPT Group UK Ltd
t/a Mecmesin
Newton House
Spring Copse Business Park
Slinfold, West Sussex
RH13 0SZ
United Kingdom

PPT Group UK Ltd is a company registered in England and Wales, company number 414668.

Mecmesin is a PPT Group brand.

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Force testing

Systems

  • Universal testing machines
  • Large format compression testers
  • Motorised force testers

Instruments

  • Digital force gauges
  • Mechanical force gauges
  • Manual test stands
Compression test on foam sample

Materials testing

Systems

  • Universal testing machines
  • Low-force materials tester

Instruments

  • Falling dart impact testers
Tensile test on plastic material sample

Torque testing

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  • Automated torque testers
  • Motorised torque testers

Instruments

  • Digital torque testers
Torque test on bottle cap

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