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Medical Devices

    Services Standards Used    

SERVICES

INDUSTRIES

CONTACT US

Anecto Ltd.,
Mervue Business Park,
Galway,
Ireland.

Phone (+353) 91 757404
Fax: (+353) 91 757387

Email sales@anecto.com

 

     

Package Integrity Testing
  Conditioning
  Transportation Testing
  Dye Penetration Testing
  Bubble Leak Testing
  Burst Testing
  Peel Testing (Tensile Testing)
  Accelerated & Real Time Aging
     
Standards Used
  ASTM D 4332
  ASTM D 4169 / ISTA
ASTM F 1929 and EN868
  ASTM F 2096
  ASTM F1140 and F2054
ASTM F 88
  ASTM F 1980
Anecto product test laboratory offers a wide range of medical device testing services that draw upon industry standards and use best practices testing techniques.

Anecto is experienced in performing tests that comply with the following medical device testing industry standards.
ISO 11607

Packaging for Terminally Sterilized Medical Devices

ASTM F1929 Standard Standard Test Method for Detecting Seal Leaks in Porous Medical Packaging by Dye Penetration,
ASTM F2096 Standard Test Method for Detecting Gross Leaks in Medical Packaging by Internal Pressurization (Bubble Leak Test),
ASTM F88

Standard Test Method for Seal Strength of Flexible Barrier Materials (Peel Testing),

ASTM F1140 Standard Test Methods for Internal Pressurization Failure Resistance of Unrestrained Packages for Medical Applications (Unrestrained Burst Test)
ASTM F2054 Standard Test Methods for Internal Pressurization Failure Resistance of Restrained Packages for Medical Applications (Restrained Burst Test)
ASTM F1980 Standard Guide for Accelerated Aging of Sterile Medical Device Packaging

For further information on any of our services please contact us

 

 

 

 

 

 

 

For all your Laboratory Testing service requirements in any of the following areas contact Anecto Ltd:-
Reliability Testing, Qualmark, HALT, Life testing, HASS, stress screening, ISTA Testing, ASTM Testing, IEC Testing, MIL-STD Testing, British Standards Testing (BS), Drop Testing, Vibration Testing (Random and Sine), Temperature Humidity Testing, Temperature Cycling, Damp Heat, Ramp Rate, Contract Manufacturing, Bubble Leak testing, Peel Testing, Dye Penetration Testing, Peel Testing, Tensile Testing, Environmental testing, Product Evaluation, Product Validation, Thermal Shock, Process Validation, Integrity Testing, IPX Testing, Ingress testing, Transportation testing, Incline Testing, Package Testing, Fault Diagnosis, Fault Analysis, Distribution service, Test development, Design Verification Testing (DVT), Cold chain testing, Aerospace, Laboratory Testing Services, Medical Device testing, Accelerated Aging, Real time aging, shelf life, Accelerated Ageing, Real time ageing, Process equipment validation, Life Science, ISO9000, ISO17025, ISO11607, Accreditation, Automotive, Engineering, Turn Key, Process Qualification, Dangerous Goods Package, Hazardous Material package testing (HMR), HazMat package testing, Dangerous goods regulations, UN regulations, UN package testing, Hydrostatic Pressure Test, leekproofness testing, Mechanical testing, Material testing, Product testing, Performance Qualification, Leak tester, fastness testers, package testing, leak detection system for blister packs, package test system, torque testers, Installation Qualification (IQ), Operational Qualification (OQ) and Performance Qualification (PQ) Performance Verification (PV)

All our equipment (Qualmark, Thermotron, Votsch, Lansmont, Derritron, Zwick) are fully calibrated and traceable to national or international standards
For further information on any of our services please contact us at sales@anecto.com or telephone +353 (0)91 757404