ASTM F1980 Accredited Testing Labs Worldwide

SC OPE OF ACCREDITATION TO ISO/IEC 17025:2017 SM ITHERS DT LLC 6539 Westland Way Suites 22 through 25 Lansing, MI 48917 Kelby Thayer Phone: (517) 322- 2400 M ECHANICAL V alid To: February 29, 2028 Certificate Number: 0363.06 I

ASTM F1980-21 Visual Inspection for flaws and channels in seals ASTM F1886-16 (2024) ASTM F1886M -16 (2024 ) Seal Strength test by rupture pressure ASTM F1140/F1140M-13 (2020) ASTM F2054/F2054M-13 (2024) Seal Integri

ASTM F1980

ASTM F1980 IEC 60068-2-30 IEC 60068-2-38 Altitude/Low Pressure (to 100,000 feet) MIL-STD-810, rev. E-H, Method 500, Procedures I & II; RTCA/DO-160, rev. E-G, Section 4.6.1; MIL-STD-202, Method 105; MIL-STD-883, Method 1001; IEC 6006

ASTM F1980 – 21 Standard Guide for Accelerated Agin g of Sterile Barrier Systems for Medical Devices ASTM F2003 – 02(2022) Standard Guide for Accelerate d Aging of Ultra-High Molecular Weight Polyethylene ASTM F2009 – 20 Standard Test M

ASTM F1980-21 + DIN 58953-6:2025 - solo/only punto 4 Metodo colturale-conta Barriera microbica/Microbial barrier DIN 58953-6:2025 - solo/only punto 4 Metodo colturale-conta Imperfezioni della saldatura dopo prova di invecchiamento accel

ASTM F1980 Conditioning Containers, Packages, or Packaging Components for Testing ASTM D4332 Resistance to humidity hot and cold cycling of trim materials test Chrysler LP-463-LB-12-01 (Method A only) Environmental Exposure Resistance

ASTM F1980 Sterilization Packaging Systems – Detecting Seal Leaks in Porous Medical Packaging by Dye Penetration ANSI/AAMI/ISO 11607-1; AAMI TIR22; ASTM F1929 Sterilization Packaging System – Dry Time Testing ANSI/AAMI ST77; AAMI TIR 12

DIN EN ISO 18562-4: 2020-05 Beurteilung der Biokompatibilität der Atemgaswege bei medizinischen Anwendungen - Teil 4: Prüfungen für herauslösbare Substanzen in Kondensaten (ISO 18562-4:2017) DIN EN ISO 20795-1: 2013-06 Zahnheilkunde – Ku

ASTM F1980 Standard Guide for Accelerated Aging of Sterile Barrier Systems for 2021 Medical Devices ASTM F2096 Standard Test Method for Detecting Gross Leaks in Packaging by 2011 (reapproved 2019) Internal Pressurization (Bubble

ASTM F1980 Standard Guide for Accelerated Aging of Sterile Barrier Systems and Medical Devices ASTM F316 Standard Test Methods for Pore Size Characteristics of Membrane Filters by Bubble Point and Mean Flow Pore Test ISO 2941 Hydraulic

ASTM F1980 Salt Fog Testing MIL-STD-202 101, MIL-STD-810 509.8 Conditioning of Paperboard TAPPI T402 (+ /-2 °C, +/-5% RH) Effect of Dry Heat on Properties of Paperboard TAPPI T453 Effect of Moist Heat on Properties of Paperboard TAPP

ASTM F1980 1 This laboratory also uses customer supplied specifications directly related to the types of tests and within the parameters listed above.

ASTM F1980 – 21 Standard Guide for Accelerated Aging of Sterile Barrier Systems for Medical Devices ASTM F2054/F2054M – 13 (Reapproved 2020) Standard Test Method for Burst Testing of Flexible Package Seals Using Internal Air Pressuriza

ASTM F1980 : 2021 Standard Guide for Accelerated Aging of Sterile Barrier Systems and Medical Devices German Federal Health Gazette 04/94, S. 274-278 : 1994-04 Testing the activity of surface disinfectants for the disinfection of tuber

ASTM F1980

ASTM F1980-21 + ASTM F3039-23 - escluso/except Method B Liquidi penetranti Verifica delle perdite mediante penetrazione del colorante/Verification of leaks by dye penetration ASTM F3039-23 - escluso/except Method B Liquidi penetranti I

ASTM F1980 Plastics ASTM D618 Complete, Filled Transport Packages and Unit Loads ISO 2233 Temperature Test for Transport Packaging ISTA 7D, ISTA 2A

ASTM F1980 Bending Modulus by Means of a Cantilever Beam ASTM D747 Ball Bursting Strength ASTM D6797, D751 (Sections 19-22); NFPA 1971 8.13 Blocking Resistance at Elevated Temperatures ASTM D751 (Sections 90-93) Brush Pilling ASTM D3

ASTM F1980 International Safe Transit Association ISTA 1A, 1B, 1C, 1D, 1G, 1H, 2A, 2B, 2C, 3A, 3B, 3E, 3F, 6-AMAZON.com-B, 6-FEDEX-A, 6-SAMSCLUB Standard Practice for Performance Testing of Shipping Containers and Systems AST

ASTM F1980

Prüfgebiet Prüfgegenstand Produkt(kategorie) Prüfungsart Prüfung Regelwerk Prüfverfahren Mikrobiologisch- hygienische Prüfungen Sterilbarriere- und Verpackungssysteme Verpackungsmaterialien Prüfung zum Nachweis der Übereinst

DIN EN 60068 -2-27 2010 -02 Environmental testing - Part 2-27: Tests - Test Ea and guidance: Shock DIN EN 60068 -2-64 2009 -04 Environmental testing - Part 2-64: Tests - Test Fh: Vibration, broadband random and guidance

ASTM F1980 : 2021 Standard Guide for Accelerated Aging of Sterile Barrier Systems and Medical Device

ASTM F1980 Portée flexible FLEX1 : le laboratoire est reconnu compétent pour pratiquer les méthodes référencées et leurs révisions ultérieures.

1.5. Klimaprüfung an Packstücken, Ladeeinheiten und Verpackungen bzw. Packmi;eln bei definierter Temperatur und definierter rela@ver Feuchte [Flex B] ASTM D 4332 2022 Standard Practice for Conditioning Containers, Packages, or Packagin

ASTM F1980 Test Technology: Parameters: Test Method(s): Static Testing: Static Load Static Torsion Stroke Angular Displacement (± 0.4 to ± 20,000) N (± 0.02 to ± 50) Nm (0 to 550) mm (0 to ±1,800) deg

ASTM F1980 Environmental Conditioning ASTM D4332 Distribution Testing Altitude ASTM D6653, ASTM D4179 (Schedule I), ASTM D7386, (Schedule K) Compressive Resistance ASTM D642, ASTM D4169 (Schedule B, C), ASTM D7386 (Schedule A) Conc

ASTM F1980; ASTM F2825; ASTM D618; ASTM D4332 Distribution Testing ASTM D4169 Altitude ASTM D6653 Drops ASTM D5276 Dart Impact ASTM D6344 Bridge Impact ASTM D5265 Random Vibration ASTM D4728 Repetitive Shoc