2010年10月27日 星期三

Package, Product & Material Testing Standards

Package, Product & Material Testing Standards

DDL is experienced in performing package, product and material tests that comply with the following industry standards:




ANSI Standards
ICWM-2004
Performance Standard for Casters & Wheels
 
AAMI Standards
  
ID 26
Infusion Pump Performance Testing
  
ASTM Standards
  
A370    Mechanical Testing of Steel Products
A931    Tension Testing of Wire Rope and Strand
B565Shear Testing of Aluminum & Aluminum-Alloy Rivets
B769
Shear Testing of Aluminum Alloys
B794Durability Wear Testing of Separable Electrical Connector Systems
C273Shear Properties of Sandwich Core Materials
C297Flatwise Tensile Strength of Sandwich Constructions
C373Water Absorption, Bulk Density, Apparent Porosity and Apparent Sp. Gravity of Fired Whiteware Products
C393Flexural Properties of Sandwich Constructions
C773Compressive Strength of Fired Whiteware Materials
C1161  Flexural Strength of Advanced Ceramics
D198Static Tests of Lumber in Structural Sizes
D412
Vulcanized Rubber & Thermoplastic Elastomers - Tension
D543Evaluating the Resistance of Plastics to Chemical Reagents
D570Water Absorption of Plastics
D575Rubber Properties in Compression
D624Tear Strength of Vulcanized Rubber and Thermoplastic Elastomers
D638Tensile Properties of Plastics
D642Standard Test Method for Determination of Compressive Resistance
D648Deflection Temperature of Plastics under Flexural Load
D695    Compressive Properties of Rigid Plastics
D696Coefficient of Linear Thermal Expansion of Plastics
D732Shear Strength of Plastics by Punch Tool
D737Air Permeability of Textile Fabrics
D747Apparent Bending Modulus of Plastics by Means of a Cantilever Beam
D774Bursting Strength of Paper
D790Flexural Properties of Plastics and Insulating Materials
D792Density and Specific Gravity of Plastics
D882Tensile Properties of Thin Plastic Sheeting
D885
Test Methods for Tire Cords and Industrial Filament Yarns
D897Tensile Properties of Adhesive Bonds
D903    Peel or Stripping Strength of Adhesive Bonds
D905Strength of Adhesive Bonds in Shear by Compression
D952Bond Strength of Sheet Plastics and Electrical Insulating Materials
D999Standard Method for Vibration Testing of Shipping Containers
D1002  Shear Strength of Single Lap Adhesive Bonds
D1004Initial Tear Resistance of Plastic Films
D1037Properties of Wood-Based Fiber and Particle Panels
D1042Linear Dimensional Changes Under Accelerated Aging Conditions
D1043Stiffness Properties of Plastics as a Function of Temperature by Means of a Torsion Test
D1204Linear Dimensional Changes of Non-rigid Thermoplastic Film at Elevated Temp
D1424Tear Resistance of Fabrics (Elmendorf Method)
D1621
Compressive Properties of Rigid Cellular Plastics
D1622Apparent Density of Rigid Cellular Plastics
D1623
Tensile and Adhesion properties of Rigid Cellular Plastics
D1708Tensile Properties of Plastics by Microtensile Specimens
D1761Mechanical Fasteners in Wood
D1876Peel Resistance of Adhesives
D1894Standard Test Method for Static and Kinetic Coefficients of Friction of Plastic Film and Sheeting
D1938Tear-Propagation Resistance (Trouser Tear) of Plastic Film
D2095
Tensile Strength of Adhesives by Bar and Rod Specimens
D2164  Testing Structural Insulating Roof Deck
D2256Tensile Properties of Yarns
D2343Tensile Properties of Glass Fiber Strands, Yarns, and Rovings
D2344Short-Beam Strength of Polymer Matrix Composite Materials
D2412External Loading Characteristics of Plastic Pipe by Parallel-Plate Loading
D2718  Structural Panels in Planar Shear
D2737Polyethylene (PE) Plastic Tubing
D2979Pressure-Sensitive Tack of Adhesives Using an Inverted Probe Machine1
D2990Tensile, Compressive, and Flexural Creep and Creep-Rupture of Plastics
D3039Tensile Properties of Polymer Matrix Composite
D3078
Standard Test Method for Determination of Leaks in Flexible Packaging by Bubble Emission
D3079
Standard Test Method for Water Vapor Transmission of Flexible Heat-Sealed Packages for Dry Products
D3163Strength of Bonded Rigid Plastic Lap-Shear Joints in Shear by Tension Loading
D3165
Strength Properties of Adhesives in Shear by Tension – Single Lap-Shear Assemblies
D3330Standard Test Method for Peel Adhesion of Pressure-Sensitive Tape
 
D3332Mechanical-Shock Fragility of Products, Using Shock Machines
D3574  Test Methods for Flexible Cellular Materials
D3580Vibration (Vertical Linear Motion) Test of Products
D3611  
Accelerated Aging of Pressure Sensitive Tapes
D3983Strength and Shear Modulus of Adhesives by Tensile-Lap Specimen
D4169Standard Practice for Performance Testing of Shipping Containers and Systems
D4332
Standard Practice for Conditioning Containers, Packages, or Packaging Components for Testing
D4475Shear Strength of Pultruded Reinforced Plastic Rods by the Short-Beam Method
D4728Standard Test Method for Random Vibration Testing of Shipping Containers
D4991
Standard Test Method for Leakage Testing of Empty Rigid Containers by Vacuum Method
D5034Breaking Strength and Elongation of Textile Fabrics
D5035
Breaking Force and Elongation of Textile Fabrics (Strip Method)
D5151Detection of Holes in Medical Gloves
D5276
Standard Test Method for Drop Test for Loaded Containers by Free Fall
D5278  
Elongation of Narrow Elastic Fabrics
D5487
Standard Test Method for Simulated Drop of Loaded Containers by Shock Machines
D5934Modulus of Elasticity for Plastic Specimens by Three-Point Bending
D6653Standard Test Methods for Determining the Effects of High Altitude on Packaging Systems by Vacuum Method
D7234Pull-Off Adhesion Strength of Coatings on Concrete Using Portable Pull-Off Adhesion Testers
E8Tension Testing of Metallic Materials
E72     
Strength Testing of Building Panels
E345Tension Testing of Metallic Foil
E1876
Dynamic Young’s Modulus, Shear Modulus, and Poisson’s Ratio by Impulse Excitation of Vibration
F88Standard Test Method for Seal Strength of Flexible Barrier Materials
F477
Elastomeric Seals (Gaskets) for Joining Plastic Pipe
F623
Performance Specs for Foley Catheters
F904
Bond Strength or Ply Adhesion of Similar Laminates Made from Flexible Materials
F1140Standard Test Methods for Internal Pressurization Failure Resistance of Unrestrained Packages for Medical Applications
F1306Slow Rate Penetration Resistance of Flexible Barrier Films and Laminates
F1464  
Oxygen Concentrators for Domiciliary Use
F1608
Standard Test Method for Microbial Ranking of Porous Packaging Materials (Exposure Chamber Method)
F1691
Determining Axial Pullout Strength of Medical Bone Screws
F 1929
Standard Test Method for Detecting Seal Leaks in Porous Medical Packaging by Dye Penetration
F1980
Standard Guide for Accelerated Aging of Sterile Medical Device Packaging
F2096
Standard Test Method for Detecting Gross Leaks in Medical Packaging by Internal Pressurization (Bubble Test)
F2372Consumer Safety Performance Specification for Shopping Carts
  
CENELEC Standards
  
EN 45502Active Implantable Medical Devices
  
EIA Standards
  
RS-186
 
  
ETS Standards
  
300-019Environmental Tests for Telecommunications Equipment
  
IEC Standards
  
60068-1Environmental Testing Part I: General guidance
60068-2-14Basic Environmental Testing Procedures Test N: Change of temperature
60068-2-33Environmental Testing- Guidance on change of temperature tests
60068-2-38Composite Temperature/Humidity Cyclic Test
60068-2-64Vibration, broad-band random (digital control) and guidance
60601-1
Medical Electrical Equipment – Part 1: General requirements for basic safety and essential performance
  
ISO Standards
  
37
Rubber, vulcanized or thermoplastic -- Determination of tensile stress-strain properties
594-1
Conical fittings with a 6 % (Luer) taper for syringes, needles and certain other medical equipment
594-2Conical fittings with 6 % (Luer) taper for syringes, needles and certain other medical equipment -- Part 2: Lock fittings
595Reusable all-glass or metal-and-glass syringes for medical use -- Part 1: Dimensions
2247Packaging -- Complete, filled transport packages and unit loads -- Vibration tests at fixed low frequency
5841-3
Implants for surgery – Cardiac Pacemakers – Part 3: Low profile connectors (IS-1) for implantable pacemakers
7864Sterile hypodermic needles for single use
7886-1Sterile Hypodermic Syringes.  Part 1: Syringes for manual use
8318
Packaging -- Complete, filled transport packages and unit loads -- Sinusoidal vibration tests using a variable frequency
8359Oxygen Concentrators for Medical Use – Safety Requirements
8536-4Infusion equipment for medical use – Part 4: Infusion sets for single use, gravity feed
8569
Measurement and evaluation of shock and vibration effects on sensitive equipment in buildings
8537
Sterle single-use syringes, with or without needle for insulin
9022-10Optics and optical instruments -- Environmental test methods -- Part 10: Combined sinusoidal vibration and dry heat or cold
9022-15
Environmental test methods -- Part 15: Combined digitally controlled broad-band random vibration and dry heat or cold
9022-19Environmental test methods -- Part 19: Temperature cycles combined with sinusoidal or random vibration
9626Stainless steel needle tubing for manufacture of medical devices
10282Single Use Sterile Rubber Gloves
10555-1Sterile, single-use intravascular catheters – general requirements
10555-3Sterile, single-use intravascular catheters – Central venous catheters
10555-5Sterile, single-use intravascular catheters – Over-needle peripheral catheters
10846-1Measurement of vibro-acoustic transfer properties of resilient elements
11070Sterile Single-use Intravascular Catheter Introducers
  
ISTA Standards
  
ISTAPre-Shipment Test Procedure
  
JIS Standards
  
C0040
 
C0041Environmental Tests – Shock and Vibration
  
MIL Standards
  
167Vibration Testing
202Electronic and Electrical Component Parts
810FTest Method Standard for Environmental Engineering Considerations and Laboratory Tests
883 
HDBK-17Composite Materials
P-26514Polyurethane Foam, Rigid or Flexible, for Packaging
  
NAVMAT Standards
  
P-9492 Temperature Cycling and Random Vibration
  
NEMA
LD-3-2000High Pressure Laminates
 
PDA Technical Reports
Tech. Report #27Pharmaceutical Package Integrity, 1998 Supplement, Vol. 52 , No: 52
Tech. Report #39Cold Chain Guidance for Medicinal Products: Maintaining the Quality of Temperature-Sensitive Medicinal Products Through The Transportation Environment, Sept/Oct 2005, Supplement, Vol. 59, No: S-3
 
SAE Standards

J1455Environmental Practices for Electronic Equipment Design
  
JEDEC Standards
  
JESD22-A104-BTemperature Cycling for Electronic Circuits
JESD22- A102-CAccelerated Moisture Resistance for Electronic Circuits
JESD22- B103-BVibration for Electronic Circuits
JESD22-B104-CMechanical Shock for Electronic Circuits
JESD22- A106-BThermal Shock for Electronic Circuits
  
TAPPI Standards
TAPPI T 410
Grammage of paper and paperboard
TAPPI T 411
Thickness (Caliper) of Paper, Paperboard and Combined Board
TAPPI T 414
Internal Tearing resistance of Paper (Elmendorf)
TAPPI T 460
Air Resistance of Paper (Gurley)
TAPPI T 494
Tensile Properties of Paper & Paperboard (using constant rate of elongation apparatus)
TAPPI T 810
Bursting Strength of Corrugated and Solid Fiberboard
TAPPI T 811
Edgewise compressive Strength of Corrugated fiberboard
TAPPI T 839
Edgewise compressive Strength of Corrugated fiberboard