EN 13430:2004
|
Packaging - Requirements for packaging recoverable by material recycling |
ASTM F 1327 : 2005
|
Standard Terminology Relating to Barrier Materials for Medical Packaging (Withdrawn 2007) |
ISO 11137-1:2006
|
Sterilization of health care products Radiation Part 1: Requirements for development, validation and routine control of a sterilization process for medical devices |
AAMI TIR19 : 1998
|
GUIDANCE FOR ANSI/AAMI/ISO 10993-7: 1995, BIOLOGICAL EVALUATION OF MEDICAL DEVICES - PART 7: ETHYLENE OXIDE STERILIZATION RESIDUALS |
ASTM D 1894 : 2014 : REDLINE
|
Standard Test Method for Static and Kinetic Coefficients of Friction of Plastic Film and Sheeting |
ASTM D 4169 : 2016 : REDLINE
|
Standard Practice for Performance Testing of Shipping Containers and Systems |
ASTM D 3420 : 2014 : REDLINE
|
Standard Test Method for Pendulum Impact Resistance of Plastic Film |
ISO 11607-2:2006
|
Packaging for terminally sterilized medical devices Part 2: Validation requirements for forming, sealing and assembly processes |
ANSI/AAMI ST58:2013(R2018)
|
CHEMICAL STERILIZATION AND HIGH-LEVEL DISINFECTION IN HEALTH CARE FACILITIES |
ASTM F 2475 : 2011 : REDLINE
|
Standard Guide for Biocompatibility Evaluation of Medical Device Packaging Materials |
EN 60118-13:2011
|
Electroacoustics - Hearing aids - Part 13: Electromagnetic compatibility (EMC) |
CFR 21(PTS170-199) : 0
|
FOOD AND DRUGS - FOOD AND DRUG ADMINISTRATION, CHAPTER 1 DEPARTMENT OF HEALTH AND HUMAN SERVICES - PARTS 170-199 |
IEC 60601-1:2005+AMD1:2012 CSV
|
Medical electrical equipment - Part 1: General requirements for basic safety and essential performance |
EN 13427:2004
|
Packaging - Requirements for the use of European Standards in the field of packaging and packaging waste |
EN 868-5:2009
|
Packaging for terminally sterilized medical devices - Part 5: Sealable pouches and reels of porous materials and plastic film construction - Requirements and test methods |
DIN 58921:2011-01
|
Test method to demonstrate the suitability of a medical device simulator during steam sterilisation - Medical device simulator testing; Text in German and English |
IEC 60118-13:2016
|
Electroacoustics - Hearing aids - Part 13: Electromagnetic compatibility (EMC) |
ISO/TS 17665-2:2009
|
Sterilization of health care products — Moist heat — Part 2: Guidance on the application of ISO 17665-1 |
ASTM F 2097 : 2016 : REDLINE
|
Standard Guide for Design and Evaluation of Primary Flexible Packaging for Medical Products |
DIN 58953-6:2016-12
|
Sterilization - Sterile supply - Part 6: Microbial barrier testing of packaging materials for medical devices which are to be sterilized |
ASTM F 2029 : 2016 : REDLINE
|
Standard Practices for Making Laboratory Heat Seals for Determination of Heat Sealability of Flexible Barrier Materials as Measured by Seal Strength |
CFR 21(PTS800-1299) : 0
|
FOOD AND DRUGS - FOOD AND DRUG ADMINISTRATION, CHAPTER 1 DEPARTMENT OF HEALTH AND HUMAN SERVICES - PARTS 800-1299 |
AAMI TIR35 : 2016
|
STERILIZATION OF HEALTH CARE PRODUCTS - RADIATION STERILIZATION - PRODUCT ADOPTION AND ALTERNATIVE SAMPLING PLANS FOR VERIFICATION DOSE EXPERIMENTS AND STERILIZATION DOSE AUDITS |
ASTM D 4321 : 2015 : REDLINE
|
Standard Test Method for Package Yield of Plastic Film |
EN 13429:2004
|
Packaging - Reuse |
AAMI TIR33 : 2005
|
STERILIZATION OF HEALTH CARE PRODUCTS - RADIATION STERILIZATION - SUBSTANTIATION OF A SELECTED STERILIZATION DOSE - METHOD VDMAX |
ASTM F 2096 : 2011
|
Standard Test Method for Detecting Gross Leaks in Packaging by Internal Pressurization (Bubble Test) |
EN 868-2:2017
|
Packaging for terminally sterilized medical devices - Part 2: Sterilization wrap - Requirements and test methods |
AAMI TIR28 : 2016
|
PRODUCT ADOPTION AND PROCESS EQUIVALENCE FOR ETHYLENE OXIDE STERILIZATION |
ISO 11135-1:2007
|
Sterilization of health care products Ethylene oxide Part 1: Requirements for development, validation and routine control of a sterilization process for medical devices |
AAMI TIR15 : 2016
|
PHYSICAL ASPECTS OF ETHYLENE OXIDE STERILIZATION |
ASTM D 2457 : 2013 : REDLINE
|
Standard Test Method for Specular Gloss of Plastic Films and Solid Plastics |
ASTM F 1929 : 2015 : REDLINE
|
Standard Test Method for Detecting Seal Leaks in Porous Medical Packaging by Dye Penetration |
ISO 14708-2:2012
|
Implants for surgery Active implantable medical devices Part 2: Cardiac pacemakers |
AAMI TIR17 : 2008
|
COMPATIBILITY OF MATERIALS SUBJECT TO STERILIZATION |
ISO 14708-1:2014
|
Implants for surgery — Active implantable medical devices — Part 1: General requirements for safety, marking and for information to be provided by the manufacturer |
ISO 20857:2010
|
Sterilization of health care products Dry heat Requirements for the development, validation and routine control of a sterilization process for medical devices |
ISO 1924-2:2008
|
Paper and board — Determination of tensile properties — Part 2: Constant rate of elongation method (20 mm/min) |
ISO/TS 11139:2006
|
Sterilization of health care products Vocabulary |
ISO 11137-3:2017
|
Sterilization of health care products — Radiation — Part 3: Guidance on dosimetric aspects of development, validation and routine control |
EN 13431:2004
|
Packaging - Requirements for packaging recoverable in the form of energy recovery, including specification of minimum inferior calorific value |
EN 13428:2004
|
Packaging - Requirements specific to manufacturing and composition - Prevention by source reduction |
DIN 58953-8:2010-05
|
STERILIZATION - STERILE SUPPLY - PART 8: LOGISTICS OF STERILE MEDICAL DEVICES |
ISO 10993-7:2008
|
Biological evaluation of medical devices Part 7: Ethylene oxide sterilization residuals |
ASTM D 1003 : 2013 : REDLINE
|
Standard Test Method for Haze and Luminous Transmittance of Transparent Plastics |
ASTM F 1886 : 1998
|
Standard Test Method for Determining Integrity of Seals for Medical Packaging by Visual Inspection |
ISO 10993-1:2009
|
Biological evaluation of medical devices Part 1: Evaluation and testing within a risk management process |
ISO 534:2011
|
Paper and board — Determination of thickness, density and specific volume |
ASTM D 1922 : 2015 : REDLINE
|
Standard Test Method for Propagation Tear Resistance of Plastic Film and Thin Sheeting by Pendulum Method |
EN 13432:2000/AC:2005
|
PACKAGING - REQUIREMENTS FOR PACKAGING RECOVERABLE THROUGH COMPOSTING AND BIODEGRADATION - TEST SCHEME AND EVALUATION CRITERIA FOR THE FINAL ACCEPTANCE OF PACKAGING |
ASTM F 1980 : 2016 : REDLINE
|
Standard Guide for Accelerated Aging of Sterile Barrier Systems for Medical Devices |
ISO/ASTM 51649:2015
|
Practice for dosimetry in an electron beam facility for radiation processing at energies between 300 keV and 25 MeV |
ISO/TS 11135-2:2008
|
Sterilization of health care products Ethylene oxide Part 2: Guidance on the application of ISO 11135-1 |
ISO 14971:2007
|
Medical devices Application of risk management to medical devices |
ISO 11607-1:2006
|
Packaging for terminally sterilized medical devices Part 1: Requirements for materials, sterile barrier systems and packaging systems |
DIN 58953-7:2010-05
|
STERILIZATION - STERILE SUPPLY - PART 7: USE OF STERILIZATION PAPER, NONWOVEN WRAPPING MATERIAL, TEXTILE MATERIALS, PAPER BAGS AND SEALABLE POUCHES AND REELS |
AAMI ST63 : 2002
|
STERILIZATION OF HEALTH CARE PRODUCTS - REQUIREMENTS FOR THE DEVELOPMENT, VALIDATION AND ROUTINE CONTROL OF AN INDUSTRIAL STERILIZATION PROCESS FOR MEDICAL DEVICES - DRY HEAT |
ISO 15747:2010
|
Plastic containers for intravenous injections |
ASTM F 1306 : 2016 : REDLINE
|
Standard Test Method for Slow Rate Penetration Resistance of Flexible Barrier Films and Laminates |
ASTM F 904 : 2016 : REDLINE
|
Standard Test Method for Comparison of Bond Strength or Ply Adhesion of Similar Laminates Made from Flexible Materials |
ASTM F 1249 : 2013 : REDLINE
|
Standard Test Method for Water Vapor Transmission Rate Through Plastic Film and Sheeting Using a Modulated Infrared Sensor |
ISO 17665-1:2006
|
Sterilization of health care products — Moist heat — Part 1: Requirements for the development, validation and routine control of a sterilization process for medical devices |
ASQ Z1.9:2003 (R2013)
|
Sampling Procedures And Tables For Inspection By Variables For Percent Nonconforming |
ASTM D 589 : 1997
|
Standard Test Method for Opacity of Paper (15°Diffuse Illuminant A, 89% Reflectance Backing and Paper Backing) |
AAMI TIR20 : 2001
|
PARAMETRIC RELEASE FOR ETHYLENE OXIDE STERILIZATION |