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ASTM F 1980 : 2016 : REDLINE

Superseded
Superseded

A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.

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superseded

A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.

Standard Guide for Accelerated Aging of Sterile Barrier Systems for Medical Devices
Superseded date

01-04-2022

Published date

09-15-2016

This guide provides information for developing accelerated aging protocols to rapidly determine the effects, if any, due to the passage of time on the sterile integrity of the sterile barrier system (SBS), as defined in ANSI/AAMI/ISO 11607–1:2006 and the physical properties of their component packaging materials.

1.1This guide provides information for developing accelerated aging protocols to rapidly determine the effects, if any, due to the passage of time on the sterile integrity of the sterile barrier system (SBS), as defined in ANSI/AAMI/ISO 11607–1:2006 and the physical properties of their component packaging materials.

1.2Information obtained using this guide may be used to support expiration date claims for medical device sterile barrier systems.

1.3The accelerated aging guideline addresses the sterile barrier systems in whole with or without devices. The sterile barrier system material and device interaction compatibility that may be required for new product development or the resulting evaluation is not addressed in this guide.

1.4Real-time aging protocols are not addressed in this guide; however, it is essential that real-time aging studies be performed to confirm the accelerated aging test results using the same methods of evaluation.

1.5Methods used for sterile barrier system validation, which include the machine process, the effects of the sterilization process, environmental challenge, distribution, handling, and shipping events, are beyond the scope of this guide.

1.6This guide does not address environmental challenging that stimulates extreme climactic conditions that may exist in the shipping and handling environment. Refer to Practice D4332 for standard conditions that may be used to challenge the sterile barrier system to realistic extremes in temperature and humidity conditions. See Terminology F1327 for a definition of “environmental challenging.”

1.7This standard does not purport to address all of the safety concerns, if any, associated with its use. It is the responsibility of the user of this standard to establish appropriate safety and health practices and determine the applicability of regulatory limitations prior to use.

Committee
F 02
DocumentType
Redline
PublisherName
American Society for Testing and Materials
Status
Superseded
SupersededBy

ISO 16840-6:2015 Wheelchair seating — Part 6: Simulated use and determination of the changes in properties of seat cushions
CAN/CSA-ISO/TS 16775:17 Packaging for terminally sterilized medical devices — Guidance on the application of ISO 11607-1 and ISO 11607-2 (Adopted ISO technical specification 16775:2014, first edition, 2014-05-15)
S.R. CEN ISO/TS 16775:2014 PACKAGING FOR TERMINALLY STERILIZED MEDICAL DEVICES - GUIDANCE ON THE APPLICATION OF ISO 11607-1 AND ISO 11607-2 (ISO/TS 16775:2014)
ASTM D 7160 : 2016 : REDLINE Standard Practice for Determination of Expiration Dating for Medical Gloves
PD ISO/TS 17137:2014 Cardiovascular implants and extracorporeal systems. Cardiovascular absorbable implants
ASTM F 1585 : 2000 Standard Guide for Integrity Testing of Porous Barrier Medical Packages (Withdrawn 2006)
CEN ISO/TS 16775:2014 Packaging for terminally sterilized medical devices - Guidance on the application of ISO 11607-1 and ISO 11607-2 (ISO/TS 16775:2014)
PD CEN ISO/TS 16775:2014 Packaging for terminally sterilized medical devices. Guidance on the application of ISO 11607-1 and ISO 11607-2
ISO/TS 17137:2014 Cardiovascular implants and extracorporeal systems Cardiovascular absorbable implants
ISO/TS 19930:2017 Guidance on aspects of a risk-based approach to assuring sterility of terminally sterilized, single-use health care product that is unable to withstand processing to achieve maximally a sterility assurance level of 10-6
AAMI TIR22 : 2007 GUIDANCE FOR ANSI/AAMI/ISO 11607, PACKAGING FOR TERMINALLY STERILIZED MEDICAL DEVICES - PART 1 AND PART 2:2006
AAMI ISO TIR 17137 : 2014 CARDIOVASCULAR IMPLANTS AND EXTRACORPOREAL SYSTEMS - CARDIOVASCULAR ABSORBABLE IMPLANTS
AAMI TIR42 : 2010 EVALUATION OF PARTICULATES ASSOCIATED WITH VASCULAR MEDICAL DEVICES
ASTM F 2150 : 2013 : REDLINE Standard Guide for Characterization and Testing of Biomaterial Scaffolds Used in Tissue-Engineered Medical Products
13/30280551 DC : 0 BS ISO 16840-6 - WHEELCHAIR SEATING - PART 6: SIMULATED USE AND DETERMINATION OF THE CHANGES IN PROPERTIES - SEAT CUSHIONS
ASTM F 1327 : 2005 Standard Terminology Relating to Barrier Materials for Medical Packaging (Withdrawn 2007)
AAMI TIR17 : 2008 COMPATIBILITY OF MATERIALS SUBJECT TO STERILIZATION
AAMI TIR17 : 2017 COMPATIBILITY OF MATERIALS SUBJECT TO STERILIZATION
ASTM F 2789 : 201 Standard Guide for Mechanical and Functional Characterization of Nucleus Devices
ASTM F 2789 : 2010 : R2015 Standard Guide for Mechanical and Functional Characterization of Nucleus Devices
ANSI/AAMI/ISO TIR16775:2014 PACKAGING FOR TERMINALLY STERILIZED MEDICAL DEVICES - GUIDANCE ON THE APPLICATION OF ISO 11607-1 AND ISO 11607-2
PD ISO/TS 19930:2017 Guidance on aspects of a risk-based approach to assuring sterility of terminally sterilized, single-use health care product that is unable to withstand processing to achieve maximally a sterility assurance level of 10-6
ISO/TS 16775:2014 Packaging for terminally sterilized medical devices Guidance on the application of ISO 11607-1 and ISO 11607-2
UNI CEN ISO/TS 16775 : 2014 PACKAGING FOR TERMINALLY STERILIZED MEDICAL DEVICES - GUIDANCE ON THE APPLICATION OF ISO 11607-1 AND ISO 11607-2
BS ISO 16840-6:2015 Wheelchair seating Simulated use and determination of the changes in properties of seat cushions
ASTM F 2097 : 2016 : REDLINE Standard Guide for Design and Evaluation of Primary Flexible Packaging for Medical Products

ASTM F 1327 : 2005 Standard Terminology Relating to Barrier Materials for Medical Packaging (Withdrawn 2007)
ASTM F 2097 : 2016 : REDLINE Standard Guide for Design and Evaluation of Primary Flexible Packaging for Medical Products
AAMI TIR22 : 2007 GUIDANCE FOR ANSI/AAMI/ISO 11607, PACKAGING FOR TERMINALLY STERILIZED MEDICAL DEVICES - PART 1 AND PART 2:2006
ASTM E 337 : 2015 : REDLINE Standard Test Method for Measuring Humidity with a Psychrometer (the Measurement of Wet- and Dry-Bulb Temperatures)

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