ASTM F 3127 : 2016
Superseded
A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.
View Superseded by
Standard Guide for Validating Cleaning Processes Used During the Manufacture of Medical Devices
Hardcopy , PDF
14-10-2022
English
08-06-2016
Important note : Users cannot be edited or removed once added to your Multi user PDF.CONTAINED IN VOL. 13.02, 2016 Gives considerations for validating cleaning processes for medical devices during initial fabrication and assembly prior to initial use.
| Committee |
F 04
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| DocumentType |
Guide
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| Pages |
16
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| PublisherName |
American Society for Testing and Materials
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| Status |
Superseded
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| SupersededBy |
1.1This guide provides considerations for validating cleaning processes for medical devices during initial fabrication and assembly prior to initial use. Validated cleaning processes are important for achieving consistency in function and consistency in biocompatibility. The considerations include but are not limited to, validation approach, equipment design, procedures and documentation, analytical methods, sampling, development of limits, and other issues.
1.2Inclusions:
1.2.1This guide describes the validation of critical cleaning processes for medical devices to reduce contaminants to acceptable levels prior to packaging.
1.3Exclusions:
1.3.1Reusable medical devices.
1.3.1.1Validation of cleaning operations for reusable medical devices is not within the scope of this standard guide. Although cleaning of reusable medical devices is beyond the scope of this guide, many of the principles outlined in this guide may be applicable to the validation of cleaning operations for reusable devices.
1.3.2Cleaning of medical devices in health care facilities.
1.3.2.1Validation of cleaning processes in patient/health care facilities is not within the scope of this standard guide.
1.4This 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.
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| ASTM G 122 : 1996 | Standard Test Method for Evaluating the Effectiveness of Cleaning Agents |
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| ASTM D 543 : 2021 | Standard Practices for Evaluating the Resistance of Plastics to Chemical Reagents |
| ASTM F 2459 : 2005 | Standard Test Method for Extracting Residue from Metallic Medical Components and Quantifying via Gravimetric Analysis |
| ASTM E 2857 : 2022 | Standard Guide for Validating Analytical Methods |
| ASTM G 131 : 1996 | Standard Practice for Cleaning of Materials and Components by Ultrasonic Techniques |
| ISO 10993-11:2017 | Biological evaluation of medical devices — Part 11: Tests for systemic toxicity |
| ASTM F 619 : 2014 : REDLINE | Standard Practice for Extraction of Medical Plastics |
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| ISO 10993-17:2002 | Biological evaluation of medical devices — Part 17: Establishment of allowable limits for leachable substances |
| ASTM D 543 : 2020 | Standard Practices for Evaluating the Resistance of Plastics to Chemical Reagents |
| ASTM E 2857 : 2011 : R2021 : EDT 1 | Standard Guide for Validating Analytical Methods |
| ASTM E 2857 : 2011 : R2016 | Standard Guide for Validating Analytical Methods |
| ASTM F 2847 : 2017 : REDLINE | Standard Practice for Reporting and Assessment of Residues on Single-Use Implants and Single-Use Sterile Instruments |
| ASTM E 2857 : 2011 | Standard Guide for Validating Analytical Methods |
| ISO 14971:2007 | Medical devices Application of risk management to medical devices |
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