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ASTM F 3127 : 2016

ASTM F 3127 : 2016

Superseded

Superseded

A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.

View Superseded by
superseded

A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.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 Validating Cleaning Processes Used During the Manufacture of Medical Devices

Available format(s)

Hardcopy , PDF

Superseded date

14-10-2022

Language(s)

English

Published date

08-06-2016

Publisher

American Society for Testing and Materials

CONTAINED IN VOL. 13.02, 2016 Gives considerations for validating cleaning processes for medical devices during initial fabrication and assembly prior to initial use.

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.

Committee
F 04
DocumentType
Guide
Pages
16
PublisherName
American Society for Testing and Materials
Status
Superseded
SupersededBy

ISO 19227:2018 Implants for surgery — Cleanliness of orthopedic implants — General requirements
ASTM F 3438 : 2021 Standard Guide for Detection and Quantification of Cleaning Markers (Analytes) for the Validation of Cleaning Methods for Reusable Medical Devices
ASTM D 8270 : 2022 : REV A Standard Terminology Relating to Cannabis
ASTM G 121 : 2018 Standard Practice for Preparation of Contaminated Test Coupons for the Evaluation of Cleaning Agents
ASTM D 8219 : 2019 Standard Guide for Cleaning and Disinfection at a Cannabis Cultivation Center

ASTM F 2459 : 2012 Standard Test Method for Extracting Residue from Metallic Medical Components and Quantifying via Gravimetric Analysis
ASTM E 2857 : 2021 Standard Guide for Validating Analytical Methods
ISO 11737-1:2006 Sterilization of medical devices Microbiological methods Part 1: Determination of a population of microorganisms on products
ASTM D 543 : 2014 : REDLINE Standard Practices for Evaluating the Resistance of Plastics to Chemical Reagents
ASTM F 2847 : 2017 Standard Practice for Reporting and Assessment of Residues on Single-Use Implants and Single-Use Sterile Instruments
ASTM G 122 : 1996 Standard Test Method for Evaluating the Effectiveness of Cleaning Agents
ASTM F 2459 : 2018 Standard Test Method for Extracting Residue from Metallic Medical Components and Quantifying via Gravimetric Analysis
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
ASTM F 2847 : 2010 Standard Practice for Reporting and Assessment of Residues on Single Use Implants
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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Hardcopy - English
PDF - English
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