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ASTM F3127-22

(Guide)

Standard Guide for Validating Cleaning Processes Used During the Manufacture of Medical Devices

Standard Guide for Validating Cleaning Processes Used During the Manufacture of Medical Devices

SIGNIFICANCE AND USE
5.1 This guide describes an approach to validate a cleaning system for a medical device. It is based on the manufacturer’s accurate and comprehensive understanding of their internal manufacturing and cleaning processes.  
5.2 This guide is not intended to provide a detailed plan or road map, but will provide considerations that can be used by the device manufacturer to develop a detailed plan for performing cleaning validation.  
5.3 In cleaning validation, as with other types of validations, there are multiple ways to achieve a compliant, scientifically sound, and practical cleaning validation program.  
5.4 There are several reference documents identified in Appendix X3 that describe cleaning validation approaches for non-medical devices (including cleaning for oxygen-enriched environments, pharmaceuticals, and semiconductors). Any of these reference documents could provide guidance for a well-defined process for establishing a manufacturer’s minimum expectation of a specific cleaning validation program.  
5.5 This guidance specifically targets cleaning validation for medical devices, in-process and at terminal cleaning so that the result is a consistently clean medical device that meets the performance expectations for that device.
SCOPE
1.1 This 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.  
1.2 Inclusions:  
1.2.1 This guide describes the validation of critical cleaning processes for medical devices to reduce contaminants to acceptable levels prior to packaging.  
1.3 Exclusions—The following items / medical devices / processes are excluded from the scope of this document:  
1.3.1 Reusable medical devices.
1.3.1.1 Validation 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.  
1.3.2 Cleaning of medical devices in health care facilities.
1.3.2.1 Validation of cleaning processes in patient/health care facilities is not within the scope of this standard guide.  
1.4 This standard does not purport to be a replacement for biological safety testing.  
1.5 This 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, health, and environmental practices and determine the applicability of regulatory limitations prior to use.  
1.6 This international standard was developed in accordance with internationally recognized principles on standardization established in the Decision on Principles for the Development of International Standards, Guides and Recommendations issued by the World Trade Organization Technical Barriers to Trade (TBT) Committee.

General Information

Status
Published
Publication Date
30-Sep-2022
ICS
11.080.01 - Sterilization and disinfection in general
Technical Committee
F04 - Medical and Surgical Materials and Devices
Drafting Committee
F04.15 - Material Test Methods
Current Stage
Ref Project

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Standards Content (Sample)

This international standard was developed in accordance with internationally recognized principles on standardization established in the Decision on Principles for the
Development of International Standards, Guides and Recommendations issued by the World Trade Organization Technical Barriers to Trade (TBT) Committee.
Designation: F3127 − 22
Standard Guide for
Validating Cleaning Processes Used During the Manufacture
1
of Medical Devices
This standard is issued under the fixed designation F3127; the number immediately following the designation indicates the year of
original adoption or, in the case of revision, the year of last revision. A number in parentheses indicates the year of last reapproval. A
superscript epsilon (´) indicates an editorial change since the last revision or reapproval.
1. Scope Development of International Standards, Guides and Recom-
mendations issued by the World Trade Organization Technical
1.1 This guide provides considerations for validating clean-
Barriers to Trade (TBT) Committee.
ing processes for medical devices during initial fabrication and
assembly prior to initial use. Validated cleaning processes are
2. Referenced Documents
important for achieving consistency in function and consis-
2
tency in biocompatibility. The considerations include but are
2.1 ASTM Standards:
not limited to: validation approach, equipment design, proce- D543 Practices for Evaluating the Resistance of Plastics to
duresanddocumentation,analyticalmethods,sampling,devel-
Chemical Reagents
opment of limits, and other issues. E1766 Test Method for Determination of Effectiveness of
Sterilization Processes for Reusable Medical Devices
1.2 Inclusions:
E2857 Guide for Validating Analytical Methods
1.2.1 This guide describes the validation of critical cleaning
E3106 Guide for Science-Based and Risk-Based Cleaning
processes for medical devices to reduce contaminants to
Process Development and Validation
acceptable levels prior to packaging.
E3219 GuideforDerivationofHealth-BasedExposureLim-
1.3 Exclusions—The following items / medical devices /
its (HBELs)
processes are excluded from the scope of this document:
E3263 Practice for Qualification of Visual Inspection of
1.3.1 Reusable medical devices.
Pharmaceutical Manufacturing Equipment and Medical
1.3.1.1 Validation of cleaning operations for reusable medi-
Devices for Residues
cal devices is not within the scope of this standard guide.
F619 Practice for Extraction of Materials Used in Medical
Although cleaning of reusable medical devices is beyond the
Devices
scope of this guide, many of the principles outlined in this
F2459 Test Method for Extracting Residue from Metallic
guide may be applicable to the validation of cleaning opera-
Medical Components and Quantifying via Gravimetric
tions for reusable devices.
Analysis
1.3.2 Cleaning of medical devices in health care facilities.
F2847 Practice for Reporting and Assessment of Residues
1.3.2.1 Validation of cleaning processes in patient/health
on Single-Use Implants and Single-Use Sterile Instru-
care facilities is not within the scope of this standard guide.
ments
1.4 This standard does not purport to be a replacement for G121 Practice for Preparation of Contaminated Test Cou-
biological safety testing. pons for the Evaluation of Cleaning Agents
G122 Test Method for Evaluating the Effectiveness of
1.5 This standard does not purport to address all of the
Cleaning Agents and Processes
safety concerns, if any, associated with its use. It is the
G131 PracticeforCleaningofMaterialsandComponentsby
responsibility of the user of this standard to establish appro-
Ultrasonic Techniques
priate safety, health, and environmental practices and deter-
3
mine the applicability of regulatory limitations prior to use. 2.2 ANSI/AAMI/ISO Standards:
1.6 This international standard was developed in accor-
ISO 10993-5 Biological Evaluation of Medical Devices—
dance with internationally recognized principles on standard- Part 5: Tests for Cytotoxicity, In Vitro Methods
ization established in the Decision on Principles for the
1 2
This guide is under the jurisdiction of ASTM Committee F04 on Medical and For referenced ASTM standards, visit the ASTM website, www.astm.org, or
Surgical Materials and Devices and is the direct responsibility of Subcommittee contact ASTM Customer Service at service@astm.org. For Annual Book of ASTM
F04.15 on Material Test Methods. Standards volume information, refer to the standard’s Document Summary page on
Current edition approved Oct. 1, 2022. Published October 2022. Originally the ASTM website.
3
approved in 2016. Last previous edition approved in 2016 as F3127 – 16. DOI: Available fromAmerican National Standards Institute (ANSI), 25 W. 43rd St.,
10.1520/F3127-22. 4th Floor, New York, NY 10036, http://www.ansi.org.
Copyright © ASTM International, 100 Barr Harbor Drive, PO Box C700, West Conshohocken, PA 19428-2959. United States
1

---------------------- Page: 1 ----------------------
F3127 − 22
ISO
...

This document is not an ASTM standard and is intended only to provide the user of an ASTM standard an indication of what changes have been made to the previous version. Because
it may not be technically possible to adequately depict all changes accurately, ASTM recommends that users consult prior editions as appropriate. In all cases only the current version
of the standard as published by ASTM is to be considered the official document.
Designation: F3127 − 16 F3127 − 22
Standard Guide for
Validating Cleaning Processes Used During the Manufacture
1
of Medical Devices
This standard is issued under the fixed designation F3127; the number immediately following the designation indicates the year of
original adoption or, in the case of revision, the year of last revision. A number in parentheses indicates the year of last reapproval. A
superscript epsilon (´) indicates an editorial change since the last revision or reapproval.
1. Scope
1.1 This 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,to: validation approach, equipment design, procedures and
documentation, analytical methods, sampling, development of limits, and other issues.
1.2 Inclusions:
1.2.1 This guide describes the validation of critical cleaning processes for medical devices to reduce contaminants to acceptable
levels prior to packaging.
1.3 Exclusions: Exclusions—The following items / medical devices / processes are excluded from the scope of this document:
1.3.1 Reusable medical devices.
1.3.1.1 Validation 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.
1.3.2 Cleaning of medical devices in health care facilities.
1.3.2.1 Validation of cleaning processes in patient/health care facilities is not within the scope of this standard guide.
1.4 This standard does not purport to be a replacement for biological safety testing.
1.5 This 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 safety, health, and healthenvironmental practices and determine the
applicability of regulatory limitations prior to use.
1.6 This international standard was developed in accordance with internationally recognized principles on standardization
established in the Decision on Principles for the Development of International Standards, Guides and Recommendations issued
by the World Trade Organization Technical Barriers to Trade (TBT) Committee.
1
This guide is under the jurisdiction of ASTM Committee F04 on Medical and Surgical Materials and Devices and is the direct responsibility of Subcommittee F04.15
on Material Test Methods.
Current edition approved April 1, 2016Oct. 1, 2022. Published May 2016October 2022. Originally approved in 2016. Last previous edition approved in 2016 as
F3127 – 16. DOI: 10.1520/F3127-1610.1520/F3127-22.
Copyright © ASTM International, 100 Barr Harbor Drive, PO Box C700, West Conshohocken, PA 19428-2959. United States
1

---------------------- Page: 1 ----------------------
F3127 − 22
2. Referenced Documents
2
2.1 ASTM Standards:
D543 Practices for Evaluating the Resistance of Plastics to Chemical Reagents
E1766 Test Method for Determination of Effectiveness of Sterilization Processes for Reusable Medical Devices
E2857 Guide for Validating Analytical Methods
E3106 Guide for Science-Based and Risk-Based Cleaning Process Development and Validation
E3219 Guide for Derivation of Health-Based Exposure Limits (HBELs)
E3263 Practice for Qualification of Visual Inspection of Pharmaceutical Manufacturing Equipment and Medical Devices for
Residues
F619 Practice for Extraction of Materials Used in Medical Devices
F2459 Test Method for Extracting Residue from Metallic Medical Components and Quantifying via Gravimetric Analysis
F2847 Practice for Reporting and Assessment of Residues on Single-Use Implants and Single-Use Sterile Instruments
G121 Practice for Preparation of Contaminated Test Coupons for the Evaluation of Cleaning Agents
G122 Test Method for Evaluating the Effectiveness of Cleaning Agents and Processes
G131 Practice for Cleaning of Materials and Components by Ultrasonic Techniques
3
2.2 ANSI/AAMI/ISO Standards:
ISO 10993-5 Biological Evaluation of Medical Devices—Part 5: Tests for Cytotoxicity, In Vitro Methods
ISO 10993-11 Biological Evaluation of Medical Devices—Art 11: Tests for Systemic Toxicity
ISO 10993-17 Biological Evaluation of Medical Devices—Part 17: Establishment of Allowable Limits for L
...

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ASTM F3438-21(Guide)
Standard Guide for Detection and Quantification of Cleaning Markers (Analytes) for the Validation of Cleaning Methods for Reusable Medical Devices

SIGNIFICANCE AND USE
5.1 This standard guide may be used by medical device manufacturers as part of their design plan and implementation of the validation of the cleaning instructions of their reusable medical devices.  
5.2 This guide helps medical device manufacturers to identify the appropriate method(s) for detecting and quantifying markers for the simulated-use test soil (see Guide F3208), thereby evaluating whether the medical device can be adequately cleaned.  
5.3 This guide describes various test methods for the different analytes.
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1.1 This standard guide provides methods and considerations for detecting and quantifying test soil(s) from reusable medical device(s) that result from simulated-use testing of medical devices during validation of the cleaning procedures as described in the instructions for use (IFU) provided by the medical device manufacturer.  
1.2 The methods described are for detecting and measuring markers (analytes) that are components within the most common test soils and are relevant to the clinical use of the device. Appropriate test soils without protein, carbon, or carbohydrates (for example, bone) will require other methods.  
1.3 This is a part of a series of ASTM standard guides for validating cleaning instructions. The scope of the first guide in the series is selecting appropriate test soils (Guide F3208). The second in the series (Guide F3293) describes methods for inoculating medical devices with test soil. The third in the series (Guide F3321) describes methods for extracting soils for measuring residual soil on medical devices after the performance of cleaning process. This is the fourth guide in the series and describes the methods of detecting and quantifying residual analytes on the device.  
1.4 Units—The values stated in SI units are to be regarded as standard. No other units of measurement are included in this standard.  
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SIGNIFICANCE AND USE
5.1 This guide provides information on how to select the test soil(s) that best simulates clinical use for devices. The test soil(s) selected for the validation should be clinically relevant and simulate what the device/component will come into contact with during the clinical procedure.  
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1.1 This guide describes methods for selecting test soils for cleaning validations based upon the characteristics of the soil, the physical characteristics of the device, and the clinical use of the device.  
1.2 This guide describes the preparation and use of some test soils for the validation of cleaning instructions for reusable medical devices.  
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SCOPE
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5.1 This standard guide may be used by medical device manufacturers as part of their design plan and implementation of the validation of the cleaning instructions of their reusable medical devices.  
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1.2 This guide describes the preparation and use of some test soils for the validation of cleaning instructions for reusable medical devices.  
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1.2 The following mechanical tests are described:    
Sections  
Tension  
7 to 14  
Bend  
15  
Hardness  
16  
Brinell  
17  
Rockwell  
18  
Portable  
19  
Impact  
20 to 30  
Keywords  
32  
1.3 Annexes covering details peculiar to certain products are appended to these test methods as follows:    
Annex  
Bar Products  
Annex A1  
Tubular Products  
Annex A2  
Fasteners  
Annex A3  
Round Wire Products  
Annex A4  
Significance of Notched-Bar Impact Testing  
Annex A5  
Converting Percentage Elongation of Round Specimens to
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Annex A6    
Testing Multi-Wire Strand  
Annex A7  
Rounding of Test Data  
Annex A8  
Methods for Testing Steel Reinforcing Bars  
Annex A9  
Procedure for Use and Control of Heat-cycle Simulation  
Annex A10  
1.4 The values stated in inch-pound units are to be regarded as standard. The values given in parentheses are mathematical conversions to SI units that are provided for information only and are not considered standard.  
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Standard Practice for Electrofusion Joining Polyethylene (PE) Pipe and Fittings for Pressure Pipe Service

SIGNIFICANCE AND USE
4.1 Using the procedures and apparatus in Sections 8 and 9 and the manufacturer's instructions, pressure-tight joints as strong as the pipe itself can be made between manufacturer-recommended combinations of pipe and fittings. See Specification F1055 for performance requirements of polyethylene electrofusion fittings.
SCOPE
1.1 This practice describes procedures for making joints suitable for pressure service with polyethylene (PE) pipe and fittings by means of electrofusion joining techniques in, but not limited to, a field environment. Other suitable electrofusion joining procedures are available from various sources including fitting manufacturers. This standard does not purport to address all possible electrofusion joining procedures, or to preclude the use of qualified procedures developed by other parties that have been proven to produce reliable electrofusion joints. (Note 1)
Note 1: Reference to the manufacturer in this practice refers to the electrofusion fitting manufacturer.  
1.2 The parameters and procedure are applicable only to joining polyethylene pipe and fittings (Note 2) which are intended for PE fuel gas pipe per Specification D2513 and PE potable water, sewer and industrial pipe manufactured per Specification F714, Specification D3035, Specification F2619, and AWWA C901 and C906.
Note 2: Commercially available materials classified with a thermoplastic pipe material designation code beginning with PE 14, PE 23, PE 24, PE 27, PE 33, PE 34, PE 36, and PE 46, and PE 47 in accordance with Specification D3350 and Terminology F412 are generally acceptable for electrofusion joining using this practice. Consult with the pipe or fitting manufacturer for specific compatibility information.  
1.3 Parts that are within the dimensional tolerances given in present ASTM specifications are required to produce sound joints between polyethylene pipe and fittings when using the joining techniques described in this practice.  
1.4 The values stated in inch-pound units are to be regarded as standard. The values given in parentheses are mathematical conversions to SI units that are provided for information only and are not considered standard.  
1.5 The text of this practice references notes, footnotes, and appendices which provide explanatory material. These notes and footnotes (excluding those in tables and figures) shall not be considered as requirements of the practice.  
1.6 This 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, health, and environmental practices and determine the applicability of regulatory limitations prior to use.  
1.7 This international standard was developed in accordance with internationally recognized principles on standardization established in the Decision on Principles for the Development of International Standards, Guides and Recommendations issued by the World Trade Organization Technical Barriers to Trade (TBT) Committee.

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ASTM
ASTM D5141-23(Test Method)
Standard Test Method for Determining Filtering Efficiency and Flow Rate of the Filtration Component of a Sediment Retention Device

SIGNIFICANCE AND USE
5.1 This test method is used to determine the filtering efficiency and flow rate of the filtration component of a sediment retention device, such as a silt fence, a silt barrier, or a silt curtain, for specific soil tested.  
5.2 This test method may be used for the design of the filtration component of a sediment retention device to meet requirements of regulatory agencies in filtering efficiency or flow rate for the specific soil tested.  
5.2.1 The designer can use this test method to determine the spacing between sediment retention devices.  
5.3 This test method is intended for performance evaluation, as the results will depend on the specific soil evaluated. Unless testing with the default soil is desired, it is recommended that the user or representative perform the test to pre-approve products, as sediment retention device manufacturers are not typically equipped to handle or test soil requirements.  
5.4 This test method provides a means of evaluating the filtration component of sediment retention devices with different soils under various conditions that simulate the conditions that exist in a sediment retention device installation. This test method may be used to simulate several storm events on the same sediment retention device specimen. Therefore, the number of times this test is repeated per specimen is dependent upon the user and the site conditions.
SCOPE
1.1 This test method is used to determine the filtering efficiency and the flow rate of the filtration component of a sediment retention device, such as a silt fence, silt barrier, or inlet protector.  
1.1.1 The results are shown as a percentage for filtering efficiency and cubic metres per square metre per minute (m3/m2/min) or gallons per square foot per minute (gal/ft2/min) for flow rate.  
1.1.2 The filtering efficiency indicates the percent of sediment removed from sediment-laden water.  
1.1.3 The flow rate is the average rate of passage of the sediment-laden water through the filtration component of a sediment retention device.  
1.2 This test method requires several specialized pieces of equipment, such as an integrated water sampler and an analytical balance, or a vacuum filtration system. At the client’s discretion, the test soil is either a site-specific soil or a soil that is representative of a target default gradation.  
1.3 The values stated in SI units are the standard, while the inch-pound units are provided for information. The values expressed in each system may not be exact equivalents; therefore, each system must be used independently of the other, without combining values in any way.  
1.4 This 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, health, and environmental practices and determine the applicability of regulatory limitations prior to use.  
1.5 This international standard was developed in accordance with internationally recognized principles on standardization established in the Decision on Principles for the Development of International Standards, Guides and Recommendations issued by the World Trade Organization Technical Barriers to Trade (TBT) Committee.

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ASTM
ASTM F2647-07(2023)(Guide)
Standard Guide for Approved Methods of Installing a CVS (Central Vacuum System)

SIGNIFICANCE AND USE
4.1 The suggestions of this guide are intended to provide proper installation materials and practices to be used during the installation of a central-vacuum system.
SCOPE
1.1 This guide demonstrates proper methods for installing a central-vacuum system.  
1.2 Appendix X1 contains additional sources of information that may be helpful to the user of this guide.  
1.3 The values stated in inch-pound units are to be regarded as the standard. The values given in parentheses are for information only.  
1.4 This 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, health, and environmental practices and determine the applicability of regulatory limitations prior to use.  
1.5 This international standard was developed in accordance with internationally recognized principles on standardization established in the Decision on Principles for the Development of International Standards, Guides and Recommendations issued by the World Trade Organization Technical Barriers to Trade (TBT) Committee.

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ASTM
ASTM F2886-17(2023)(Specification)
Standard Specification for Metal Injection Molded Cobalt-28Chromium-6Molybdenum Components for Surgical Implant Applications

ABSTRACT
This specification covers chemical, mechanical, and metallurgical general requirements for metal injection molded (MIM) cobalt-28chromium-6molybddenum components to be used in manufacturing surgical implants. In this specification, the MIM components covered may have been densified beyond their as-sintered density by post-sinter processing. For the chemical requirements, the components supplied in this specification must conform in accordance to the chemical requirements specified herein in Table 1. The product analysis tolerances must also conform to the product tolerances presented in Table 2. The specification also enumerates the mechanical requirements for MIM components wherein the tensile properties of the MIM must conform to the mechanical properties in Table 3. The microstructural requirements and specimen preparation shall be in accordance with Guide E3 and Practice E407.
SCOPE
1.1 This specification covers chemical, mechanical, and metallurgical requirements for metal injection molded (MIM) cobalt-28chromium-6molybdenum components to be used in the manufacture of surgical implants  
1.2 The MIM components covered by this specification may have been densified beyond their as-sintered density by post-sinter processing.  
1.3 Units—The values stated in either SI units or inch-pound units are to be regarded separately as standard. The values stated in each system may not be exact equivalents; therefore, each system shall be used independently of the other. Combining values from the two systems may result in nonconformance with the standard.  
1.4 This international standard was developed in accordance with internationally recognized principles on standardization established in the Decision on Principles for the Development of International Standards, Guides and Recommendations issued by the World Trade Organization Technical Barriers to Trade (TBT) Committee.

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