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ASTM F3127-16

(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, 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:  
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 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.

General Information

Status
Historical
Publication Date
31-Mar-2016
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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ASTM F3127-16 - Standard Guide for Validating Cleaning Processes Used During the Manufacture of Medical Devices
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NOTICE: This standard has either been superseded and replaced by a new version or withdrawn.
Contact ASTM International (www.astm.org) for the latest information
Designation: F3127 − 16
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 D543 Practices for Evaluating the Resistance of Plastics to
Chemical Reagents
1.1 This guide provides considerations for validating clean-
E2857 Guide for Validating Analytical Methods
ing processes for medical devices during initial fabrication and
F619 Practice for Extraction of Medical Plastics
assembly prior to initial use. Validated cleaning processes are
F2459 Test Method for Extracting Residue from Metallic
important for achieving consistency in function and consis-
Medical Components and Quantifying via Gravimetric
tency in biocompatibility. The considerations include but are
Analysis
not limited to, validation approach, equipment design, proce-
F2847 Practice for Reporting and Assessment of Residues
dures and documentation, analytical methods, sampling, devel-
on Single Use Implants
opment of limits, and other issues.
G121 Practice for Preparation of Contaminated Test Cou-
1.2 Inclusions:
pons for the Evaluation of Cleaning Agents
1.2.1 This guide describes the validation of critical cleaning
G122 Test Method for Evaluating the Effectiveness of
processes for medical devices to reduce contaminants to
Cleaning Agents
acceptable levels prior to packaging.
G131 PracticeforCleaningofMaterialsandComponentsby
1.3 Exclusions: Ultrasonic Techniques
3
1.3.1 Reusable medical devices.
2.2 ANSI/AAMI/ISO Standards:
1.3.1.1 Validation of cleaning operations for reusable medi-
ISO 10993-5 Biological Evaluation of Medical Devices—
cal devices is not within the scope of this standard guide.
Part 5: Tests for Cytotoxicity, In Vitro Methods
Although cleaning of reusable medical devices is beyond the
ISO 10993-11 Biological Evaluation of Medical Devices—
scope of this guide, many of the principles outlined in this
Art 11: Tests for Systemic Toxicity
guide may be applicable to the validation of cleaning opera-
ISO 10993-17 Biological Evaluation of Medical Devices—
tions for reusable devices.
Part 17: Establishment ofAllowable Limits for Leachable
1.3.2 Cleaning of medical devices in health care facilities.
Substances
1.3.2.1 Validation of cleaning processes in patient/health
ISO 11737-1 Sterilization of Medical Devices—
care facilities is not within the scope of this standard guide.
Microbiological Methods—Part 1: Determination of a
Population of Microorganisms on Products
1.4 This standard does not purport to address all of the
ISO 14971 Medical Devices—Application of Risk Manage-
safety concerns, if any, associated with its use. It is the
ment to Medical Devices
responsibility of the user of this standard to establish appro-
AAMI ST72 Bacterial Endotoxins—Test Methodologies,
priate safety and health practices and determine the applica-
Routine Monitoring, and Alternatives to Batch Testing
bility of regulatory limitations prior to use.
AAMI TIR30 A Compendium of Processes, Materials, Test
Methods, and Acceptance Criteria for Cleaning Reusable
2. Referenced Documents
Medical Devices
2
2.1 ASTM Standards:
2.3 United States Pharmacopoeia (USP) – General Chap-
ters:
USP <85> Bacterial Endotoxins Test
1
This guide is under the jurisdiction of ASTM Committee F04 on Medical and
USP <87> Biological Reactivity Tests, In Vitro
Surgical Materials and Devices and is the direct responsibility of Subcommittee
F04.15 on Material Test Methods.
USP <88> Biological Reactivity Tests, In Vivo
Current edition approved April 1, 2016. Published May 2016. DOI: 10.1520/
USP <1225> Validation of Compendial Procedures
F3127-16
2
For referenced ASTM standards, visit the ASTM website, www.astm.org, or
contact ASTM Customer Service at service@astm.org. For Annual Book of ASTM
3
Standards volume information, refer to the standard’s Document Summary page on Available fromAmerican National Standards Institute (ANSI), 25 W. 43rd St.,
the ASTM website. 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 − 16
2.4 International Conference on Harmonization of Techni- 3.1.12 monitoring, v—verification testing at predefined in-
cal Requirements for Registration of Pharmaceuticals for tervals.
Human Use (ICH):
3.1.13 no observed adverse effect level (NOAEL),
ICHQ2 ValidationofAnalyticalProcedures:TextandMeth-
n—greatest concentration or amo
...

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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.  
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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:  
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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.  
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.  
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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.  
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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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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.  
5.2 This guide will help standardize the test soils used by medical device manufacturers when validating the cleaning procedures of reusable medical devices and reprocessing equipment  
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5.4 For devices that come into contact with mucus, the simulated test soils are those described under 7.1.3.  
5.5 For devices that come in contact with soils of a source other than the patient (e.g., bone cement), the simulated test soils should be similar to those described in 7.2. These can be used alone or in combination with 7.1.  
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1.5.3 Test soils described are not intended for use by health care facilities to verify the effectiveness of their cleaning process.  
1.5.4 The test soil recipes are not intended to encompass every biological residue with which a medical device is likely to come into contact.  
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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.  
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1.2.1 This guide describes the validation of critical cleaning processes for medical devices to reduce contaminants to acceptable levels prior to packaging.  
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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.  
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SCOPE
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.  
1.3 Reusable medical devices such as endoscopes, arthroscopic shavers, surgical instruments, and suction tubes are exposed to biological soils during clinical use. Preparation of these devices for reuse requires cleaning and disinfection and/or sterilization as applicable. Adequate cleaning is the first step in a process intended to prevent contaminant transfer to the next patient and medical practitioner. The soils, if inadequately removed, can interfere with disinfection and sterilization processes, as well as performance of the device. Acceptance criteria are based either on a visual assessment or quantitatively specified marker(s) endpoint(s) of the soil or both (ISO/TS 15883-5, Section 1). Endpoints after cleaning should be based upon possible interference with disinfection/sterilization, risk to the patient or health care worker from the contaminant during further handling, and endpoints for cleaning established in the scientific literature.  
1.4 The test soils are designed to simulate the contaminants that medical devices are likely to come in contact with during clinical use. The test soils discussed in this guide are a mixture of constituents that simulate what is commonly found in human secretions, blood, tissue, and bone fragments/shavings as well as non-patient derived soil (e.g., bone cement, lubricants, and dyes) during clinical procedures. The test soils also simulate the physical parameters (e.g., viscosity, adhesion) of clinical material to which the medical devices will be exposed.  
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ASTM
ASTM D1751-23(Specification)
Standard Specification for Preformed Expansion Joint Filler for Concrete Paving and Structural Construction (Nonextruding and Resilient Asphalt Types)

SCOPE
1.1 This specification covers preformed expansion joint filler having relatively little extrusion and substantial recovery after release from compression.  
1.2 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.  
Note 1: Attention is called to Specifications D1752 and D994/D994M.  
1.3 The text of this standard references notes and footnotes which provide explanatory material. These notes and footnotes (excluding those in tables and figures) shall not be considered as requirements of 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.

  • Technical specification
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  • Technical specification
    2 pages
    English language
    sale 15% off