ASTM F3127 - 16 - Standard Guide for Validating Cleaning Processes Used During the Manufacture of Medical Devices

ASTM F3127 - 16

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

Status : Current   Published : April 2016

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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: 

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.




Standard NumberASTM F3127 - 16
TitleStandard Guide for Validating Cleaning Processes Used During the Manufacture of Medical Devices
StatusCurrent
Publication Date01 April 2016
Normative References(Required to achieve compliance to this standard)No other standards are normatively referenced
Informative References(Provided for Information)No other standards are informatively referenced
Descriptors Medical Devices, Cleaning Processes
ICS11.040.40
PublisherASTM
FormatA4
DeliveryYes
Pages16
File Size305 KB
Price£45.00


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