Part B: Supplementary Information Sheet (SIS) |
FR Recognition List Number
|
040
|
Date of Entry 08/14/2015
|
FR Recognition Number
|
14-463
|
Standard | |
ISO ASTM 51608 Second edition 2015-03-15 Practice for dosimetry in an X-ray (bremsstrahlung) facility for radiation processing at energies between 50 KeV and 7.5 MeV |
|
Scope/AbstractISO/ASTM 51608:2015 outlines the dosimetric procedures to be followed during installation qualification, operational qualification, performance qualification and routine processing at an X-ray (bremsstrahlung) irradiator. Other procedures related to operational qualification, performance qualification and routine processing that may influence absorbed dose in the product are also discussed. ISO/ASTM 51608:2015 is one of a set of standards that provides recommendations for properly implementing and utilizing dosimetry in radiation processing. It is intended to be read in conjunction with ISO/ASTM Practice 52628, "Practice for Dosimetry in Radiation Processing". In contrast to monoenergetic gamma radiation, the X-ray energy spectrum extends from low values (about 35 keV) up to the maximum energy of the electrons incident on the X-ray target. |
|
Extent of Recognition
|
Rationale for Recognition
This standard is relevant to medical devices and is recognized on its scientific and technical merit and/or because it supports existing regulatory policies. |
|
Relevant FDA Guidance and/or Supportive Publications*
ISO 11137-1 First edition 2006-04-15, Sterilization of health care products - Radiation- Part 1: Requirements for development, validation and routine control of a sterilization process for medical devices [Including: Amendment 1 (2013)]
ISO 11137-2 Third edition 2013-06-01, Sterilization of health care products - Radiation - Part 2: Establishing the sterilization dose
ISO 11137-3 First edition 2006-04-15, Sterilization of health care products - Radiation - Part 3: Guidance on dosimetric aspects
Appropriate Use of Voluntary Consensus Standards in Premarket Submissions for Medical Devices - Guidance for Industry and Food and Drug Administration Staff, issued September 2018. |
|
FDA Technical Contacts
|
Standards Development Organizations
|
FDA Specialty Task Group (STG)
|
*These are provided as examples and others may be applicable. |