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ASTM Int'l Releases 'Standards on Sterilization of Health Care Products'

January 13, 2008 // Published as a news service by IHS

 
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ASTM International released ASTM Standards on Sterilization of Health Care Products.

The online collection provides access to 14 ASTM standards related to International Organization for Standardization (ISO) 11137 - Sterilization of Health Care Products -Requirements for Validation and Routine Control-Radiation Sterilization and will feature current information as standards are updated throughout the year.

The standards included describe the requirements for a radiation sterilization process intended to sterilize medical devices and apply to gamma, X-ray and electron-beam radiation processing.

Subjects covered in the collection include:

  • Calibration of dosimetry systems used to measure absorbed doses in gamma-ray or X-ray fields and in electron beams used for radiation processing.
  • Different mathematical methods that may be used to calculate absorbed dose and criteria for their selection.
  • Materials description, dosimeter preparation and procedures for using the alanine-EPR dosimetry system.
  • Procedures for handling, testing and using a radiochromic film dosimetry system.
  • Estimating uncertainties in dosimetry for radiation processing.

An annual online subscription of ASTM Standards on Sterilization of Health Care Products is available at www.astm.org.

Source: ASTM International.

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