UNLIMITED FREE ACCESS TO THE WORLD'S BEST IDEAS

SUBMIT
Already an Engineering360 user? Log in.

This is embarrasing...

An error occurred while processing the form. Please try again in a few minutes.

Customize Your Engineering360 Experience

Select Your Free Newsletters

Industry Newsletters

Select Your Free Product Alerts

Finish!
Privacy Policy

This is embarrasing...

An error occurred while processing the form. Please try again in a few minutes.

BSI - BS EN ISO 11137-3

Sterilization of health care products - Radiation Part 3: Guidance on dosimetric aspects of development, validation and routine control

active, Most Current
Buy Now
Organization: BSI
Publication Date: 31 August 2017
Status: active
Page Count: 52
ICS Code (Sterilization and disinfection in general): 11.080.01

Document History

BS EN ISO 11137-3
August 31, 2017
Sterilization of health care products - Radiation Part 3: Guidance on dosimetric aspects of development, validation and routine control
A description is not available for this item.
BS EN ISO 11137-3
March 30, 2007
Sterilization of health care products - Radiation - Part 3: Guidance on dosimetric aspects
A description is not available for this item.

References

This document references:
ISO TS 13004 - Sterilization of health care products - Radiation - Substantiation of selected sterilization dose: Method VDmaxSD
Published by ISO on May 1, 2013
This Technical Specification describes a method for substantiating a selected sterilization dose of 17,5, 20, 22,5, 27,5, 30, 32,5 or 35 kGy that achieves a sterility assurance level (SAL) of 10−6 or...
This document references:
ISO/IEC 17025 - General requirements for the competence of testing and calibration laboratories
Published by ISO on November 1, 2017
This document specifies the general requirements for the competence, impartiality and consistent operation of laboratories. This document is applicable to all organizations performing laboratory...
This document references:
ISO/ASTM 51401 - Practice for Use of a Dichromate Dosimetry System
Published by ISO on November 15, 2013
This practice covers the preparation, testing, and procedure for using the acidic aqueous silver dichromate dosimetry system to measure absorbed dose to water when exposed to ionizing radiation. The...
This document references:
ISO/ASTM 51205 - Practice for use of a ceric-cerous sulfate dosimetry system
Published by ISO on May 1, 2017
This practice covers the preparation, testing, and procedure for using the ceric-cerous sulfate dosimetry system to measure absorbed dose to water when exposed to ionizing radiation. The system...
This document references:
BS EN ISO 11137-1 - Sterilization of health care products — Radiation Part 1: Requirements for development, validation and routine control of a sterilization process for medical devices
Published by BSI on July 31, 2015
A description is not available for this item.
This document references:
BS EN ISO 11137-1 - Sterilization of health care products — Radiation Part 1: Requirements for development, validation and routine control of a sterilization process for medical devices
Published by BSI on July 31, 2015
A description is not available for this item.
This document references:
ISO/ASTM 51205 - Practice for use of a ceric-cerous sulfate dosimetry system
Published by ISO on May 1, 2017
This practice covers the preparation, testing, and procedure for using the ceric-cerous sulfate dosimetry system to measure absorbed dose to water when exposed to ionizing radiation. The system...
This document references:
ISO/ASTM 51401 - Practice for Use of a Dichromate Dosimetry System
Published by ISO on November 15, 2013
This practice covers the preparation, testing, and procedure for using the acidic aqueous silver dichromate dosimetry system to measure absorbed dose to water when exposed to ionizing radiation. The...
This document is referenced by:
BS EN ISO 11737-1 + A1 - Sterilization of health care products - Microbiological methods Part 1: Determination of a population of microorganisms on products
Published by BSI on February 28, 2018
A description is not available for this item.
This document is referenced by:
BS EN ISO 7197 - Neurosurgical implants - Sterile, single-use hydrocephalus shunts and components
Published by BSI on October 31, 2009
A description is not available for this item.
This document is referenced by:
BS EN ISO 13408-1 - Aseptic processing of health care products Part 1: General requirements
Published by BSI on August 31, 2015
A description is not available for this item.
This document is referenced by:
BS EN ISO 10451 - Dentistry - Contents of technical file for dental implant systems
Published by BSI on July 31, 2010
A description is not available for this item.
View Less
View All
Advertisement