Standard Technical specification · SIS-CEN ISO/TS 13004:2016

Sterilization of health care products - Radiation - Substantiation of selected sterilization dose: Method VDmaxSD (ISO/TS 13004:2013)

Status: Withdrawn

· Replaced by: SS-EN ISO 13004:2023
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Standard Technical specification · SIS-CEN ISO/TS 13004:2016

Sterilization of health care products - Radiation - Substantiation of selected sterilization dose: Method VDmaxSD (ISO/TS 13004:2013)
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Scope
1.1 InclusionsThis 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 less for radiation sterilization of health care products. This Technical Specification also specifies a method of sterilization dose audit used to demonstrate the continued effectiveness of the substantiated sterilization dose.NOTE Selection and substantiation of the sterilization dose is used to meet the requirements for establishing the sterilization dose within process definition in ISO 11137-1.1.2 ExclusionsThis method is for the substantiation of a selected sterilization dose of 17,5, 20, 22,5, 27,5, 30, 32,5, or 35 kGy only and is not used to substantiate other sterilization doses. The method is not used for the substantiation of a selected sterilization dose if the average bioburden of the entire product item exceeds the limit specified for the selected sterilization dose (see Table 3).NOTE The methods for substantiation of selected sterilization doses of 25 kGy and 15 kGy are not included in this Technical Specification; they are described in ISO 11137-2.1.3 ApplicationIf the decision is made to use this method of sterilization dose establishment, the method is to be followed according to the requirements (shall) and guidance (should) stipulated herein.

Subjects

Sterilization and disinfection in general (11.080.01)


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Standard Technical specification · SIS-CEN ISO/TS 13004:2016

Sterilization of health care products - Radiation - Substantiation of selected sterilization dose: Method VDmaxSD (ISO/TS 13004:2013)
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Price: 1 615 SEK
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Product information

Language: English

Written by: Svenska institutet för standarder

International title:

Article no: STD-8018844

Edition: 1

Approved: 2/12/2016

No of pages: 72

Replaced by: SS-EN ISO 13004:2023