Standard Swedish standard · SS-EN ISO 13004:2023

Sterilization of health care products - Radiation - Substantiation of selected sterilization dose: Method VDmaxSD (ISO 13004:2022)

Status: Valid

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Standard Swedish standard · SS-EN ISO 13004:2023

Sterilization of health care products - Radiation - Substantiation of selected sterilization dose: Method VDmaxSD (ISO 13004:2022)
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Scope
Adoption of ISO 13004:2022 – This is currently in FDIS and will be publishing in October 2022.

This document 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.

Subjects

Sterilization and disinfection in general (11.080.01)


Buy this standard

Standard Swedish standard · SS-EN ISO 13004:2023

Sterilization of health care products - Radiation - Substantiation of selected sterilization dose: Method VDmaxSD (ISO 13004:2022)
Subscribe on standards - Read more Dölj
Price: 1 538 SEK
standard ikon pdf

PDF

Price: 1 538 SEK
standard ikon

Paper

Price: 2 460,80 SEK
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Product information

Language: English

Written by: Svenska institutet för standarder

International title:

Article no: STD-80043865

Edition: 1

Approved: 7/4/2023

No of pages: 68

Replaces: SIS-CEN ISO/TS 13004:2016