Standard ISO standard · ISO/TS 13004:2013

Sterilization of health care products -- Radiation -- Substantiation of selected sterilization dose: Method VDmaxSD

Status: Withdrawn

· Replaced by: ISO 13004:2022
Buy this standard

Standard ISO standard · ISO/TS 13004:2013

Sterilization of health care products -- Radiation -- Substantiation of selected sterilization dose: Method VDmaxSD
Subscribe on standards - Read more Dölj
Price: 2 550 SEK
standard ikon pdf

PDF

Price: 2 550 SEK
standard ikon

Paper

Show more Show less
Preview this standard
Scope
ISO/TS 13004:2013 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. ISO/TS 13004:2013 also specifies a method of sterilization dose audit used to demonstrate the continued effectiveness of the substantiated sterilization dose.

Subjects

Sterilization and disinfection in general (11.080.01)


Buy this standard

Standard ISO standard · ISO/TS 13004:2013

Sterilization of health care products -- Radiation -- Substantiation of selected sterilization dose: Method VDmaxSD
Subscribe on standards - Read more Dölj
Price: 2 550 SEK
standard ikon pdf

PDF

Price: 2 550 SEK
standard ikon

Paper

Show more Show less

Product information

Language: English

Written by: ISO

International title:

Article no: STD-916168

Edition: 1

Approved: 5/6/2013

No of pages: 64

Replaced by: ISO 13004:2022