Type 5 Integrator Chemical Indicator developed for monitoring loads, challenge packages and surgical packages in steam sterilization cycles.
Integrates the three critical sterilization parameters: time, temperature and saturated steam. According to RDC 15, it should be utilized in all surgical packages, in every load and in challenge packages.
For services not subject to the RDC 15 (Dentistry and Veterinary, for example) it is suggested the use of at least one Integrator Chemical Indicator per day, in the first cycle of each day, and in all surgical packages.
Easy reading, when the sterilization was successfully performed, the dark bar will enter the blue “SAFE” area.
It may be filed in a monitoring records book or on the patient's records.
Classification: Type 5 (ISO 11140-1:2005) / Type D (EN 867-1).
Composition: Product free from lead, mercury, barium and latex. Common residue.
Parameters: Type 5 - 135 °C for 1.5 minutes / 121 °C for 21 minutes.
Strip Dimensions: 102 x 19 mm (W x L).
Package Dimensions: 128.58 x 152.40 mm.
Presentation: Package with 100 units.
Expiration date informed on the package of the product.
Made in the USA, validated according to the ISO 11140-1:2005 Standard, registered at FDA and according to AMMI ST60.
Product exempt from ANVISA register.
For further information, see the manual.
Cristófoli, brazilian importing company and manufacturer of health care products certified by ISO 13485 – Health care Products – Quality Management System – Requirements for Regulatory Purposes and compliance with RDC 665/2022 - BPF – Boas Práticas de Fabricação – ANVISA requirements (Brazilian standard similar to GMP - FDA/US).
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