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Due to the high reliability of the fluorescent result
there is no advantage to incubating 1295 BIs after the
fluorescent result has been determined by the 490H
Auto-reader or 490 Auto-reader having software
version 4.0.0 or greater or 490M Auto-reader
and recorded.
1295 BIs meet ISO 11138-1:2017.
Indications for Use
Use the 3M™ Attest™ Rapid Readout Biological
Indicator 1295 in conjunction with the 3M™ Attest™
Auto-reader 490H or 490 Auto-reader having software
version 4.0.0 or greater or 490M Auto-reader as a
standard method of routine monitoring of vaporized
hydrogen peroxide sterilization processes in the
following systems:
STERRAD 100S
Sterilization System
®
STERRAD NX
Sterilization System (Standard and
®
Advanced cycles)
STERRAD 100NX
Sterilization System (Standard, Flex,
®
Express, and Duo cycles)
STERRAD NX
with ALLClear
®
System (Standard and Advanced cycles)
STERRAD 100NX
with ALLClear
®
Sterilization System (Standard, Flex, Express, and
Duo cycles)
V-PRO
1 Low Temperature Sterilization System
®
(Lumen cycle)
V-PRO
1 Plus Low Temperature Sterilization System
®
(Lumen and Non Lumen cycles)
V-PRO
maX Low Temperature Sterilization System
®
(Lumen, Non Lumen, and Flexible cycles)
V-PRO
60 Low Temperature Sterilization System
®
(Lumen, Non Lumen, and Flexible cycles)
V-PRO
maX 2 Low Temperature Sterilization
®
System (Lumen, Non Lumen, Flexible, and Fast Non
Lumen cycles)
V-PRO
s2 Low Temperature Sterilization System
®
(Lumen, Non Lumen, Flexible, and Fast cycles)
Technology Sterilization
®
Technology
®
Sterilizer Qualification (Operational and
Performance) and Process Validation Outside
the U.S.
3M™ Attest™ 1295 is a biological indicator (BI).
• 3M™ Attest™ 1295 complies with the biological
indicator standard ISO 11138-1: Sterilization of
health care products—Biological indicators—Part 1:
General requirements; 2017
• 3M™ Attest™ 1295 is cleared as a biological
indicator by the U.S. FDA under product
classification code FRC (indicator, biological
sterilization process).
• 3M™ Attest™ 1295 is a biological indicator per
the definition of a biological indicator in ISO 11139,
Sterilization of health care products — Vocabulary of
terms used in sterilization and related equipment and
process standards; 2018 section 3.29
• 3M™ Attest™ 1295 is a biological indicator
per the definition of a biological indicator in
CAN/CSA-Z314-18 Annex I: Indicators for
sterilization monitoring
3M™ Attest™ 1295 is a biological indicator and it may
be used for sterilizer qualification testing (operational
and performance) or process validation outside the U.S.
as described in international standards (e.g. ISO 14937
Sterilization of health care products—General
requirements for characterization of a sterilizing agent
and the development, validation, and routine control of
a sterilization process for medical devices) when the
standard recommends qualification testing or process
validation testing with a BI intended for use in vaporized
hydrogen peroxide processes.
Contraindications
None
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