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TAPE, AUTOCLAVE STEAM INDICATOR, 50 m x 19 mm

https://unicat.msf.org/cat/product/13796
STD ESTETAAU1--

Valid Article

Single use
A single-use device, also referred to as a disposable device, is intended for use on one patient during a single procedure. It is not intended to be reprocessed (i.e., cleaned and disinfected or sterilized).
Z12011385 - Cleaning, disinfection and sterilisation instruments - consumables
European Medical Device Nomenclature (EMDN) is the nomenclature of use by manufacturers when registering their medical devices in the EUDAMED database. EMDN is characterised by its alphanumeric structure that is established in a seven-level hierarchical tree.
CT30
Thermosensitive codes are defined for storage and transportation temperature requirements of the products.
The product is part of at least one Kit. A kit is a collection of products (medical and/or logistic) that are needed for a certain intervention in emergency. The choice and quantity of the articles reflects the MSF protocols for this specific situation. The use of Kits allows to start an intervention without a detailed evaluation.
OC subscriptions: included in supply or field order tools (e.g. UniField)
SC subscriptions: included in supply or field tools
OC validations: approved for procurement and use by an OC for international or local orders specifying context and activity in Medical Standard Lists (MSL)

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TAPE, AUTOCLAVE STEAM INDICATOR

Definition

A sterilization indicator designed to be placed within a sterilizing chamber, and to respond with a characteristic chemical and/or physical change to one or more of the physical conditions within the chamber, to validate the sterilization process.

Chemical indicator type 1: indicates the exposure to the sterilisation process to allow differentiation between unprocessed items, and / or indicate gross failure of the sterilization process.

Synonym

autoclave tape

Specifications

Quality standards

ISO 11140-1, 2014, edition 3, (confirmed 2021) Sterilization of health care products – chemical indicators –Part 1: General requirements

Technical specifications

  • Adhesive crepe paper with white stripes
  • Roll, 50 m x 1.9 cm
  • Steam-sensitive ink indicator
  • Change of colour when in contact with steam:
    • at 121ºC for 3 minutes minimum
    • at 134ºC for 30 seconds minimum
  • Important contrast between colours: white stripes changing to black
  • Word "autoclave" written inside the roll / on package

Packaging & Labelling

Unit packaging

Instructions for use

  • Seal the packages to be sterilized with autoclave steam indicator tape after having written the content, the date and the number of the sterilization cycle on it (use a ball-point rather than a marker which risks to leak on the tape).
  • Fold the end of the tape down in order to ease the opening of the packages.

Remark

The tape indicates that the package has been exposed to steam at 134ºC for 30 seconds and at 121ºC for 3 minutes minimum. It does not guarantee the efficiency of the sterilization process. The sterilization cycles are validated by indicators like TST strips.

(Cf Introduction: Disinfection and sterilization in the field)

Storage

Store in cool, dry conditions, out of direct sunlight​

MSF requirements

Double interest: tape to seal the packages and external visual and rapid indicator of going through the autoclave.

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