Masking tape, type 1 steam indicator

GENERAL DESCRIPTION
Masking tape, for sterilization pack, fitted with a type 1 steam sterilizer indicator.

INTENDED USE
Used to close paper crepe packs for steam sterilization. Easy released pressure sensitive adhesive, easy to tear paper, easy to remove. Includes a type 1 steam sterilizer indicator which is designed to indicate exposure to steam, but not designed to verify either the correct functioning of an autoclave or whether items have been properly sterilized.

TECHNICAL SPECIFICATIONS
Paper-based adhesive tape with strips.
Including steam-sensitive ink indicator which changes colour when in contact with steam:
- at 121°C for 3 minutes minimum
- at 134°C for 30 seconds minimum
The colour change of the steam-sensitive indicator is distinct from white to a dark brown or black colour.
Maintains integrity and sticks to surface during steam sterilization cycle and drying temperatures.
Leaves no residue.
Does not damage the surface to which it is applied.
Size: width between 19mm x length 50m.

SHELF LIFE
Between 24 up to 36 months depending on product.

WARRANTY
Two years.

ENVIRONMENTAL CONDITIONS
Storage and operating conditions: room temperature, keep away from humidity and sunlight.

WEIGHT AND VOLUME (Packaged)
Weight: 0.136 kg.
Volume: 0.380 dm³.

RELATED PRODUCTS
S0845177, Papersheet,crepe,for ster. pack/PAC-100
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S0156000, Sterilizer,steam,39L
S0157000, Sterilizer,steam,24L
S0002020, Sterilizer,steam,20L,electric,w/access
S0002022, Sterilizer,steam,40L,electric,w/access
S0004045, Sterilizer,steam,large,electric,w/access

COMPONENT OF A KIT
S9901030 - IEHK2017,kit,suppl.3-renewable

QUALITY MANAGEMENT SYSTEM
- Manufacturer is certified for ISO 13485 Medical devices - Quality management systems - Requirements for regulatory purposes.
- Supplier is certified for ISO 9001 Quality management systems – Requirements.

MARKET CLEARANCE AND DEVICE CLASSIFICATION
Not classified as a medical device.

SAFETY AND PRODUCT STANDARDS
- ISO 11140-1:2014, Class 6: Sterilization of health care products — Chemical indicators — Part 1: General requirements.

NOMENCLATURE
GMDN Code: 35362