Intended purpose of use: A non-sterile bag intended to collect and contain disposable materials/devices that need to be autoclaved before disposal.
Product description:
Plastic bag that is autoclavable & impervious to microorganisms
Material: High molecular weight, high density (HMHD) Polythene of Polypropylene (PP).
Colour: Yellow, Used for pathological waste such as tissues of body parts of other solid infectious waste such as gauze, dressings etc.
Pattern: Imprinted in black with English language text 'Biohazard' and the 'black tri-sickle logo' according U+2623 both sides of the bag.
Empty field for an end-user to add name and address.
Size: approx. 600×800 mm
Capacity: approx. 50 L
Thickness: minimum 0.050 mm
With metal closure strip, one per bag
Bags resist punctures, tears, and leaks: Dart Impact Strength >530g and Elmendorf Tear Resistance 200g in MD and 980g in TD.
Leak proof bottom seal for added safety.
Bag can be autoclaved prior to the disposal in temperatures +121°C up to +135 °C.
Steam autoclave indicator on the bag (During autoclaving the colour changes providing proof that bag has been exposed to high temperatures for sterilisation)
Shelf life 5 yrs
Supplied with: N/A
Accessories / Spare Parts / Consumables (available but not supplied): N/A
Instructions for use:
Instructions and warnings for use are printed onto the bag.
Not to be used if product of packaging has been visually compromised.
The bag must not be completely closed when autoclaving.
Printed with a sterilisation patch that changes colour when subject to steam sterilization.
Storage conditions to be specified
Packaging and Labelling:
One (1) roll of box of fifty (50) individual bags.
Manufacturer's product code of reference number.
Manufacturer identification.
Address of the manufacturing site.
How the device should be used, maintained and stored.
Lot/Batch and MFD.
Any residual device risks, warnings, limitations of contraindications.
Symbols used according ISO 15223.
Regulatory & Conformity Requirements:
CE mark Comply to EU Council Directive 93/42/EEC (MDD) of EU Regulations 2017/745 (MDR) with valid EC Certificate and Declaration of Conformity for the CE mark is applicable.
US FDA 510(K) clearance
CE certificate available for Class IIa and above devices
Manufacturer’s Quality Management System is certified to ISO 13485 : 2016
Classification:
Not a medical device
Safety and Product Standards:
ASTM D1922 - Elmendorf Tear Resistance .
ASTM 1709- Dart Impact Strength
Environmental Requirements:
ISO 14001: Environmental management systems
Product description:
Plastic bag that is autoclavable & impervious to microorganisms
Material: High molecular weight, high density (HMHD) Polythene of Polypropylene (PP).
Colour: Yellow, Used for pathological waste such as tissues of body parts of other solid infectious waste such as gauze, dressings etc.
Pattern: Imprinted in black with English language text 'Biohazard' and the 'black tri-sickle logo' according U+2623 both sides of the bag.
Empty field for an end-user to add name and address.
Size: approx. 600×800 mm
Capacity: approx. 50 L
Thickness: minimum 0.050 mm
With metal closure strip, one per bag
Bags resist punctures, tears, and leaks: Dart Impact Strength >530g and Elmendorf Tear Resistance 200g in MD and 980g in TD.
Leak proof bottom seal for added safety.
Bag can be autoclaved prior to the disposal in temperatures +121°C up to +135 °C.
Steam autoclave indicator on the bag (During autoclaving the colour changes providing proof that bag has been exposed to high temperatures for sterilisation)
Shelf life 5 yrs
Supplied with: N/A
Accessories / Spare Parts / Consumables (available but not supplied): N/A
Instructions for use:
Instructions and warnings for use are printed onto the bag.
Not to be used if product of packaging has been visually compromised.
The bag must not be completely closed when autoclaving.
Printed with a sterilisation patch that changes colour when subject to steam sterilization.
Storage conditions to be specified
Packaging and Labelling:
One (1) roll of box of fifty (50) individual bags.
Manufacturer's product code of reference number.
Manufacturer identification.
Address of the manufacturing site.
How the device should be used, maintained and stored.
Lot/Batch and MFD.
Any residual device risks, warnings, limitations of contraindications.
Symbols used according ISO 15223.
Regulatory & Conformity Requirements:
CE mark Comply to EU Council Directive 93/42/EEC (MDD) of EU Regulations 2017/745 (MDR) with valid EC Certificate and Declaration of Conformity for the CE mark is applicable.
US FDA 510(K) clearance
CE certificate available for Class IIa and above devices
Manufacturer’s Quality Management System is certified to ISO 13485 : 2016
Classification:
Not a medical device
Safety and Product Standards:
ASTM D1922 - Elmendorf Tear Resistance .
ASTM 1709- Dart Impact Strength
Environmental Requirements:
ISO 14001: Environmental management systems
| Pack Size | Avg. Price |
|---|---|
| Pack of 50 | $16.02 |
