IMPORTANT NOTE:
These technical specifications are generic and may vary depending on the selected Vendor.
Intended use: The draw sheet is used to protect the examination, delivery, operating tables and/of bed mattresses from soiling.
Product description:
Rectangular rubber sheet, used to protect operating tables and patient beds.
Material: Natural of synthetic rubber.
Size: length 150cm, width between 90 to 100 cm.
Waterproof, resistant to urine and acids.
Colour: white cream.
Washing: normal, withstands boiling and steam sterilization, resists to 0.5% chlorine.
Instructions for use:
The draw sheet is used to protect the examination, delivery, operating tables and/of bed mattresses from soiling.
The draw sheet must be washed, can be disinfected with chlorine solution (0.05% concentration) and dried after use.
If the draw sheet is damaged (perforation, etc.) it must be disposed in waste container, collected and destroyed. Please refer to WHO publication ""Safe management of waste for Health Care"".
Supplied with:
Manufacturer's instruction for use.
Packaging and labelling:
Unit presentation: 1 draw sheet, hygienically clean, for medical use, non-sterile, multiple uses.
Packaging: Can be packaged as one unit, of
Per roll: 90cmx25m (cut to size, according to requirements).
Labelling:
- Product name, size, reference number.
- Manufacturer's name and address.
- CE mark of similar
- LOT of batch number
- UDI (if MDR followed)
- use-by-date
- symbol for medical device
- Information for particular storage conditions (temperature, pressure, light, humidity, etc.), as appropriate (of equivalent harmonised symbol).
Symbols used according ISO 15223
CE Mark
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:
Classified under EU MDR 2017/745 as Class I device
Safety & product Standards:
ISO 13485 Quality management systems -- Requirements for regulatory purposes
ISO 14971 Medical Devices- Application of risk management to medical devices
Environmental requirements:
ISO 14001
These technical specifications are generic and may vary depending on the selected Vendor.
Intended use: The draw sheet is used to protect the examination, delivery, operating tables and/of bed mattresses from soiling.
Product description:
Rectangular rubber sheet, used to protect operating tables and patient beds.
Material: Natural of synthetic rubber.
Size: length 150cm, width between 90 to 100 cm.
Waterproof, resistant to urine and acids.
Colour: white cream.
Washing: normal, withstands boiling and steam sterilization, resists to 0.5% chlorine.
Instructions for use:
The draw sheet is used to protect the examination, delivery, operating tables and/of bed mattresses from soiling.
The draw sheet must be washed, can be disinfected with chlorine solution (0.05% concentration) and dried after use.
If the draw sheet is damaged (perforation, etc.) it must be disposed in waste container, collected and destroyed. Please refer to WHO publication ""Safe management of waste for Health Care"".
Supplied with:
Manufacturer's instruction for use.
Packaging and labelling:
Unit presentation: 1 draw sheet, hygienically clean, for medical use, non-sterile, multiple uses.
Packaging: Can be packaged as one unit, of
Per roll: 90cmx25m (cut to size, according to requirements).
Labelling:
- Product name, size, reference number.
- Manufacturer's name and address.
- CE mark of similar
- LOT of batch number
- UDI (if MDR followed)
- use-by-date
- symbol for medical device
- Information for particular storage conditions (temperature, pressure, light, humidity, etc.), as appropriate (of equivalent harmonised symbol).
Symbols used according ISO 15223
CE Mark
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:
Classified under EU MDR 2017/745 as Class I device
Safety & product Standards:
ISO 13485 Quality management systems -- Requirements for regulatory purposes
ISO 14971 Medical Devices- Application of risk management to medical devices
Environmental requirements:
ISO 14001
| Pack Size | Avg. Price |
|---|---|
| Pack of 1 | $3.47 |
