Product description:
Rectangular plastic sheet, used to protect equipment from soiling.
Material: Opaque of translucent plastic (PVC)
Width: 90-110cm
Length: 150-180 cm
Thickness: 10-20 microns
Washing: normal, withstands boiling and steam sterilization, resists to 0.5% chlorine.
Reusable and non-sterile.
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:
Primary packaging: Unit of use.
One (1) plastic draw sheet in a plastic bag.
Labelling:
- Product name, size, reference number.
- Manufacturer's name and address.
- CE marked 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).
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
Rectangular plastic sheet, used to protect equipment from soiling.
Material: Opaque of translucent plastic (PVC)
Width: 90-110cm
Length: 150-180 cm
Thickness: 10-20 microns
Washing: normal, withstands boiling and steam sterilization, resists to 0.5% chlorine.
Reusable and non-sterile.
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:
Primary packaging: Unit of use.
One (1) plastic draw sheet in a plastic bag.
Labelling:
- Product name, size, reference number.
- Manufacturer's name and address.
- CE marked 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).
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 | $1.24 |
