IMPORTANT NOTE:
These technical specifications are generic and may vary depending on the selected Vendor.
Intended use: To cover patients on the operating table and to maintain aseptic conditions in the operation area.
Product description:
To cover patients on the operating table and to maintain aseptic conditions in the operation area.
Material: 100% cotton of 50% polyester - 50% cotton.
Reusable woven fabrics:
Fabric: 100% cotton
- Weight per m²: 196 g/m²
- Number of threads per 3 cm: Warp: 75; Weft: 75
- Metric count: Warp: 28 / Weft: 27
of
Fabric: cretonne, cotton 100%:
- Number of threads/cm: warp: 24, weft: 24
- Metric count: warp: 28, weft: 28
- Weight per m²: 180g
of
Fabric : 50%polyesther-50% cotton fabric
- Weight per m²: +/- 175gr/m²
- Number of threads: Warp: 24; Weft 22
- Metric count: Warp: 28; Weft 28
Size: approx. 90 x 150 cm.
Colour: blue of green, but not khaki-green.
Colour quality must be able to withstand repeated washings and sterilizations.
All fabrics used must be suitable for normal washing - boiling and autoclaving- and be resistant to a 0.1% chlorine solution.
Instructions for use:
To cover patients on the operating table and to maintain aseptic conditions in the operation area.
Supplied with:
Manufacturer's instruction for use.
Packaging and labelling:
Unit presentation: 1 drape, non-sterile, multiple-use, size and Manufacturer's name.
Packaging: Protected in a plastic bag, single of multiple units.
Labelling of the primary packaging displays, at least: Product name, size, reference number, manufacturer's name and address, CE mark, lot number 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), if applicable.
Instruction for sterilization
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:
Must comply with following standards:
ISO 13485 Medical devices -- Quality management systems -- Requirements for regulatory purposes BSÂ ENÂ 13795Â Surgical drapes, gowns and clean air suits, used as medical devices for patients, clinical staff and equipment. General requirements for manufacturers, processors and products, test methods, performance requirements and performance levels
ISO 17664 Sterilization of medical devices -- Information to be provided by the manufacturer for the processing of re-sterilizable medical devices
ISO 13934-1 and ISO 6330 Tensile strength loss after washing
Environmental requirements:
ISO 14001
free from heavy metals, substances of very high concern (SVHC), allergy-causing chemicals, azo dyes, formaldehyde etc.
These technical specifications are generic and may vary depending on the selected Vendor.
Intended use: To cover patients on the operating table and to maintain aseptic conditions in the operation area.
Product description:
To cover patients on the operating table and to maintain aseptic conditions in the operation area.
Material: 100% cotton of 50% polyester - 50% cotton.
Reusable woven fabrics:
Fabric: 100% cotton
- Weight per m²: 196 g/m²
- Number of threads per 3 cm: Warp: 75; Weft: 75
- Metric count: Warp: 28 / Weft: 27
of
Fabric: cretonne, cotton 100%:
- Number of threads/cm: warp: 24, weft: 24
- Metric count: warp: 28, weft: 28
- Weight per m²: 180g
of
Fabric : 50%polyesther-50% cotton fabric
- Weight per m²: +/- 175gr/m²
- Number of threads: Warp: 24; Weft 22
- Metric count: Warp: 28; Weft 28
Size: approx. 90 x 150 cm.
Colour: blue of green, but not khaki-green.
Colour quality must be able to withstand repeated washings and sterilizations.
All fabrics used must be suitable for normal washing - boiling and autoclaving- and be resistant to a 0.1% chlorine solution.
Instructions for use:
To cover patients on the operating table and to maintain aseptic conditions in the operation area.
Supplied with:
Manufacturer's instruction for use.
Packaging and labelling:
Unit presentation: 1 drape, non-sterile, multiple-use, size and Manufacturer's name.
Packaging: Protected in a plastic bag, single of multiple units.
Labelling of the primary packaging displays, at least: Product name, size, reference number, manufacturer's name and address, CE mark, lot number 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), if applicable.
Instruction for sterilization
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:
Must comply with following standards:
ISO 13485 Medical devices -- Quality management systems -- Requirements for regulatory purposes BSÂ ENÂ 13795Â Surgical drapes, gowns and clean air suits, used as medical devices for patients, clinical staff and equipment. General requirements for manufacturers, processors and products, test methods, performance requirements and performance levels
ISO 17664 Sterilization of medical devices -- Information to be provided by the manufacturer for the processing of re-sterilizable medical devices
ISO 13934-1 and ISO 6330 Tensile strength loss after washing
Environmental requirements:
ISO 14001
free from heavy metals, substances of very high concern (SVHC), allergy-causing chemicals, azo dyes, formaldehyde etc.
| Pack Size | Avg. Price |
|---|---|
| Pack of 1 | $4.81 |
