Product Description:
Sterile scissors (Mod. USA) designed for umbilical cord cutting after child birth.
Material: Martensitic stainless steel (AISI 440 or equivalent) or strong medical grade polymer.
Length: 10 to 14 cm.
Blades: Cutting, sharp. Single-edged preferred, double-edged acceptable (inner blade edges can be sharp, outer edges and blade tips must be blunt).
Blade tips: Blunt.
Scissors may come with a blunt protective sheath.
Sterile.
Supplied with:
Manufacturer's instructions for use (written and/or pictorial) are printed onto the primary package.
If scissors are supplied as 'initially sterile' but are inteded for reuse:
Instructions for cleaning, disinfection and sterilization are required.
Accessories / Spare Parts / Consumables (available but not supplied):
N/A
Intended use:
Scissors are designed for cutting the umbilical cord after child birth.
Scissors are supplied as initially sterile.
IMPORTANT: The scissors are part of IARH kit 2A - Individual Delivery. Prevention of the kit's individual plastic bag puncturing is to be taken into consideration in the product design or packaging, e.g. by introducing sterile steath for the blade.
Packaging and Labelling:
One (1) unit in a protective packaging with a label that includes:
Device identity and intended purpose.
Manufacturer's product code or reference number.
Manufacturer identification.
Address of the manufacturing site.
EC Rep identification.
How the device should be used, maintained and stored.
Lot/Batch and MFD and EXP.
Any residual device risks, warnings, limitations or contraindications.
Symbols used according ISO 15223.
CE mark.
The word "sterile" (or equivalent harmonised symbol).
Sterilisation method (or equivalent harmonised symbol).
The words "for single use" (or equivalent harmonised symbol), if applicable.
The words "check the package integrity before use", or similar warning.
The words "dispose after use", if applicable.
Regulation and Conformity Requirements:
CE mark (conforming to Medical Device Directive MDD 93/42/EEC, MDR 2017/745) or FDA 510k approved or equivalent.
Declaration of Conformity according to ISO 17050.
ISO 13485
Classification:
Class I sterile (MDD 93/42/EEC, MDR 2017/745)
Safety and Product Standards (current versions of the following standards):
ISO 11137 or equivalent for the applied sterilization method.
ISO 11607-1: Packaging for Terminally sterilized medical devices - Part 1 : Requirements for materials, sterile barrier systems and packaging systems.
ISO 11607-2: Packaging for terminally sterilized medical devices - Part 2: Validation requirements for forming, sealing and assembly processes.
ISO 10993 -1: Biological evaluation of medical devices - Part 1 Evaluation and testing within a risk management process
ISO 7153-1: Surgical instruments - Metallic materials - Part 1 Stainless steel
ISO 13402: Surgical and dental hand instruments - Determination of resistance against autoclaving corrosion and thermal exposure
ISO 7741: Instruments for surgery - Scissors and shears - General requirements and test methods
ISO 17664: Sterilization of Medical Devices - Information to be provided by the manufacturer for the processing of resterilizable medical devices
Environmental Requirements:
ISO 14001: Environmental management systems
Sterile scissors (Mod. USA) designed for umbilical cord cutting after child birth.
Material: Martensitic stainless steel (AISI 440 or equivalent) or strong medical grade polymer.
Length: 10 to 14 cm.
Blades: Cutting, sharp. Single-edged preferred, double-edged acceptable (inner blade edges can be sharp, outer edges and blade tips must be blunt).
Blade tips: Blunt.
Scissors may come with a blunt protective sheath.
Sterile.
Supplied with:
Manufacturer's instructions for use (written and/or pictorial) are printed onto the primary package.
If scissors are supplied as 'initially sterile' but are inteded for reuse:
Instructions for cleaning, disinfection and sterilization are required.
Accessories / Spare Parts / Consumables (available but not supplied):
N/A
Intended use:
Scissors are designed for cutting the umbilical cord after child birth.
Scissors are supplied as initially sterile.
IMPORTANT: The scissors are part of IARH kit 2A - Individual Delivery. Prevention of the kit's individual plastic bag puncturing is to be taken into consideration in the product design or packaging, e.g. by introducing sterile steath for the blade.
Packaging and Labelling:
One (1) unit in a protective packaging with a label that includes:
Device identity and intended purpose.
Manufacturer's product code or reference number.
Manufacturer identification.
Address of the manufacturing site.
EC Rep identification.
How the device should be used, maintained and stored.
Lot/Batch and MFD and EXP.
Any residual device risks, warnings, limitations or contraindications.
Symbols used according ISO 15223.
CE mark.
The word "sterile" (or equivalent harmonised symbol).
Sterilisation method (or equivalent harmonised symbol).
The words "for single use" (or equivalent harmonised symbol), if applicable.
The words "check the package integrity before use", or similar warning.
The words "dispose after use", if applicable.
Regulation and Conformity Requirements:
CE mark (conforming to Medical Device Directive MDD 93/42/EEC, MDR 2017/745) or FDA 510k approved or equivalent.
Declaration of Conformity according to ISO 17050.
ISO 13485
Classification:
Class I sterile (MDD 93/42/EEC, MDR 2017/745)
Safety and Product Standards (current versions of the following standards):
ISO 11137 or equivalent for the applied sterilization method.
ISO 11607-1: Packaging for Terminally sterilized medical devices - Part 1 : Requirements for materials, sterile barrier systems and packaging systems.
ISO 11607-2: Packaging for terminally sterilized medical devices - Part 2: Validation requirements for forming, sealing and assembly processes.
ISO 10993 -1: Biological evaluation of medical devices - Part 1 Evaluation and testing within a risk management process
ISO 7153-1: Surgical instruments - Metallic materials - Part 1 Stainless steel
ISO 13402: Surgical and dental hand instruments - Determination of resistance against autoclaving corrosion and thermal exposure
ISO 7741: Instruments for surgery - Scissors and shears - General requirements and test methods
ISO 17664: Sterilization of Medical Devices - Information to be provided by the manufacturer for the processing of resterilizable medical devices
Environmental Requirements:
ISO 14001: Environmental management systems
| Pack Size | Avg. Price |
|---|---|
| Pack of 1 | $3.25 |
| Pack of 20 | $26.69 |
