Syringe,A-D,BCG,0.05ml,SIP,w/ndl/BOX-100

General Description:
Syringe, auto-disable, 0.05ml, with needle (27Gx 3/8” or 0.4x10mm) and protective cap. The syringe has an auto-disable technology feature that passively activates upon starting administration of the intended fixed vaccine dose to prevent subsequent re-use of the syringe and the needle conform to ISO7886-3:2020. Blister packed. Pre-set volume limit.
The syringe has a sharps injury prevention feature conform to ISO 23908:2013 to protect against accidental needle stick injuries (SIP feature) of the following categories:

Active safety feature
sharps protection feature that requires an additional step by the user to activate, separate from any action needed to perform the primary intended function of the device

OR:

Passive safety feature
sharps protection feature that does not require an additional step by the user to activate, separate from any action needed to perform the primary intended function of the device


Intended use: Intradermal delivery of 0.05ml dose of reconstituted BCG vaccine.

Technical specifications:
Capacity: 0.05 ml

Graduation: Marking scale on the barrel, easy to read. Graduated scale: only two markings, the zero line and the nominal capacity line (i.e. the total graduated capacity line). These lines shall be of uniform thickness. They shall lie in planes at right angles to the axis of the barrel conform to ISO 7886-1:2017.

Needle: Fixed needle with protective cap conform to ISO 7864:2016.

Needle size: 27G x 3/8" (0.4x10mm).

Material:

Syringe: Medical grade plastic (Polypropylene (PP)/ polystyrene (PS)/ polyethylene (PE).
Needle: Stainless steel conform to ISO 9626:2016.

Disposable.

Sterile (ethylene oxide sterilization compiles to ISO 11135:2019).

Standards:

Product and packaging conform to ISO 7886-3:2020, ISO 7886-1:2017, ISO 7864:2016, ISO 9626:2016, ISO 11135:2019.

Product listed under WHO Performance Specification (PQS) Category E008 Auto-Disable syringe for fixed dose immunization

Quality management system (QMS): Products and manufacturer must be certified and comply with ISO 13485: 2016 requirements (or equivalent).

Marketing approval certificate: Product and manufacturer must conform to European Medical Device Regulation (EU) 2017/745 (or equivalent).

Shelf life:
5 years

Packaging and labelling:
Over packing in water-resistant export cartons.

Primary:
Unit of use (1 unit of use + packaging):
Peel-off or rigid packaging.
The words “for single use” or equivalent (such as symbol for single use, reference ISO 7000-1051); the term “disposable” shall not be used;
The symbol indicating that the device possesses an auto-disable function for re-use prevention
Name or logo of manufacturer.
The word “sterile” or equivalent harmonized symbol;
The lot number prefixed by the word “LOT” (or equivalent harmonized symbol);
The expiry date by year and month, prefixed by the word “EXP” (or an equivalent harmonized symbol);
The description of contents including the nominal capacity and type of the needle, if included.
External diameter and length of the needle, if included.

Secondary:
Protected unit (1 or more units of use + protective packaging).
Rigid packaging.
The words “for single use” or equivalent (such as symbol for single use, reference ISO 7000-1051); the term “disposable” shall not be used;
The symbol indicating that the device possesses an auto-disable function for re-use prevention
Name or logo of manufacturer.
The words “sterile” or equivalent harmonized symbol;
The lot number prefixed by the word “LOT” (or equivalent harmonized symbol);
The expiry date by year and month, prefixed by the word “EXP” (or an equivalent harmonized symbol);
The description of the contents including the nominal capacity and type of the needle, if included;
A warning to check the integrity of the primary container before use;
A warning not to recap the needle, or equivalent symbol;
Any information for handling, storage and disposal of syringe;
The instructions for use, including the instructions appropriate to the auto-disable feature; alternatively, the instructions for use can be indicated on a separate insert;
The number of units per secondary container.

Packaging unit:
(protected units + extra packaging).
Rigid packaging.
The description of contents including the nominal capacity and the type of needle, if included;
The symbol indicating that the device possesses an auto-disable function for re-use prevention
The lot number prefixed by the word “LOT” (or equivalent harmonized symbol);
The expiry date by year and month, prefixed by the word “EXP” (or an equivalent harmonized symbol);
The word “sterile” or equivalent harmonized symbol;
Name or Logo of manufacturer and address of the manufacturer or supplier;
Any information for handling, storage and transportation of the contents (or equivalent symbols as given in ISO 7000 or ISO 780);
The number of units per storage container.

Related products
S0782208Safety box f.used syrgs/ndls 5lt/BOX-25

Useful links
http://apps.who.int/immunization_ standards/vaccine_quality/pqs_catalogue/categorypage.aspx?id_cat=37