19/30393103 DC - BS EN ISO 7886-3. Sterile hypodermic syringes for single use. Part 3. Auto-disabled syringes for fixed-dose immunization

19/30393103 DC

BS EN ISO 7886-3. Sterile hypodermic syringes for single use. Part 3. Auto-disabled syringes for fixed-dose immunization

Status : Current, Draft for public comment   Published : May 2019

Format
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This document specifies the properties and performance of sterile single-use hypodermic syringes with or without needle, made of plastic, rubber or other materials and intended for the filling and the injection of vaccines immediately after filling. Upon delivering a fixed dose of vaccine, the syringe is automatically rendered unusable.

This document does not specify the design of the auto-disable feature, which is left to the discretion of the manufacturer.

This document is not applicable to syringes for use with insulin (specified in ISO 8537), syringes for use with power-driven syringe pumps (specified in ISO 7886-2), reuse prevention syringes (specified in ISO 7886-4) and syringes designed to be prefilled. It does not address compatibility with injection fluids/vaccines.

NOTE

Prefilled syringes are covered in the ISO 11040- series.




Standard Number19/30393103 DC
TitleBS EN ISO 7886-3. Sterile hypodermic syringes for single use. Part 3. Auto-disabled syringes for fixed-dose immunization
StatusCurrent, Draft for public comment
Publication Date21 May 2019
Normative References(Required to achieve compliance to this standard)ASTM D5276-98, ISO 80369-7, ISO 7000, ISO 14971, ISO 15223-1, ISO 9626, ASTM D999-01, ISO 10993-1, ISO 23908, ISO 8537:2016, ISO 7864:2016, ISO 7886-1:2017
Informative References(Provided for Information)ISO 7886-4:2018, ISO 780:2015
International RelationshipsISO/DIS 7886-3
Draft Expiry Date10 July 2019
DescriptorsGraduations, Labels, Marking, Immunization, Performance testing, Medical equipment, Determination of content, Dimensional tolerances, Sterile equipment, Performance, Injection instruments, Volume, Disposable, Graphic characters, Dimensions, Syringes
ICS11.040.25
Title in FrenchSeringues hypodermiques stériles, non réutilisables — Partie 3: Seringues autobloquantes pour vaccination à dose fixe Partie 3: Seringues autobloquantes pour vaccination à dose fixe
CommitteeCH/84
PublisherBSI
FormatA4
DeliveryYes
Pages23
File Size421 KB
NotesWarning: this draft is not current beyond its expiry date for comments.
Price£20.00


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