iTeh StandardsiTeh Standards
EURUSD
Your shopping cart is empty.
CEN

prEN ISO 7886-3

(Main)

Sterile hypodermic syringes for single use - Part 3: Auto-disable syringes for fixed-dose immunization (ISO/DIS 7886-3:2016)

Sterile hypodermic syringes for single use - Part 3: Auto-disable syringes for fixed-dose immunization (ISO/DIS 7886-3:2016)

2018-08-02: WI abandoned to folllow cancellation of WI in ISO (ISO notification in dataservice on 2018-08-02)

Sterile Einmalspritzen für medizinische Zwecke - Teil 3: Selbstblockierende Spritzen für die Injektion mit fixer Impfstoffdosis (ISO/DIS 7886-3:2016)

Seringues hypodermiques stériles, non réutilisables - Partie 3: Seringues autobloquantes pour vaccination à dose fixe (ISO/DIS 7886-3:2016)

Sterilne podkožne injekcijske brizge za enkratno uporabo - 3. del: Brizge za točno določen odmerek imunizacije s sistemom za samouničenje (ISO/DIS 7886-3:2016)

General Information

Status
Not Published
Publication Date
24-Jun-2018
Withdrawal Date
31-Dec-2018
ICS
11.040.25 - Syringes, needles an catheters
Technical Committee
CEN/TC 205 - Non-active medical devices
Drafting Committee
CEN/TC 205 - Non-active medical devices
Current Stage
4098 - Decision to abandon - Enquiry
Completion Date
02-Aug-2018
Directive
2007/47/EC - Directive 2007/47/EC of the European Parliament and of the council of 5 September 2007 amending Council Directive 90/385/EEC on the approximation of the laws of the Member States relating to active implantable medical devices, Council Directive 93/42/EEC concerning medical devices and Directive 98/8/EC concerning the placing of biocidal products on the market
93/42/EEC - Council Directive 93/42/EEC of 14 June 1993 concerning medical devices
Mandate
M/295 - Standardization mandate to CEN/CENELEC concerning the development of European standards relating to medical devices
Ref Project
oSIST prEN ISO 7886-3:2017 - Sterile hypodermic syringes for single use - Part 3: Auto-disable syringes for fixed-dose immunization (ISO/DIS 7886-3:2016)

Relations

Revises
EN ISO 7886-3:2009 - Sterile hypodermic syringes for single use - Part 3: Auto-disable syringes for fixed-dose immunization (ISO 7886-3:2005)
Effective Date
19-Jan-2023

Buy Standard

prEN ISO 7886-3:2017prEN ISO 7886-3:2017
PreviousNext
Draft
prEN ISO 7886-3:2017
English language
22 pages
sale 10% off
Preview
sale 10% off
Preview
e-Library read for
1 day

Standards Content (Sample)

SLOVENSKI STANDARD
oSIST prEN ISO 7886-3:2017
01-februar-2017
6WHULOQHSRGNRåQHLQMHNFLMVNHEUL]JH]DHQNUDWQRXSRUDERGHO%UL]JH]DWRþQR
GRORþHQRGPHUHNLPXQL]DFLMHVVLVWHPRP]DVDPRXQLþHQMH ,62',6
Sterile hypodermic syringes for single use - Part 3: Auto-disable syringes for fixed-dose
immunization (ISO/DIS 7886-3:2016)
Sterile Einmalspritzen für medizinische Zwecke - Teil 3: Selbstblockierende Spritzen für
die Injektion mit fixer Impfstoffdosis (ISO/DIS 7886-3:2016)
Seringues hypodermiques stériles, non réutilisables - Partie 3: Seringues autobloquantes
pour vaccination à dose fixe (ISO/DIS 7886-3:2016)
Ta slovenski standard je istoveten z: prEN ISO 7886-3
ICS:
11.040.25 Injekcijske brizge, igle in Syringes, needles an
katetri catheters
oSIST prEN ISO 7886-3:2017 en
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

---------------------- Page: 1 ----------------------
oSIST prEN ISO 7886-3:2017

---------------------- Page: 2 ----------------------
oSIST prEN ISO 7886-3:2017
DRAFT INTERNATIONAL STANDARD
ISO/DIS 7886-3
ISO/TC 84 Secretariat: DS
Voting begins on: Voting terminates on:
2016-11-28 2017-02-19
Sterile hypodermic syringes for single use —
Part 3:
Auto-disabled syringes for fixed-dose immunization
Seringues hypodermiques stériles, non réutilisables —
Partie 3: Seringues autobloquantes pour vaccination à dose fixe
ICS: 11.040.25
THIS DOCUMENT IS A DRAFT CIRCULATED
This document is circulated as received from the committee secretariat.
FOR COMMENT AND APPROVAL. IT IS
THEREFORE SUBJECT TO CHANGE AND MAY
NOT BE REFERRED TO AS AN INTERNATIONAL
STANDARD UNTIL PUBLISHED AS SUCH.
IN ADDITION TO THEIR EVALUATION AS
ISO/CEN PARALLEL PROCESSING
BEING ACCEPTABLE FOR INDUSTRIAL,
TECHNOLOGICAL, COMMERCIAL AND
USER PURPOSES, DRAFT INTERNATIONAL
STANDARDS MAY ON OCCASION HAVE TO
BE CONSIDERED IN THE LIGHT OF THEIR
POTENTIAL TO BECOME STANDARDS TO
WHICH REFERENCE MAY BE MADE IN
Reference number
NATIONAL REGULATIONS.
ISO/DIS 7886-3:2016(E)
RECIPIENTS OF THIS DRAFT ARE INVITED
TO SUBMIT, WITH THEIR COMMENTS,
NOTIFICATION OF ANY RELEVANT PATENT
RIGHTS OF WHICH THEY ARE AWARE AND TO
©
PROVIDE SUPPORTING DOCUMENTATION. ISO 2016

---------------------- Page: 3 ----------------------
oSIST prEN ISO 7886-3:2017
ISO/DIS 7886-3:2016(E)

COPYRIGHT PROTECTED DOCUMENT
© ISO 2016, Published in Switzerland
All rights reserved. Unless otherwise specified, no part of this publication may be reproduced or utilized otherwise in any form
or by any means, electronic or mechanical, including photocopying, or posting on the internet or an intranet, without prior
written permission. Permission can be requested from either ISO at the address below or ISO’s member body in the country of
the requester.
ISO copyright office
Ch. de Blandonnet 8 • CP 401
CH-1214 Vernier, Geneva, Switzerland
Tel. +41 22 749 01 11
Fax +41 22 749 09 47
copyright@iso.org
www.iso.org
ii © ISO 2016 – All rights reserved

---------------------- Page: 4 ----------------------
oSIST prEN ISO 7886-3:2017
ISO/DIS 7886-3:2016(E)

Contents Page
Foreword .v
Introduction .vi
1 Scope . 1
2 Normative references . 1
3 Terms and definitions . 2
4 Nomenclature . 2
5 Requirements . 3
5.1 General Requirements . 3
6 Cleanliness .
...

Questions, Comments and Discussion

Ask us and Technical Secretary will try to provide an answer. You can facilitate discussion about the standard in here.

This May Also Interest You

CEN
EN ISO 10555-1:2023(Main)
Intravascular catheters - Sterile and single-use catheters - Part 1: General requirements (ISO 10555-1:2023)
SIST EN ISO 10555-1:2024

This document specifies general requirements for intravascular catheters, supplied sterile and intended for single use, for any application.
This document does not apply to intravascular catheter accessories, e.g. those covered by ISO 11070.

  • Standard
    52 pages
    English language
    sale 10% off
    e-Library read for
    1 day
CEN
EN ISO 10555-4:2023(Main)
Intravascular catheters - Sterile and single-use catheters - Part 4: Balloon dilatation catheters (ISO 10555-4:2023)
SIST EN ISO 10555-4:2024

This document specifies requirements for balloon dilatation catheters supplied sterile and intended for single use.
This document does not specify requirements for vascular stents (see ISO 25539-2).
NOTE            Guidance on the selection of balloon materials is given in Annex G.

  • Standard
    25 pages
    English language
    sale 10% off
    e-Library read for
    1 day
CEN
EN ISO 11608-5:2023(Main)
Needle-based injection systems for medical use - Requirements and test methods - Part 5: Automated functions (ISO 11608-5:2022)
SIST EN ISO 11608-5:2023

This part of ISO 11608 specifies requirements and test methods for needle-based injection systems with automated functions (referred to in the standard as NIS-AUTO), for the administration of medicinal products in humans. This document does not cover remote communication from the NIS-AUTO.

  • Standard
    30 pages
    English language
    sale 10% off
    e-Library read for
    1 day
CEN
EN ISO 11608-3:2022(Main)
Needle-based injection systems for medical use - Requirements and test methods - Part 3: Containers and integrated fluid paths (ISO 11608-3:2022, Corrected version 2023-01)
SIST EN ISO 11608-3:2022

This document specifies requirements and test methods for design verification of containers and integrated fluid paths used with Needle-Based Injection Systems (NISs) according to ISO 11608-1.
It is applicable to single and multi-dose containers either filled by the manufacturer (primary container closure) or by the end-user (reservoir) (e.g. cartridges, syringes) and fluid paths that are integrated with the NIS at the point of manufacture.
This document is also applicable to prefilled syringes (see ISO 11040-8) when used with a NIS (see also scope of ISO 11608-1:2022).
This document is not applicable to the following products:
—    sterile hypodermic needles;
—    sterile hypodermic syringes;
—    sterile single-use syringes, with or without needle, for insulin;
—    containers that can be refilled multiple times;
—    containers intended for dental use;
—    catheters or infusion sets that are attached or assembled separately by the user.

  • Standard
    35 pages
    English language
    sale 10% off
    e-Library read for
    1 day
CEN
EN ISO 11608-2:2022(Main)
Needle-based injection systems for medical use - Requirements and test methods - Part 2: Double-ended pen needles (ISO 11608-2:2022)
SIST EN ISO 11608-2:2022

This document specifies requirements and test methods for single-use, double-ended, sterile needles intended to be used with some needle-based injection systems (NISs) that use a non-integrated double-ended needle according to ISO 11608-1.
This document is not applicable to the following:
—    needles for dental use;
—    pre-attached syringe needles;
—    hypodermic needles;
—    needles intended for different routes of administration (e.g. intravenous, intrathecal, intraocular);
—    materials that form the medicinal product contact surfaces of the primary container closure.
However, while this document is not intended to directly apply to these needle products, it does contain requirements and tests methods that can be used to help design and evaluate them.
NOTE       Needles provided by the manufacturer integrated into the fluid path or container are covered in ISO 11608‑3, and hypodermic needles provided separately are covered in ISO 7864.

  • Standard
    40 pages
    English language
    sale 10% off
    e-Library read for
    1 day
CEN
EN ISO 11608-1:2022(Main)
Needle-based injection systems for medical use - Requirements and test methods - Part 1: Needle-based injection systems (ISO 11608-1:2022)
SIST EN ISO 11608-1:2022

This document specifies requirements and test methods for Needle-Based Injection Systems (NISs) for single-patient use intended to deliver discrete volumes (bolus) of medicinal product, which can be delivered through needles or soft cannulas for intradermal, subcutaneous and/or intramuscular delivery, incorporating pre-filled or user-filled, replaceable or non-replaceable containers.
This document applies in cases where the NIS incorporates a prefilled syringe. However, stand-alone prefilled syringes defined by ISO 11040-8 are not covered by this document (see exclusions below).
It is important to note that other functions and characteristics of the prefilled syringe, such as dose accuracy, are subject to the requirements (delivered volume) in ISO 11040-8 and not this document, unless the addition impacts the delivery function (e.g. a mechanism that intends to restrict or stop the plunger movement, which would limit the dose delivered). In that case, the system is completely covered by this document and applicable requirements of the ISO 11608 series.
Excluded from the scope are:
—    stand-alone prefilled syringes defined by ISO 11040-8 (with noted exceptions above);
—    NISs that provide continuous delivery and require a delivery rate clinically specified in the medicinal product labelling or determined by a physician based on clinical relevance (i.e. medication efficacy) as would be the case with insulin patch pumps or traditional infusion pumps (e.g. IEC 60601-2-24, ISO 28620) associated with continuous delivery of medicinal products (e.g. insulin);
—    NISs with containers that can be refilled multiple times;
—    requirements relating to methods or equipment associated with user filling of containers unless they are dedicated accessories (a component necessary for primary function, whether included in the original kitted product or not);
—    NISs intended for dental use;
—    NISs intended for different routes of administration (e.g. intravenous, intrathecal, intraocular).
NOTE       These products that are excluded might benefit from elements in this document but might not completely fulfil the basic safety and effectiveness of such products.

  • Standard
    81 pages
    English language
    sale 10% off
    e-Library read for
    1 day
CEN
EN ISO 11608-4:2022(Main)
Needle-based injection systems for medical use - Requirements and test methods - Part 4: Needle-based injection systems containing electronics (ISO 11608-4:2022)
SIST EN ISO 11608-4:2022

This document specifies requirements and test methods for needle-based injection systems (NISs) containing electronics with or without software (NIS-Es).
The needle-based injection system containing electronics can be single use or reusable and can be operated with or without electrical/conductive connections to other devices. The system is intended to deliver medication to a patient by self-administration or by administration by one other operator (e.g. caregiver or health care provider).
This document applies to electronic accessories that are intended to be physically connected to a NIS or NIS-E according to the NIS/NIS-E intended use.
This document also applies to electronic accessories that are intended to have electrical/conductive connections to a NIS or NIS-E according to the NIS/NIS-E intended use.
This document does not specify requirements for software in programmable NIS-E.
NOTE       IEC 60601-1:2005+AMD1:2012+AMD2:2020, Clause 14 addresses software life cycle processes.
This document does not specify requirements for cybersecurity.

  • Standard
    72 pages
    English language
    sale 10% off
    e-Library read for
    1 day
CEN
EN ISO 7886-3:2020(Main)
Sterile hypodermic syringes for single use - Part 3: Auto-disabled syringes for fixed-dose immunization (ISO 7886-3:2020)
SIST EN ISO 7886-3:2020

This document specifies the properties and performance of sterile single-use hypodermic syringes with an auto-disable syringe feature intended to deliver a fixed dose of vaccine immediately after filling. The syringes can be made of plastic, rubber or other materials and can be with or without needle and needle protection feature.
This document does not specify the design of the auto-disable syringe feature.
This document is not applicable to syringes for use with insulin (covered by ISO 8537), syringes for use with power-driven syringe pumps (covered by ISO 7886-2), reuse prevention syringes (covered by ISO 7886-4) or syringes designed to be prefilled (covered by the ISO 11040 series). It does not address compatibility with injection fluids/vaccines.

  • Standard
    24 pages
    English language
    sale 10% off
    e-Library read for
    1 day
CEN
EN ISO 7886-2:2020(Main)
Sterile hypodermic syringes for single use - Part 2: Syringes for use with power-driven syringe pumps (ISO 7886-2:2020)
SIST EN ISO 7886-2:2020

This document specifies requirements for sterile single-use hypodermic syringes of nominal capacity 1 ml and above, made of plastic materials and intended for use with power-driven syringe pumps.
This document does not apply to syringes with auto-disable syringe features (ISO 7886-3[2]), syringes for use with insulin (ISO 8537[3]), single-use syringes made of glass, syringes prefilled with the injection by the manufacturer and syringes supplied with the injection as a kit for filling by a pharmacist. It does not address compatibility with injection fluids.

  • Standard
    27 pages
    English language
    sale 10% off
    e-Library read for
    1 day
CEN
EN ISO 20695:2020(Main)
Enteral feeding systems - Design and testing (ISO 20695:2020)
SIST EN ISO 20695:2020

This document specifies requirements for enteral feeding systems comprising enteral giving sets, enteral extension sets, enteral syringes, enteral feeding catheters, and enteral accessories.
This document is not applicable to oral syringes.

  • Standard
    52 pages
    English language
    sale 10% off
    e-Library read for
    1 day