oSIST prEN ISO 7886-3:2017
(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)
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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.
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oSIST prEN ISO 7886-3:2017
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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
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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
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ii © ISO 2016 – All rights reserved
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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 . 4
7 Limits for acidity or alkalinity. 4
8 Limits for extractable metals . 4
9 Lubricant . 4
10 Tolerance on nominal capacity . 4
11 Graduated scale . 5
11.1 Scale . 5
11.2 Position of scale . 5
12 Barrel . 5
12.1 Dimensions . 5
12.2 Barrel flanges . 5
13 Plunger stopper/plunger assembly. 5
13.1 Design . 5
13.2 Fit of the plunger stopper/plunger in the barrel . 6
13.3 Fiducial line . 6
14 Needle . 6
14.1 Integrated needle . 6
14.2 Non-integrated needle . 6
14.3 Sharps protection features . 6
15 Performance . 7
15.1 General . 7
15.2 Dead space . 7
15.3 Freedom from air and liquid leakage . 7
15.4 Auto-disable feature . 7
15.5 Performance after shipping . 7
15.6 Guidance on materials . 7
16 Packaging . 8
16.1 Unit packaging providing sterile barrier . 8
16.2 User packaging . 8
17 Information supplied by the manufacturer . 8
17.1 General . 8
17.2 Syringes . 8
17.3 Unit packaging providing sterile barrier . 8
17.4 User packaging . 9
17.5 Storage containers . 9
17.6 Transport wrapping .10
Annex A (normative) Method for preparation of extracts .12
Annex B (informative) Test method for forces required to operate piston .13
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ISO/DIS 7886-3:2016(E)
Annex C (normative) Test method for testing auto-disable feature .15
Bibliography .16
iv © ISO 2016 – All rights reserved
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oSIST prEN ISO 7886-3:2017
ISO/DIS 7886-3:2016(E)
Foreword
ISO (the International Organization for Standardization) is a worldwide federation of national standards
bodies (ISO member bodies). The work of preparing International Standards is normally carried out
through ISO technical committees. Each member body interested in a subject for which a technical
committee has been established has the right to be represented on that committee. International
organizations, governmental and non-governmental, in liaison with ISO, also take part in the work.
ISO collaborates closely with the International Electrotechnical Commission (IEC) on all matters of
electrotechnical standardization.
The procedures used to develop this document and those intended for its further maintenance are
described in the ISO/IEC Directives, Part 1. In particular the different approval criteria needed for the
different types of ISO documents should be noted. This document was drafted in accordance with the
editorial rules of the ISO/IEC Directives, Part 2 (see www.iso.org/directives).
Attention is drawn to the possibility that some of the elements of this document may be the subject of
patent rights. ISO shall not be held responsible for identifying any or all such patent rights. Details of
any patent rights identified during the development of the document will be in the Introduction and/or
on the ISO list of patent declarations received (see www.iso.org/patents).
Any trade name used in this document is information given for the convenience of users and does not
constitute an endorsement.
For an explanation on the meaning of ISO specific terms and expressions related to conformity assessment,
as well as information about ISO’s adherence to the World Trade Organization (WTO) principles in the
Technical Barriers to Trade (TBT) see the following URL: www.iso.org/iso/foreword.html.
ISO 7886-3 was prepared by Technical Committee ISO/TC 84, Devices for administration of medicinal
products and catheters.
In some countries national regulations are legally binding and the requirements may take precedence
over this International Standard.
This second edition cancels and replaces ISO 7886-3:2005, which has been technically revised.
ISO 7886 consists of the following parts, under the general title Sterile hypodermic syringes for single use:
— Part 1: Syringes for manual use
— Part 2: Syringes for use with power-driven syringe pumps
— Part 3: Auto-disabled syringes for fixed-dose immunization
— Part 4: Syringes with re-use prevention feature
The main changes to the previous edition of ISO 7886-3 introduced by this revision are:
Change in scope of the standard: Upon commencement of injection of a nominal fixed dose of vaccine,
the auto-disable feature of the syringe is passively activated so that the syringe cannot be reused.
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oSIST prEN ISO 7886-3:2017
ISO/DIS 7886-3:2016(E)
Introduction
ISO 7886 was first published in 1984. It was subsequently decided to divide it into two parts, ISO 7886-1
retaining essentially the scope of ISO 7886:1984, and ISO 7886-2 being applicable to sterile, single-use
syringes for use with power-driven pumps.
The preparation of this third part of ISO 7886 was recognized as a high priority requirement to prevent
the re- use of fixed dose immunization syringes in the developing and transitional countries. Re-use of
injection equipment in the absence of sterilization has increasingly led to transmission of blood-borne
pathogens.
The World Health Organization had produced a specification for syringes that are rendered inactive
after one use (commonly referred to as “auto-disabled” syringes). Both the WHO and ISO agreed that an
additional part of ISO 7886 would be required to cover “auto-disabled” syringes, whilst leaving in place
ISO 7886 Parts 1 and 2 without modification, as a large number of devices in common use would not be
intended to comply with the auto-disable properties suggested.
This part of ISO 7886 is intended to cover “fixed dose” immunization syringes that are passively
rendered non-reusable for another application after the commencement of injection intended to deliver
a nominal vaccine dose. These syringes are not covered by Parts 1 and 2 of ISO 7886.
Based on field feedback, the World Health Organization recommended to make further amendments to
this standard for enhanced safety and to bring more clarification to requirements. These amendments
are covered in this revision of this standard.
It is recognized that syringes designed to reduce the risk of needle stick injuries, may also comply with
this part of ISO 7886 with regard to their auto-disable properties, but it is stressed that needle stick
protection features of syringes are not in themselves addressed in this part of ISO 7886. Requirements
for sharps injury protection features are covered by ISO 23908.
Guidance on transition periods for implementing the requirements of this standard is given in
ISO/TR 19244 ‘Guidance on transition periods for standards developed by ISO/TC 84 - Devices for
administration of medicinal products and catheters’.
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oSIST prEN ISO 7886-3:2017
DRAFT INTERNATIONAL STANDARD ISO/DIS 7886-3:2016(E)
Sterile hypodermic syringes for single use —
Part 3:
Auto-disabled syringes for fixed-dose immunization
1 Scope
This part of ISO 7886 specifies the properties and performance of sterile single-use hypodermic syringes
with or without needle, made of plastic or other materials and intended for the filling and the injection of
vaccines immediately after filling. Upon commencement of injection of a nominal fixed dose of vaccine,
the auto-disable feature of the syringe is passively activated so that the syringe cannot be reused.
This part of ISO 7886 does not specify the design of the auto-disable feature, which is left to the
discretion of the manufacturer.
This part of ISO 7886 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 under ISO 11040- series.
2 Normative references
The following documents, in whole or in part, are normatively referenced in this document and are
indispensable for its application. For dated references, only the edition cited applies. For undated
references, the latest edition of the referenced document (including any amendments) applies
ISO 594-1:1986, Conical fittings with a 6 % (Luer) taper for syringes, needles and certain other medical
equipment — Part 1: General requirements
ISO 594-2:1998, Conical fittings with a 6 % (Luer) taper for syringes, needles and certain other medical
equipment — Part 2: Lock fittings
ISO 7864:1993, Sterile hypodermic needles for single use
ISO 7886-1:1993, Sterile hypodermic syringes for single use — Part 1: Syringes for manual use
ISO 8537:2016, Sterile single-use syringes, with or without needle, for insulin
ISO 9626, Stainless steel needle tubing for the manufacture of medical devices — Requirements and
test methods
ISO 14971, Medical devices — Application of risk management to medical devices
ISO 10993-1, Biological evaluation of medical devices — Part 1: Evaluation and testing within a risk
management process
ISO 23908, Sharps injury protection — Requirements and test methods — Sharps protection features for
single-use hypodermic needles, introducers for catheters and needles used for blood sampling
ASTM D999-08, Standard methods for vibration testing of shipping containers
ASTM D5276-98, Standard test method for drop test of loaded containers by free fall
NOTE ISO 594-1:1986 and ISO 594-2:1998 will be replaced by ISO 80369-7.
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oSIST prEN ISO 7886-3:2017
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3 Terms and definitions
For the purposes of this document, the terms and definitions given in ISO 7886-1 (except 3.2) and
ISO 8537 (except 3.5) and the following apply.
ISO and IEC maintain terminological databases for use in standardization at the following addresses:
— IEC Electropedia: available at http://www.electropedia.org/
— ISO Online browsing platform: available at http://www.iso.org/obp
3.1
auto-disabled syringe feature
feature that passively activates upon commencement of injection of the nominal fixed dose to prevent
subsequent re-use of the syringe and the needle
3.2
passive activation
activation of the reuse prevention feature that does not require an additional step by the user, separate
from any action needed to perform the primary intended injection function of the device
3.3
active activation
activation of the reuse prevention feature that does require an additional step by the user
3.4
normal conditions of use
operation by any user according to the device instructions for use
3.5
integrated needle
stainless steel cannula that is directly bonded into the barrel of the syringe
3.6
non-integrated needle
hypodermic needle assembly that is fixed or bonded by the manufacturer to the barrel, or a hypodermic
needle that is attached by the user prior to making an injection
3.7
barrel flanges
flanges that protrude from the barrel (also referred to as finger grips) to provide the user a means of
gripping the syringe during injection
3.8
needle cap or shield
sheath intended to physically protect the needle prior to use
4 Nomenclature
The nomenclature for components of auto-disabled syringes for fixed dose is shown in Figure 1.
2 © ISO 2016 – All rights reserved
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oSIST prEN ISO 7886-3:2017
ISO/DIS 7886-3:2016(E)
Key
1 needle cap or shield (if used) 8 fiducial line
2 needle 9 seal(s)
3 zero line 10 barrel flanges (finger grips)
4 barrel 11 plunger
5 auto-disable feature 12 push-button
6 nominal capacity line 13 plunger cap (if used)
7 plunger stopper
NOTE The drawing is intended to be illustrative of components of an auto-disabled syringe only.
Figure 1 — Schematic representation of auto-disabled syringe for fixed dose
5 Requirements
5.1 General Requirements
The general requirements listed below are considered to be design input for manufacturers.
a) Syringes shall be free from defects affecting appearance, safety and serviceability for their intended
use. The syringe’s barrel flanges shall be of adequate size, shape and strength for the intended
purpose. The design specifications for the barrel flanges shall be determined through risk analysis
and confirmed through usability validation testing. The materials shall not cause the syringes to
yield, under conditions of normal use, significant amounts of toxic substances and shall permit
them to satisfy the appropriate national requirements or regulations for freedom from pyrogenic
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oSIST prEN ISO 7886-3:2017
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materials and abnormal toxicity. Materials used in the construction of the wall of the syringe barrel
shall have sufficient clarity to enable dosages to be read without difficulty. The standard does
not specify materials to be used for the construction and lubrication of the device, because their
selection will depend, to some extent, upon the manufacturers specific syringe design, process of
manufacture and sterilization method.
Syringes with integrated or add-on sharps protection shall comply with ISO 23908.
b) The length of the barrel shall allow the expulsion of any air bubbles without removal of the plunger
stopper and still inject nominal capacity. The length of the barrel shall be designed to enable
accurate dosage whilst avoiding unnecessary waste of vaccine.
c) The materials used in the syringe shall be tested and qualified according to ISO 10993-1.
d) The auto-disabled syringe shall be of adequate size, shape and strength for the delivery of vaccine
under normal condition of use. The design specifications for the device shall be determined through
risk analysis and confirmed through usability validation testing.
e) The forces required to use a syringe with auto-disable feature shall be appropriate for the
intended users of the device. Although the activation of the auto-disable feature itself is passive,
an appropriate force shall be selected that eases the initiation of the injection. The appropriate
initiation force shall be determined using a risk-based approach in accordance with ISO 14971.
6 Cleanliness
The surfaces of the syringe and needle that come in contact with the vaccine shall be clean and free
from extraneous matter.
NOTE Compliance with this requirement will be determined through inspection by an individual with
normal vision (or corrected-to-normal vision), without magnification.
7 Limits for acidity or alkalinity
When determined with a laboratory pH meter and using a general purpose electrode, the pH value of an
extract prepared in accordance with Annex A shall be within one unit of pH of that of the control fluid.
8 Limits for extractable metals
When tested by a recognized micro analytical method, for example by an atomic absorption method,
an extract prepared in accordance with Annex A shall, when corrected for the metals content of the
control fluid, contain no greater than a combined total of 5 mg/l of lead, tin, zinc and iron. The cadmium
content of the extract shall, when corrected for the cadmium content of the control fluid, be lower than
0,1 mg/l.
9 Lubricant
Clause 7 of ISO 7886-1 and 4.10.4 of ISO 7864 shall apply.
10 Tolerance on nominal capacity
The volume of water at (23 ± 5) °C expelled from the syringe when the fiducial line of the piston
traverses the full scale (i.e. the nominal fixed dose) shall be within the tolerances on the nominal
capacity as specified in Table 1. The nominal capacity shall be designated in millilitres.
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oSIST prEN ISO 7886-3:2017
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Table 1 — Nominal capacity and dead space
Minimal
gradua-
Maximum
Maximum dead Maximum tion length
Tolerance on dead space for
Nominal capacity space for integrat- displacement of between the
nominal capacity non-integrat-
ed needle position of scale fiducial line
ml ed needle
% and fixed
ml %
ml dose
mm
0,05ml up to 0,2ml ± 20 % 0,02 0,025 ± 20 % 0,2
>0,2ml up to 0,5ml ± 5 % 0,07 0,07 ± 5 % 5
>0,5ml up to
± 5 % 0,07 0,07 ± 5 % 10
1,0 ml
11 Graduated scale
11.1 Scale
The scale shall have 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.
11.2 Position of scale
When the plunger stopper is fully inserted, the zero line of the scale shall coincide with the fiducial line
on the plunger stopper to the maximal displacement of position of scale as given in Table 1.
12 Barrel
12.1 Dimensions
The length of the barrel and the design of the auto-disable feature shall be such that the maximum
usable capacity shall not exceed the nominal capacity by 25 %.
12.2 Barrel flanges
10.2 of ISO 7886-1:1993 shall apply.
13 Plunger stopper/plunger assembly
13.1 Design
The design of the plunger and push-button of the syringe shall be such that, when the barrel is held in
one hand, the plunger can be depressed by the thumb of that hand. The plunger stopper shall not become
detached from the plunger when tested in accordance with Annex B of ISO 8537:2016 for a syringe with
integrated needle or in accordance with Annex B of ISO 7886-1:1993 for a syringe without needle.
The plunger should be of a length adequate to allow the piston properly to deliver the nominal fixed
dose. It should not be possible to defeat the auto-disable feature by removing and re-inserting the
plunger.
The projection of the plunger and the configuration of the push-button should be such as to allow the
plunger to be operated without difficulty. When the fiducial line of the plunger stopper coincides with
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oSIST prEN ISO 7886-3:2017
ISO/DIS 7886-3:2016(E)
the zero graduation line, the preferred minimum length of the plunger from the surface of the barrel
flanges nearer to the push-button, as shown in Figure 2, shall be 8 mm.
Key
1 Mini
...
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