SIST EN ISO 7886-3:2005

Sterile hypodermic syringes for single use - Part 3: Auto-disable syringes for fixed-dose immunization (ISO 7886-3:2005)

2005-04-05 - Work item transferred from 00205166 following resolution 2 of the 25th BT/TCMG

Sterile Einmalspritzen für medizinische Zwecke - Teil 3: Selbstblockierende Spritzen für die Injektion mit fixer Impfstoffdosis (ISO 7886-3:2005)

Dieser Teil von ISO 7886 legt Anforderungen für sterile Einmalspritzen aus Kunststoff und nichtrostendem Stahl mit und ohne Kanüle fest, die für das Aufziehen von Flüssigkeiten oder für die Injektion von Flüssigkeiten unmittelbar nach ihrem Befüllen vorgesehen sind. Nach Abgabe einer festgelegten Dosis einer medizinischen Substanz wird die Spritze automatisch unbrauchbar gemacht.
Dieser Teil von ISO 7886 gilt nicht für Insulinspritzen (Festlegungen in ISO 8537), Glasspritzen (Festlegungen in ISO 595), Spritzen für Druckinfusionsapparate (Festlegungen in ISO 7886-2), selbstblockierende Spritzen für die Abgabe unterschiedlicher Dosen und zur Vorfüllung ausgelegte Spritzen. Er behandelt nicht die Verträglichkeit mit Injektionsflüssigkeiten bzw. Impfstoffen.
ANMERKUNG   Ein vierter Teil von ISO 7886 ist in Vorbereitung, der selbstblockierende Spritzen für allgemeine Zwecke behandelt.

Seringues hypodermiques stériles, non réutilisables - Partie 3: Seringues autobloquantes pour vaccination a dose fixe (ISO 7886-3:2005)

Sterilne podkožne injekcijske brizge za enkratno uporabo - 3. del: Brizge za točno določen odmerek imunizacije s sistemom za samouničenje (ISO 7886-3:2005)

General Information

• Status: Withdrawn
• Publication Date: 31-May-2005
• Withdrawal Date: 19-Nov-2009
• ICS: 11.040.25 - Syringes, needles an catheters
• Technical Committee: VAZ - Healthcare
• Current Stage: 9900 - Withdrawal (Adopted Project)
• Start Date: 20-Nov-2009
• Due Date: 13-Dec-2009
• Completion Date: 20-Nov-2009
• Directive: 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: EN ISO 7886-3:2005 - Sterile hypodermic syringes for single use - Part 3: Auto-disable syringes for fixed-dose immunization (ISO 7886-3:2005)

Relations

• Replaced By: SIST EN ISO 7886-3:2010 - Sterile hypodermic syringes for single use - Part 3: Auto-disable syringes for fixed-dose immunization (ISO 7886-3:2005)
• Effective Date: 01-Jan-2010
• Replaced By: SIST EN ISO 7886-3:2010 - Sterile hypodermic syringes for single use - Part 3: Auto-disable syringes for fixed-dose immunization (ISO 7886-3:2005)
• Effective Date: 08-Jun-2022

Standards Content (Sample)

SLOVENSKI STANDARD
SIST EN ISO 7886-3:2005
01-junij-2005
6WHULOQHSRGNRåQHLQMHNFLMVNHEUL]JH]DHQNUDWQRXSRUDERGHO%UL]JH]DWRþQR
GRORþHQRGPHUHNLPXQL]DFLMHVVLVWHPRP]DVDPRXQLþHQMH,62
Sterile hypodermic syringes for single use - Part 3: Auto-disable syringes for fixed-dose
immunization (ISO 7886-3:2005)
Sterile Einmalspritzen für medizinische Zwecke - Teil 3: Selbstblockierende Spritzen für
die Injektion mit fixer Impfstoffdosis (ISO 7886-3:2005)
Seringues hypodermiques stériles, non réutilisables - Partie 3: Seringues autobloquantes
pour vaccination a dose fixe (ISO 7886-3:2005)
Ta slovenski standard je istoveten z: EN ISO 7886-3:2005
ICS:
11.040.25 Injekcijske brizge, igle in Syringes, needles an
katetri catheters
SIST EN ISO 7886-3:2005 en
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

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SIST EN ISO 7886-3:2005

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SIST EN ISO 7886-3:2005

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SIST EN ISO 7886-3:2005

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SIST EN ISO 7886-3:2005

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SIST EN ISO 7886-3:2005

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SIST EN ISO 7886-3:2005


INTERNATIONAL ISO
STANDARD 7886-3
First edition
2005-03-01


Sterile hypodermic syringes for single
use —
Part 3:
Auto-disable syringes for fixed-dose
immunization
Seringues hypodermiques stériles, non réutilisables —
Partie 3: Seringues autobloquantes pour vaccination à dose fixe




Reference number
ISO 7886-3:2005(E)
©
ISO 2005

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SIST EN ISO 7886-3:2005
ISO 7886-3:2005(E)
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©  ISO 2005
All rights reserved. Unless otherwise specified, no part of this publication may be reproduced or utilized in any form or by any means,
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ii © ISO 2005 – All rights reserved

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SIST EN ISO 7886-3:2005
ISO 7886-3:2005(E)
Contents Page
Foreword. iv
Introduction . v
1 Scope. 1
2 Normative references . 1
3 Terms and definitions. 2
4 Nomenclature . 2
5 Cleanliness . 3
6 Limits for acidity or alkalinity . 3
7 Limits for extractable metals . 3
8 Lubricant. 3
9 Tolerance on nominal capacity . 3
10 Graduated scale . 3
11 Barrel. 4
12 Piston/plunger assembly. 4
13 Needle. 4
14 Performance . 5
15 Packaging . 6
16 Labelling. 6
Annex A (normative) Method for preparation of extracts . 9
Annex B (informative) Test method for forces required to operate plunger . 10
Annex C (normative) Test method for testing auto-disable feature. 12
Bibliography . 13

iii© ISO 2005 – All rights reserved iii

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SIST EN ISO 7886-3:2005
ISO 7886-3:2005(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.
International Standards are drafted in accordance with the rules given in the ISO/IEC Directives, Part 2.
The main task of technical committees is to prepare International Standards. Draft International Standards
adopted by the technical committees are circulated to the member bodies for voting. Publication as an
International Standard requires approval by at least 75 % of the member bodies casting a vote.
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.
ISO 7886-3 was prepared by Technical Committee ISO/TC 84, Devices for administration of medicinal
products and intravascular catheters, Subcommittee SC 1, Syringes, needles and intravascular catheters for
single use.
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-disable syringes for fixed-dose immunization
 Part 4: Syringes with reuse prevention feature
For the purposes of this part of ISO 7886, the CEN annex regarding fulfilment of European Council Directives
has been removed.
iv © ISO 2005 – All rights reserved

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SIST EN ISO 7886-3:2005
ISO 7886-3:2005(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 use
(commonly referred to as “auto-disable” syringes). Both the WHO and ISO agreed that an additional part of
ISO 7886 would be required to cover “auto-disable” 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 rendered inoperable
after delivery of the intended dose. These syringes are not covered by Parts 1 and 2 of ISO 7886.
It is recognized that syringes designed to reduce the risk of needlestick injuries, in addition to preventing
sharps injuries, may also comply with this part of ISO 7886 with regard to their auto-disable properties, but it is
stressed that anti-needlestick properties of syringes are not in themselves addressed in this part of ISO 7886.
v© ISO 2005 – All rights reserved v

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SIST EN ISO 7886-3:2005

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SIST EN ISO 7886-3:2005
INTERNATIONAL STANDARD ISO 7886-3:2005(E)

Sterile hypodermic syringes for single use —
Part 3:
Auto-disable 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 materials and stainless steel and intended for the aspiration of vaccines or
for the injection of vaccines immediately after filling. Upon delivering a fixed dose of vaccine, the syringe is
automatically rendered unusable.
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 made
of glass (specified in ISO 595), syringes for use with power-driven syringe pumps (specified in ISO 7886-2),
auto-disable syringes for variable dose delivery and syringes designed to be prefilled. It does not address
compatibility with injection fluids/vaccines.
NOTE A fourth part of ISO 7886 is being prepared to cover syringes with reuse prevention feature.
2 Normative references
The following referenced documents are indispensable for the application of this document. For dated
references, only the edition cited applies. For undated references, the latest edition of the referenced
document (including any amendments) applies.
ISO 3696:1987, Water for analytical laboratory use — Specification and test methods
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 8537:1991, Sterile single-use syringes, with or without needle, for insulin
ISO 9626, Stainless steel needle tubing for the manufacture of medical devices
ASTM D999-01, Standard methods for vibration testing of shipping containers
ASTM D5276-98, Standard test method for drop test of loaded containers by free fall
© ISO 2005 – All rights reserved 1

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SIST EN ISO 7886-3:2005
ISO 7886-3:2005(E)
3 Terms and definitions
For the purposes of this document, the terms and definitions given in ISO 7886-1:1993 (except 3.2) and
ISO 8537:1991 (except 3.1) and the following apply.
3.1
auto-disable syringe feature
feature that automatically activates upon administration of the intended fixed dose to prevent subsequent
re-use of the syringe and the needle
4 Nomenclature
The nomenclature for components of auto-disable syringes for fixed dose is shown in Figure 1.

Key
1 needle cap or end cap (if used) 8 fiducial line
2 needle 9 seal(s)
3 zero line 10 finger grips
4 barrel 11 plunger
5 auto-disable feature 12 push-button
6 nominal capacity line 13 protective end cap (if used)
7 piston
NOTE The drawing is intended to be illustrative of components of an auto-disable syringe only.
Figure 1 — Schematic representation of auto-disable syringe for fixed dose
2 © ISO 2005 – All rights reserved

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SIST EN ISO 7886-3:2005
ISO 7886-3:2005(E)
5 Cleanliness
Clause 5 of ISO 7886-1:1993 shall apply.
6 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.
7 Limits for extractable metals
When tested by a recognized microanalytical 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.
8 Lubricant
Clause 8 of ISO 7886-1:1993 and 11.4 of ISO 7864:1993 shall apply.
9 Tolerance on nominal capacity
The volume of water at (20 ± 5) °C [or, for tropical countries (27 ± 5) °C] expelled from the syringe when the
fiducial line of the piston traverses the full scale (i.e. the intended fixed dose) shall be within the tolerances on
the nominal capacity as specified in Table 1.
Table 1 — Nominal capacity and dead space
Maximum dead space
Nominal capacity Tolerance on nominal capacity
for integrated and non-integrated needle
ml % ml
0,05 u V u 0,2 ± 20 % 0,025
0,2 < V u 2 ± 5 % 0,07
10 Graduated scale
10.1 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.
10.2 Position of scale
10.4 of ISO 7886-1:1993 shall apply.
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SIST EN ISO 7886-3:2005
ISO 7886-3:2005(E)
11 Barrel
11.1 Dimensions
The length of the barrel and the design of the auto-disable feature shall be such that the syringe has a
maximum usable capacity of at least 10 % more than the nominal capacity and a recommended maximum
capacity of 20 % more than the nominal capacity.
11.2 Finger grips
11.2 of ISO 7886-1:1993 shall apply.
12 Piston/plunger assembly
12.1 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 b
...