SIST EN ISO 8537:2008
(Main)Sterile single-use syringes, with or without needle, for insulin (ISO 8537:2007)
Sterile single-use syringes, with or without needle, for insulin (ISO 8537:2007)
This part of the standard requirements and test methods for sterile syringes with or without needles intended for single use solely for the injection of insulin and primarily in humans. It covers syringes for use with 40 units of insulin/ml (U-40) and 100 units of unsulin/ml (U-100). Sterile syringes specified in this standard are intended for use soon after filling as they are not suitable for containing insulin over extended periods of time.
Sterile Insulin-Einmalspritzen mit oder ohne Kanüle (ISO 8537:2007)
Diese Internationale Norm legt Anforderungen und Prüfungen für sterile Insulin-Spritzen mit oder ohne Kanüle fest, die ausschließlich zur Injektion von Insulin dienen. Diese Einmal-Spitzen sind vorrangig für die Anwendung am Menschen vorgesehen. Sie gilt für Spritzen zur Verwendung mit Insulin der Konzentration von 40 Einheiten/ml (U-40) und 100 Einheiten/ml (U-100).
Die in dieser Internationalen Norm beschriebenen sterilen Spritzen sind zum alsbaldigen Gebrauch nach dem Füllen bestimmt, da sie nicht zur Aufbewahrung von Insulin über längere Zeit vorgesehen sind.
Seringues à insuline, stériles, non réutilisables, avec ou sans aiguille (ISO 8537:2007)
L'ISO 8537:2007 spécifie des exigences et des méthodes d'essai applicables aux seringues stériles avec ou sans aiguille destinées uniquement à l'injection d'insuline. Les seringues ne sont pas réutilisables et sont utilisées principalement chez l'homme. Elle couvre les seringues utilisées avec 40 unités d'insuline/ml (U-40) et 100 unités d'insuline/ml (U-100).
Les seringues stériles dans l'ISO 8537:2007 sont prévues pour être utilisées immédiatement après leur remplissage, puisqu'elles ne sont pas adaptées pour contenir de l'insuline pendant de longues périodes.
Sterilne injekcijske brizge za insulin za enkratno uporabo, z iglo ali brez nje (ISO 8537:2007)
General Information
Relations
Standards Content (Sample)
SLOVENSKI STANDARD
SIST EN ISO 8537:2008
01-september-2008
1DGRPHãþD
SIST EN ISO 8537:2000
SIST EN ISO 8537:2000/A1:2001
Sterilne injekcijske brizge za insulin za enkratno uporabo, z iglo ali brez nje (ISO
8537:2007)
Sterile single-use syringes, with or without needle, for insulin (ISO 8537:2007)
Sterile Insulin-Einmalspritzen mit oder ohne Kanüle (ISO 8537:2007)
Seringues à insuline, stériles, non réutilisables, avec ou sans aiguille (ISO 8537:2007)
Ta slovenski standard je istoveten z: EN ISO 8537:2008
ICS:
11.040.25 Injekcijske brizge, igle in Syringes, needles an
katetri catheters
SIST EN ISO 8537:2008 en
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.
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SIST EN ISO 8537:2008
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SIST EN ISO 8537:2008
EUROPEAN STANDARD
EN ISO 8537
NORME EUROPÉENNE
EUROPÄISCHE NORM
July 2008
ICS 11.040.25 Supersedes EN ISO 8537:1994
English Version
Sterile single-use syringes, with or without needle, for insulin
(ISO 8537:2007)
Seringues à insuline, stériles, non réutilisables, avec ou Sterile Insulin-Einmalspritzen mit oder ohne Kanüle (ISO
sans aiguille (ISO 8537:2007) 8537:2007)
This European Standard was approved by CEN on 15 June 2008.
CEN members are bound to comply with the CEN/CENELEC Internal Regulations which stipulate the conditions for giving this European
Standard the status of a national standard without any alteration. Up-to-date lists and bibliographical references concerning such national
standards may be obtained on application to the CEN Management Centre or to any CEN member.
This European Standard exists in three official versions (English, French, German). A version in any other language made by translation
under the responsibility of a CEN member into its own language and notified to the CEN Management Centre has the same status as the
official versions.
CEN members are the national standards bodies of Austria, Belgium, Bulgaria, Cyprus, Czech Republic, Denmark, Estonia, Finland,
France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal,
Romania, Slovakia, Slovenia, Spain, Sweden, Switzerland and United Kingdom.
EUROPEAN COMMITTEE FOR STANDARDIZATION
COMITÉ EUROPÉEN DE NORMALISATION
EUROPÄISCHES KOMITEE FÜR NORMUNG
Management Centre: rue de Stassart, 36 B-1050 Brussels
© 2008 CEN All rights of exploitation in any form and by any means reserved Ref. No. EN ISO 8537:2008: E
worldwide for CEN national Members.
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SIST EN ISO 8537:2008
EN ISO 8537:2008 (E)
Contents Page
Foreword.3
2
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SIST EN ISO 8537:2008
EN ISO 8537:2008 (E)
Foreword
The text of ISO 8537:2007 has been prepared by Technical Committee ISO/TC 84 “Medical devices for
injections” of the International Organization for Standardization (ISO) and has been taken over as EN ISO
8537:2008 by Technical Committee CEN/TC 205 “Non-active medical devices” the secretariat of which is held
by DIN.
This European Standard shall be given the status of a national standard, either by publication of an identical
text or by endorsement, at the latest by January 2009, and conflicting national standards shall be withdrawn at
the latest by January 2009.
Attention is drawn to the possibility that some of the elements of this document may be the subject of patent
rights. CEN [and/or CENELEC] shall not be held responsible for identifying any or all such patent rights.
This document supersedes EN ISO 8537:1994.
According to the CEN/CENELEC Internal Regulations, the national standards organizations of the following
countries are bound to implement this European Standard: Austria, Belgium, Bulgaria, Cyprus, Czech
Republic, Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia,
Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Romania, Slovakia, Slovenia, Spain,
Sweden, Switzerland and the United Kingdom.
Endorsement notice
The text of ISO 8537:2007 has been approved by CEN as a EN ISO 8537:2008 without any modification.
3
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SIST EN ISO 8537:2008
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SIST EN ISO 8537:2008
INTERNATIONAL ISO
STANDARD 8537
Second edition
2007-10-01
Sterile single-use syringes, with or
without needle, for insulin
Seringues à insuline, stériles, non réutilisables, avec ou sans aiguille
Reference number
ISO 8537:2007(E)
©
ISO 2007
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SIST EN ISO 8537:2008
ISO 8537:2007(E)
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ii © ISO 2007 – All rights reserved
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SIST EN ISO 8537:2008
ISO 8537:2007(E)
Contents Page
Foreword. iv
Introduction . v
1 Scope . 1
2 Normative references . 1
3 Terms and definitions. 1
4 Types of syringe . 3
5 Freedom from extraneous matter . 3
6 Limits for extraneous matter . 3
7 Lubrication of syringes and needles . 4
8 Range of sizes. 4
9 Graduated scale . 4
10 Barrel. 5
11 Piston/plunger assembly . 5
12 Nozzle. 6
13 Needle tubing and needles . 6
14 Performance of assembled syringe. 6
15 Packaging . 7
16 Marking . 8
Annex A (normative) Fluid for determination of acidity/alkalinity and extractable metals . 11
Annex B (normative) Test method for air leakage past syringe piston during aspiration . 12
Annex C (normative) Test method for force required to operate plunger. 14
Annex D (normative) Properties of needles and needle tubing . 15
Annex E (normative) Test method for determination of dead space. 17
Annex F (normative) Test method for liquid leakage at syringe piston and syringe nozzle/hub or
needle/barrel unions during compression. 18
Annex G (normative) Test method for air leakage past nozzle/hub or needle/barrel unions during
aspiration. 20
Annex H (informative) Preparation of extract for test for pyrogenicity and toxicity . 21
Annex I (informative) Symbol for “do not re-use” . 22
Bibliography . 23
© ISO 2007 – All rights reserved iii
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SIST EN ISO 8537:2008
ISO 8537:2007(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 8537 was prepared by Technical Committee ISO/TC 84, Devices for administration of medicinal products
and intravascular catheters.
This second edition cancels and replaces the first edition (ISO 8537:1991) and its Amendment 1
(ISO 8537:1991/Amd.1:2000), which have been technically revised.
iv © ISO 2007 – All rights reserved
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SIST EN ISO 8537:2008
ISO 8537:2007(E)
Introduction
This International Standard deals with products primarily intended for use with humans and provides
performance requirements, but permits some variations of design and of the methods of packaging and
sterilization by individual manufacturers.
Materials to be used for the construction and lubrication of sterile syringes and needles for single use are not
specified as their selection will depend to some extent upon the design, process of manufacture and
sterilization method employed by individual manufacturers.
Syringes and needles should be manufactured and sterilized in accordance with recognized national or
international codes of good manufacturing practice for medical devices, and should be free from defects
affecting appearance, safety and serviceability for their intended use.
Certain grades of polypropylene, polystyrene and styrene/acryIonitrile copolymer have been extensively used
for the barrels of sterile syringes for single use. A high quality natural rubber composition is frequently used for
the piston, although other materials such as silicone rubber are also used, the surface of the piston being
lubricated with polydimethylsiloxane. For 2 ml syringes, high density polyethylene is frequently used for the
seal of the two-component design of syringe in combination with a polypropylene barrel containing a fatty acid
amide slip additive.
When selecting materials, make the following considerations:
⎯ Clarity of barrel: Materials used in the construction of the wall of the syringe barrel should be of sufficient
clarity to enable dosages to be read without difficulty and for air bubbles to be seen.
⎯ Compatibility with insulin preparations: The materials of syringes and needles (including lubricant) and
packaging should not, in their final form after sterilization and under conditions of normal use,
detrimentally affect the efficacy, safety and acceptability of insulin preparations: neither should the
construction materials themselves be affected physically or chemically by insulin preparations.
⎯ Biocompatibility: The materials should not cause the syringes and needles to yield, under conditions of
normal use, significant amounts of toxic substances and should permit them to satisfy the appropriate
national requirements or regulations for freedom from pyrogenic materials and abnormal toxicity. For
testing these properties, an extract as specified in Annex H may be used.
It is strongly recommended that regulatory authorities, pharmacopoeia and relevant trade associations should
recognize the need for further testing, especially for incompatibility between the insulins and syringes when
they are in contact for prolonged periods.
In some countries national regulations are legally binding and the requirements may take precedence over
this International Standard.
This International Standard describes syringes with or without needles for use with 40 units of insulin/ml
(U-40) and 100 units of insulin/ml (U-100). It is recommended that syringes graduated for only one strength of
insulin be used in each country to avoid accidents. For those countries using more than one strength of
insulin, the importance of having individual syringes appropriately graduated for only one strength of insulin as
specified in this International Standard is emphasized. Serious problems may result if a syringe is used with a
strength of insulin for which it is not designed. If the syringe is used for mixing different types of insulin, it is
strongly recommended that the procedure is performed in the same order each time.
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SIST EN ISO 8537:2008
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SIST EN ISO 8537:2008
INTERNATIONAL STANDARD ISO 8537:2007(E)
Sterile single-use syringes, with or without needle, for insulin
1 Scope
This International Standard specifies requirements and test methods for sterile syringes, with or without
needles, solely for the injection of insulin. The syringes are single-use only, primarily for use in humans. It
covers syringes for use with 40 units of insulin/ml (U-40) and 100 units of insulin/ml (U-100).
Sterile syringes specified in this International Standard are intended for use soon after filling as they are not
suitable for containing insulin over extended periods of time.
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 594-1:1986, Conical fittings with a 6 % (Luer) taper for syringes, needles and certain other medical
equipment — Part 1: General requirements
ISO 7864:1993, Sterile hypodermic needles for single use
ISO 9626, Stainless steel needle tubing for manufacture of medical devices
3 Terms and definitions
For the purposes of this document the following terms and definitions apply. The nomenclature of some
components of syringes for single use is given in Figure 1.
3.1
graduated capacity
volume of water at 20 °C ± 3 °C or 27 °C ± 3 °C expelled from the syringe when the fiducial line on the piston
traverses a given scale interval or intervals
3.2
needle cap
protective end cap intended to maintain the sterility of the needle tube and to protect physically the needle
tube and needle hub, if present
3.3
needle sheath
cover intended to provide physical protection to the needle tube
3.4
protective end caps
covers intended to enclose the projecting portion of the plunger and push-button at one end and the nozzle
and/or the needle at the other end
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SIST EN ISO 8537:2008
ISO 8537:2007(E)
Key
1 needle cap 9 push-button
2 protective end cap 10 protective end cap
3 nozzle lumen 11 finger grips
4 nozzle 12 fiducial line
5 barrel 13 nominal capacity
6 piston 14 graduation lines
7 seals 15 zero line
8 plunger
NOTE This figure is intended to be illustrative of components of a syringe only. It does not show a detachable needle
or a permanently attached needle tube, and does not form part of the specification. The piston/plunger assembly might or
might not be of integral construction and might incorporate more than one seal.
Figure 1 — Schematic representation of insulin syringe for single use
2 © ISO 2007 – All rights reserved
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SIST EN ISO 8537:2008
ISO 8537:2007(E)
4 Types of syringe
The types of syringe shall be designated as follows in relation to their packaging and combinations with
needles:
Type 1: Syringe having a 6 % (Luer) male conical fitting, supplied without a needle and packaged in a unit
container.
Type 2: Syringe having a 6 % (Luer) male conical fitting, and supplied without a needle and fitted with
protective end caps.
Type 3: Syringe having a 6 % (Luer) male conical fitting, and supplied with a detached or detachable needle
and packaged in a unit container.
Type 4: Syringe having a 6 % (Luer) male conical fitting, and supplied with a detachable needle and fitted
with protective end caps.
Type 5: Syringe having a fitting other than a 6 % (Luer) taper, supplied with a needle not intended to be
detached and packaged in a unit container.
Type 6: Syringe having a fitting other than a 6 % (Luer) taper, supplied with a needle not intended to be
detached and fitted with protective caps.
Type 7: Syringe with fixed needle tube and packaged in a unit container.
Type 8: Syringe with fixed needle tube and fitted with protective end caps.
NOTE 1 Eight types are designated to encompass different presentations, but it is likely that the number of types in use
in a particular country will be less than eight.
NOTE 2 In addition safety syringes with insulin graduation are available in most markets. At time of publication, a
general standard relating to medical sharps prevention features is in development.
5 Freedom from extraneous matter
The surfaces of the syringe and needle, which come in contact with insulin, shall be clean and free from
extraneous matter when viewed by normal or corrected vision without magnification.
6 Limits for extraneous matter
6.1 Limits for acidity or alkalinity
The pH value of the extract prepared as described in Annex A shall be determined with a laboratory
potentiometric pH meter using a general purpose electrode, and shall be within one pH unit of that of the
control fluid.
6.2 Limits for extractable metals
An extract prepared as described in Annex A shall contain not more than a combined total of 5 mg/kg of lead,
tin, zinc and iron when tested by a recognized micro-analytical method, for example by an atomic absorption
method. The cadmium content of the extract shall be less than 0,1 mg/kg.
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SIST EN ISO 8537:2008
ISO 8537:2007(E)
7 Lubrication of syringes and needles
If the interior surface of the syringe, including the piston, and the exterior surface of the needle tube are
lubricated, the lubricant shall not form pools of fluid on the interior surface of the syringe nor drops on the
exterior surface of the needle tube or in the bore.
8 Range of sizes
The range of sizes of syringes and graduations shall be as given in Table 1.
Table 1 — Insulin syringes, range of sizes, graduated scale and tolerance on graduated capacity
Unit scale Nominal Minimum length Scale interval Tolerance on graduated capacity
capacity of scale
Volumes less than Volumes equal to or
ml mm units half the nominal greater than half the
capacity nominal capacity
0,3 41 0,5
0,3 41 1
0,5 43 1
U-100
1,0 57 1
1,0 57 2
± 1 ½ % of the
nominal capacity ± 5 % of the
0,5 43 0,5
+ 2 % of the expelled volume
expelled volume
0,5 43 1
U-40
1,0 50 1
2,0 60 1
2,0 60 2
NOTE Syringes having different nominal capacities and scale intervals are designated to encompass different
presentations, but the number of types in use in a particular country can be fewer than those given in Table 1.
9 Graduated scale
9.1 Scale
The scale shall be graduated in units of insulin and shall refer to one strength of insulin only. The nominal
capacity shall be designated in millilitres (ml).
The tolerances on the graduated capacity shall be in accordance with Table 1.
NOTE The graduated capacity can be conveniently determined by weighing the expelled fluid. See 3.1.
The graduation lines shall be of a uniform thickness between 0,2 mm and 0,4 mm. They shall lie in planes at
right angles to the axis of the barrel.
The graduation lines shall be evenly spaced along the longitudinal axis between the zero line and the line for
the total graduated capacity.
When the syringe is held vertically, the ends of all graduation lines of similar length shall be vertically beneath
each other with a tolerance of ± 0,5 mm.
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SIST EN ISO 8537:2008
ISO 8537:2007(E)
The length of the short graduation lines shall be approximately half the length of the long lines.
The scale and scale numbers should be legible and of a colour that contrasts clearly with the syringe.
9.2 Numbering of scale
The graduation lines shall be numbered at every five units for the 0,3 ml and 0,5 ml syringes and at every
10 units for the 1,0 ml and 2,0 ml syringes.
The minimum height of the figures should be at least 3 mm.
When the syringe is held vertically with the zero line uppermost and with the scale to the front, the numbers
shall appear upright on the scale and in a position such that they would be bisected by a prolongation of the
graduation lines to which they relate. The numbers shall be close to, but shall not touch, the ends of the
graduation lines to which they relate.
10 Barrel
10.1 Dimensions
The barrel length shall be such that the syringe has a usable capacity of at least 10 % more than the nominal
capacity or 5 mm of plunger travel beyond the scale marking, whichever is less.
10.2 Finger grips
The open end of the barrel shall be provided with finger grips which shall ensure that the syringe will not roll
when it is placed with the scale uppermost on a flat surface inclined at an angle of 10° to the horizontal.
The finger grips shall be free from flash and sharp edges.
Finger grips should be of adequate size, shape and strength for the intended purpose and should enable the
syringe to be held securely during use.
11 Piston/plunger assembly
11.1 General
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 piston shall not become detached from the
plunger during the test described in Annex B.
The projection of the plunger and the configuration of the push-button should be such as to enable the
plunger, when in the fully inserted position, to be grasped and drawn back without difficulty.
11.2 Fit of piston in barrel
When the syringe is filled with water and held vertically with first one and then the other end uppermost, the
plunger shall not move by reason of its own mass and the mass of the water contained. When a needle is
secured to the syringe in accordance with the instructions of the manufacturer, the force required to initiate
movement of the plunger to expel water from the syringe shall not exceed 15 N when measured in
accordance with Annex C.
The fit of the piston in the barrel should be such that the piston slides smoothly throughout the graduated
length of the barrel.
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SIST EN ISO 8537:2008
ISO 8537:2007(E)
12 Nozzle
12.1 Conical fitting
The male conical fitting of the syringe nozzle on syringe types 1, 2, 3 and 4 shall comply with the requirements
of ISO 594-1.
12.2 Position of nozzle on end of barrel
The syringe nozzle shall be situated centrally, i.e. shall be co-axial with the barrel.
13 Needle tubing and needles
13.1 Needles for syringes of types 3 and 4
Needles for syringes of types 3 and 4 shall be in accordance with ISO 7864, except for the dimensions and
test parameters which shall be in accordance with Annex D of this International Standard.
13.2 Needle tubing for syringes of types 5, 6 ,7 and 8
Needle tubing for syringes of types 5, 6, 7 and 8 shall be in accordance with ISO 9626, except for the
dimensions and test parameters which shall be in accordance with Annex D of this International Standard.
The needle point shall be in accordance with ISO 7864.
14 Performance of assembled syringe
14.1 Dead space
When tested in accordance with Annex E, the dead space shall not exceed the limits given in Table 2.
Table 2 — Maximum dead space
Type of syringe Maximum dead space
ml
1 and 2 0,07
3 and 4 0,10
5 and 6 0,02
7 and 8 0,01
14.2 Freedom from leakage at needle
When tested as described in Annex F, there shall be no leakage of water sufficient to form a falling drop within
30 s from the unions listed in F.2.9.
When tested as described in Annex G, there shall be no continued formation of air bubbles from the unions
listed in G.2.6.
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SIST EN ISO 8537:2008
ISO 8537:2007(E)
14.3 Liquid and air leakage past piston
When tested as described in Annex F, there shall be no leakage of water past the piston seal.
When tested as described in Annex B, there shall be no leakage of air past the piston seal, and there shall be
no fall in the manometer reading.
15 Packaging
15.1 Unit containers and self-contained syringe units
15.1.1 General
Syringes of types 1, 3, 5 and 7 shall be packed in unit containers and syringes of types 2, 4, 6 and 8 shall be
packed as self-contained syringe units.
15.1.2 Unit containers (syringes of types 1, 3, 5 and 7)
The syringe, together with the needle if supplied, shall be sealed individually in a unit container.
For types 3, 5 and 7, the needle shall be supplied with a protective needle sheath.
The needle of type 3 syringes may be packaged in its own container inside the unit container.
The materials and design of the unit container should have no detrimental effects on the contents and should
ensure the following:
a) maintenance of sterility of the contents under dry, clean and adequately ventilated storage conditions;
b) minimum risk of contamination of the contents during opening and removal from the container;
c) adequate protection of the contents during normal handling, transit and storage;
d) that once opened, the container cannot be easily re-sealed, and it should be obvious that the container
has been opened.
15.1.3 Self-contained syringe units (syringes of types 2, 4, 6 and 8)
The syringe shall be fitted with protective end cap.
The materials and design of the syringe unit should ensure
a) maintenance of sterility of the interior o
...
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