Sterile hypodermic syringes for single use - Part 1: Syringes for manual use (ISO 7886-1:2017)

This document specifies requirements and test methods for verifying the design of empty sterile singleuse
hypodermic syringes, with or without needle, made of plastic or other materials and intended for
the aspiration and injection of fluids after filling by the end-users. This document does not provide
requirements for lot release. The syringes are primarily for use in humans.
Sterile syringes specified in this document are intended for use immediately after filling and are not
intended to contain the medicament for extended periods of time.
It excludes syringes for use with insulin (see ISO 8537), single-use syringes made of glass, syringes for
use with power-driven syringe pumps, syringes pre-filled by the manufacturer, and syringes intended
to be stored after filling (e.g. in a kit for filling by a pharmacist).
Hypodermic syringes without a needle specified in this document are intended for use with hypodermic
needles specified in ISO 7864.

Sterile Einmalspritzen für medizinische Zwecke - Teil 1: Spritzen zum manuellen Gebrauch (ISO 7886-1:2017)

Dieses Dokument legt Anforderungen an und Prüfverfahren für die Verifizierung der Auslegung leerer steriler Einmalspritzen für medizinische Zwecke aus Kunststoff und anderen Werkstoffen mit oder ohne Kanüle fest, die für das Ansaugen und die Injektion von Flüssigkeiten nach dem Füllen durch die Endanwender vorgesehen sind. Dieses Dokument enthält keine Anforderungen an die Losfreigabe. Die Spritzen sind vorwiegend für die Anwendung beim Menschen vorgesehen.
Die in diesem Dokument festgelegten sterilen Spritzen sind für den Einsatz unmittelbar nach dem Füllen vorgesehen und sind nicht dafür vorgesehen, über einen längeren Zeitraum mit dem Arzneimittel gefüllt zu sein.
Ausgenommen sind Insulinspritzen (siehe ISO 8537), Einmalspritzen aus Glas, Spritzen für Druckinfusionsapparate, durch den Hersteller vorgefüllte Spritzen sowie Spritzen, die für die Lagerung nach dem Füllen vorgesehen sind (z. B. Beilagespritzen, die vom Apotheker gefüllt werden).
Spritzen für medizinische Zwecke ohne Kanüle nach diesem Dokument sind für den Einsatz mit Spritzen für medizinische Zwecke nach ISO 7864 vorgesehen.

Seringues hypodermiques stériles, non réutilisables - Partie 1: Seringues pour utilisation manuelle (ISO 7886-1:2017)

ISO 7886-1:2017 fixe les exigences et les méthodes d'essai relatives à la vérification de la conception des seringues hypodermiques stériles non réutilisables vides, avec ou sans aiguille, constituées de matières plastiques ou d'autres matières et destinées à l'aspiration et à l'injection de liquides après remplissage par les utilisateurs finaux. Le présent document ne spécifie pas d'exigences applicables à la libération des lots. Les seringues sont destinées en premier lieu à l'Homme.
Les seringues stériles spécifiées dans le présent document sont prévues pour être utilisées immédiatement après leur remplissage et ne sont pas destinées à contenir le médicament pendant de longues périodes.
Il exclut les seringues utilisables avec de l'insuline (voir l'ISO 8537), les seringues non réutilisables en verre, les seringues pour pousse-seringues mus par un moteur, les seringues pré-remplies par le fabricant et les seringues prévues pour être conservées après leur remplissage (par exemple dans un kit prévu pour être rempli par un pharmacien).
Les seringues hypodermiques sans aiguille spécifiées dans le présent document sont destinées à être utilisées avec les aiguilles hypodermiques indiquées dans l'ISO 7864.

Sterilne podkožne injekcijske brizge za enkratno uporabo - 1. del: Injekcijske brizge za ročno injiciranje (ISO 7886-1:2017)

Ta dokument določa zahteve in preskusne metode za preverjanje zasnove praznih sterilnih podkožnih injekcijskih brizg z iglo ali brez nje, izdelanih iz plastike ali drugih materialov, ki so namenjene za aspiracijo in injiciranje tekočin, s katerimi jih napolni končni uporabnik. Ta dokument ne podaja zahtev za izdajo serij. Injekcijske brizge so namenjene predvsem za uporabo pri ljudeh.
Sterilne injekcijske brizge, ki so določene v tem dokumentu, so namenjene za uporabo takoj po polnjenju in ne smejo vsebovati zdravila dalj časa.
V tem dokumentu niso zajete injekcijske brizge za inzulin (glej standard ISO 8537), steklene injekcijske brizge za enkratno uporabo, injekcijske brizge za uporabo z injekcijskimi črpalkami, injekcijske brizge, ki jih predhodno napolni proizvajalec, in injekcijske brizge, ki so namenjene za shranjevanje po polnjenju (npr. v kompletu, ki ga napolni farmacevt).
Podkožne injekcijske brizge brez igle, ki so navedene v tem dokumentu, so namenjene za uporabo s podkožnimi
iglami, ki so navedene v standardu ISO 7864.

General Information

Status
Published
Public Enquiry End Date
29-Nov-2015
Publication Date
16-May-2018
Technical Committee
Current Stage
6060 - National Implementation/Publication (Adopted Project)
Start Date
06-Apr-2018
Due Date
11-Jun-2018
Completion Date
17-May-2018

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SLOVENSKI STANDARD
SIST EN ISO 7886-1:2018
01-junij-2018
1DGRPHãþD
SIST EN ISO 7886-1:2000
6WHULOQHSRGNRåQHLQMHNFLMVNHEUL]JH]DHQNUDWQRXSRUDERGHO,QMHNFLMVNH
EUL]JH]DURþQRLQMLFLUDQMH ,62

Sterile hypodermic syringes for single use - Part 1: Syringes for manual use (ISO 7886-

1:2017)
Sterile Einmalspritzen für medizinische Zwecke - Teil 1: Spritzen zum manuellen
Gebrauch (ISO 7886-1:2017)

Seringues hypodermiques stériles, non réutilisables - Partie 1: Seringues pour utilisation

manuelle (ISO 7886-1:2017)
Ta slovenski standard je istoveten z: EN ISO 7886-1:2018
ICS:
11.040.25 Injekcijske brizge, igle in Syringes, needles an
katetri catheters
SIST EN ISO 7886-1:2018 en

2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

---------------------- Page: 1 ----------------------
SIST EN ISO 7886-1:2018
---------------------- Page: 2 ----------------------
SIST EN ISO 7886-1:2018
EN ISO 7886-1
EUROPEAN STANDARD
NORME EUROPÉENNE
March 2018
EUROPÄISCHE NORM
ICS 11.040.25 Supersedes EN ISO 7886-1:1997
English Version
Sterile hypodermic syringes for single use - Part 1:
Syringes for manual use (ISO 7886-1:2017)

Seringues hypodermiques stériles, non réutilisables - Sterile Einmalspritzen für medizinische Zwecke - Teil

Partie 1: Seringues pour utilisation manuelle (ISO 1: Spritzen zum manuellen Gebrauch (ISO 7886-

7886-1:2017) 1:2017)
This European Standard was approved by CEN on 28 February 2017.

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-CENELEC 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-CENELEC Management

Centre has the same status as the official versions.

CEN members are the national standards bodies of Austria, Belgium, Bulgaria, Croatia, Cyprus, Czech Republic, Denmark, Estonia,

Finland, Former Yugoslav Republic of Macedonia, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania,

Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Romania, Serbia, Slovakia, Slovenia, Spain, Sweden, Switzerland,

Turkey and United Kingdom.
EUROPEAN COMMITTEE FOR STANDARDIZATION
COMITÉ EUROPÉEN DE NORMALISATION
EUROPÄISCHES KOMITEE FÜR NORMUNG
CEN-CENELEC Management Centre: Rue de la Science 23, B-1040 Brussels

© 2018 CEN All rights of exploitation in any form and by any means reserved Ref. No. EN ISO 7886-1:2018 E

worldwide for CEN national Members.
---------------------- Page: 3 ----------------------
SIST EN ISO 7886-1:2018
EN ISO 7886-1:2018 (E)
Contents Page

European foreword ....................................................................................................................................................... 3

Endorsement notice ..................................................................................................................................................... 4

Annex ZA (informative) Relationship between this European Standard and the Essential

Requirements of Directive 93/42/EEC [OJ L 169] aimed to be covered ..................................... 5

---------------------- Page: 4 ----------------------
SIST EN ISO 7886-1:2018
EN ISO 7886-1:2018 (E)
European foreword

This document (EN ISO 7886-1:2017) has been prepared by Technical Committee ISO/TC 84 " Devices

for administration of medicinal products and catheters " in collaboration with 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 September 2018, and conflicting national standards

shall be withdrawn at the latest by September 2018.

Attention is drawn to the possibility that some of the elements of this document may be the subject of

patent rights. CEN shall not be held responsible for identifying any or all such patent rights.

This document supersedes EN ISO 7886-1:1997.

This document has been prepared under a mandate given to CEN by the European Commission and the

European Free Trade Association, and supports essential requirements of EU Directive(s).

For relationship with EU Directive(s), see informative Annex ZA, which is an integral part of this

document.

The following referenced documents are indispensable for the application of this document. For

undated references, the latest edition of the referenced document (including any amendments) applies.

For dated references, only the edition cited applies. However, for any use of this standard ‘within the

meaning of Annex ZA’, the user should always check that any referenced document has not been

superseded and that its relevant contents can still be considered the generally acknowledged state-of-

art.

When an IEC or ISO standard is referred to in the ISO standard text, this shall be understood as a

normative reference to the corresponding EN standard, if available, and otherwise to the dated version

of the ISO or IEC standard, as listed below.

NOTE The way in which these referenced documents are cited in normative requirements determines the

extent (in whole or in part) to which they apply.

Table 1 — Correlation between normative references and dated EN and ISO standards

Normative references as listed Equivalent dated standard
in Clause 2 of the ISO standard
EN ISO or IEC
ISO 15223-1:2016 EN ISO 15223-1:2016 ISO 15223-1:2016
ISO 23908 EN ISO 23908:2013 ISO 23908:2011
ISO 80369-7 EN ISO 80369-7:2017 ISO 80369-7:2016

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,

Croatia, Cyprus, Czech Republic, Denmark, Estonia, Finland, Former Yugoslav Republic of Macedonia,

France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta,

Netherlands, Norway, Poland, Portugal, Romania, Serbia, Slovakia, Slovenia, Spain, Sweden, Switzerland,

Turkey and the United Kingdom.
---------------------- Page: 5 ----------------------
SIST EN ISO 7886-1:2018
EN ISO 7886-1:2018 (E)
Endorsement notice

The text of ISO 7886-1:2017 has been approved by CEN as EN ISO 7886-1:2018 without any

modification.
---------------------- Page: 6 ----------------------
SIST EN ISO 7886-1:2018
EN ISO 7886-1:2018 (E)
Annex ZA
(informative)
Relationship between this European Standard and the Essential
Requirements of Directive 93/42/EEC [OJ L 169] aimed to be covered

This European standard has been prepared under a Commission’s standardisation request M/295

concerning the development of European Standards related to medical devices to provide one voluntary

means of conforming to essential requirements of Council Directive 93/42/EEC of 14 June 1993

concerning medical devices [OJ L 169].

Once this standard is cited in the Official Journal of the European Union under that Directive,

compliance with the normative clauses of this standard given in Table ZA.1 confers, within the limits of

the scope of this standard, a presumption of conformity with the corresponding essential requirements

of that Directive, and associated EFTA regulations.

NOTE 1 Where a reference from a clause of this standard to the risk management process is made, the risk

management process needs to be in compliance with Directive 93/42/EEC as amended by 2007/47/EC. This

means that risks have to be reduced ‘as far as possible’, ‘to a minimum’, ‘to the lowest possible level’, ‘minimized’

or ‘removed’, according to the wording of the corresponding essential requirement.

NOTE 2 The manufacturer’s policy for determining acceptable risk must be in compliance with essential

requirements 1, 2, 5, 6, 7, 8, 9, 11 and 12 of the Directive.

NOTE 3 This Annex ZA is based on normative references according to the table of references in the European

foreword, replacing the references in the core text.

NOTE 4 When an Essential Requirement does not appear in Table ZA.1, it means that it is not addressed by this

European Standard.

Table ZA.1 — Correspondence between this European Standard and Annex I of Directive

93/42/EEC [OJ L 169]
Essential Requirements of Clause(s)/subclause(s) of Remarks/Notes
Directive 93/42/EEC this EN
7.3 6.2 Standard Clause 6.2 meets ER
7.3 in respect of the device
altering the pH of the
contents of the device.
7.5 13.2 Standard Clause 13.2 covers
ER 7.5 only in respect of
leakage past the plunger.
7.6 14.1.1, 14.1.2 Standard Clause 14.1.1 meets
ER 7.6 in respect of
packaging only.
Standard Clause 14.1.2 meets
the ER 7.6 up to the point of
use.
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SIST EN ISO 7886-1:2018
EN ISO 7886-1:2018 (E)
Essential Requirements of Clause(s)/subclause(s) of Remarks/Notes
Directive 93/42/EEC this EN
8.3 14.1.1, 14.1.2
9.2 5, 6, 10, 11 Standard Clauses 5, 6, 10 and
11 meet ER 9.2 for the
aspects detailed in the
Standard Clauses.
10.1 8, 9.4, 11.2 Standard Clause 8 meets ER
10.1 except for the last
sentence.
Standard Clauses 9.4 and
11.2 meet the requirements
of ER 10.1 as they relates to
the relationship between the
zero graduation line of the
scale and the fiducial line on
the plunger stopper only.
10.2 9.1, 9.2
10.3 15.2.1 b)
13.1 15
13.3 (a) 15.2.2 b), 15.3 f), 15.4.1 b),
15.5 e)
13.3 (b) 15.3 e), 15.4.1 e), 15.5 f), 15.6
13.3 (c) 15.3 a), 15.4.2 a), 15.5 a), 15.5
b), 15.6 c)
13.3 (d) 15.3 c), 15.4.1 c), 15.5 d), 15.6
13.3 (e) 15.3 g), 15.4.1 f), 15.5 g), 15.6
13.3 (f) 15.2.2 a), 15.3 b), 15.4.1 a),
15.5 c)
13.3 (i) 15.6 e)
13.3 (k) 15.4.2 b)

WARNING 1: Presumption of conformity stays valid only as long as a reference to this European

standard is maintained in the list published in the Official Journal of the European Union. Users of this

standard should consult frequently the latest list published in the Official Journal of the European

Union.

WARNING 2: Other Union legislation may be applicable to the product(s) falling within the scope of this

standard.
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SIST EN ISO 7886-1:2018
INTERNATIONAL ISO
STANDARD 7886-1
Second edition
2017-05
Sterile hypodermic syringes for
single use —
Part 1:
Syringes for manual use
Seringues hypodermiques stériles, non réutilisables —
Partie 1: Seringues pour utilisation manuelle
Reference number
ISO 7886-1:2017(E)
ISO 2017
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SIST EN ISO 7886-1:2018
ISO 7886-1:2017(E)
COPYRIGHT PROTECTED DOCUMENT
© ISO 2017, 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 2017 – All rights reserved
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SIST EN ISO 7886-1:2018
ISO 7886-1:2017(E)
Contents Page

Foreword ..........................................................................................................................................................................................................................................v

Introduction ................................................................................................................................................................................................................................vi

1 Scope ................................................................................................................................................................................................................................. 1

2 Normative references ...................................................................................................................................................................................... 1

3 Terms and definitions ..................................................................................................................................................................................... 1

4 Nomenclature .......................................................................................................................................................................................................... 3

5 General requirements ..................................................................................................................................................................................... 5

6 Extraneous matter .............................................................................................................................................................................................. 5

6.1 General ........................................................................................................................................................................................................... 5

6.2 Limits for acidity or alkalinity ................................................................................................................................................... 5

6.3 Limits for extractable metals ...................................................................................................................................................... 5

7 Lubricant ...................................................................................................................................................................................................................... 6

8 Tolerance on graduated capacity ........................................................................................................................................................ 6

9 Graduated scale ..................................................................................................................................................................................................... 7

9.1 Scale .................................................................................................................................................................................................................. 7

9.2 Numbering of scales ........................................................................................................................................................................... 8

9.3 Overall length of scale to nominal capacity line ......................................................................................................... 8

9.4 Position of scale ...................................................................................................................................................................................... 9

10 Barrel ................................................................................................................................................................................................................................ 9

10.1 Dimensions ................................................................................................................................................................................................. 9

10.2 Barrel flanges ........................................................................................................................................................................................... 9

11 Plunger stopper/plunger assembly.................................................................................................................................................. 9

11.1 Design ............................................................................................................................................................................................................. 9

12 Nozzle ............................................................................................................................................................................................................................10

12.1 Conical fitting ........................................................................................................................................................................................10

12.2 Position of nozzle on end of barrel .....................................................................................................................................10

12.3 Nozzle lumen .........................................................................................................................................................................................10

13 Performance ...........................................................................................................................................................................................................10

13.1 Dead space ...............................................................................................................................................................................................10

13.2 Freedom from air and liquid leakage past plunger stopper .........................................................................10

13.3 Force to operate the piston........................................................................................................................................................10

13.4 Fit of plunger stopper/plunger in barrel ......................................................................................................................10

14 Packaging ..................................................................................................................................................................................................................11

14.1 Unit packaging and self-contained syringe units ...................................................................................................11

14.1.1 Unit packaging ................................................................................................................................................................11

14.1.2 Self-contained syringe units ...............................................................................................................................11

14.2 Multiple unit pack..............................................................................................................................................................................11

14.3 User packaging .....................................................................................................................................................................................11

15 Information supplied by the manufacturer ..........................................................................................................................12

15.1 General ........................................................................................................................................................................................................12

15.2 Syringes ......................................................................................................................................................................................................12

15.2.1 General...................................................................................................................................................................................12

15.2.2 Additional marking for self-contained syringe units.....................................................................12

15.3 Unit packaging ......................................................................................................................................................................................12

15.4 Multiple unit packs ...........................................................................................................................................................................13

15.4.1 General...................................................................................................................................................................................13

15.4.2 Multiple unit packs with self-contained syringes.............................................................................13

15.5 User packaging .....................................................................................................................................................................................13

© ISO 2017 – All rights reserved iii
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SIST EN ISO 7886-1:2018
ISO 7886-1:2017(E)

15.6 Storage container ...............................................................................................................................................................................14

15.7 Transport wrapping ........................................................................................................................................................................14

Annex A (normative) Method for preparation of extracts ..........................................................................................................15

Annex B (normative) Test method for air leakage past syringe plunger stopper during

aspiration, and for separation of plunger stopper and plunger ......................................................................16

Annex C (normative) Method for determination of dead space ............................................................................................18

Annex D (normative) Test method for liquid leakage at syringe plunger stopper

under compression .........................................................................................................................................................................................19

Annex E (informative) Test method for the determination of forces required to operate

the piston ...................................................................................................................................................................................................................21

Annex F (informative) Test method for the quantity of silicone ...........................................................................................25

Bibliography .............................................................................................................................................................................................................................28

iv © ISO 2017 – All rights reserved
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SIST EN ISO 7886-1:2018
ISO 7886-1:2017(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 voluntary nature of standards, 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: w w w . i s o .org/ iso/ foreword .html.

This document was prepared by Technical committee ISO/TC 84, Devices for administration of medicinal

products and catheters.

This second edition cancels and replaces the first edition (ISO 7886-1:1993), which has been technically

revised. It also incorporates the Technical corrigendum ISO 7886-1:1993/Cor.1:1995.

The main changes to the previous edition are the following:
a) clarified the Scope, e.g. excluding single-use syringes made of glass;
b) added new Normative references;
c) added new terms and definitions;
d) clarified the drawing to illustrate the component of the syringe;
e) included general requirements;
f) revised test methods for syringes;
g) revised the labelling requirement;
h) clarified the type of lubricant for the different types of syringes;

i) replaced Annex E (informative): Examples of test methods for incompatibility between syringes

and injection fluids with Annex E (informative): Test method for the determination of forces

required to operate the piston;
j) added Annex F (informative): Test method for the quantity of silicone;
k) informative annex on materials has been deleted.
A list of all parts in the ISO 7886 series can be found on the ISO website.
© ISO 2017 – All rights reserved v
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SIST EN ISO 7886-1:2018
ISO 7886-1:2017(E)
Introduction

The ISO 7886 series covers hypodermic syringes primarily intended for human use and provides

performance and testing requirements. It permits broader variation in design so as not to limit

innovation and methods of packaging. Its appearance and layout are consistent with other related

standards which are designed to be more performance-based compared to design prescriptive.

General requirements as design guidelines for manufacturers are introduced in this document. Several

limits for requirements which are historic based but confirmed in practice for many years have been kept.

Materials to be used for the construction and lubrication of sterile syringes 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. The materials of the syringe should be

compatible with injection fluids. If this is not the case, the attention of the user should be drawn to the

exception by labelling on unit packaging. It is not practicable to specify a universally acceptable test

method for incompatibility, as the only conclusive test is that an individual specific injection fluid is

compatible with a specific syringe.

Manufacturers of pharmaceuticals use solvents in injectable preparations. Such solvents should be

tested by the manufacturer of the injectable preparation for any possible incompatibility with the

materials frequently used in syringe construction. If an incompatibility is identified, the injection

fluid should be suitably labelled. The impossibility of testing any one injection fluid with all available

syringes is recognized and it is strongly recommended that regulatory authorities and relevant trade

associations should recognize the problem and take appropriate measures to assist manufacturers of

injectable preparations.

Syringes should be manufactured and sterilized in accordance with recognized national or international

codes of good manufacturing practice for medical devices.

The sampling plans for inspection selected for the ISO 7886 series are intended to verify the design at a

high confidence level. The sampling plans for inspection do not replace the more general manufacturing

quality systems requirements that appear in standards on quality systems, for example the ISO 9000

series and ISO 13485.

Manufacturers are expected to follow a risk-based approach and employ usability engineering during

the design, development and manufacture of syringes.

Guidance on transition periods for implementing the requirements of ISO 7886 (all parts) is given in

ISO/TR 19244.
vi © ISO 2017 – All rights reserved
---------------------- Page: 14 ----------------------
SIST EN ISO 7886-1:2018
INTERNATIONAL STANDARD ISO 7886-1:2017(E)
Sterile hypodermic syringes for single use —
Part 1:
Syringes for manual use
1 Scope
This document specifies requirements and test methods for verifying the desig
...

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