Sterile single-use syringes, with or without needle, for insulin (ISO 8537:2016)

This International Standard specifies requirements and test methods for empty, sterile, single-use
syringes, with or without needles, made of plastic materials and intended solely for the injection of
insulin, with which the syringes are filled by the end user. This International Standard covers syringes
intended for single-use only in humans and with insulins of various concentrations.
The insulin syringes specified in this International Standard are intended for use (i.e. insulin injection)
immediately after filling and are not intended to contain insulin for extended periods of time.
This International Standard excludes single-use syringes made of glass, syringes for use with powerdriven
syringe pumps, syringes that are pre-filled by the manufacturer, and syringes intended to be
stored after filling (e.g. in a kit intended for filling by a pharmacist).

Sterile Insulin-Einmalspritzen mit oder ohne Kanüle (ISO 8537:2016)

Diese Internationale Norm legt Anforderungen an und Prüfverfahren für leere, sterile Einmalspritzen mit oder ohne Kanüle fest, die aus Kunststoffmaterialien hergestellt und ausschließlich zur Injektion von Insulin vorgesehen sind, mit dem die Spritzen vom Endverbraucher befüllt werden. Diese Internationale Norm gilt für Einmalspritzen, die für die Anwendung am Menschen und für verschiedene Insulinkonzentrationen vorgesehen sind.
Die in dieser Internationalen Norm festgelegten Insulinspritzen sind zum unverzüglichen Gebrauch (d. h. Insulininjektion) nach dem Befüllen bestimmt und sind nicht dafür vorgesehen, Insulin über eine längere Zeitdauer aufzubewahren.
Diese Norm gilt nicht für Einmalspritzen aus Glas, Spritzen zur Verwendung mit Spritzenpumpen, vom Hersteller vorgefüllte Spritzen und Spritzen, die für eine Lagerung nach dem Befüllen vorgesehen sind (z. B. in einem Satz, der zum Befüllen durch einen Apotheker bestimmt ist).

Seringues à insuline, stériles, non réutilisables, avec ou sans aiguille (ISO 8537:2016)

ISO 8537:2016 spécifie des exigences et des méthodes d'essai applicables aux seringues stériles vides non réutilisables, avec ou sans aiguille, constituées de plastique et uniquement destinées à l'injection d'insuline, avec laquelle les seringues sont remplies par l'utilisateur final. La présente Norme internationale concerne les seringues non réutilisables utilisées uniquement chez l'être humain et remplies d'insuline en concentrations variables.
Les seringues à insuline décrites dans la présente Norme internationale sont prévues pour être utilisées (par exemple, injection d'insuline) immédiatement après leur remplissage et ne sont pas adaptées pour contenir de l'insuline pendant de longues périodes.
ISO 8537:2016 exclut les seringues non réutilisables en verre, les seringues utilisables avec les pousse-seringues électriques, 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).

Sterilne injekcijske brizge za insulin za enkratno uporabo, z iglo ali brez nje (ISO 8537:2016)

Ta mednarodni standard določa zahteve in preskusne metode za prazne, sterilne
injekcijske brizge za enkratno uporabo, z iglo ali brez nje, ki so izdelane iz plastike in namenjene zgolj za vbrizganje
inzulina, pri čemer injekcije napolni končni uporabnik. Ta mednarodni standard zajema injekcijske brizge, ki so namenjene za enkratno uporabo samo pri ljudeh, z inzulinom v različnih koncentracijah.
Injekcijske brizge za inzulin, ki so določene v tem mednarodnem standardu, so namenjene za uporabo (tj. injekcija inzulina) takoj po polnjenju in ne smejo vsebovati inzulina dlje časa.
V tem mednarodnem standardu niso zajete injekcijske brizge za enkratno uporabo, izdelane iz stekla, 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).

General Information

Status
Published
Public Enquiry End Date
04-Dec-2014
Publication Date
19-May-2016
Technical Committee
Current Stage
6060 - National Implementation/Publication (Adopted Project)
Start Date
22-Apr-2016
Due Date
27-Jun-2016
Completion Date
20-May-2016

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SLOVENSKI STANDARD
SIST EN ISO 8537:2016
01-junij-2016

Sterilne injekcijske brizge za insulin za enkratno uporabo, z iglo ali brez nje (ISO

8537:2016)
Sterile single-use syringes, with or without needle, for insulin (ISO 8537:2016)
Sterile Insulin-Einmalspritzen mit oder ohne Kanüle (ISO 8537:2016)

Seringues à insuline, stériles, non réutilisables, avec ou sans aiguille (ISO 8537:2016)

Ta slovenski standard je istoveten z: EN ISO 8537:2016
ICS:
11.040.25 Injekcijske brizge, igle in Syringes, needles an
katetri catheters
SIST EN ISO 8537:2016 en

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

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SIST EN ISO 8537:2016
---------------------- Page: 2 ----------------------
SIST EN ISO 8537:2016
EN ISO 8537
EUROPEAN STANDARD
NORME EUROPÉENNE
April 2016
EUROPÄISCHE NORM
ICS 11.040.20 Supersedes EN ISO 8537:2008
English Version
Sterile single-use syringes, with or without needle, for
insulin (ISO 8537:2016)

Seringues à insuline, stériles, non réutilisables, avec ou Sterile Insulin-Einmalspritzen mit oder ohne Kanüle

sans aiguille (ISO 8537:2016) (ISO 8537:2016)
This European Standard was approved by CEN on 27 February 2016.

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, 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: Avenue Marnix 17, B-1000 Brussels

© 2016 CEN All rights of exploitation in any form and by any means reserved Ref. No. EN ISO 8537:2016 E

worldwide for CEN national Members.
---------------------- Page: 3 ----------------------
SIST EN ISO 8537:2016
EN ISO 8537:2016 (E)
Contents Page

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

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

Requirements of EU Directive 93/42/EEC amended by Directive 2007/47/EEC ................... 5

---------------------- Page: 4 ----------------------
SIST EN ISO 8537:2016
EN ISO 8537:2016 (E)
European foreword

This document (EN ISO 8537:2016) 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 October 2016, and conflicting national standards shall

be withdrawn at the latest by October 2016.

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 8537:2008.

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.

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, Slovakia, Slovenia, Spain, Sweden, Switzerland, Turkey and the

United Kingdom.

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.
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SIST EN ISO 8537:2016
EN ISO 8537:2016 (E)
Table — Correlation between normative references and dated EN and ISO standards
Normative references Equivalent dated standard
as listed in Clause 2 of the ISO
EN ISO or IEC
standard
ISO 594-1 EN ISO 594-1:1986 ISO 594-1:1986
ISO 7864 EN ISO 7864:1995* ISO 7864:1993*
ISO 9626 EN ISO 9626:1995* ISO 9626:1991*
ISO 14971 EN ISO 14971:2012 ISO 14971
ISO 62366-1 EN ISO 62366-1:2015 IEC 62366-1:2015
ISO 15223-1 EN ISO 15223-1:2012 ISO 15223-1:2012
ISO 10993-1 EN ISO 10993-1:2009 ISO 10993-1:2003
ISO 80369-7 EN ISO 80369-7:2016** ISO 80369-7:2016**
* New versions expected end of 2015.
** Expected 2016.
Endorsement notice

The text of ISO 8537:2016 has been approved by CEN as EN ISO 8537:2016 without any modification.

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SIST EN ISO 8537:2016
EN ISO 8537:2016 (E)
Annex ZA
(informative)
Relationship between this European Standard and the Essential
Requirements of EU Directive 93/42/EEC amended by Directive
2007/47/EEC

This European Standard has been prepared under a mandate given to CEN by the European

Commission and the European Free Trade Association to provide a means of conforming to the

Essential Requirements of Directive 93/42/EEC.

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

been implemented as a national standard in at least one Member State, 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 Directive 93/42/EEC

Essential
Clause(s)/subclause(s) of this Requirements (ERs)
Qualifying remarks/notes
European Standard of Directive
93/42/EEC
5.1 m 7.1
6.1.2 c, 6.1.3 c, 6.2 b 7.2
5.2, 5.4 7.3
5.11.2, 5.11.3 7.5
6.1 7.6
6.1.2, 6.1.3, 7.2.2, 7.3, 7.4 8.3
5.1 n 8.4
5.1, 5.4, 5.6, 5.7, 7.3 g, 7.4 h, 7.5 h, 7.6 f 9.2
5.1 e, 5.1 g 10.1
5.1 e, 5.2 10.2
5.1 f 10.3
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SIST EN ISO 8537:2016
EN ISO 8537:2016 (E)
Clause 7 13.1
Clause 7 13.2
7.2.1, 7.2.2, 7.3, 7.4, 7.5, 7.6, 7.7 13.3
7.2.1 b, 7.3 e, 7.4 g 13.4
13.6 The information is provided on
7.4, 7.5, 7.6 the packaging and no additional
instruction for use is required

WARNING — Other requirements and other EU Directives may be applicable to the product(s) falling

within the scope of this standard.
---------------------- Page: 8 ----------------------
SIST EN ISO 8537:2016
INTERNATIONAL ISO
STANDARD 8537
Third edition
2016-03-15
Sterile single-use syringes, with or
without needle, for insulin
Seringues à insuline, stériles, non réutilisables, avec ou sans aiguille
Reference number
ISO 8537:2016(E)
ISO 2016
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SIST EN ISO 8537:2016
ISO 8537:2016(E)
COPYRIGHT PROTECTED DOCUMENT
© ISO 2016, Published in Switzerland

All rights reserved. Unless otherwise specified, no part of this publication may be reproduced or utilized otherwise in any form

or by any means, electronic or mechanical, including photocopying, or posting on the internet or an intranet, without prior

written permission. Permission can be requested from either ISO at the address below or ISO’s member body in the country of

the requester.
ISO copyright office
Ch. de Blandonnet 8 • CP 401
CH-1214 Vernier, Geneva, Switzerland
Tel. +41 22 749 01 11
Fax +41 22 749 09 47
copyright@iso.org
www.iso.org
ii © ISO 2016 – All rights reserved
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SIST EN ISO 8537:2016
ISO 8537:2016(E)
Contents Page

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

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

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

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

3 Terms and definitions ..................................................................................................................................................................................... 2

4 Types of syringes .................................................................................................................................................................................................. 5

5 Requirements .......................................................................................................................................................................................................... 5

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

5.2 Material selection ................................................................................................................................................................................. 6

5.3 Colour coding ........................................................................................................................................................................................... 6

5.4 Extraneous matter ............................................................................................................................................................................... 7

5.4.1 General...................................................................................................................................................................................... 7

5.4.2 Limits for acidity or alkalinity .............................................................................................................................. 7

5.4.3 Limits for extractable metals................................................................................................................................. 7

5.5 Lubrication ................................................................................................................................................................................................. 7

5.5.1 Lubrication of syringes ............................................................................................................................................... 7

5.5.2 Lubrication of needle tube ...................................................................................................................................... 8

5.6 Dimensions ................................................................................................................................................................................................. 8

5.6.1 Barrel and plunger stopper .................................................................................................................................... 8

5.6.2 Finger grips .......................................................................................................................................................................... 8

5.7 Plunger/plunger stopper ............................................................................................................................................................... 8

5.7.1 General...................................................................................................................................................................................... 8

5.7.2 Fit of plunger stopper in barrel ........................................................................................................................... 8

5.8 Nozzle.............................................................................................................................................................................................................. 8

5.8.1 Conical fitting ...................................................................................................................................................................... 8

5.8.2 Position of nozzle on end of barrel .................. ................................................................................................. 8

5.9 Needle tubing and needles ........................................................................................................................................................... 9

5.9.1 Needles for syringe types 3 and 4 ..................................................................................................................... 9

5.9.2 Needle tubing for syringe types 5, 6, 7 and 8 .......................................................................................... 9

5.9.3 Bond between hub and needle tube ............................................................................................................... 9

5.10 Standard test environmental conditions .......................................................................................................................... 9

5.11 Performance of assembled syringe ....................................................................................................................................... 9

5.11.1 Dead space ............................................................................................................................................................................ 9

5.11.2 Freedom from leakage at needle .....................................................................................................................10

5.11.3 Freedom from leakage past plunger stopper .......................................................................................10

6 Packaging ..................................................................................................................................................................................................................10

6.1 Unit packaging and self-contained syringe units ...................................................................................................10

6.1.1 General...................................................................................................................................................................................10

6.1.2 Unit packaging providing sterile barrier syringes (types 1, 3, 5 and 7) .......................10

6.1.3 Self-contained syringes with sterile interiors (types 2, 4, 6 and 8) ..................................10

6.2 Multiple-unit packaging (for syringe types 2, 4, 6 and 8) ...............................................................................11

6.3 User packaging .....................................................................................................................................................................................11

7 Information supplied by the manufacturer ..........................................................................................................................11

7.1 General ........................................................................................................................................................................................................11

7.2 Syringes ......................................................................................................................................................................................................11

7.2.1 General...................................................................................................................................................................................11

7.2.2 Additional marking for self-contained syringes (syringe types 2, 4, 6 and 8) .........12

7.3 Unit packaging (for syringe types 1, 3, 5 and 7) ......................................................................................................12

7.4 Multiple unit packs (syringe types 2, 4, 6 and 8) ...................................................................................................12

7.5 User packaging .....................................................................................................................................................................................13

7.6 Storage container ...............................................................................................................................................................................14

7.7 Transport wrapping ........................................................................................................................................................................14

© ISO 2016 – All rights reserved iii
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SIST EN ISO 8537:2016
ISO 8537:2016(E)

Annex A (normative) Fluid for determination of acidity/alkalinity and extractable metals .................15

Annex B (normative) Test method for air leakage past syringe piston during aspiration and

for separation of rubber stopper and plunger ...................................................................................................................16

Annex C (normative) Test method for determination of forces required to operate piston ...................18

Annex D (normative) Test method for determination of dead space ..............................................................................20

Annex E (normative) Test method for liquid leakage at syringe piston and syringe nozzle/

hub or needle/barrel unions during compression ........................................................................................................21

Annex F (normative) Test method for air leakage past nozzle/hub or needle/barrel unions

during aspiration ..............................................................................................................................................................................................23

Annex G (normative) Preparation of extract for test for pyrogenicity and toxicity .........................................24

Annex H (normative) Syringe sizes and graduated scales ..........................................................................................................25

Bibliography .............................................................................................................................................................................................................................27

iv © ISO 2016 – All rights reserved
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SIST EN ISO 8537:2016
ISO 8537:2016(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 WTO principles in the Technical

Barriers to Trade (TBT) see the following URL: Foreword - Supplementary information.

The committee responsible for this document is ISO/TC 84, Devices for administration of medicinal

products and catheters.

This third edition cancels and replaces the second edition (ISO 8537:2007), which has been technically

revised to include the following changes:
a) revised the introduction;

b) revised the scope to include various concentrations of insulin, specified plastic materials and

excluded, e.g. single-use syringes made of glass;
c) added some normative references;
d) added new definitions;
e) added new colour codes for higher concentration of insulin;
f) clarified the drawing to illustrate the component of the syringe;
g) included general requirements;
h) revised test methods for syringes;
i) revised the labelling requirement;
j) moved the syringe sizes and graduated scales in Annex H;
k) deleted Annex I.
© ISO 2016 – All rights reserved v
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SIST EN ISO 8537:2016
ISO 8537:2016(E)
Introduction

This International Standard covers insulin syringes primarily intended for human use and provides

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

innovation in technology or methods of packaging. Its appearance and layout are consistent with

other TC 84 International Standards, which are designed to be more performance-based than design-

prescriptive.

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

the design, development and manufacture of insulin syringes.

This edition introduces general requirements as design guidelines for manufacturers. This edition

retains a number of limits on requirements, which were originally based on consensus opinion but

subsequently have been confirmed in practice.

This International Standard does not specify materials to be used for the construction and lubrication

of sterile insulin syringes and needles for single use because their selection will depend, to some extent,

upon the manufacturer’s specific syringe design, process of manufacture, and sterilization method.

Insulin syringes and needles are to be manufactured and sterilized in accordance with recognized

national or international codes of good manufacturing practice for medical devices.

This International Standard emphasizes the importance of having individual syringes that are

appropriately graduated and labelled for only one concentration of insulin. Serious problems can

result if a syringe is used with a concentration of insulin that is different from the one for which it was

designed. Hazards associated with dosing errors with highly concentrated insulin (U300 and U500) are

considered higher than the experience with U40 and U100.

It is preferred that when more than one insulin concentration is in a market, the new concentration be

provided in a dedicated delivery system that make miss-dosing less likely.

In acknowledgement that insulin in higher concentrations in vials are available in some markets, new

formulations are under development and dedicated delivery systems other than syringes are not always

appropriate for all markets, this International Standard introduces new colour codes to differentiate

syringes for the new higher concentrations of insulin.

The sampling plans for inspection selected for this International Standard 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 that appear in standards on quality systems, for example, the ISO 9000

series and ISO 13485.

Guidance on transition periods for implementing the requirements of this International Standard is

given in ISO/TR 19244, developed by ISO/TC 84.
vi © ISO 2016 – All rights reserved
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SIST EN ISO 8537:2016
INTERNATIONAL STANDARD ISO 8537:2016(E)
Sterile single-use syringes, with or without needle, for
insulin
1 Scope

This International Standard specifies requirements and test methods for empty, sterile, single-use

syringes, with or without needles, made of plastic materials and intended solely for the injection of

insulin, with which the syringes are filled by the end user. This International Standard covers syringes

intended for single-use only in humans and with insulins of various concentrations.

The insulin syringes specified in this International Standard are intended for use (i.e. insulin injection)

immediately after filling and are not intended to contain insulin for extended periods of time.

This International Standard excludes single-use syringes made of glass, syringes for use with power-

driven syringe pumps, syringes that are pre-filled by the manufacturer, and syringes intended to be

stored after filling (e.g. in a kit intended for filling by a pharmacist).
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 , Conical fittings with a 6 % (Luer) taper for syringes, needles and certain other medical

equipment — Part 1: General requirements
ISO 3696, Water for analytical laboratory use — Specification and test methods
ISO 7864, Sterile hypodermic needles for single use
ISO 9626, Stainless steel needle tubing for the manufacture of medical devices

ISO 10993-1, Biological evaluation of medical devices — Part 1: Evaluation and testing within a risk

management process

ISO 11608–1, Needle-based injection systems for medical use — Requirements and test methods — Part 1:

Needle-based injection systems

ISO 11608–5, Needle-based injection systems for medical use — Requirements and test methods — Part 5:

Automated functions
ISO 14971, Medical devices — Application of risk management to medical devices
ISO 15223-1:2012, Medical devices — Sy
...

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