FprEN ISO 14708-4

Implants for surgery - Active implantable medical devices - Part 4: Implantable infusion pump systems (ISO/FDIS 14708-4:2021)

ISO 14708-4:2008 is applicable to active implantable medical devices intended to deliver medicinal substances to site-specific locations within the human body.
ISO 14708-4:2008 is also applicable to some non-implantable parts and accessories of the devices.
The tests that are specified in ISO 14708-4:2008 are type tests intended to be carried out on a sample of a device to show compliance, and are not intended to be used for the routine testing of manufactured products.

Chirurgische Implantate - Aktive implantierbare medizinische Geräte - Teil 4: Implantierbare Infusionspumpen (ISO/FDIS 14708-4:2021)

Dieses Dokument gilt für aktive implantierbare medizinische Geräte, die zur Verabreichung von medizinischen Substanzen an wirkortspezifischen Stellen innerhalb des menschlichen Körpers vorgesehen sind.
Dieses Dokument gilt auch für einige nicht implantierbare Teile und Zubehörteile der Geräte, wie in Abschnitt 3 definiert.
Die in diesem Dokument festgelegten Prüfungen sind Typprüfungen und sollen an einem Prüfling eines Geräts durchgeführt werden, um die Einhaltung der Anforderungen offenzulegen, sind jedoch nicht dafür vorgesehen, zur Stückprüfung der hergestellten Produkte angewendet zu werden.
ANMERKUNG Dieses Dokument ist nicht dafür vorgesehen, für nicht implantierbare Infusionssysteme zu gelten.

Implants chirurgicaux - Dispositifs médicaux implantables actifs - Partie 4: Systèmes de pompe à perfusion implantables (ISO/FDIS 14708-4:2021)

Vsadki (implantati) za kirurgijo - Aktivni medicinski pripomočki za vsaditev - 4. del: Sistemi za vsadljive infuzijske črpalke (ISO/FDIS 14708-4:2021)

General Information

• Status: Not Published
• ICS: 11.040.40 - Implants for surgery, prosthetics and orthotics
• Technical Committee: CEN/CLC/JTC 16 - CEN/CENELEC Joint Working Group on Active Implantable Medical Devices
• Current Stage: 6055 - CEN Ratification completed (DOR) - Publishing
• Due Date: 11-Feb-2022
• Completion Date: 11-Feb-2022
• Directive: 2017/745 - Regulation (EU) 2017/745 of the European Parliament and of the Council of 5 April 2017 on medical devices, amending Directive 2001/83/EC, Regulation (EC) No 178/2002 and Regulation (EC) No 1223/2009 and repealing Council Directives 90/385/EEC and 93/42/EEC
• Directive: 90/385/EEC - Council Directive 90/385/EEC of 20 June 1990 on the approximation of the laws of the Member States relating to active implantable medical devices
• Mandate: M/023 - Standardization mandate to CEN/CENELEC concerning the development of European standards relating to medical devices
• Mandate: M/565 - Medical devices and in vitro diagnostic medical devices in support of Regulation (EU) 2017/745 of the European Parliament and of the Council and Regulation (EU) 2017/746
• Ref Project: kSIST FprEN ISO 14708-4:2021 - Implants for surgery - Active implantable medical devices - Part 4: Implantable infusion pump systems (ISO/FDIS 14708-4:2021)

Standards Content (sample)

SLOVENSKI STANDARD
oSIST prEN ISO 14708-4:2020
01-junij-2020

Vsadki (implantati) za kirurgijo - Aktivni medicinski pripomočki za vsaditev - 4. del:

Vsadljive infuzijske črpalke (ISO/DIS 14708-4:2020)

Implants for surgery - Active implantable medical devices - Part 4: Implantable infusion

pumps (ISO/DIS 14708-4:2020)
Chirurgische Implantate - Aktive implantierbare medizinische Geräte - Teil 4:
Implantierbare Infusionspumpen (ISO/DIS 14708-4:2020)

Implants chirurgicaux - Dispositifs médicaux implantables actifs - Partie 4 : Systèmes de

pompe à perfusion implantables (ISO/DIS 14708-4:2020)
Ta slovenski standard je istoveten z: prEN ISO 14708-4
ICS:
11.040.40 Implantanti za kirurgijo, Implants for surgery,
protetiko in ortetiko prosthetics and orthotics
oSIST prEN ISO 14708-4:2020 en,fr,de

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

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oSIST prEN ISO 14708-4:2020
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oSIST prEN ISO 14708-4:2020
DRAFT INTERNATIONAL STANDARD
ISO/DIS 14708-4
ISO/TC 150/SC 6 Secretariat: ANSI
Voting begins on: Voting terminates on:
2020-04-02 2020-06-25
Implants for surgery — Active implantable medical
devices —
Part 4:
Implantable infusion pump systems
Implants chirurgicaux — Dispositifs médicaux implantables actifs —
Partie 4: Pompes d'infusion en implant
ICS: 11.040.40
THIS DOCUMENT IS A DRAFT CIRCULATED
This document is circulated as received from the committee secretariat.
FOR COMMENT AND APPROVAL. IT IS
THEREFORE SUBJECT TO CHANGE AND MAY
NOT BE REFERRED TO AS AN INTERNATIONAL
STANDARD UNTIL PUBLISHED AS SUCH.
IN ADDITION TO THEIR EVALUATION AS
ISO/CEN PARALLEL PROCESSING
BEING ACCEPTABLE FOR INDUSTRIAL,
TECHNOLOGICAL, COMMERCIAL AND
USER PURPOSES, DRAFT INTERNATIONAL
STANDARDS MAY ON OCCASION HAVE TO
BE CONSIDERED IN THE LIGHT OF THEIR
POTENTIAL TO BECOME STANDARDS TO
WHICH REFERENCE MAY BE MADE IN
Reference number
NATIONAL REGULATIONS.
ISO/DIS 14708-4:2020(E)
RECIPIENTS OF THIS DRAFT ARE INVITED
TO SUBMIT, WITH THEIR COMMENTS,
NOTIFICATION OF ANY RELEVANT PATENT
RIGHTS OF WHICH THEY ARE AWARE AND TO
PROVIDE SUPPORTING DOCUMENTATION. ISO 2020
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oSIST prEN ISO 14708-4:2020
ISO/DIS 14708-4:2020(E)
COPYRIGHT PROTECTED DOCUMENT
© ISO 2020

All rights reserved. Unless otherwise specified, or required in the context of its implementation, 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
CP 401 • Ch. de Blandonnet 8
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Phone: [phone]
Fax: [phone]
Email: [e-mail]
Website: www.iso.org
Published in Switzerland
ii © ISO 2020 – All rights reserved
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oSIST prEN ISO 14708-4:2020
ISO/DIS 14708-4:2020(E)
Contents Page

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

Introduction ..............................................................................................................................................................................................................................vii

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

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

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

4 Symbols and abbreviated terms ........................................................................................................................................................... 3

5 General requirements for active implantable medical devices ........................................................................... 3

5.1 General requirements for non-implantable parts .................................................................................................... 3

5.2 General requirements for software ....................................................................................................................................... 3

5.3 Usability of non-implantable parts ........................................................................................................................................ 3

5.4 Data security and protection from harm caused by unauthorized information tampering 3

5.5 General requirements for risk management ................................................................................................................. 3

5.6 Misconnection of parts of the active implantable medical device .............................................................. 3

6 Requirements for particular active implantable medical devices ................................................................... 4

6.1 Implantable infusion pump system specifications .................................................................................................. 4

6.2 Septum puncture test ........................................................................................................................................................................ 4

7 General arrangement of the packaging ........................................................................................................................................ 5

8 General markings for active implantable medical devices ...................................................................................... 5

9 Markings on the sales packaging ......................................................................................................................................................... 6

10 Construction of the sales packaging ................................................................................................................................................. 6

11 Markings on the sterile pack.................................................................................................................................................................... 6

12 Construction of the non-reusable pack ......................................................................................................................................... 7

13 Markings on the active implantable medical device ....................................................................................................... 7

14 Protection from unintentional biological effects caused by the active implantable

medical device......................................................................................................................................................................................................... 7

15 Protection from harm to the patient or user caused by external physical features of

the active implantable medical device .......................................................................................................................................... 8

16 Protection from harm to the patient caused by electricity ...................................................................................... 8

17 Protection from harm to the patient caused by heat ...................................................................................................... 8

18 Protection from ionizing radiation released or emitted from the active implantable

medical device......................................................................................................................................................................................................... 9

19 Protection from unintended effects caused by the active implantable medical device .............9

20 Protection of the active implantable medical device from damage caused by

external defibrillators .................................................................................................................................................................................... 9

21 Protection of the active implantable medical device from changes caused by high-

power electrical fields applied directly to the patient ...............................................................................................10

22 Protection of the active implantable medical device from changes caused by

miscellaneous medical treatments ................................................................................................................................................10

23 Protection of the active implantable medical device from mechanical forces .................................11

24 Protection of the active implantable medical device from damage caused by

electrostatic discharge ................................................................................................................................................................................12

25 Protection of the active implantable medical device from damage caused by

atmospheric pressure changes ...........................................................................................................................................................12

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26 Protection of the active implantable medical device from damage caused by

temperature changes ....................................................................................................................................................................................12

27 Protection of the active implantable medical device from electromagnetic non-

ionizing radiation .............................................................................................................................................................................................12

27.1 General ........................................................................................................................................................................................................12

27.2 Test conditions .....................................................................................................................................................................................12

27.2.1 Acceptance criteria .....................................................................................................................................................12

27.2.2 Test configuration ........................................................................................................................................................13

27.2.3 Operating functions, modes, and settings ...............................................................................................13

27.3 Documentation ....................................................................................................................................................................................13

27.4 Protection from static magnetic fields of flux density up to 50 mT .......................................................14

27.5 Protection from magnetic fields over the frequency range 16 Hz to 26 MHz ................................14

27.6 Protection from EM disturbances over the frequency range 80 MHz to 2,7 GHz .......................16

27.7 Protection from proximity fields due to RF wireless communications equipment ..................17

27.8 Optional characterization testing ........................................................................................................................................17

28 Accompanying documentation ...........................................................................................................................................................18

Annex A (informative) Relationship between the fundamental principles in
[4]

ISO/TR 14283 and the clauses of this document .......................................................................................................20

Annex B (informative) Rationale ...........................................................................................................................................................................40

Annex C (informative) Guidance on the allocation of requirements to non-implantable

parts connected to a power source .................................................................................................................................................49

Annex Z (informative) A Relationship between this European standard and the General

Safety and Performance Requirements of Regulation (EU) 2017/745 aimed to be

covered ......... ................................................................................................................................................................................................................56

Bibliography .............................................................................................................................................................................................................................67

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oSIST prEN ISO 14708-4:2020
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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. 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. 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

This document was prepared by Technical Committee ISO/TC 150, Implants for surgery, SC 6, Active

implants.

This second edition cancels and replaces the first edition (ISO 14708-4:2008), which has been

technically revised.
The main changes compared to the previous edition are as follows
— The title was modified,
— 9.4 additions deleted,
— 11.101 deleted,
— 14.2 replacement deleted,
— 14.101 deleted,
— 14.5 added,
— 17 revised,
— 19.2 replacement deleted,
— 19.3 replacement deleted,
— 19.101 deleted,
— 19.7 added,
— 23.2 amendment deleted,
— 27 revised,
— 28.8 additions deleted,
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oSIST prEN ISO 14708-4:2020
ISO/DIS 14708-4:2020(E)
— 28.10 additions deleted,
— 28.12 addition deleted,
— 28.101 through 28.103 deleted,
— 28.31 and 28.31 added.
A list of all parts in the ISO 14708 series can be found on the ISO website.

Any feedback or questions on this document should be directed to the user’s national standards body. A

complete listing of these bodies can be found at www .iso .org/ members .html.
vi © ISO 2020 – All rights reserved
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oSIST prEN ISO 14708-4:2020
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Introduction

This document specifies particular requirements for active implantable medical devices intended

to deliver a medicinal substance to site-specific locations within the human body, to provide basic

assurance of safety for both patients and users. It amends and supplements ISO 14708-1:2014. The

requirements of document take priority over those of ISO 14708-1.

An implantable infusion pump system is a device that delivers either a constant flow rate or a variable

flow rate from which a medicinal substance is delivered via an implanted catheter to site-specific

locations within the human body. An external programmer might be used to adjust device parameters.

Requirements for physiologic sensing functions of implantable infusion pump systems are not included in

this edition of this document but might be considered in future editions.
Annex A, Annex B and Annex C are provided for information only.
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oSIST prEN ISO 14708-4:2020
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oSIST prEN ISO 14708-4:2020
DRAFT INTERNATIONAL STANDARD ISO/DIS 14708-4:2020(E)
Implants for surgery — Active implantable medical
devices —
Part 4:
Implantable infusion pump systems
1 Scope

This document is applicable to active implantable medical devices intended to deliver medicinal

substances to site-specific locations within the human body.

This document is also applicable to some non-implantable parts and accessories of the devices as

defined in Clause 3.

The tests that are specified in this document are type tests intended to be carried out on a sample of

a device to show compliance and are not intended to be used for the routine testing of manufactured

products.
NOTE This document is not intended to apply to non-implantable infusion systems.
2 Normative references

The following documents are referred to in the text in such a way that some or all of their content

constitutes requirements 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 14708-1:2014, Implants for surgery — Active implantable medical devices — Part 1: General

requirements for safety, marking and for information to be provided by the manufacturer

ISO 14971, Medical devices — Application of risk management to medical devices

ISO/TS 10974:2018, Assessment of the safety of magnetic resonance imaging for patients with an active

implantable medical device

I EC 6 06 01-1:20 05+A 1: 2012 , Medical electrical equipment — Part 1: General requirements for basic safety

and essential performance

I EC 6 06 01-1-2:2014 +A 1: 2020, Medical electrical equipment — Part 1-2: General requirements for basic

safety and essential performance — Collateral standard: Electromagnetic compatibility — Requirements

and tests

IEC 61000-4-3:2006, _A1:2007+A2: 2010, Electromagnetic compatibility (EMC) — Part 4–3: Testing and

measurement techniques — Radiated, radio-frequency, electromagnetic field immunity test

3 Terms and definitions

For the purposes of this document, the terms and definitions given in ISO 14708-1 and the following apply.

ISO and IEC maintain terminological databases for use in standardization at the following addresses:

— IEC Electropedia: available at http:// www .electropedia .org/
— ISO Online browsing platform: available at http:// www .iso .org/ obp
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oSIST prEN ISO 14708-4:2020
ISO/DIS 14708-4:2020(E)
3.1
bolus

specific amount of fluid (dose or volume) delivered once for a prescribed length of time (duration)

3.2
catheter access port
port allowing access to the delivery catheter
3.3
fluid pathway

internal surfaces of the implantable infusion pump system which are in direct contact with a medicinal

substance
Note 1 to entry: Note to entry: This also includes catheters and refill kits.
3.4
implantable infusion pump system

active implantable medical device intended for delivery of a medicinal substance to a specific location

within the human body

Note 1 to entry: Note to entry: For purposes of this document, an implantable infusion pump system can be a single

article, or a set of components and accessories. Not all of these components or accessories might be required to

be partially or totally implanted, e.g. programmers.
3.5
infusion accuracy
how close the true (actual) infusion rate is to the programmed rate
3.6
maximum rate
highest rate selectable by the user
3.7
minimum rate
lowest rate selectable by the user
3.8
MR Conditional

an item with demonstrated safety in the MR environment within defined conditions for the static

magnetic field, the time-varying gradient magnetic field and the radiofrequency fields

[SOURCE: ASTM F2503-13, 3.1.11]
3.9
pump

implantable part of an implantable infusion pump system containing the fluid reservoir, energy source

and, in some cases, control electronics
3.10
refill access port
port allowing access to the fluid reservoir
3.11
repeatability

ability to consistently deliver the same results over time, under the same conditions

[1]

Note 1 to entry: Note to entry: A method for calculating repeatability is given in Annex B of ISO 11631 .

3.12
reservoir
a space designed to hold fluid
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oSIST prEN ISO 14708-4:2020
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3.13
reservoir volume
fluid volume of the reservoir that can be discharged
3.14
service life

period after implantation when the implantable infusion pump system remains within stated

specifications and characteristics
3.15
stability interval

calculated interval between two subsequent reservoir refills to assure stability of the medicinal

substance
4 Symbols and abbreviated terms
The text in clause 4 of ISO 14708-1:2014 applies with the following addition:
DUT device under test
5 General requirements for active implantable medical devices
5.1 General requirements for non-implantable parts
The text in 5.1 of ISO 14708-1:2014 applies.
5.2 General requirements for software
The text in 5.2 of ISO 14708-1:2014 applies.
5.3 Usability of non-implantable parts
The text in 5.3 of ISO 14708-1:2014 applies.
5.4 Data security and protection from harm caused by unauthorized information
tampering
The text in 5.4 of ISO 14708-1:2014 applies.
5.5 General requirements for risk management
The text in 5.5 of ISO 14708-1:2014 applies.
5.6 Misconnection of parts of the active implantable medical device
The text in 5.6 of ISO 14708-1:2014 applies.
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6 Requirements for particular active implantable medical devices
6.1 Implantable infusion pump system specifications

The specifications (e.g. infusion accuracy and repeatability) stated by the manufacturer in the

accompanying documentation (see 28.8) shall be maintained over the service life and over the range of

environmental conditions and characteristics (e.g. reservoir volume) stated by the manufacturer.

NOTE Minimum environmental conditions for atmospheric pressure are specified in Clause 25.

Infusion accuracy shall be stated for all selectable rates (including bolus rates).

The manufacturer shall provide a plot of infusion accuracy versus environmental conditions and

characteristics (e.g. reservoir volume) that affect infusion accuracy. For variable rate implantable infusion

pump systems, the plot shall contain curves for minimum rate, maximum rate, and at least one rate in

between the minimum rate and maximum rate.

The method of computing and determining the infusion accuracy shall be clearly stated in the

accompanying documentation. Environmental test conditions used to establish infusion accuracy shall

also be stated. Environmental conditions and characteristics that affect infusion accuracy shall be

clearly stated in the accompanying documentation.

For all selectable infusion rates, the repeatability of the actual rate shall also be stated. The method

of computing and determining the stated repeatability shall be clearly described in the accompanying

documentation.

Compliance is checked by inspection of accompanying documentation and test procedures and reports,

supported by the manufacturer’s calculations, as appropriate.
6.2 Septum puncture test

A septum that allows entry to an access port (e.g. refill access port or catheter access port), shall be able

to withstand repeated insertions of a hypodermic needle while maintaining the integrity of the fluid

reservoir throughout the service life.

Test: The DUT shall be conditioned at 37 °C ± 1 °C for not less than 12 h to achieve thermal equilibration.

Each pump septum shall be punctured randomly using the needle specified by the manufacturer for

septum puncture and in accordance with the manufacturer’s instructions. The needle used for septum

puncture shall be replaced if damage to the needle or the needle’s tip is noted by the operator. The

needle shall completely penetrate the septum and care should be taken not to damage the needle’s tip

during the test. Puncturing shall be done using a straight-line motion parallel to the septum's axial

centre-line as shown in Figure 1.

Septum leakage shall be determined by immersing the test unit in a water bath at 37 °C ± 1 °C and

allowing the temperature of the assembly to stabilize for a minimum of 30 min. Leakage shall be

determined by air pressure applied slowly to a pressure of twice the pump’s maximum operating

pressure or a minimum of 276 kPa. The septum’s exposed surfaces shall be examined for air bubble

leakage for 1 min.

The maximum number of punctures for which the septum maintains integrity shall be stated (see 28.8).

Compliance is checked by inspection of accompanying documents and test reports.
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Key
1 needle
2 septum
Figure 1 — Septum puncture test
7 General arrangement of the packaging
7.1 The text in 7.1 of ISO 14708-1:2014 applies.
7.2 The text in 7.2 of ISO 14708-1:2014 applies.
8 General markings for active implantable medical devices
8.1 The text in 8.1 of ISO 14708-1:2014 applies.
8.2 The text in 8.2 of ISO 14708-1:2014 applies.

8.3 If special handling measures have to be taken during transport, the shipping packaging shall be

marked accordingly.
Compliance is checked by inspection.

8.4 The permissible environmental conditions for transport shall be marked on the outside of the

[2]
shipping packaging (see ISO 15223-1 ).
Compliance is checked by inspection.
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9 Markings on the sales packaging
9.1 The text in 9.1 of ISO 14708-1:2014 applies.
9.2 The text in 9.2 of ISO 14708-1:2014 applies.
9.3 The text in 9.3 of ISO 14708-1:2014 applies.
9.4 The text in 9.4 of ISO 14708-1:2014 applies.
9.5 The text in 9.5 of ISO 14708-1:2014 applies.
9.6 The text in 9.6 of ISO 14708-1:2014 applies.
9.7 The text in 9.7 of ISO 14708-1:2014 applies.
9.8 The text in 9.8 of ISO 14708-1:2014 applies.
9.9 The text in 9.9 of ISO 14708-1:2014 applies.
9.10 The text in 9.10 of ISO 14708-1:2014 applies.
9.11 The text in 9.11 of ISO 14708-1:2014 applies.
9.12 The text in 9.12 of ISO 14708-1:2014 applies.
9.13 The text in 9.13 of ISO 14708-1:2014 applies.
9.14 The text in 9.14 of ISO 14708-1:2014 applies.
10 Construction of the sales packaging
10.1 The text in 10.1 of ISO 14708-1:2014 applies.
10.2 The text in 10.2 of ISO 14708-1:2014 applies.
10.3 The text in 10.3 of ISO 14708-1:2014 applies.
10.4 The text in 10.4 of ISO 14708-1:2014 applies.
11 Markings on the sterile pack
11.1 The text in 11.1 of ISO 14708-1:2014 applies.
11.2 The text in 11.2 of ISO 14708-1:2014 applies.
11.3 The text in 11.3 of ISO 14708-1:2014 applies.
11.4 The text in 11.4 of ISO 14708-1:2014 applies.
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11.5 The text in 11.5 of ISO 14708-1:2014 applies.
11.6 The text in 11.6 of ISO 14708-1:2014 applies.
11.7 The text in 11.7 of ISO 14708-1:2014 applies.
11.8 The text in 11.8 of ISO 14708-1:2014 applies.
11.9 The text in 11.9 of ISO 14708-1:2014 applies.
12 Construction of the non-reusable pack
12.1 The text in 12.1 of ISO 14708-1:2014 applies.
12.2 The text in 12.2 of ISO 14708-
...