SIST EN ISO 16106:2006

SLOVENSKI STANDARD
SIST EN ISO 16106:2006
01-september-2006
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Packaging - Transport packages for dangerous goods - Dangerous goods packagings,
intermediate bulk containers (IBCs) and large packagings - Guidelines for the application
of ISO 9001 (ISO 16106:2006)
Verpackung - Verpackungen zur Beförderung gefährlicher Güter -
Gefahrgutverpackungen, Großpackmittel (IBC) und Großverpackungen - Leitfaden für
die Anwendung der ISO 9001 (ISO 16106:2006)
Emballage - Emballage de transport pour marchandises dangereuses - Emballage pour
marchandises dangereuses, grands récipients vrac (GRV) et grands emballages -
Directives pour l'application de l'ISO 9001 (ISO 16106:2006)
Ta slovenski standard je istoveten z: EN ISO 16106:2006
ICS:
03.120.10 Vodenje in zagotavljanje Quality management and
kakovosti quality assurance
13.300 Varstvo pred nevarnimi Protection against dangerous
izdelki goods
55.180.99 Drugi standardi v zvezi z Other standards related to
distribucijo blaga s prevozom freight distribution of goods
SIST EN ISO 16106:2006 en,fr,de
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

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SIST EN ISO 16106:2006

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SIST EN ISO 16106:2006
EUROPEAN STANDARD
EN ISO 16106
NORME EUROPÉENNE
EUROPÄISCHE NORM
March 2006
ICS 55.020; 13.300

English Version
Packaging - Transport packages for dangerous goods -
Dangerous goods packagings, intermediate bulk containers
(IBCs) and large packagings - Guidelines for the application of
ISO 9001 (ISO 16106:2006)
Emballage - Emballage de transport pour marchandises Verpackung - Verpackungen zur Beförderung gefährlicher
dangereuses - Emballage pour marchandises Güter - Gefahrgutverpackungen, Großpackmittel (IBC) und
dangereuses, grands récipients vrac (GRV) et grands Großverpackungen - Richtlinien für die Anwendung der ISO
emballages - Directives pour l'application de l'ISO 9001 9001 (ISO 16106:2006)
(ISO 16106:2006)
This European Standard was approved by CEN on 3 February 2006.
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 Central Secretariat 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 Central Secretariat has the same status as the official
versions.
CEN members are the national standards bodies of Austria, Belgium, Cyprus, Czech Republic, Denmark, Estonia, Finland, France,
Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Romania,
Slovakia, Slovenia, Spain, Sweden, Switzerland and United Kingdom.
EUROPEAN COMMITTEE FOR STANDARDIZATION
COMITÉ EUROPÉEN DE NORMALISATION
EUROPÄISCHES KOMITEE FÜR NORMUNG
Management Centre: rue de Stassart, 36  B-1050 Brussels
© 2006 CEN All rights of exploitation in any form and by any means reserved Ref. No. EN ISO 16106:2006: E
worldwide for CEN national Members.

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SIST EN ISO 16106:2006

EN ISO 16106:2006 (E)


Foreword

This document (EN ISO 16106:2006) has been prepared by Technical Committee CEN/TC
261 "Packaging", the secretariat of which is held by AFNOR, in collaboration with Technical
Committee ISO/TC 122 "Packaging".

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 2006, and conflicting
national standards shall be withdrawn at the latest by September 2006.

According to the CEN/CENELEC Internal Regulations, the national standards organizations of
the following countries are bound to implement this European Standard: Austria, Belgium,
Cyprus, Czech Republic, Denmark, Estonia, Finland, France, Germany, Greece, Hungary,
Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland,
Portugal, Romania, Slovakia, Slovenia, Spain, Sweden, Switzerland and United Kingdom.

2

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SIST EN ISO 16106:2006


INTERNATIONAL ISO
STANDARD 16106
First edition
2006-03-01

Packaging — Transport packages for
dangerous goods — Dangerous goods
packagings, intermediate bulk containers
(IBCs) and large packagings —
Guidelines for the application of ISO 9001
Emballage — Emballage de transport pour marchandises
dangereuses — Emballage pour marchandises dangereuses, grands
récipients vrac (GRV) et grands emballages — Directives pour
l'application de l'ISO 9001




Reference number
ISO 16106:2006(E)
©
ISO 2006

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SIST EN ISO 16106:2006
ISO 16106:2006(E)
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©  ISO 2006
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ii © ISO 2006 – All rights reserved

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SIST EN ISO 16106:2006
ISO 16106:2006(E)
Contents Page
Foreword. iv
Introduction . v
1 Scope . 1
2 Normative references . 1
3 Terms and definitions. 1
4 Quality management system . 2
5 Management responsibility . 2
6 Resource management . 2
7 Product realization. 2
7.1 Planning of product realization . 2
7.2 Customer-related processes . 2
7.3 Design and development . 2
7.4 Purchasing . 2
7.5 Production and service provision. 3
7.6 Control of monitoring and measuring devices. 3
8 Measurement, analysis and improvement . 3
8.1 General. 3
8.2 Monitoring and measurement . 3
8.3 Control of nonconforming product. 4
8.4 Analyses of data . 4
8.5 Improvement . 4
Annex A (normative) Packaging specifications. 5
Annex B (normative) IBC specifications. 14
Annex C (normative) Items and elements of verification, controls, monitoring and validation . 19
Annex D (informative) Typical frequencies for the verification of conformity with design and
performance requirements . 24
Bibliography . 27

© ISO 2006 – All rights reserved iii

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SIST EN ISO 16106:2006
ISO 16106:2006(E)
Foreword
ISO (the International Organization for Standardization) is a worldwide federation of national standards bodies
(ISO member bodies). The work of preparing International Standards is normally carried out through ISO
technical committees. Each member body interested in a subject for which a technical committee has been
established has the right to be represented on that committee. International organizations, governmental and
non-governmental, in liaison with ISO, also take part in the work. ISO collaborates closely with the
International Electrotechnical Commission (IEC) on all matters of electrotechnical standardization.
International Standards are drafted in accordance with the rules given in the ISO/IEC Directives, Part 2.
The main task of technical committees is to prepare International Standards. Draft International Standards
adopted by the technical committees are circulated to the member bodies for voting. Publication as an
International Standard requires approval by at least 75 % of the member bodies casting a vote.
Attention is drawn to the possibility that some of the elements of this document may be the subject of patent
rights. ISO shall not be held responsible for identifying any or all such patent rights.
ISO 16106 was prepared by the European Committee for Standardization (CEN) Technical Committee
CEN/TC 261, Packaging, in collaboration with Technical Committee ISO/TC 122, Packaging, Subcommittee
SC 3, Performance requirements and tests for means of packaging, packages and unit loads (as required by
ISO/TC 122), in accordance with the Agreement on technical cooperation between ISO and CEN (Vienna
Agreement).
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SIST EN ISO 16106:2006
ISO 16106:2006(E)
Introduction
This International Standard gives guidance for the application of the ISO 9000 quality management system to
the manufacture, measuring and monitoring of design type approved dangerous goods packagings,
Intermediate Bulk Containers (IBCs) and large packagings.
[1]
The United Nations Recommendations on the Transport of Dangerous Goods (referred to in this
International Standard as the UN Model Regulations) require the application of a quality assurance
programme for the manufacture and testing of packagings, IBCs and large packagings that satisfies the
competent authority in order to ensure that each manufactured packaging, IBC and large packaging meets the
requirements.
The UN Model Regulations are given legal entity by the provision of a series of international modal
agreements and national legislation for the transport of dangerous goods. These international agreements
include
[2]
⎯ the European Agreement Concerning the International Carriage of Dangerous Goods by Road (ADR) ;
[3]
⎯ the Regulations Concerning the International Carriage of Dangerous Goods by Rail (RID) ;
⎯ the International Civil Aviation Organization’s Technical Instructions for the Safe Transport of Dangerous
[4]
Goods by Air ;
[5]
⎯ the International Maritime Dangerous Goods Code (IMDG) .
The application of this International Standard will need to take into account the requirements of these
international agreements and the national legislation for the transport of dangerous goods.
Compliance with this International Standard does not replace the agreement of competent authorities with
quality assurance programmes. In conjunction with ISO 9001, this International Standard specifies a system for
applying quality processes and assurance to the production of dangerous goods packagings, IBCs and large
packagings.
The change in terminology in the ISO 9000 series from “quality assurance programmes” (1987 edition), over
“quality systems” (1994 edition) to “quality management systems” (2000 edition), is not reflected in the UN Model
Regulations and the international agreements referred to in the bibliography of this International Standard. The
former term “quality assurance programme” is still used there. Furthermore, the term “testing”, which was used in
the 1994 edition of the ISO 9000 series in the context of product inspection and testing has now been replaced
by “measurement and monitoring” in the 2000 edition. For the purposes of this International Standard, the latest
terminology is used in accordance with ISO 9000. This difference in terminology should not deter users from
using this International Standard.
The reasons for establishing this International Standard in addition to the ISO 9000 series are as follows.
a) The wording of the requirements in 6.1.1.4, 6.5.1.6.1 and 6.6.1.2 of the UN Model Regulations is
restricted to the bare need that a quality assurance programme be applied that satisfies the competent
authority. This allows different interpretations.
b) Dangerous goods packagings, IBCs and large packagings are subject to legal requirements. The
conformity of any manufactured item with the relevant legal provisions is based on the principle of official
design type testing and approval, which requires that specific measures be applied in order to secure the
conformity of any of the unlimited number of items with the requirements of an approved design. Quality
assurance can help standardize these specific measures.
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SIST EN ISO 16106:2006
ISO 16106:2006(E)
c) In view of the cost implications of quality assurance/quality management measures, complete freedom of
interpretation could have an avoidable negative impact on competition.
d) The establishment of quality assurance/quality management measures is, particularly for smaller
companies, a large undertaking and calls for further guidance.
e) Interactions between companies and competent authorities on the adequacy of quality assurance/quality
management programmes need to be rationalized to minimize unnecessary effort.
This International Standard is based on Revision 14 of the UN Model Regulations.
Clause referencing in this International Standard corresponds to ISO 9001:2000, with the exception of the
annexes.
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SIST EN ISO 16106:2006
INTERNATIONAL STANDARD ISO 16106:2006(E)

Packaging — Transport packages for dangerous goods —
Dangerous goods packagings, intermediate bulk containers
(IBCs) and large packagings — Guidelines for the application of
ISO 9001
1 Scope
This International Standard gives guidance on quality management provisions applicable to the manufacture,
measuring and monitoring of design type approved dangerous goods packagings, intermediate bulk
containers (IBCs) and large packagings.
This International Standard can only be used in combination with ISO 9001:2000 and is not a stand-alone
document.
It does not apply to design type testing, for which reference is made to 6.1.5, 6.5.4 and 6.6.5 of the UN Model
[1]
Regulations .
2 Normative references
The following referenced documents are indispensable for the application of this document. For dated
references, only the edition cited applies. For undated references, the latest edition of the referenced
document (including any amendments) applies.
ISO 9000, Quality management systems — Fundamentals and vocabulary
ISO 9001:2000, Quality management systems — Requirements
ISO/IEC 17050-2, Conformity assessment — Supplier’s declaration of conformity — Part 2: Supporting
documentation
3 Terms and definitions
For the purposes of this document, the terms and definitions given in ISO 9000 and the following apply.
3.1
competent authority
any national regulatory body or authority designated, or otherwise recognized as such, for any purpose in
connection with the international agreements referred to in the bibliography of ISO 16106:2006
3.2
design type approved packaging, IBC or large packaging
dangerous goods packaging that has been tested and approved in accordance with chapters 6.1.5, 6.5.4 and
6.6.5 of the UN Model Regulations, the modal agreements listed in the bibliography of ISO 16106:2006 or with
national regulations
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SIST EN ISO 16106:2006
ISO 16106:2006(E)
4 Quality management system
The management system requirements of ISO 9001:2000, Clause 4 apply.
Documentation specified in ISO 9001:2000, 4.2.4 should be kept during the assumed lifetime of packagings,
IBCs and large packagings or for five years, whichever is longer.
5 Management responsibility
The management system requirements of ISO 9001:2000, Clause 5 apply.
NOTE Documentation can be subject to audit by the competent authority.
6 Resource management
The management system requirements of ISO 9001:2000, Clause 6 apply.
7 Product realization
7.1 Planning of product realization
The management system requirements of ISO 9001:2000, 7.1 apply.
The product specifications for packaging and IBCs should conform to Annex A and Annex B.
NOTE Annex A and Annex B are extracted from ISO 16104:2003, Annex G and ISO 16467:2003, Annex C,
respectively.
7.2 Customer-related processes
The management system requirements of ISO 9001:2000, 7.2 apply.
7.3 Design and development
The management system requirements of ISO 9001:2000, 7.3 apply.
For the design validation process, specified in ISO 9001:2000, 7.3.6, reference should be made to the official
design validation process (design type testing and approval procedure) which is completed by the allocation of
the UN marking, as required in 6.1.3, 6.5.2 and 6.6.3 of the UN Model Regulations.
7.4 Purchasing
The management system requirements of ISO 9001:2000, 7.4 apply.
Purchased products should conform to customer requirements and the approved design type specification.
Verification of conformity by certificates of conformity in accordance with ISO/IEC 17050-2 or any other
documentation providing the same level of confidence, or, where those are not provided with the delivery, by
tests, should be based on the criteria given in C.1.
The conformity of components with the approved design type specification should be verified in accordance
with the minimum specification data given in Annex A and Annex B.
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SIST EN ISO 16106:2006
ISO 16106:2006(E)
7.5 Production and service provision
7.5.1 Control of production and service provision
The management system requirements of ISO 9001:2000, 7.5.1 apply.
After any change in process parameters, visual inspection should be carried out to ensure that the changes do
not impair or change the specified design type criteria.
NOTE Changes in process parameters can change the design characteristics and require retesting in accordance
with 6.1.5, 6.5.4 and 6.6.5 of the UN Model Regulations.
7.5.2 Validation of processes for production and service provision
Manufacturing processes should be validated using the control parameters given in C.2.
The design type test and approval procedure is also required as validation of the manufacturing process and
the equipment, personnel and procedures involved.
7.5.3 Identification and traceability
The management system requirements of ISO 9001:2000, 7.5.3 apply
7.5.4 Customer property
The management system requirements of ISO 9001:2000, 7.5.4 apply
7.5.5 Preservation of product
The management system requirements of ISO 9001:2000, 7.5.5 apply
7.6 Control of monitoring and measuring devices
The management system requirements of ISO 9001:2000, 7.6 apply.
8 Measurement, analysis and improvement
8.1 General
The management system requirements of ISO 9001:2000, 8.1 apply.
8.2 Monitoring and measurement
The management system requirements ISO 9001:2000, 8.2 apply.
Monitoring of production should be based on visual or computer-aided automated monitoring of the
manufacturing process to identify any need for adjustment to the function of machines and installations.
At initial production, first samples should be checked for conformity with the design type specifications as
described in Annex A and Annex B. Where applicable, conformity of the following should be verified:
⎯ dimensions;
⎯ masses;
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SIST EN ISO 16106:2006
ISO 16106:2006(E)
⎯ quality of openings;
⎯ quality of seams.
Monitoring and measurement of the manufactured packagings, IBCs and large packagings should include (as
a minimum) the items/elements given in C.3.
Conformity with the approved performance levels of packaging, IBC and large packaging design types should
be verified periodically as specified in a test plan or procedure (including frequency and acceptance limits) to
confirm the continuing ability of the manufacturing process to satisfy its intended purpose.
NOTE 1 See 6.1.5, 6.5.4 and 6.6.5 of the UN Model Regulations for the relevant regulatory requirements.
NOTE 2 See Annex D for examples of typical frequencies for the verification of conformity.
Performance test conditions should be specified. For the execution of the performance tests listed in C.4 and
C.5, the design type performance test requirements should be met.
NOTE 3 For the purpose of production monitoring, the test conditions may differ from the design type test requirements
and may be restricted to comparisons with previous test results.
NOTE 4 The monitoring and measurement of product can also be used to demonstrate compliance with 6.1.5.1.3,
6.5.1.6.7 and 6.6.5.1.3 of the UN Model Regulations. For this purpose, performance tests at random may be performed on
production samples at intervals agreed with the competent authority.
8.3 Control of nonconforming product
The management system requirements of ISO 9001:2000, 8.3 apply.
If controls have previously shown nonconformities during production, appropriate measures, such as final
inspection of the complete lot, or performance testing at a higher frequency, should be carried out in context
with corrective/preventive actions.
NOTE Corrective actions can be subject to the agreement of the competent authority.
8.4 Analyses of data
The management system requirements of ISO 9001:2000, 8.4 apply.
8.5 Improvement
The management system requirements of ISO 9001:2000, 8.5 apply.
NOTE In order to achieve conformity with the approved design type specifications, the procedures for corrective
action may require agreement with the competent authority.
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SIST EN ISO 16106:2006
ISO 16106:2006(E)
Annex A
(normative)

Packaging specifications
NOTE This annex is a modified extract of ISO 16104:2003, Annex G.
A.1 Specification data
Tables A.1.1, A.1.2, A.2.1, A.2.2, A.3.1, A.3.2, A.4, A.5.1 and A.5.2 correlate the different packaging types
with data, which are necessary for the identification of test packagings by users, test facilities and competent
authorities.
Specification data in this annex are grouped for the following five categories of packagings:
1) drums, jerricans, bottles, jars, etc. — Tables A.1.1 and A.1.2;
2) boxes — Tables A.2.1 and A.2.2;
3) bags — Tables A.3.1 and A.3.2;
4) inner receptacles of composite packagings — Table A.4;
5) inner packagings of combination packagings — Tables A.5.1 and A.5.2.
Tables A.1.1, A.2.1, A.3.1 and A.5.1 apply to all packagings in that category. Tables A.1.2, A.2.2, A.3.2 and
A.5.2 apply only to particular packaging types when indicated by an “S”.
Each item in the tables is numbered and at the end of this annex there are explanatory notes for many of the
numbers to assist in interpretation.
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SIST EN ISO 16106:2006
ISO 16106:2006(E)
Table A.1.1 — Drums, jerricans, bottles, jars, etc.: packaging specification detail applicable to all
No. No.
1 Packaging description (code and trade name) 17 Closure(s), [or neck(s)] position(s)
2 Manufacturer’s name and address 18 Closure(s), material(s) and grade
3 Method of construction 19 Closure(s), type, identification
4 Nominal capacity 20 Closure(s), thread, type and pitch
5 Brimful capacity 21 Closure(s) mass
6 Diameter, nominal (cylindrical) internal 22 Closure manufacturer’s name and address
7 Diameter, external at widest point 23 Closure torque(s)
8 Nominal diameters (conical, i.e. pails) 24 Type of overseal
9 Body/section dimensions (non-round) 25 Closure(s) seal, material
10 Recess of ends 26 Neck internal diameter
11 Height overall 27 Height to neck face
12 Stacking height 28 Neck height (external)
13 End seams type 29 Neck thread, type and pitch
14 Side seam type 30 Neck thread number of starts
15 Handles: material type, number and position 31 Tare mass
16 Closure(s), diameter(s) and design
NOTE See A.2.
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SIST EN ISO 16106:2006
ISO 16106:2006(E)
Table A.1.2 — Drums, jerricans, bottles, jars, etc.: packaging specification detail
applicable as indicated
No.
32 Nominal thickness and material type and grade, S S  S S S
head or lid
33 Nominal thickness and material type and grade, S S  S S S
body
34 Nominal thickness and material type and grade, S S S S S
base
35 Material type and grade (polymer), body  S S
36 Material type and grade (polymer), base  S S
37 Material type and grade (polymer), lid/head  S S S S
38 Material lid gasket S S S S S
39 Body corrugations, number S S
40 Body corrugation, heights S S
41 Rolling hoops: number, height and location S S S S S S
42 Closing ring type S S S S
43 Closing ring material S S S S
44 Thickness closing ring S S S S
45 Number of plies (body)   S
46 Grammage per ply body, and combined   S
47 Inner lining or coating material   S
48 Chime reinforcement S S  S S
49 Method of lid retention (other than closing ring) S S S S S
50 Mass body  S S  S
NOTE See A.2.
© ISO 2006 – All rights reserved 7
Non-removable head metal
Removable head metal
Non-removable head plastics
Removable head plastics
Fibreboard
Plywood
Glass and other materials

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SIST EN ISO 16106:2006
ISO 16106:2006(E)
Table A.2.1 — Boxes packaging specification detail: applicable to all
No.
1 Packaging description (code and trade name)
2 Manufacturer’s name and address
3 Method of construction
9 Dimension, internal (l × b × h)
12 Stacking height
15 Handles: material type, number and position
31 Tare mass
51 Design standard, drawing, or style
52 Dimension, external (l × b × h)
53 Closures: number, type, position and materials
54 Reinforcements: type, position and material
...