BS EN ISO 23640:2015

BSI Standards Publication

In vitro diagnostic medical

devices — Evaluation of
stability of in vitro diagnostic
reagents
BS EN ISO 23640:2015 BRITISH STANDARD

National foreword
This British Standard is the UK implementation of
EN ISO 23640:2015. It is identical to ISO 23640:2011. It
supersedes BS EN ISO 23640:2013 which is withdrawn.
The UK participation in its preparation was entrusted to Technical
Committee CH/212, IVDs.
A list of organizations represented on this committee can be
obtained on request to its secretary.
This publication does not purport to include all the necessary
provisions of a contract. Users are responsible for its correct
application.
© The British Standards Institution 2015.
Published by BSI Standards Limited 2015
ISBN 978 0 580 90814 9
ICS 11.100.10
Compliance with a British Standard cannot confer immunity from
legal obligations.
This British Standard was published under the authority of the
Standards Policy and Strategy Committee on 30 June 2015.
Amendments/corrigenda issued since publication
Date Text affected
EUROPEAN STANDARD EN ISO 23640
NORME EUROPÉENNE
EUROPÄISCHE NORM June 2015

ICS 11.100.10 Supersedes EN ISO 23640:2013

English Version

In vitro diagnostic medical devices - Evaluation of stability of in

vitro diagnostic reagents (ISO 23640:2011)

Dispositifs médicaux de diagnostic in vitro - Évaluation de la In-vitro-Diagnostika - Haltbarkeitsprüfung von Reagenzien

stabilité des réactifs de diagnostic in vitro (ISO 23640:2011) für in-vitro-diagnostische Untersuchungen (ISO
23640:2011)

This European Standard was approved by CEN on 3 June 2015.

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

© 2015 CEN All rights of exploitation in any form and by any means reserved Ref. No. EN ISO 23640:2015 E
worldwide for CEN national Members.
BS EN ISO 23640:2015
EN ISO 23640:2015 (E)

Foreword

The text of ISO 23640:2011 has been prepared by Technical Committee ISO/TC 212 “Clinical laboratory
testing and in vitro diagnostic test systems” of the International Organization for Standardization (ISO) and has
been taken over as EN ISO 23640:2015 by Technical Committee CEN/TC 140 “In vitro diagnostic 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 December 2015, and conflicting national standards shall be withdrawn
at the latest by June 2018.

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 23640:2013.

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.

For relationship with EU Directive, 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 edition of the referenced document (including any amendments) listed below 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 — Correlation between normative references and dated EN and ISO standards

Normative references Equivalent dated standard

as listed in Clause 2 of the ISO
standard EN ISO

ISO 14971 EN ISO 14971:2012 ISO 14971:2007, Corrected

version 2007-10-01
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.

Endorsement notice

The text of ISO 23640:2011 has been approved by CEN as EN ISO 23640:2015 without any modification.

3
 BS EN ISO 23640:2015
EN ISO 23640:2015 (E)

Annex ZA
(informative)

Relationship between this European Standard and the Essential

Requirements of EU Directive 98/79/EC

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 Essential Requirements of
Directive 98/79/EC in vitro diagnostic medical devices.

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 98/79/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
Part A: 1, 2 and 5; Part B: 1.2, 2, 3, 5, 6 and 7 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 98/79/EC

Clause(s)/sub-clause(s) of this EN Essential Requirements (ERs) Qualifying remarks/notes

of Directive 98/79/EC
4.1, 4.2, 4.3, 5.1, 5.2, 5.3 A.4 This Standard covers stability
evaluations of diverse transport,
storage and use conditions that
are foreseen by the IVD
manufacturer based on the
intended purpose and the
anticipated use of the device. In
case of self-testing devices, the
tested conditions should reflect the
normal routine conditions of use by
a lay-user.
Particular storage, transport and/or
handling conditions must be
specified by the IVD manufacturer
as provided on the label and in the
instructions for use.
WARNING — Other requirements and other EU Directives may be applicable to the product(s) falling within
the scope of this standard.

4
 BS EN ISO 23640:2015
ISO 23640:2011(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 23640 was prepared by Technical Committee ISO/TC 212, Clinical laboratory testing and in vitro diagnostic
test systems.

© ISO 2011 – All rights reserved  iii

BS EN ISO 23640:2015
ISO 23640:2011(E)

Introduction

One important aspect of the development and manufacture of in vitro diagnostic (IVD) medical device reagents
is initially designing the stability of a product, then determining and verifying the expiry date of the product that is
placed on the market. To determine shelf life, transport stability, and in-use stability, the manufacturer performs
an evaluation. In order to provide this important information to the customer, the manufacturer identifies critical
factors that might influence stability of the IVD reagent and carefully evaluates these characteristics. Stability
of the IVD reagent affects the performance of the device and therefore has an impact on patient results.

It is the manufacturer’s responsibility to determine and monitor stability of IVD reagents to ensure that
performance characteristics of the product are maintained. This is best accomplished by developing a stability
evaluation protocol, and producing valid data and analysis to establish appropriate shelf life, transport limitations
and in-use stability information, which are then provided to the customers.

The basis for this ISO standard is EN 13640, Stability testing of in vitro diagnostic reagents [2].

iv  © ISO 2011 – All rights reserved

 BS EN ISO 23640:2015
INTERNATIONAL STANDARD ISO 23640:2011(E)

In vitro diagnostic medical devices — Evaluation of stability of

in vitro diagnostic reagents

1 Scope
This International Standard is applicable to the stability evaluation of in vitro diagnostic medical devices, including
reagents, calibrators, control materials, diluents, buffers and reagent kits, hereinafter called IVD reagents. This
International Standard can also be applied to specimen collection devices that contain substances used to
preserve samples or to initiate reactions for further processing of the sample in the collection device.

This International Standard specifies general requirements for stability evaluation and gives specific
requirements for real time and accelerated stability evaluation when generating data in:

— the establishment of IVD reagent shelf life, including transport conditions suitable to ensure that product
specifications are maintained;

— the establishment of stability of the IVD reagent in use after the first opening of the primary container;

EXAMPLE On-board stability, stability after reconstitution, open vial/bottle stability.

— the monitoring of stability of IVD reagents already placed on the market;

— the verification of stability specifications after modifications of the IVD reagent that might affect stability.

This International Standard is not applicable to instruments, apparatus, equipment, systems or specimen
receptacles, or the sample subject to examination.

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

3 Terms and definitions

For the purposes of this document, the following terms and definitions apply.

3.1
accelerated stability evaluation
study designed to increase the rate of chemical and/or physical degradation, or change, of an IVD reagent by
using stress environmental conditions to predict shelf life

NOTE The design of an accelerated stability evaluation can include extreme conditions of temperature, humidity, light
or vibration.

3.2
Arrhenius plot
mathematical function that describes the approximate relationship between the rate constant of a chemical
reaction and the temperature and energy of activation

[CLSI EP25-A]

© ISO 2011 – All rights reserved  1

BS EN ISO 23640:2015
ISO 23640:2011(E)

3.3
batch
lot
defined amount of material that is uniform in its properties and has been produced in one process or series of
processes

[ISO 18113-1:2009, definition 3.5]

3.4
batch code
lot number
distinctive set of numbers and/or letters that specifically identifies a batch and permits its manufacturing,
packaging, labelling and distribution history to be traced

[ISO 18113-1:2009, definition 3.6]

3.5
expiry date
expiration date
upper limit of the time interval during which the performance characteristics of a material stored under specified
conditions can be assured

NOTE Expiry dates are assigned to IVD reagents, calibrators, control materials and other components by the
manufacturer based on experimentally determined stability properties.

[ISO 18113-1:2009, definition 3.17]

3.6
IVD medical device
in vitro diagnostic medical device
device, used alone or in combination, intended by the manufacturer for the in vitro examination of specimens
derived from the human body solely or principally to provide information for diagnostic, monitoring or compatibility
purposes, which can include reagents, calibrators, control materials, specimen receptacles, software, and
related instruments or apparatus or other articles

[ISO 18113-1:2009, definition 3.27]

3.7
IVD reagent
in vitro diagnostic reagent
chemical, biological or immunological components, solutions or preparations intended by the manufacturer to
be used as an IVD medical device

[ISO 18113-1:2009, definition 3.28]

3.8
real time stability evaluation
study designed to establish or verify the shelf life of the IVD reagent when exposed to the conditions specified
by the manufacturer

NOTE Conditions that can affect stability of an IVD reagent include temperature, transport conditions, vibration, light,
humidity.

3.9
shelf life
period of time until the expiry date, during which an IVD reagent, in its original packaging, maintains its stability
under the storage conditions specified by the manufacturer

NOTE Stability (3.10) and expiry date (3.5) are related concepts.

[ISO 18113-1:2009, definition 3.66]

2  © ISO 2011 – All rights reserved

 BS EN ISO 23640:2015
ISO 23640:2011(E)

3.10
stability
ability of an IVD medical device to maintain its performance characteristics within the limits specified by the
manufacturer

NOTE 1 Stability applies to:

— IVD reagents, calibrators and controls, when stored, transported and used in the conditions specified by the
manufacturer;

— reconstituted lyophilized materials, working solutions and materials removed from sealed containers (when
prepared, used and stored according to the manufacturer’s instructions for use).

NOTE 2 Stability of an IVD reagent or measuring system is normally quantified with respect to time:

— in terms of the duration of a time interval over which a metrological property changes by a stated amount;

— in terms of the change of a property over a stated time interval.

[ISO 18113-1:2009, definition 3.68]

3.11
verification
provision of objective evidence that a given item fulfils specified requirements

EXAMPLE 1 Confirmation that a given material as claimed is homogeneous for the quantity value and measurement
procedure concerned.

EXAMPLE 2 Confirmation that performance properties or requirements of a measuring system are achieved within the
specified expiry date.

EXAMPLE 3 Confirmation that the magnitude and direction of a consistent change over time from initial determination
will conform to the stated specification throughout the claimed stability of the IVD reagent.

EXAMPLE 4 Confirmation that a target measurement uncertainty can be met.

NOTE 1 The item can be a process, measurement procedure, material or compound examination or measuring system
response.

NOTE 2 The specified requirements can be, for example, that a manufacturer’s claims or specifications are met.

NOTE 3 Adapted from ISO 18113-1:2009, definition 3.73.

4 General requirements

4.1 General principles

Stability claims shall be justified by adequate data, considering the risks associated with the use of the IVD
reagent, and with consideration of components that might be labile.

Data from accelerated stability studies and/or experience gained with IVD reagents that can reasonably be
expected to be comparable with regard to their stability characteristics may be taken into account for establishing
initial expiry dating. Experience with similar reagents and the risk associated with the use of the device should
be used to establish the basis for initial expiry dating. If, at the time of placing an IVD reagent onto the market,
stability claims are based on such previous data, the claim shall be verified with real time study data.

The evaluation shall be performed on IVD reagents manufactured under conditions that are essentially
equivalent to routine production conditions. If this is not the case, or if the IVD reagent is not stored in the final
configuration, the manufacturer shall provide justification for the stability claims.

The manufacturer shall establish whether there is a need for a stability monitoring programme and establish
one where necessary. Evaluation at the end of shelf life can be sufficient for this purpose.

© ISO 2011 – All rights reserved  3

BS EN ISO 23640:2015
ISO 23640:2011(E)

Subsequent product or manufacturing process modifications shall be reviewed to determine whether changes
in the stability programme are necessary.

4.2 Protocol
Conclusions on IVD reagent stability shall be based on data that are generated in accordance with a pre-
established protocol that includes:

— responsibilities;

— clear IVD reagent identification;

— use conditions;

EXAMPLE 1 Considering variation in environmental factors, including the worst case.

— objective and purpose of the evaluation;

— information about the reagent samples;

EXAMPLE 2 Numbers of batches, amount, container, identification of the source, and concentrations.

— potential influence of critical components;

NOTE “Critical” is meant with respect to stability.

— storage conditions recommended for the reagent samples;

EXAMPLE 3 Between 2 °C and 8 °C, less than 20 °C.

— simulation of transport;

— intervals between examination time points;

— examinations to be performed at the end of each interval;

EXAMPLE 4 Procedure and extent of examinations.

— the number of examinations to be performed with an IVD reagent, which depends on the precision of the
test methods used (considering the variability which might be encountered due to equipment and IVD
reagents);

— the duration of the stability study protocol, which might include an additional confidence margin beyond the
targeted stability claim;

— description of the data analysis;

EXAMPLE 5 References to any statistical techniques and conditions for accepting or rejecting a data point.

— acceptance criteria to be met;

— interpretation of data.

The protocol shall be part of the technical documentation related to the IVD reagent.

4.3 Stability reports

Stability reports shall be prepared in order to document the study, or studies.

EXAMPLE Interim and final reports.

Reports shall, at a minimum, include or refer to:

— the protocol which was followed;

4  © ISO 2011 – All rights reserved

 BS EN ISO 23640:2015
ISO 23640:2011(E)

— the batch(es) involved;

— all results obtained;

— analysis of data;

— acceptance criteria with pass/fail determination;

— conclusions regarding stability.

Reports shall be maintained as part of the technical documentation related to the IVD reagent.

5 Procedures

5.1 General

5.1.1 Purpose

Procedures shall be performed to evaluate and verify the stability claims of the IVD reagent.

NOTE CLSI EP25‑A[3] contains information regarding conditions and procedures that can be useful to the design and
conduct of stability evaluation studies.

5.1.2 Examinations

Examinations shall be performed according to the procedures described in the protocol. The number of
examinations to be performed with an IVD reagent representing a specific storage condition and time depends
upon the precision of the methods used.

Examinations shall be undertaken at specified time points as indicated in the protocol. The time intervals shall
be chosen to cover, as a minimum, the whole of the target shelf life. The number of time points should be
appropriately chosen so that trends can be distinguished from the variability of the data.

There shall be a sufficient amount of the IVD reagent sample to be examined to last for the entire evaluation
period and for any re-examination.

Stability evaluation conditions of the IVD reagent that differ from the final configuration shall be justified in the
risk assessment (see ISO 14971 for guidance on risk management for IVD medical devices).

EXAMPLE Differences in reagent volumes or conducted in materials that differ from the primary reagent container.

5.1.3 Number of batches to be examined

The minimum number of batches to be examined shall depend on the objective of the evaluation as follows:

— 3 batches for the evaluation of a new IVD reagent shelf life (real time stability);

— 3 batches for the extension of an IVD reagent shelf life;

— 1 batch for transport simulation;

— 1 batch for in-use stability of the IVD reagent;

— 1 batch for an IVD reagent modification, if the risk assessment for the IVD reagent in accordance with
ISO 14971 indicates that stability evaluation is required.

Using fewer than the number of batches required shall be justified in the risk assessment of the IVD reagent,
in accordance with ISO 14971.

© ISO 2011 – All rights reserved  5

BS EN ISO 23640:2015
ISO 23640:2011(E)

5.2 Real time stability evaluation

5.2.1 Shelf life

During shelf life evaluation the IVD reagent shall be stored under the conditions stated by the manufacturer.

NOTE Specifications can be determined by the capabilities of the equipment being used in the examination or the
conditions in which the product is expected to be stored.

EXAMPLE Refrigerators used for reagent storage in laboratories generally claim that control temperature is between
2 °C to 8 °C. The shelf life evaluation should not include temperatures below 2 °C or above 8 °C.

5.2.2 Stability during transport

The manufacturer shall verify that the specified transport conditions will not affect the IVD reagent expiry date.

If transport conditions are simulated, then the protocol design shall be based on the knowledge of the transport
conditions. If not already known, an investigation shall be performed to determine the real transport conditions
as a basis for this simulation.

EXAMPLE Duration of transport, expected temperatures, humidity.

5.2.3 In-use stability

The in-use stability shall reflect the routine conditions of use.

EXAMPLE On-board stability, reconstitution, and open vial/bottle stability.

5.3 Accelerated stability evaluation

5.3.1 General

Accelerated stability evaluation shall be acceptable as the basis for establishing initial expiry dating for product
introduction.

NOTE 1 For some reagents, accelerated stability evaluations might not be appropriate.

NOTE 2 See CLSI EP25‑A[3] for information regarding accelerated stability evaluation procedures.

5.3.2 Procedure

The material under investigation shall be stored under the conditions described in the information supplied
by the manufacturer until the examination begins. Material included in the accelerated stability evaluation
shall then be exposed to the defined stress conditions. Samples shall be removed at the specified times and
examined or returned to the storage conditions, as described in the information supplied by the manufacturer,
until the examination proceeds according to established protocol.

5.3.3 Analysis of data

Analysis of accelerated stability data shall be conducted according to the protocol.

EXAMPLE Arrhenius plot, non-linear modelling.

5.3.4 Evaluations and conclusions

Establish the expiry date based on data analysis, interpretation and pre-established acceptance criteria.

6  © ISO 2011 – All rights reserved

 BS EN ISO 23640:2015
ISO 23640:2011(E)

Bibliography

[1] ISO 18113-1:2009, In vitro diagnostic medical devices — Information supplied by the manufacturer
(labelling) — Part 1: Terms, definitions and general requirements

[2] EN 13640, Stability testing of in vitro diagnostic reagents

[3] CLSI EP25-A, Evaluation of Stability of In Vitro Diagnostic Reagents; Approved Guideline, CLSI,
Wayne, PA, 2009

© ISO 2011 – All rights reserved  7

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