SIST-V CEN/CLC Guide 12:2009

The concept of Affiliation with CEN and CENELEC

CEN/CLC guide approved by AG Resolution 11/2007 in Cyprus (June 2007)

Medizinprodukte - Anwendung des Risikomanagements auf Medizinprodukte - Änderung 1: Begründung der Anforderungen (ISO 14971:2000/Amd.1:2003)

Wie bereits in der Einleitung erläutert, ist eine Norm zum Risikomanagement erforderlich, die auf sämtliche Medizinprodukte anzuwenden ist. Risiken treten während des gesamten Lebenszyklus eines Produktes auf, und Risiken, die an einem bestimmten Punkt des Lebenszyklus offensichtlich werden, dürfen gegebenenfalls durch eine Maßnahme zu einem ganz anderen Zeitpunkt während des Lebenszyklus behandelt werden. Aus diesem Grunde ist diese Internationale Norm dazu vorgesehen, für den gesamten Lebenszyklus zu gelten. Das bedeutet, dass die Norm Anweisungen für die Hersteller enthält, die Prinzipien des Risikomanagements auf ein Medizinprodukt von dessen anfänglicher Konzipierung bis zur letztendlichen Entnahme aus dem Verkehr und Entsorgung anzuwenden.
Diese Internationale Norm ist nicht dazu bestimmt, auf die klinische Entscheidungsfindung angewendet zu werden. Die Entscheidung über die Einleitung eines klinischen Verfahrens unter Verwendung eines Medizinproduktes macht es erforderlich, die Restrisiken gegen den zu erwartenden Nutzen des Verfahrens abzuwägen. Bei derartigen Beurteilungen sollten der bestimmungsgemäße Gebrauch/die Zweckbestimmung, die Leistung und die mit dem Medizinprodukt verbundenen Risiken sowie die mit dem klinischen Verfahren oder den Anwendungsbedingungen verbundenen Risiken und der entsprechende Nutzen berücksichtigt werden. Einige dieser Beurteilungen dürfen nur von einem qualifizierten medizinischen Praktiker vorgenommen werden, der den Gesundheitszustand des einzelnen Patienten und die eigene Meinung des Patienten kennt.
Obgleich es erhebliche Diskussionen darüber gegeben hat, bis zu welchem Wert ein Risiko noch als vertretbar gilt, legt diese Internationale Norm keine Werte für die Vertretbarkeit von Risiken fest. Die Festlegung eines einzigen Wertes für die Vertretbarkeit eines Risikos wäre nicht angemessen, weil
   die große Vielzahl der von dieser Norm betroffenen Produkten und Situationen einen einzigen Wert bedeutungslos machen würde, un

Dispositifs médicaux - Application de la gestion des risques aux dispositifs médicaux - Amendement 1: Justification des exigences (ISO 14971:2000/AM1:2003)

Koncept pridruženega članstva v CEN in CENELEC

General Information

• Status: Withdrawn
• Publication Date: 17-Aug-2009
• Withdrawal Date: 13-Mar-2017
• ICS: 01.120 - Standardization. General rules
• ICS: 11.040.01 - Medical equipment in general
• ICS: 11.120.01 - Pharmaceutics in general
• Technical Committee: I10 - Imaginarni 10 za neaktivna TDT na elektro področju
• Current Stage: 9900 - Withdrawal (Adopted Project)
• Start Date: 13-Mar-2017
• Due Date: 05-Apr-2017
• Completion Date: 14-Mar-2017
• Ref Project: EN ISO 14971:2000/A1:2003 - Medical devices - Application of risk management to medical devices - Amendment 1: Rationale for requirements (ISO 14971:2000/AM1:2003)

Standards Content (Sample)

SLOVENSKI STANDARD
SIST-V CEN/CLC Guide 12:2009
01-september-2009
.RQFHSWSULGUXåHQHJDþODQVWYDY&(1LQ&(1(/(&
The concept of Affiliation with CEN and CENELEC
Ta slovenski standard je istoveten z: CEN/CLC Guide 12:2007
ICS:
01.120 Standardizacija. Splošna Standardization. General
pravila rules
SIST-V CEN/CLC Guide 12:2009 en,fr,de
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

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CEN/CENELEC Guide 12


The concept of
Affiliation
with CEN and CENELEC






















The present guide defines the affiliation status, presents the conditions for granting affiliation, describes the
rights and obligations of Affiliates of CEN and/or CENELEC, and indicates the principles and information
sources for the calculation of the annual affiliation fee. The General Assemblies of CEN and CENELEC
approved the second edition of this Guide in 2008. This Guide replaces the CEN document “CEN Affiliates –
Guidelines and information package” and CENELEC Guide 27 “Affiliation with CENELEC”.

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European Committee for European Committee for
Standardization Electrotechnical
Standardization

Rue de Stassartstraat, 36 Rue de Stassartstraat, 35
B – 1050 Brussels B – 1050 Brussels

Tel: [phone] Tel: [phone]
Fax: [phone] Fax: [phone]

www.cen.eu www.cenelec.org




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CEN/CENELEC Guide 12 The concept of Affiliation with CEN and CENELEC

Introduction to the CEN and CENELEC models
of cooperation with third country
or regional standardization bodies
Besides their dedication and commitment to international standardization through their memberships
and the Vienna and Dresden agreements, CEN and CENELEC as European Regional
Standardization bodies have always been open for cooperation/collaboration with other
standardization bodies worldwide, since they clearly acknowledge the importance of the European
Standards they develop for trade and welfare inside as well as outside the European Economic
Area.
CEN and CENELEC recognize that the cooperation/collaboration with third country National
Standardization Bodies (NSBs) or with regional standardization bodies may take several shapes
depending on their links with Europe, their wish to participate in technical activities and their interest
in the results of the European Standardization process. In that respect CEN and CENELEC are
proposing four different models of cooperation:
For NSBs in third countries the concepts of:
 Affiliation,
 Standardization Partnership (PSB),
 Agreement;
for the regional grouping of those NSBs:
 Memorandum of Understanding (MoU).
The AFFILIATION is open for an NSB/NC member of ISO or IEC respectively which represents or
has the ambition to represent all parties concerned in an evolving market industry. They belong to a
EU neighbouring country which has links with EU or EFTA in relation to technical scientific political
and social conditions. The details regarding this status are given in the present CEN/CENELEC
Guide 12.
The STANDARDIZATION PARTNERSHIP is offered to an NSB/NC member of ISO or IEC
respectively which represents or has the ambition to represent all parties concerned in an evolving
market economy of a country which cannot obtain the status of CEN or CENELEC Member nor the
status of CEN or CENELEC Affiliate. The details regarding this PSB status are given in
CEN/CENELEC Guide 13.
The AGREEMENT is offered to any kind of NSB not desiring to become Affiliate or PSB but
interested in developing official relations with CEN and/or CENELEC. This model of cooperation
may comprise elements such as exchange of information, transfer of knowledge, cooperation in
standardization activities and bodies.
The MEMORANDUM OF UNDERSTANDING is a tool established to start official cooperation
relations with recognized Regional Groupings of third country NSBs.


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CEN/CENELEC Guide 12 The concept of Affiliation with CEN and CENELEC

CONTENTS
1 Historical background . 7
2 Definition of affiliation . 7
3 Conditions for granting affiliation . 8
4 Rights and obligations of Affiliates . 8
5 Annual Affiliation fees . 9
Annex 1 – Basic rights and obligations of Affiliates .10
Annex 2 – Agreement on the conditions to be respected by an Affiliate when implementing a
European Standard (EN) .11
Annex 3 – Exploitation Agreement to be respected by an Affiliate .13
Annex 4 – Estimates of GDP for EU neighbouring countries .20



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CEN/CENELEC Guide 12 The concept of Affiliation with CEN and CENELEC

1 Historical background
As a consequence of the political evolution, which took place in the late eighties in Central and
Eastern Europe, several standardization bodies of these countries had asked for the possibility of
obtaining a special status in the existing European standardization structures. In response, an
affiliation status had been created in CEN and CENELEC. At that time affiliation was considered as
a pre-member status.
st
On 1 May 2004, the European Union (EU) has entered a new and historic phase: an enlarged
st
union of 25 countries. Moreover on 1 January 2007 Romania and Bulgaria joined the European
Union. Beyond these milestones, negotiations proceed further at Commission level with the
candidate and potential candidate countries for EU accession, i.e. Turkey and the Balkan countries.
The whole enlargement process brings us in contact with new neighbours. In this context a
Commission Communication (COM(2003)104 final of 2003-03-11) “Wider Europe-Neighbourhood: A
new Framework for Relations with our Eastern and Southern Neighbours” highlights the political and
economical importance of enhancing the relations with Russia, with the Western Newly Independent
States (Ukraine, Moldova, Belarus) and the southern Mediterranean (Algeria, Egypt, Israel, Jordan,
Lebanon, Libya, Morocco, Palestinian Authority, Syria, Tunisia). The European Neighbourhood
policy was extended to also include the countries of the Southern Caucasus with whom Bulgaria,
Romania and the present candidate country Turkey share either a maritime or land border (i.e.
Armenia, Azerbaijan and Georgia). These countries mentioned under the European Neighbourhood
Policy, together with the (potential) candidate countries for EU accession are referred to hereafter
as "EU neighbouring countries".
It is in this historical and politico-economical context that the present Guide has been developed, on
the basis of previously existing material. It defines affiliation and describes the conditions for
granting affiliation, the rights of Affiliates and their obligations; a summary table of these aspects
being reproduced in Annex 1.
It is acknowledged that affiliation with CEN and/or CENELEC does not constitute a pre-membership
status for the affiliated body. Moreover, CEN and CENELEC being independent organizations, the
fact to be recognized as Affiliate by one organization does not imply ipso facto the recognition by the
other one.
2 Definition of affiliation
Affiliation with CEN is available to a National Standards Body, which is a member (or corresponding
member) of the ISO, and which represents or has the ambition to represent all parties concerned in
an evolving market economy of a EU neighbouring country having links with the EU or EFTA in
relation to technical, scientific, economic, political and social conditions.
Affiliation with CENELEC is available to a National Electrotechnical Committee, which is a member
(or associate member) of the IEC, and which represents or has the ambition to represent all parties
concerned in an evolving market economy of a EU neighbouring country having links with the EU or
EFTA in relation to technical, scientific, economic, political and social conditions.


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3 Conditions for granting affiliation
In the spirit of the definition above, the following conditions shall be met by an applicant for
affiliation:
 recognized as the only National Standards Body/National Electrotechnical Committee from a
EU neighbouring country,
 member or corresponding member of the ISO/member or associate member of the IEC,
 registered in the ISO/IEC List of Standardizing Bodies having notified acceptance of the
WTO Code of Good Practice for the Preparation, Adoption and Application of Standards.
From a procedural perspective, the candidate organization shall submit to the CEN Secretary
General and/or CENELEC Director General a written application to become an Affiliate, in which it
shows proof of its compliance with the above conditions. The application is referred to the pertinent
General Assembly(ies) and is granted on a two-third majority decision of the Members, either in a
statutory meeting or by correspondence. The decision also specifies the commencement date for
the Affiliate status.
4 Rights and obligations of Affiliates
4.1 Rights
 To participate without voting rights, in the General Assembly (AG) of CEN and/or CENELEC
and, with the agreement of AG, in identified bodies with an open character;
 To participate in Technical Bodies as an observer. Requests for such participation should be
addressed to the CEN Management Center (CMC) and/or CENELEC Central Secretariat
(CS), which will provide access to the relevant document server and inform the Technical
Body of this observership;
 To reproduce and sell, within its own country, drafts for Enquiry, UAP and Formal Vote;
 To implement European Standards (EN) as national standards in its own language or in one
of the official languages of CEN and CENELEC and to withdraw conflicting national
standards – see Annex 2 for the Agreement on the conditions to be respected by an Affiliate
when implementing a European Standard (EN). The supply of the texts of the ratified
European Standards, as well as of Harmonization Documents (HD), Technical Specifications
(TS), Technical Reports (TR) and Workshop Agreements (CWA), will start at the
commencement date of the Affiliation status and does normally not include the supply of
previously issued publications;
 To sell ENs not adopted as national standards by arrangement with one or more CEN
National Members or CENELEC National Committees in accordance with the
CEN/CENELEC Guide 10 “Guidelines for the distribution and sales of CEN/CENELEC
publications”;
 To receive and sell corporate publications of CEN and/or CENELEC, in accordance with
CEN and/or CENELEC practices. These publications include amongst others the Catalogue,
the Guides, the Internal Regulations, as well as Press Releases (freely reproducible with
source acknowledgement) and any future corporate publication.


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4.2 Obligations
 To commit to comply with the rules set or to be set in the future by the CEN Statutes and/or
CENELEC Articles of Association, the CEN/CENELEC Internal Regulations and other
relevant resolutions taken by the General Assembly and Administrative Board of CEN
and/or CENELEC, including financial obligations;
 To implement ENs, developed by Technical Bodies in which it participates, as national
standards in accordance with the CEN/CENELEC Internal Regulations – Part 2, to show
evidence of the adoption of ENs and to withdraw conflicting national standards;
 To notify all national implementations of European Standards to the CEN Management
Center and/or CENELEC Central Secretariat;
 To strictly apply CEN/CENELEC Guide 10 “Guidelines for the distribution and sales of
CEN/CENELEC Publications”;
 To respect the agreements established between CEN and ISO and/or between CENELEC
and IEC;
 To notify all new national projects to the CEN Management Center and/or CENELEC
Central Secretariat, and implement standstill on national work in accordance with the
procedure for the provision of information in the field of standards, as given in Directive
98/34/EC;
 To sign and abide by the terms of the Agreement on the conditions to be respected by an
Affiliate when implementing a European Standard (EN) (see Annex 2);
 To sign and abide by the terms of the binding Exploitation Agreement for the distribution and
sales of publications of CEN and/or CENELEC (see Annex 3).
5 Annual Affiliation fees
Among the obligations, mention is made of the financial obligations. These include the payment by
the Affiliate of an annual fee, decided by the General Assembly of CEN and/or CENELEC. The
General Assembly decision shall be based on the following calculation principles.
 the affiliation fee shall be the multiplication of a base fee, decided annually by the General
Assembly, with a correcting factor linked to the GDP at current prices in US dollars of the
country of the (candidate) Affiliate – see also Annex 4,
 the base fee for affiliation shall not exceed the contribution unit used for the calculation of
the individual financial contribution of the National Members of CEN and/or CENELEC,
 the correcting factors are as follows:
GDP Intervals (in million USD) Correcting factor
0 - 20 000 1
20 000 - 60 000 1,5
60 000 - 250 000 2
250 000 - 1 000 000 2,5
1 000 000 - 1 500 000 3
> 1 500 000 3,5


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Annex 1

Basic rights and obligations of Affiliates
A national organization entrusted with standardization, member of ISO and/or IEC, in a
Definition
EU neighbouring country
 Only national, recognized organization in a EU neighbouring country
 Member of ISO and/or IEC
Criteria
 Acceptance of the WTO Code of Practice for the preparation, adoption and
application of standards
 To participate without voting rights, in the General Assembly (AG), and identified
bodies with an open character
 To participate in selected Technical Bodies as an observer
 To reproduce and sell, within own country, drafts for Enquiry, UAP and Formal Vote
 To implement ENs as national standards and withdraw conflicting national standards
Rights
 To sell ENs, not adopted as national standards, by arrangement with one or more
CEN National Members or CENELEC National Committees in accordance with the
CEN/CENELEC Guide 10 (Guidelines for the distribution and sales of
CEN/CENELEC publications)
 To receive and sell corporate publications of CEN and/or CENELEC in accordance
with CEN/CENELEC Guide 10
 To commit to comply with the rules set by the CEN Statutes and/or CENELEC
Articles of Association, Internal Regulations and other relevant resolutions taken by
the AG and CA of CEN and/or CENELEC, including financial obligations
 To implement ENs developed by Technical Bodies in which it participates as national
standards and to withdraw conflicting national standards
 To notify national implementations of ENs
 To notify all new national projects and to implement standstill on national work in
Obligations
accordance with the procedure for the provision of information in the field of
standards, as given in Directive 98/34/EC
 To strictly apply CEN/CENELEC Guide 10 “Guidelines for the distribution and sales
of CEN/CENELEC Publications”
 To respect the agreements between ISO & CEN and IEC & CENELEC
 To abide by the terms of the Agreements on implementation and exploitation of
CEN/CENELEC publications
 Corporate documentation, e.g. Catalogue, Guides
Documentation
 prENs submitted to Enquiry, UAP and Formal Vote
received
 Ratified texts of ENs
Annual – Base fee fixed by AG multiplied by a correcting factor according
...