CEN Standard on Medical Physics Services:
CEN standardization procedure
Luca Moro
AIFM representative on the
EFOMP Working Group
CEN Standard on:
Medical Physics Services
luca.moro@fsm.it
Luca Moro, ECMP 2014, 11 – 14 September 2014, Athens, Greece
1
WHO
CEN (European Committee for Standardization) is:
•
a private international non-profit organization based in
Brussel that brings together the National Standardization
Bodies of 33 European countries (Members) and 17
Affiliates plus other international Partners;
•
one of three European Standardization Organizations
(together with CENELEC and ETSI) that have been officially
recognized by the European Union and by the European
Free Trade Association (EFTA) as being responsible for
developing and defining voluntary standards at European
level.
2
WHO
The CEN System consists of three
main levels or functions:
• Technical Board (BT) and Administrative Board (BA): policy
setting, general co-ordination, overall management and
arbitration.
• Technical Committees (TC) and CEN-CENELEC Management
Centre: programming and planning of the execution of
future standards and other deliverables, and management
of consensus building processes.
• Working Groups (WG): drafting of documents leading to the
timely production of high quality standards and other
deliverables.
3
WHAT
Interested
parties
members
stakeholder
CEN brings together knowledge and
expertise from its members, from all
interested parties - including
manufacturers, users, consumers and
regulators - and from other
stakeholders, in order to develop
European Standards and technical
specifications for products, materials
and services through a transparent,
open and consensus based process.
4
HOW
Proposals for new work:
• may originate from a European trade, professional,
technical or scientific organization,
• are introduced by a CEN member.
5
HOW
The appropriate CEN Technical Committee makes a
decision on the adoption of the proposal.
An adopted standardization project is allocated to
one of the Working Groups for the drafting of the
standard.
6
HOW
Once the draft of a European Standard is prepared, it is
released for public comment, a process known in CEN as
the ‘CEN Enquiry’.
During the public commenting
stage, everyone who has an
STAKEHOLDERS
interest (e.g. manufacturers,
public authorities, consumers,
etc.) may comment on the draft.
DRAFT
These views are collated by the National Standards Bodies
and analyzed by the CEN Technical Committee.
7
HOW
Taking into consideration the comments resulting from the
CEN Enquiry, a final version is drafted, which is then
submitted to the CEN national Members for a weighted
formal vote.
8
HOW
After ratification by CEN, each of the National Standards
Bodies adopts the European Standard as an identical
national standard and withdraws any national standards
which conflict with the new European Standard.
Hence one European Standard becomes the national
standard in the 33 member countries of CEN.
9
HOW
PROPOSAL
ACCEPTANCE
DRAFTING
CEN ENQUIRY
ADOPTION
BY
WEIGHTED
VOTE
PUBLICATION
OF THE
EUROPEAN
STANDARD
(EN)
3 YEARS
10