17.11.  75 Official  Journal  of the European  Communities No C 263/39 
5. Comments  on the annexes 
The Committee  draws  attention  to the observations 
in the report  of the Section  for Industry,  Commerce, 
Crafts  and  Services  concerning  certain  aspects  of the 
technical  specifications  included  in the  annexes  to 
the draft  Directive.  The  Committee  does  not  feel 
competent  to take  up positions  on these  technical 
matters,  but  it is concerned  to ensure  that  the 
standards  laid  down  in the Directive  are not such  as 
to require  major  re-design  and  re-tooling  without  any 
appreciable  improvement  in safety.  The  Committee therefore  suggests  that,  in consultation  with  users 
and producers,  the  Commission  should  re-examine 
the specifications  on which  observations  are made  in 
the abovementioned  report. 
Done  at Brussels,  28 May  1975. 
The Chairman 
of the Economic  and  Social  Committee 
Henri  CANONGE 
Opinion  on the 
proposal  for  a Council  Directive  on the  approximation  of the  laws  of the  Member 
States  relating  to electro-medical  equipment 
proposal  for  a Council  Directive  on the  approximation  of the  laws  of the  Member 
States  relating  to medical  X-ray  equipment  operating  at 10 to 400  kV 
The text  referred  to the Committee  was  published  in Official  Journal  of the European 
Communities  No  C 33 of 12 February  1975,  page  5. 
A. LEGAL  BASIS  FOR  THE  OPINION 
On 15 January  1975,  the  Council  referred  the  abovementioned  proposals  to the 
Economic  and  Social  Committee  under  Article  100  of the  Treaty  establishing  the 
European  Economic  Community. 
B. OPINION  OF  THE  ECONOMIC  AND  SOCIAL  COMMITTEE 
The Economic  and  Social  Committee  drew  up its Opinion  at its 130th  plenary  session, 
held in Brussels  on 28 and  29 May  1975. 
The Opinion  is published  below. 
THE  ECONOMIC  AND  SOCIAL  COMMITTEE, 
Having  regard  to the referral  on 17 January  1975  by 
the Council  of the  European  Communities  of the 
proposal  for  a  Council  Directive  on  the 
approximation  of the  laws  of the  Member  States 
relating  to electro-medical  equipment,  and  the 
Proposal  for  a  Council  Directive  on  the 
approximation  of the  laws  of the  Member  States 
relating  to medical  X-ray  equipment  operating  at 10 
to 400  kV; 
Having  regard  to  Article  100  of  the  Treaty 
establishing  the European  Economic  Community; Having  regard  to the decision  taken  by its Bureau  on 
28 January  1975,  instructing  the Section  for Industry, 
Commerce,  Crafts  and  Services  to prepare  the 
Committee's  work  on the matter; 
Having  regard  to the  Opinion  adopted  by  the 
Section  for Industry,  Commerce,  Crafts  and  Services 
at its meeting  on 7 May  1975; 
Having  regard  to the  report  submitted  by  the 
Rapporteur,  Sir John  Peel; 
No C 263/40 Official  Journal  of the  European  Communities 17.11.  75 
Having  regard  to the discussions  at its meeting  on 28 
May  1975  (130th  plenary  session  of 28 and  29 May 
1975); 
Whereas  it is desirable  to reduce  technical  barriers  to 
trade  within  the  common  market,  it is essential  that 
both  electro-medical  equipment  and  medical  X-ray 
equipment  must  satisfy  high  and  clearly  defined 
standards  of safety; 
Whereas  it is necessary  that  manufacturers  should 
recognize  their  responsibility  in regard  to safety  by 
conforming  to agreed  standards  and  indicating  their 
appropriate  markings  on the apparatus; 
Whereas  it is necessary  that  technological  progress 
should  be capable  of prompt  adaptation  through  the 
medium  of a Committee, 
HAS  ADOPTED  THE  FOLLOWING  OPINION 
by a unanimous  vote: 
The Committee  approves  the  Commission's 
proposals  in both  Directives  but  wishes  to make  the 
following  comments: 
1. General  comments 
1.1. While  generally  favouring  total  harmonization 
in the interests  of trade  by the  removal  of technical 
barriers,  the  Committee  approves  the  alternative  of 
optional  harmonization  applied  to electro-medical 
and medical  X-ray  equipment,  because  of the  need 
for special  safety  precautions.  This  applies  especially 
to X-ray  equipment,  where  there  is a particular  risk 
of radiation  hazards,  both  to doctors  and  technicians 
using  the  apparatus  and  to  patients  receiving 
treatment  or undergoing  investigation. 
1.2. In  the  case  of electro-medical  equipment,  the 
Committee  notes  that  much  of  the  equipment 
excluded  from  the  Directive  is of greater  practical 
importance  than  that  which,  by  implication,  is 
included.  For  example,  the  Directive  does  not  cover 
machines  used  for  electro-cardiography, 
defibrillation,  electro-encephalography  and  cardiac 
catherisation.  These,  and  many  other  appliances,  are 
in constant  use  in specialist  units  in hospitals 
throughout  the  Community.  While  appreciating  that 
this exclusion  is due  to the fact  that  safety  standards 
have  not  yet  been  agreed,  the  Committee  urges  the 
Commission  to  press  the  international  electro-
technical  Commission,  to proceed  as fast  as possible 
so that  agreement  can  be reached  on safety  standards 
and the equipment  so far excluded  is brought  within the ambit  of future  directives  as soon  as possible. 
The Committee  notes  that  the draft  Directive  adopts 
a negative  system.  The  equipment  referred  to in 
Annex  I does  not come  within  the ambit  of the draft 
Directive.  The  'electro-medical  equipment'  is a 
particularly  vague  term  and  the  Committee  would 
prefer  the  Directive  to specify  clearly  what  type  of 
equipment  it covers.  It asks  the  Commission  to 
examine  again  the  possibility  of establishing  a 
positive  list,  which  should  be updated  from  time  to 
time. 
1.3. While  it is true  that  X-ray  equipment 
operating  in the  range  of 10  to 400  kV  covers 
apparatus  in  most  common  use  in  diagnostic 
radiology,  much  of modern  radio-therapy  employs 
apparatus  outside  this  range.  The  Committee  would 
like to know  when  further  Directives  may  be 
forthcoming  to cover  equipment  outside  the range  of 
10 to 400  kV. 
1.4. The  Committee  particularly  welcomes  the 
provision  that  applications  for  EEC  type  approval 
may not  be submitted  to more  than  one  Member 
State,  and  hopes  that  there  will  be rigid  adherence  to 
this, thereby  avoiding  the  possibility  of 'shopping 
around'  and  obtaining  equipment  with  inferior 
safety  standards. 
1.5. The  whole  area  of electro-medical  equipment 
is one  in which  research  and  technical  progress  is 
advancing  very  rapidly,  and  this  should  be 
encouraged.  The  Committee  hopes  that  the proposed 
committee  on the  adaptation  to technical  progress 
will not  operate  in any  restrictive  way  by delaying 
the procedure  whereby  newly-developed  equipment 
may be made  available  for sale  and  use  throughout 
the Community. 
1.6. The  Committee  notes  that  the  Directive  does 
not cover  either  the place  of use  or the qualifications 
and training  of the  people  permitted  to use  the 
equipment.  No  matter  how  many  safety  regulations 
regarding  the  equipment  itself  are  introduced, 
dangers  can  and  do arise  as a result  of the machines 
being  used  under  unsuitable  conditions  or  by 
individuals  incompletely  trained  and  inexperienced 
in their  use.  It is not  mandatory  yet  in all  the 
Member  States  for  X-ray  technicians  and 
maintenance  engineers  for  example,  to  possess 
standard  qualifications  and  to have  had  specified 
training  before  being  allowed  to handle  what  is 
manifestly  dangerous  apparatus.  The  Committee 
hopes  that  the  Commission  will  bear  this  aspect  of 
17.11.  75 Official  Journal  of the European  Communities No C 263/41 
the problem  in mind  in relation  to the  right  of 
establishment  and  mutual  recognition  of 
qualifications  and training. 
2. Specific  comments 
(a) First  proposal  concerning  electro-medical 
equipment 
Article  2 
In this  Article  provision  is  made  for  the 
manufacturer  to attest  conformity  by declaration  of 
compliance  with  the  requirement  of IEC  document 
TC 62A  (SEC).  It is not  clear  whether  this  shall  be 
by mark  or certification  and  also  whether  if by mark 
this shall  be similar  to the  mark  depicted  in the 
Annex  and  also  whether  the  affixation  of such  a 
mark  by manufacturer  alone  shall  be treated  with 
parity  of regard  with  a similar  mark  affixed  to a 
similar  piece  of  equipment  by  an  approved 
laboratory. 
Article  10 
This  Article  directs  that  Member  States  shall  apply 
the provisions  necessary  to  comply  with  the 
requirements  of the Directive  with  effect  from  1 July 
1977.  Taking  into  account  the technical  complexity, 
the high  technology  involved,  the  amount  of 
thorough  testing  necessary  to prove  design  changes 
and the  long  production  time  and  relatively  slow 
turnover,  it is considered  that  the  time  allowed  for 
application  is much  too short. 
(b) Second  proposal  on medical  X-ray  equipment 
A r t i c 1 e 1 
The directive  is only  to cover  medical  X-ray 
equipment  operating  at 10 to 400  kV.  The  definition 
in Article  1 (2) — electrical  equipment  which  uses 
ionizing  radiation  from  an electrical  or radioactive 
source  — is thus  misleading.  Article  1 (2) should 
read:  'Medical  X-ray  equipment  is understood  to 
mean  medical  electrical  equipment  which  uses 
X-rays'. Article  5 
The criteria  governing  withdrawal  of type-approval 
(Article  5 (3))  should  be made  more  comprehensive 
so as to cover  new  developments  in particular  new 
knowledge. 
The Committee  would  like  to add  a new  Section  2 to 
Article  5: 
'The  inspection  carried  out  prior  to the granting 
of type-approval  can  be carried  out either  by the 
manufacturer,  the  granting  authority,  or the 
purchaser'. 
Article  6 
A differentiation  must  be drawn  in Article  6 between 
— the  mark  denoting  EEC  type-approval  (Article  2 
(1), first  indent)  in regard  to the  radiological 
safety  of the X-ray  generator,  and 
— the  mark  denoting  the manufacturer's  attestation 
(Article  2 (1)  second  indent)  in regard  to the 
X-ray  equipment's  meeting  other  safety  standards. 
The Committee  would  prefer  Article  6 to read  as 
follows: 
'The  mark  of EEC  type-approval,  affixed  to the 
equipment  by the  manufacturer,  attests  that  the 
equipment  is in conformity  with  the  equipment 
described  in the report  referred  to in Article  5 (2) 
and that  the measurement  results  are the same  as 
those  of the equipment  in respect  of which  type-
approval  was  granted'. 
A r t i c 1 e 11 
This  Article  directs  that  Member  States  shall  apply 
the provisions  necessary  to  comply  with  the 
requirements  of the Directive  with  effect  from  1 July 
1977.  Taking  into  account  the technical  complexity, 
the high  technology  involved,  the  amount  of 
thorough  testing  necessary  to prove  design  changes 
and the  long  production  time  and  relatively  slow 
turnover,  it is considered  that  the  time  allowed  for 
application  is much  too short. 
Done  at Brussels,  28 May  1975. 
The Chairman 
of the Economic  and  Social  Committee 
Henri  CANONGE