Welcome to Scribd, the world's digital library. Read, publish, and share books and documents. See more
Download
Standard view
Full view
of .
Look up keyword
Like this
8Activity
0 of .
Results for:
No results containing your search query
P. 1
SymolsN154 Draft PrEN 980

SymolsN154 Draft PrEN 980

Ratings: (0)|Views: 910|Likes:
Published by medic011

More info:

Categories:Topics, Art & Design
Published by: medic011 on May 31, 2010
Copyright:Attribution Non-commercial

Availability:

Read on Scribd mobile: iPhone, iPad and Android.
download as PDF, TXT or read online from Scribd
See more
See less

11/12/2012

pdf

text

original

 
Document type: European StandardDocument subtype:Document stage: prENDocument language: ECEN/TC 257 N154
CEN/TC 257 N154
CEN/TC 257
 
Date: 2005-12-12Secretariat: SFSTermination of the commenting period:
2006-01-25
WORKING DRAFT prEN 980Symbols for use in the labelling of medical devices —
Symbole zur Kennzeichnung von Medizinprodukten —
Symboles utilisés pour l'étiquetage des dispositifs médicaux —ICS:Descriptors:
 
CEN/TC 257 N154
prEN 980:2005 (E)
2
Contents
1
 
Scope..............................................................................................................................................................6
 
2
 
Normative references....................................................................................................................................6
 
3
 
Definitions......................................................................................................................................................6
 
4
 
General requirements....................................................................................................................................7
 
4.1
 
Proposal of symbols for adoption...............................................................................................................7
 
4.2
 
Requirements for usage................................................................................................................................7
 
5
 
Symbols already in use.................................................................................................................................8
 
5.1
 
General............................................................................................................................................................8
 
5.2
 
Symbol for "DO NOT REUSE"......................................................................................................................8
 
5.3
 
Symbol for "USE BY"....................................................................................................................................9
 
5.4
 
Symbol for "BATCH CODE"..........................................................................................................................9
 
5.5
 
Symbol for "SERIAL NUMBER"..................................................................................................................10
 
5.6
 
Symbol for "DATE OF MANUFACTURE"...................................................................................................10
 
5.7
 
Symbol for "STERILE"................................................................................................................................11
 
5.8
 
Symbols for "STERILE", including the method of sterilization..............................................................11
 
5.9
 
Symbol for “STERILE BY ASEPTIC TECHNIQUES”.................................................................................12
 
5.10
 
Symbol for "CATALOGUE NUMBER"........................................................................................................13
 
5.11
 
Symbol for "CAUTION, CONSULT ACCOMPANYING DOCUMENTS "...................................................13
 
5.12
 
Symbol for "MANUFACTURER".................................................................................................................14
 
5.13
 
Symbol for "AUTHORISED REPRESENTATIVE IN THE EUROPEAN COMMUNITY"............................14
 
5.14
 
Symbol for " SUFFICIENT FOR "................................................................................................................15
 
5.15
 
Symbol for "FOR IVD PERFORMANCE EVALUATION ONLY "...............................................................15
 
5.16
 
Symbol for "IN VITRO DIAGNOSTIC MEDICAL DEVICE"........................................................................16
 
5.17
 
Symbols for ”TEMPERATURE LIMITS” including indication of limits of temperature.........................16
 
5.18
 
Symbol for "CONSULT INSTRUCTIONS FOR USE".................................................................................18
 
5.19
 
Symbol for "BIOLOGICAL RISKS".............................................................................................................18
 
6
 
New symbols................................................................................................................................................18
 
6.1
 
General..........................................................................................................................................................18
 
6.2
 
Symbol for “DEVICE CONTAINS NATURAL RUBBER LATEX”..............................................................19
 
6.3
 
Symbol for “DO NOT USE IF PACKAGE IS DAMAGED”..........................................................................19
 
6.4
 
Symbol for “STERILE FLUID PATH”..........................................................................................................19
 
6.5
 
Symbol for “KEEP AWAY FROM SUNLIGHT”..........................................................................................20
 
6.6
 
Symbol for “GLOBAL MEDICAL DEVICE NOMENCLATURE CODE”.....................................................20
 
Annex A (informative) Examples of uses of symbols given in this standard...................................................21
 
A.1
 
Examples of use of symbol for "USE BY".................................................................................................21
 
A.2
 
Example of use of symbol for "BATCH CODE"........................................................................................21
 
A.3
 
Examples of use of symbol for "SERIAL NUMBER"................................................................................21
 
A.4
 
Examples of use of symbol for "DATE OF MANUFACTURE".................................................................21
 
A.5
 
Examples of use of symbol for "CATALOGUE NUMBER"......................................................................22
 
A.6
 
Examples of use of symbol for "MANUFACTURER"...............................................................................22
 
A.7
 
Example of use of symbol for “MANUFACTURER” combined with “DATE OF MANUFACTURE”.....22
 
A.8
 
Examples of use of symbol for " AUTHORISED REPRESENTATIVE IN THE EUROPEANCOMMUNITY"...............................................................................................................................................22
 
A.9
 
Examples of use of symbol for " SUFFICIENT FOR"...............................................................................23
 
A.10
 
Example of use of symbol for "UPPER LIMIT OF TEMPERATURE".......................................................23
 
A.11
 
Example of use of symbol for "LOWER LIMIT OF TEMPERATURE"......................................................23
 
A.12
 
Example of use of symbol for "TEMPERATURE LIMITATION"...............................................................23
 
A.13
 
Examples of use of symbol for “STERILE FLUID PATH”........................................................................23
 
A.14
 
Examples of use of symbol for ‘GLOBAL MEDICAL DEVICE NOMENCLATURE CODE”....................24
 
Annex B (informative) Use of the general prohibition symbol............................................................................25
 
 
prEN 980:2005 (E)
3Annex ZA (informative) Clauses of this European Standard addressing essential requirements or other provisions of the Council Directive 93/42/EEC concerning medical devices.............................26
 
Annex ZB (informative) Clauses of this European Standard addressing essential requirements or other provisions of the Council Directive 90/385/EEC relating to active implantable medicaldevices..........................................................................................................................................................27
 
Annex ZC (informative) Clauses of this European Standard addressing essential requirements or other provisions of the European Parliament and the Council Directive 98/79/EC on in vitrodiagnostic medical devices........................................................................................................................28
 

Activity (8)

You've already reviewed this. Edit your review.
1 hundred reads
1 thousand reads
Aref Modanlu liked this
Aref Modanlu liked this
Peter Sheridan liked this
Nebojsa Djuric liked this
digitar559076 liked this

You're Reading a Free Preview

Download
scribd
/*********** DO NOT ALTER ANYTHING BELOW THIS LINE ! ************/ var s_code=s.t();if(s_code)document.write(s_code)//-->