Please select and order
€38.42
excl. VAT
CONFIGURE NOW
Norm
ÖNORM EN 13641
Issue date: 2002 07 01
Elimination or reduction of risk of infection related to in vitro diagnostic reagents
This European Standard specifies requirements related to design and manufacture in order to effectively control
the risk of infection caused by in vitro diagnostic reage...
Read more
Valid
Publisher:
Austrian Standards International
Format:
Digital | 8 Pages
Language:
German
| English
| Download GER/ENG
Optionally co-design standards:
ICS
This European Standard specifies requirements related to design and manufacture in order to effectively control
the risk of infection caused by in vitro diagnostic reagents including reagent products, calibrators, control materials
and kits, hereinafter called IVD reagents. The standard is applicable to in vitro diagnostic reagents containing
material of human origin. The standard is also applicable to in vitro diagnostic reagents containing materials
obtained by biotechnology processes or materials of animal origin, in particular in view of relevant zoonoses, when
the results of a risk analysis reveal that there is a risk of human infection.
The standard does not apply to the following:
instruments and specimen receptacles;
NOTE 1 The prevention of infection due to handling of biological materials throughout such equipment is
addressed in other relevant International and/or European Standards.
general aspects of workers protection;
transportation of infectious goods;
disposal measures.
NOTE 2 Some of the most relevant documents relating to aspects not covered by this standard are listed in
Bibliography for information.
ÖNORM EN 13641
2002 07 01
Elimination or reduction of risk of infection related to in vitro diagnostic reagents
Norm
↖
Norm
ÖNORM EN 375
Issue date :
2001 04 01
Information supplied by the manufacturer with in vitro diagnostic reagents for professional use
Norm
ÖNORM EN 376
Issue date :
2002 05 01
Information supplied by the manufacturer with in vitro diagnostic reagents for self-testing