SIST EN 46003:2002

Oznaka standarda: SIST EN 46003:2002
Koda projekta: QS000001
Organizacija: SIST
Naslov (angleški): Quality systems - Medical devices - Particular requirements for the application of EN ISO 9003
Naslov (slovenski): Quality systems - Medical devices - Particular requirements for the application of EN ISO 9003
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Ime Jezik Status Cena Dodaj v košarico
SIST EN 46003:2002 angleški jezik Withdrawn SIST-C: 41.80 EUR
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Tehnični odbor: VAZ - Varovanje zdravja
ICS: 03.100.70 11.020.01
Status: Razveljavljen
Objavljen: 01-feb-2002
Refer. št. objave: Sporocila 2002-02-01
Razveljavitev: 01-nov-2009
Referenca razveljavitve: Sporočila 2009-11
Področje projekta (angleško): This European Standard specifies, in conjunction with EN ISO 9003 : 1994, the quality system requirements for the final inspection and test of medical devices excluding in vitro diagnostic medical devices and active implantable medical devices, and is applicable when a medical device supplier's quality system is assessed in accordance with regulatory requirements. NOTE: For sterile medical devices the relevant particular clauses inEN 46002 : 1996 apply as this standard alone is not sufficient for manufacturers of sterile medical devices seeking to comply with regulatory requirements. As part of an assessment by a third party for the purpose of regulatory requirements, the supplier may be required to provide access to confidential data in order to demonstrate compliance with this standard. The supplier may be required to exhibit these data but is not obliged to provide copies for retention.
Povezava na standarde
Povezava Ime Datum
Nadomeščen z SIST EN ISO 13485:2003 - Medicinski pripomočki – Sistemi vodenja kakovosti – Zahteve za zakonodajne namene (ISO 13485:2003) 01-nov-2009
OJ SIST EN ISO 13485:2003 - Medicinski pripomočki – Sistemi vodenja kakovosti – Zahteve za zakonodajne namene (ISO 13485:2003) 27-jan-2009


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