SIST EN 46002:1999

Oznaka standarda: SIST EN 46002:1999
Koda projekta: QS000953
Organizacija: SIST
Naslov (angleški): Quality systems - Medical devices - Particular requirements for the application of EN ISO 9002
Naslov (slovenski): Quality systems - Medical devices - Particular requirements for the application of EN ISO 9002
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Ime Jezik Status Cena Dodaj v košarico
SIST EN 46002:1999 angleški jezik Withdrawn SIST-C: 41.80 EUR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-nov-1999
Refer. št. objave: Sporocila 1999-11-01
Razveljavitev: 01-nov-2009
Referenca razveljavitve: Sporočila 2009-11
Področje projekta (angleško): This European Standard specifies, in conjunction with EN ISO 9002, the quality system requirements for the production, and where relevant, installation of medical devices. The field of application of EN ISO 9002 applies. In addition, this European Standard, in conjunction with EN ISO 9002, is applicable when a medical device supplier's quality system is assessed in accordance 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
Nadomešča SIST EN 46002:1995 - Quality systems - Medical devices - Particular requirements for the application of EN 29002/Amendment 01-nov-1999
Nadomeščen z SIST EN ISO 13485:2003 - Medicinski pripomočki – Sistemi vodenja kakovosti – Zahteve za zakonodajne namene (ISO 13485:2003) 01-nov-2009


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