NS-EN ISO 13485:2016

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Status: Check Published
Norwegian title: Medisinsk utstyr - Systemer for kvalitetsstyring - Krav for å oppfylle regelverk (ISO 13485:2016)
English title: Medical devices - Quality management systems - Requirements for regulatory purposes (ISO 13485:2016)
Item type: Standard
Language: Engelsk
Edition: 1 (2016-06-01)
Supersedes: NS-EN ISO 13485:2012 Alert Withdrawn
NS-EN ISO 13485:2012/AC:2012 Alert Withdrawn
NS-EN ISO 13485:2012 Alert Withdrawn
Number of pages: 72
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NOK 779,00 (excl. VAT)
NOK 973,75 (with VAT)

Included in: NS ICS 03.120
NS ICS 03.120.10
NS ICS 03
NS ICS 03.100
NS ICS 11
NS ICS 11.040
NS ICS 11.040.01
NS og NS-EN komplett (eks NS-EN ISO)
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Committee: SN/K 113
Adopted: 2016-06-01
ICS: 03.100.70 - Ledelsessystemer
03.120.10 - Kvalitetsledelse og kvalitetssikring
11.040.01 - Medisinsk utstyr generelt