NS-EN ISO 13485:2016+AC:2018

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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: 2016-03 (2018-06-01)
Supersedes: NS-EN ISO 13485:2016/AC:2016 Alert Withdrawn
Number of pages: 76
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NOK 893,00 (excl. VAT)
NOK 1 116,25 (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)
Adopted: 2018-06-01
ICS: 03.100.70 - Ledelsessystemer
11.040.01 - Medisinsk utstyr generelt
03.120.10 - Kvalitetsledelse og kvalitetssikring