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Standard ČSN EN ISO 13485-ed.2 1.12.2016 preview

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ČSN EN ISO 13485-ed.2 (855001)

Medical devices - Quality management systems - Requirements for regulatory purposes

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STANDARD published on 1.12.2016


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The information about the standard:

Designation standards: ČSN EN ISO 13485-ed.2
Classification mark: 855001
Catalog number: 501287
Publication date standards: 1.12.2016
SKU: NS-668693
The number of pages: 56
Approximate weight : 168 g (0.37 lbs)
Country: Czech technical standard
Category: Technical standards ČSN

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Quality management and quality assuranceMedical equipment in general

Annotation of standard text ČSN EN ISO 13485-ed.2 (855001):

Tato mezinárodní norma stanovuje požadavky na systém managementu kvality, který může využít organizace podílející se na jedné nebo více etapách životního cyklu zdravotnického prostředku. Tuto mezinárodní normu mohou také využít interní a externí strany, včetně certifikačních orgánů, pro posouzení schopnosti organizace plnit požadavky zákazníka a požadavky přepisů na systém managementu kvality a vlastní požadavky organizace. Toto vydání ISO 13485 ruší a nahrazuje přechozí vydání (ISO 3485:2003) a ISO/TR 14969:2004 a představuje technickou revizi

These changes apply to this standard:

Preview ČSN EN ISO 13485-ed.2:2016/A11 1.4.2022
ČSN EN ISO 13485-ed.2:2016/A11 (855001) Change

Zdravotnické prostředky - Systémy managementu kvality - Požadavky pro účely předpisů.

Change published on 1.4.2022

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These corrections apply to this standard:

Preview ČSN EN ISO 13485-ed.2:2016/Oprava1 1.7.2017
ČSN EN ISO 13485-ed.2:2016/Oprava1 (855001) Correction

Zdravotnické prostředky - Systémy managementu kvality - Požadavky pro účely předpisů.

Correction published on 1.7.2017

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Preview of the standard ČSN EN ISO 13485-ed.2 (855001)

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