ISO 13485 is designed to be used by organizations involved in the design, production, installation and servicing of medical devices and related services. It can also be used by internal and external parties, such as certification bodies, to help them with their auditing processes.

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USA: s FDA-certifiering, EU CE-certifiering, ISO9001, ISO13485-certifiering. Custom China Disposable Factory Wholesale Non-woven 3ply Face Mask typ Form: Dammmask Funktion: Rutinskyddstil: Elastisk öronslinga Standard: GB / T 3 Ply Surgical Face Mask Produktimplementeringsstandard: YY / T 0969-2013 S: Vi' vi har FDA, CE, ISO 13485 och vissa licenser för hemmamarknaden. Nyckelring med mun mot mun-mask (EN 13485:2003). Från 20,00 kr.

Nyckelring med andningsmask. Nyckelring med mun mot mun-mask (EN 13485:2003). Standard: EN149, EN149:2001+A1:2009. Filter Rating: >95%. Feature: Medical,Non-Sterile.

ISO 13485:2016 is the international standard that specifies requirements for a quality management system where an organization needs to demonstrate its ability to provide medical devices and related services that consistently meet customer requirements and regulatory requirements applicable to medical devices and related services.

lagring och distribution. ISO 13485 Medical devices -- Quality management systems -- Requirements for regulatory purposes is an International Organization for Standardization (ISO) standard published for the first time in 1996; it represents the requirements for a comprehensive quality management system for the design and manufacture of medical devices. ISO 13485:2016 can be used to test an organization’s ability to meet both customer and regulatory requirements.

Nyckelring med mun mot mun-mask (EN 13485:2003).

ISO 13485 is the main Quality Management System (QMS) standard for medical devices, although several countries have their own set of regulations.As an example, the United States plans to harmonize the Food and Drug Administration (FDA) requirements for medical devices with ISO 13485. EN ISO 13485 certification of your QMS demonstrates your commitment to operating at a global standard. The EN ISO 13485 certification process includes on-site audits to verify the capability and reliability of your quality management system.

5.Soft, lätt, icke-irriterande, latexfria masker. 6. Standard maskstorlek: 17,5 Art.nr. P265.244. Nyckelring med mun mot mun-mask (EN 13485:2003).
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Nyckelring med mun mot mun-mask (EN 13485:2003). Nyckelfunktioner:En medicinsk mask typ II med öronslingorBakteriell filtreringseffektivitet (BFE) I Compliance with product standards:EN 14683 Type II, EN ISO 11737-1 Quality standards:EN ISO 13485Label information and EN ISO 13485. Nyckelring med mun mot mun-mask (EN 13485:2003).

TIMTAKBO Medicinsk Allt material är kvalificerat följer ISO 13485 standard och producerar process. Det räcker inte att lita på standardprodukter; endast munskydd med höga 98%, partikelstorlek: 3,1μm; CE-märkt; EN ISO 13485:2016; Certifierad EN14683 Köp Underhållsfri halvtäckande mask, FFA2P3 R D · Underhållsfri halvtäckande mask, FFA2P3 R D. Art.nr..
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Nyckelring med mun mot mun-mask (EN 13485:2003). Pris : 17,50 SEK. Leverera med tryck : Ca 10 arbetsdagar. Leverera utan tryck : Ca 5 arbetsdagar.

EN 14683 TYPE IIR Standard EN ISO 13485:2016.