SURGICAL AND MEDICAL DEVICES

UNE-EN 13976-2:2011

UNE-EN 13976-2:2011

Superseded Historical

Rescue systems - Transportation of incubators - Part 2: System requirements

€54.00

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UNE-EN ISO 13408-3:2011

UNE-EN ISO 13408-3:2011

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Aseptic processing of health care products - Part 3: Lyophilization (ISO 13408-3:2006)

€69.00

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UNE-EN ISO 13408-4:2011

UNE-EN ISO 13408-4:2011

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Aseptic processing of health care products - Part 4: Clean-in-place technologies (ISO 13408-4:2005)

€69.00

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UNE-EN ISO 13408-5:2011

UNE-EN ISO 13408-5:2011

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Aseptic processing of health care products - Part 5: Sterilization in place (ISO 13408-5:2006)

€69.00

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UNE-EN ISO 13408-6:2011

UNE-EN ISO 13408-6:2011

Superseded Historical

Aseptic processing of health care products - Part 6: Isolator systems (ISO 13408-6:2005)

€72.00

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UNE-EN ISO 25424:2011

UNE-EN ISO 25424:2011

Superseded Historical

Sterilization of medical devices - Low temperature steam and formaldehyde - Requirements for development, validation and routine control of a sterilization process for medical devices (ISO 25424:2009)

€97.00

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UNE-EN ISO 14160:2012

UNE-EN ISO 14160:2012

Superseded Historical

Sterilization of health care products - Liquid chemical sterilizing agents for single-use medical devices utilizing animal tissues and their derivatives - Requirements for characterization, development, validation and routine control of a sterilization process for medical devices (ISO 14160:2011)

€91.00

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UNE-EN ISO 8536-1:2012

UNE-EN ISO 8536-1:2012

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Infusion equipment for medical use - Part 1: Infusion glass bottles (ISO 8536-1:2011)

€54.00

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UNE-EN ISO 14155:2012

UNE-EN ISO 14155:2012

Superseded Historical

Clinical investigation of medical devices for human subjects - Good clinical practice (ISO 14155:2011)

€116.00

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UNE-EN ISO 8362-4:2012

UNE-EN ISO 8362-4:2012

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Injection containers and accessories - Part 4: Injection vials made of moulded glass (ISO 8362-4:2011)

€54.00

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UNE-EN ISO 15882:2009

UNE-EN ISO 15882:2009

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Sterilization of health care products - Chemical indicators - Guidance for selection, use and interpretation of results (ISO 15882:2008)

€85.00

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UNE-EN ISO 10993-7:2009

UNE-EN ISO 10993-7:2009

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Biological evaluation of medical devices - Part 7: Ethylene oxide sterilization residuals (ISO 10993-7:2008)

€132.00

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UNE-EN 14563:2009 (R2016)

UNE-EN 14563:2009 (R2016)

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Chemical disinfectants and antiseptics - Quantitative carrier test for the evaluation of mycobactericidal or tuberculocidal activity of chemical disinfectants used for instruments in the medical area - Test method and requirements (phase 2, step 2)

€84.00

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UNE-EN ISO 10993-14:2009

UNE-EN ISO 10993-14:2009

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Biological evaluation of medical devices - Part 14: Identification and quantification of degradation products from ceramics (ISO 10993-14:2001)

€69.00

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UNE-EN ISO 10993-17:2009

UNE-EN ISO 10993-17:2009

Superseded Historical

Biological evaluation of medical devices - Part 17: Establishment of allowable limits for leachable substances (ISO 10993-17:2002)

€80.00

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