SURGICAL AND MEDICAL DEVICES

UNE-EN ISO 80369-7:2022

UNE-EN ISO 80369-7:2022

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Small-bore connectors for liquids and gases in healthcare applications - Part 7: Connectors for intravascular or hypodermic applications (ISO 80369-7:2021)

€109.00

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UNE-EN ISO 15883-5:2022

UNE-EN ISO 15883-5:2022

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Washer-disinfectors - Part 5: Performance requirements and test method criteria for demonstrating cleaning efficacy (ISO 15883-5:2021)

€126.00

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UNE-EN ISO 17664-1:2022

UNE-EN ISO 17664-1:2022

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Processing of health care products - Information to be provided by the medical device manufacturer for the processing of medical devices - Part 1: Critical and semi-critical medical devices (ISO 17664-1:2021)

€85.00

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UNE-EN ISO 14971:2020/A11:2022

UNE-EN ISO 14971:2020/A11:2022

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Medical devices - Application of risk management to medical devices (ISO 14971:2019)

€53.00

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UNE-EN ISO 80369-6:2016

UNE-EN ISO 80369-6:2016

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Small bore connectors for liquids and gases in healthcare applications - Part 6: Connectors for neuraxial applications (ISO 80369-6:2016, Corrected version 2016-11-15)

€105.00

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UNE-EN ISO 8871-5:2017

UNE-EN ISO 8871-5:2017

Superseded Historical

Elastomeric parts for parenterals and for devices for pharmaceutical use - Part 5: Functional requirements and testing (ISO 8871-5:2016)

€64.00

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UNE-EN ISO 8536-13:2017

UNE-EN ISO 8536-13:2017

Superseded Historical

Infusion equipment for medical use - Part 13: Graduated flow regulators for single use with fluid contact (ISO 8536-13:2016)

€62.00

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UNE-EN ISO 11138-4:2017

UNE-EN ISO 11138-4:2017

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Sterilization of health care products - Biological indicators - Part 4: Biological indicators for dry heat sterilization processes (ISO 11138-4:2017)

€62.00

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UNE-EN ISO 11138-5:2017

UNE-EN ISO 11138-5:2017

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Sterilization of health care products - Biological indicators - Part 5: Biological indicators for low-temperature steam and formaldehyde sterilization processes (ISO 11138-5:2017)

€60.00

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UNE-EN ISO 11607-2:2017

UNE-EN ISO 11607-2:2017

Superseded Historical

Packaging for terminally sterilized medical devices - Part 2: Validation requirements for forming, sealing and assembly processes (ISO 11607-2:2006, including Amd 1:2014)

€73.00

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UNE-EN ISO 10993-6:2017

UNE-EN ISO 10993-6:2017

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Biological evaluation of medical devices - Part 6: Tests for local effects after implantation (ISO 10993-6:2016)

€94.00

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UNE-EN 868-2:2017

UNE-EN 868-2:2017

Superseded Historical

Packaging for terminally sterilized medical devices - Part 2: Sterilization wrap - Requirements and test methods

€73.00

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UNE-EN 868-3:2017

UNE-EN 868-3:2017

Superseded Historical

Packaging for terminally sterilized medical devices - Part 3: Paper for use in the manufacture of paper bags (specified in EN 868-4) and in the manufacture of pouches and reels (specified in EN 868-5) - Requirements and test methods

€69.00

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UNE-EN 868-4:2017

UNE-EN 868-4:2017

Superseded Historical

Packaging for terminally sterilized medical devices - Part 4: Paper bags - Requirements and test methods

€62.00

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UNE-EN 868-6:2017

UNE-EN 868-6:2017

Superseded Historical

Packaging for terminally sterilized medical devices - Part 6: Paper for low temperature sterilization processes - Requirements and test methods

€69.00

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