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  • BS ISO 19611:2017

    Current The latest, up-to-date edition.

    Traditional Chinese medicine. Air extraction cupping device

    Available format(s):  Hardcopy, PDF

    Language(s):  English

    Published date:  28-06-2017

    Publisher:  British Standards Institution

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    Table of Contents - (Show below) - (Hide below)

    Foreword
    Introduction
    1 Scope
    2 Normative references
    3 Terms and definitions
    4 Configuration
    5 Requirements
    6 Package
    7 Labelling
    Annex A (normative) - Test methods for a cupping device
    Bibliography

    Abstract - (Show below) - (Hide below)

    Gives requirements for an air extraction cupping device which operates using negative pressure.

    Scope - (Show below) - (Hide below)

    This document specifies requirements for an air extraction cupping device which operates using negative pressure. This document includes requirements for the material, pressure, sterilization or disinfection, and packaging of the cupping device, as well as appropriate test methods.

    The document is applicable to single-use type and multiple-use type devices.

    This document does not apply to the suction pump used to create the negative pressure.

    General Product Information - (Show below) - (Hide below)

    Committee CH/100/1
    Development Note Supersedes 16/30302520 DC. (07/2017)
    Document Type Standard
    Publisher British Standards Institution
    Status Current
    Supersedes

    Standards Referencing This Book - (Show below) - (Hide below)

    ISO 11137-1:2006 Sterilization of health care products Radiation Part 1: Requirements for development, validation and routine control of a sterilization process for medical devices
    ISO 11607-2:2006 Packaging for terminally sterilized medical devices Part 2: Validation requirements for forming, sealing and assembly processes
    ISO 11135:2014 Sterilization of health-care products Ethylene oxide Requirements for the development, validation and routine control of a sterilization process for medical devices
    ISO 13485:2016 Medical devices Quality management systems Requirements for regulatory purposes
    ISO 2533:1975 Standard Atmosphere
    ISO/IEC Guide 63:2012 Guide to the development and inclusion of safety aspects in International Standards for medical devices
    ISO/IEC Guide 51:2014 Safety aspects Guidelines for their inclusion in standards
    ISO 14971:2007 Medical devices Application of risk management to medical devices
    ISO 11607-1:2006 Packaging for terminally sterilized medical devices Part 1: Requirements for materials, sterile barrier systems and packaging systems
    ISO 15223-1:2016 Medical devices Symbols to be used with medical device labels, labelling and information to be supplied Part 1: General requirements
    ISO 17664:2017 Processing of health care products Information to be provided by the medical device manufacturer for the processing of medical devices
    ISO 17665-1:2006 Sterilization of health care products — Moist heat — Part 1: Requirements for the development, validation and routine control of a sterilization process for medical devices
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