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    Relevant Essential Principles Format

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    Rosenda Monette
    The document outlines an essential principles conformity checklist for medical devices. It lists 5 essential principles for medical device design and manufacturing including that devices should not compromise patient safety, conform to safety principles by reducing risks, achieve the manufacturer's intended performance, maintain performance during a device's lifetime, and maintain characteristics during transport and storage. It also lists additional design considerations to ensure safety such as material choice and biocompatibility. The checklist can be used by manufacturers to ensure medical devices meet fundamental safety standards.

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    Download as PDF, TXT or read online from Scribd

    Relevant Essential Principles Format

    Uploaded by

    Rosenda Monette
    222 views1 page
    The document outlines an essential principles conformity checklist for medical devices. It lists 5 essential principles for medical device design and manufacturing including that devices should not compromise patient safety, conform to safety principles by reducing risks, achieve the manufacturer's intended performance, maintain performance during a device's lifetime, and maintain characteristics during transport and storage. It also lists additional design considerations to ensure safety such as material choice and biocompatibility. The checklist can be used by manufacturers to ensure medical devices meet fundamental safety standards.

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    The document outlines an essential principles conformity checklist for medical devices. It lists 5 essential principles for medical device design and manufacturing including that devices should not compromise patient safety, conform to safety principles by reducing risks, achieve the manufacturer's intended performance, maintain performance during a device's lifetime, and maintain characteristics during transport and storage. It also lists additional design considerations to ensure safety such as material choice and biocompatibility. The checklist can be used by manufacturers to ensure medical devices meet fundamental safety standards.

    Copyright:

    © All Rights Reserved
    Download as PDF, TXT or read online from Scribd
    Download as pdf or txt
    222 views1 page

    Relevant Essential Principles Format

    Uploaded by

    Rosenda Monette
    The document outlines an essential principles conformity checklist for medical devices. It lists 5 essential principles for medical device design and manufacturing including that devices should not compromise patient safety, conform to safety principles by reducing risks, achieve the manufacturer's intended performance, maintain performance during a device's lifetime, and maintain characteristics during transport and storage. It also lists additional design considerations to ensure safety such as material choice and biocompatibility. The checklist can be used by manufacturers to ensure medical devices meet fundamental safety standards.

    Copyright:

    © All Rights Reserved
    Download as PDF, TXT or read online from Scribd
    Download as pdf or txt
    of 1

    ANNEX K: EXAMPLE OF AN ESSENTIAL PRINCIPLES CONFORMITY

    CHECKLIST

    Applicable Method of Identity of


    Essential Principle to the Specific
    device? Conformity Documents
    1. Medical devices should be designed and manufactured in such a way that, Yes
    when used under the conditions and for the purposes intended and, where
    applicable, by virtue of the technical knowledge, experience, education or
    training of intended users, they will not compromise the clinical condition
    or the safety of patients, or the safety and health of users or, where
    applicable, other persons, provided that any risks which may be associated
    with their use constitute acceptable risks when weighed against the
    benefits to the patient and are compatible with a high level of protection
    of health and safety.
    2. The solutions adopted by the manufacturer for the design and Yes
    construction of the dew'ces should conform to safety principles, taking
    account of the generally acknowledged state of the art. In selecting the
    most appropriate solutions, the manufacturer should apply the following
    principles in the following order:
    0 Identify hazards and the associated risks arising from the
    intended use and foreseeable misuse;
    0 Eliminate or reduce risks as far as possible (inherently safe
    design and construction);
    0 Where appropriate take adequate protection measures
    including alarms if necessary, in relation to risks that cannot be
    eliminated,
    0 Inform users of the residual risks due to any shortcomings of
    the protection measures adopted.
    3. Devices should achieve the performance intended by the manufacturer Yes
    and be designed, manufactured and packaged in such a way that they are
    suitable for one or more of the functions within the scope of the definition
    of a medical device applicable in each jurisdiction.
    4. The characteristics and performances referred to in Clauses l, 2 and 3 Yes
    _
    should not be adversely affected to such a degree that the clinical
    conditions and safety of the patients and, where applicable, of other
    persons are compromised during the lifetime of the device, as indicated by
    the manufacturer, when the device is subjected to the stresses which can
    occur during normal conditions of use and has been properly maintained
    in accordance with the manufacturer’s instructions.
    5. The devices should be designed, manufactured and packed in such a way Yes
    that their characteristics and performances during their intended use will
    not be adversely affected during transport and storage taking account of
    the instructions and information provided by the manufacturer.
    7.1 The devices should be designed and manufactured in such a way as to
    ensure the characteristics and performance referred to in Section I of the
    “General Requirements”. Particular attention should be paid to:
    o The choice of materials used, particularly as regards toxicity and,
    where appropriate, flammability,
    0 The compatibility between the materials used and biological
    tissues, cells and body fluids, taking into account the intended
    purpose of the device.
    0 The choice of materials used which should reflect, where
    appropriate, matters such as hardness, wear and fatigue strength.
    7.2 The devices should be designed, manufactured and packed in such a way
    as to minimize the risk posed by contaminants and residues to the persons
    involved in the transport, storage and use of the devices and to the patients,
    taking account of the intended purpose of the product. Particular attention
    should be paid to the tissues exposed and to the duration and frequency of
    exposure

    27

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