BS EN ISO 20072:2013 pdf free download.Aerosol drug delivery device design verification Requirements and test methods (ISO 20072:2009).
5 Requirements
5.1 General
Unless justified by the risk assessment, the following general requirements apply.
a) The ADDD shall be designed so thatten operated in accordance with the instwctions for use, it provides the emitted mass or dose as specified and verified by the ADDD manufacturer (see 5.4).
b) The ADDD shall be designed so that the operator is aware that the ADDD has been actuated.
c) The ADDD shall be designed to minimize the risk of inadvertent actuation,
d) The performance of the combination of the ADDD and any accessory specified by the ADDD manufacturer shall comply with the device functionality profile and system verification test applicable to that combination. The manufacturer shall identify as part of the ADDD or ADDD system the specific accessories that are suitable for use.
e) The ADDD shall be designed so that the operator can determine when the medication intended to be delivered is near completion and is near or has reached exhaustion.
1) A prefilled ADDD with an actuation counter or content indicator shall not reset once the end of life is reached. A refillable ADDD with an integrated counter shal allow for resetting once the ADDD is replenished with medication.
g) The manufacturer shall provide information to the operator to indicate when the ADDD needs to be replaced or has reached the end of its in-use life (see Annex A for rationale). This requirement also applies to all accessories necessary to meet the device functionality profile requirements.
h) The design process shall include a provision of rationale for the selection of materials. In the selection of materials to be used in device manufacture, the first consideration should be fitness for purpose with regard to characteristics and properties, including chemical, toxicological, physical, electrical, morphological and mechanical attributes of the material.
To give assurance that the final product will perform as intended and be safe for human use, the programme shall include an appropriate biological evaluation in accordance with ISO 10993-1.
NOTE 1 ISO 10993-1 gives guidance on which parts of the ISO 10993 series are r&evant to comply with,
I) The ADDDs shall be designed to minimize:
— ingress of foreign particles:
— creation of particles from the A000 itself (e.g. abrasion);
— microbiological contamination.
j) ADDDS and/or their components which by their design or intended purpose are required to be sterile, shall be designed so that they can be subjected to sterilization processes in accordance with Iso 17665-1,Iso 11135-1 or IsO 11137 or other validated sterilization process.
5.2 Risk assessment requirements
The manufacturer shall conduct a risk assessment, in accordance with ISO 14971, that will determine the parameters that shall then be included in the device functionality profile. The risk assessment shall also determine the appropriate statistical requirements for the system verification test. That risk assessment shall consider, at a minimum, all aspects of the intended use of the ADDD, as listed in ISo 14971:2007, Annex C.
5.3 Device functionality profile
There shall be established a device functionality profile (DFP) based on the outcome of the risk assessment in 5.2. The DFP shall consist of identified critical functions and design features, test methodology, tolerance limits and acceptance criteria (see Annex B).BS EN ISO 20072 pdf download.
Tags: Aerosol drug delivery
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