ISO 10993-1:2018 pdf download – Biological evaluation of medicaldevices— Part 1: Evaluation and testing within a risk management process.
4.9 The biological risk assessment of materials or final products shall be re—evaluate(l if any of the following occur:
a) any change in the source or in the specification of the materials used in the manufacture of the p i’o duct;
b) any change in the formulation, processing, primary packaging or sterilization of the product;
c) any change in the manufacturer’s instructions or expectations concerning storage, e.g. changes in shell life and/or transport;
d) any change in the intended use of the product;
e) any evidence that the product can produce adverse biological effects when used in humans.
4.10 The biological evaluation shall take into account preclinical tests, clinical investigations, post— market experience from similar medical devices or materials, and other relevant information (see Annex B).
4.11 This document shall not be used to mandate re-testing of historical products assessed previously using the appropriate edition of this document at the time of the assessment. Nevertheless, compliance to this new edition shall be shown, by providing a justification for omission of further testing. Where recommendations for endpoint assessment per Annex A are different from prior [)llhliShed versions of this document, a history of sale clinical use can be used to document why additional testing on a commercially—marketed medical device is not needed. Howevem; if any of the changes descnbed in Clause 4.9 occum; an evaluation of the biologic risks related to the change shall be performed using the current version of this standard.
5 Categorization of medical devices
5.1 General
Medical devices shall he categorized according to the nature and duration of body contact as specified in 52 and 53. The categorization of medical devices facilitates selection of appropriate data sets (see informative Annex A).
The evaluation of any medical device that does not fall into one of the categories specified shall follow the general principles contained in this document. Certain medical devices might fall into more than one body contact or duration category, in which case evaluation appropriate to each category shall be carried out.
EXAMPLE For medical devices that include both an implanted component, and a delivery system that is used only dii ring a surgical procedure to place the medical device, the implant should 1)e assessed separately from the delivery system.
EXAMILE For gas pathway device components with only indirect contact, device specific standards should be used to determine the relevant type of biocompatibility evaluations [see ISO 18562 (all parts)].
5.2 Categorization by nature of body contact
5.2.1 Non-contacting medical devices
These include medical devices (or components) that have neither (lirect nor indirect contact with the body and where biocompatibility information would not be necessary. Diagnostic software, an in vitro diagnostic device and a blood-collection tube are examples of non-contact devices.
5.2.2 Surface-contacting medical devices
These include medical devices in contact with the following.
— Medical devices that contact intact skin surfaces only.
EXAMPLES Electrodes, external prostheses, fixation tapes, compression bandages and monitors o various types.
NOTE Some medical devices Lised in either sterile or non-sterile environments include components that can come into contact with a user’s ungloved hands such as human interfaces for electronic equipment (e.g. computer keyboards, dials or buttons, touch screens, S[) cards, USB sticks); housings for electronic monitors or program mers that can come into contact with any intact skin (e.g. electronic devices like cell phones, tablets); or components that can come into contact with a user’s gloved hand (e.g. catheter handles). lithese types of components can be shown to be made from materials in common use for other consumer products with a similar nature of contact, no further 1)iological evaluation is needed.
Mucosal membranes
Medical devices that contact intact mucosal membranes.
EXAMPLES Contact lenses, urinary catheters, intravaginal and intra-intestinal devices (stomach tubes, sigmoidoscopes, colonoscopes, gastroscopes), endotracheal tubes, hronchoscopes, some dental prostheses and orthodontic devices.
c) Breached or compromised surfaces
— Medical devices that contact breached or otherwise compromised body surfaces.
EXAMPLES Dressings or healing devices and occlusive patches for ulcers, burns and granulation
5.2.3 Externally communicating medical devices
Externally communicating medical devices shall be categorized according to their contact with the following apphcation sites.