1 Scope
This document specifies a framework for the identification, and if necessary,
quantification of constituents of a medical device,
allowing the identification of biological hazards and the estimation and
control of biological risks from material constituents, using a generally stepwise
approach to the chemical
characterization which can include one or more of the
following:
-
— the identification of its materials of construction (medical device configuration);
-
— the characterization of the materials of construction via the identification and quantification of their chemical constituents (material composition);
-
— the characterization of the medical device for chemical substances that were introduced during manufacturing (e.g. mould release agents, process contaminants, sterilization residues);
-
— the estimation (using laboratory extraction conditions) of the potential of the medical device, or its materials of construction, to release chemical substances under clinical use conditions (extractables);
-
— the measurement of chemical substances released from a medical device under its clinical conditions of use (leachables).
This document can also be used for chemical characterization (e.g. the
identification and/or quantification) of degradation products.
Information on other aspects of degradation assessment are covered in
ISO 10993‑9,
ISO 10993‑13,
ISO 10993‑14
and
ISO 10993‑15.
The ISO 10993 series is applicable when the material or
medical device has direct or indirect body contact (see
ISO 10993‑1
for categorization by nature of body contact).
This document is intended for suppliers of materials and
manufacturers of medical devices, to support a biological
evaluation.