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This document specifies a framework for the identification of biological hazards and the estimation and control of biological risks from material constituents, using a stepwise approach to the characterization of a medical device through:

— 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);

— the estimation 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 may 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 of standards 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.

This document applies to medical devices other than in vitro diagnostic medical devices manufactured utilizing materials of animal origin, which are non-viable or have been rendered non-viable. It specifies, in conjunction with ISO 14971, a procedure to identify the hazards and hazardous situations associated with such devices, to estimate and evaluate the resulting risks, to control these risks, and to monitor the effectiveness of that control. Furthermore, it outlines the decision process for the residual risk acceptability, taking into account the balance of residual risk, as defined in ISO 14971, and expected medical benefit as compared to available alternatives. This document is intended to provide requirements and guidance on risk management related to the hazards typical of medical devices manufactured utilizing animal tissues or derivatives such as:

a) contamination by bacteria, moulds or yeasts;

b) contamination by viruses;

c) contamination by agents causing Transmissible Spongiform Encephalopathies (TSE);

d) material responsible for undesired pyrogenic, immunological or toxicological reactions.

For parasites and other unclassified pathogenic entities, similar principles can apply.

This document does not stipulate levels of acceptability which, because they are determined by a multiplicity of factors, cannot be set down in such an International Standard except for some particular derivatives mentioned in Annex C. Annex C stipulates levels of TSE risk acceptability for tallow derivatives, animal charcoal, milk and milk derivatives, wool derivatives and amino acids.

This document does not specify a quality management system for the control of all stages of production of medical devices.

This document does not cover the utilization of human tissues in medical devices.

NOTE 1 It is not a requirement of this document to have a full quality management system during manufacture. However, attention is drawn to International Standards for quality management systems (see ISO 13485) that control all stages of production or reprocessing of medical devices.

NOTE 2 For guidance on the application of this document see Annex A.

This International Standard specifies requirements for SUCTION CATHETERS, made of flexible materials and intended for use in suctioning of the respiratory tract.

SUCTION CATHETERS intended for use with flammable anaesthetic gases or agents, lasers or electrosurgical equipment are not covered by this International Standard.

NOTE See ISO/TR 11991 for guidance on airway management during laser surgery of the upper airway.[5]

This European Standard specifies requirements and the relevant tests for large steam sterilizers primarily used in health care for the sterilization of medical devices and their accessories contained in one or more sterilization modules. The test loads described in this European Standard are selected to represent the majority of loads (i.e. wrapped goods consisting of metal, rubber and porous materials) for the evaluation of general purpose steam sterilizer for medical devices. However, specific loads (e. g. heavy metal objects or long and/or narrow lumen) will require the use of other test loads.

Large steam sterilizers can also be used during the commercial production of medical devices.

This European Standard does not specify requirements for equipment intended to use, contain or be exposed to flammable substances or substances which could cause combustion. This European Standard does not specify requirements for equipment intended to process pathogenic substances or human tissues.

This European Standard applies to steam sterilizers designed to accommodate at least one sterilization module or having a chamber volume of at least 60 l.

This European Standard does not describe a quality management system for the control of all stages of the manufacture of the sterilizer.

NOTE Attention is drawn to the standards for quality management systems e. g. EN ISO 13485.

Planning and design of sterilizers applying to this European Standard should consider the environmental impact from the product during its life cycle. Environmental aspects are addressed in Annex A.