This part of ISO 10993 describes

a) the general principles governing the biological evaluation of medical devices;
b) the categorization of devices based on the nature and duration of their contact with the body;
c) the selection of appropriate tests.

This part of ISO 10993 does not cover testing of materials and devices that do not come into direct or indirect contact with the patients body, nor does it cover biological hazards arising from any mechanical failure. Other parts of ISO 10993 cover specific tests as indicated in the foreword. (See also the rationale in A.2.)

Scope

This Standard provides a generic procedure for the seizure, handling, storage, disposal and destruction of drugs and drug related materials for law enforcement purposes.
This Standard does not cover the mechanisms of various drug destruction techniques, for example, the details of incineration or mulching.

Scope

NOTE 2: EN 550, EN 552, EN 554, ISO 14160 and EN 1174 may be relevant for bacteria, moulds and yeast (see Bibliography).
1.2 This Part of EN 12442 does not cover the utilization of human tissues in medical devices.
1.3 This Part of EN 12442 does not describe a quality assurance system for the control of
all stages of manufacture.
NOTE: Attention is drawn to the standards for quality systems (e.g. EN ISO 9001 and EN 46001 or EN ISO 9002 and EN 46002, see Bibliography) which may be used to control all stages of manufacture. It is not a requirement of this standard to apply a complete quality system during manufacture but certain elements of such a system are required and these are addressed at appropriate places in the text.
1.4 This Part of EN 12442 does not consider the effect of any method of elimination and/or
inactivation on the suitability of the medical device for its intended use .
1.1 This Part of EN 12442 specifies requirements for the validation of elimination and/or
inactivation of viruses and/or transmissible agents during the manufacture of medical devices
(excluding in-vitro diagnostic medical devices) utilizing materials of animal origin. It is not
applicable to bacteria, moulds and yeasts.
NOTE 1: Analysis and management of risk and conventional processes used for sterilization, when used for the treatment of animal tissues for medical devices, have not been shown to be completely effective in inactivating the causative agents of spongiform encephalopathies. Selective sourcing is extremely important (see EN 12442-1 and EN 12442-2).

Scope

1.1 This Part of EN 12442 specifies requirements for controls on the sourcing, collection and handling (which includes storage and transport) of animals and tissues for the manufacture of medical devices utilizing materials of animal origin other than in vitro diagnostic medical devices.
NOTE 1: Requirements for the risk analysis of the use of materials of animal origin in medical devices are described in EN 12442-1.
NOTE 2: Conventional processes used for sterilization, when used for the treatment of
animal tissues for medical devices, have not been shown to be completely effective in inactivating the causative agents of spongiform encephalopathies. Selective sourcing is thus extremely important. Manufacturers should refer to EN 12442-3 for information on the validation of the elimination and/or inactivation of viruses and transmissible agents.
1.2 This Part of EN 12442 does not cover the utilization of human tissues in medical devices.
1.3 This Part of EN 12442 does not describe a quality assurance system for the control of
all stages of manufacture.
NOTE: Attention is drawn to the standards for quality systems (see EN ISO 9001 and EN 46001 or EN ISO 9002 and EN 46002) which relate to all stages of manufacture. It is not a requirement of this standard to have a complete quality system during manufacture but certain elements of such a system are required.
1.4 This Part of EN 12442 does not consider the effect of any method of elimination and/or
inactivation on the suitability of the medical device for its intended use.

Scope

1.1 This Part of EN 12442 applies to medical devices (excluding in-vitro diagnostic medical devices) manufactured utilizing animal tissue or products derived from animal tissue, which are non-viable or have been rendered non-viable. It specifies, in conjunction with EN 1441, a procedure to investigate, using available information, the safety of such devices by
identifying hazards and estimating the risks associated with the device (risk analysis).
1.2 This Part of EN 12442 is intended to provide requirements and guidance on risk analysis related to the typical hazards of medical devices manufactured utilizing animal tissues or derivatives such as
a) contamination by bacteria, moulds or yeasts;
b) contamination by viruses or transmissible agents such as pathogenic entities, or agents causing spongiform encephalopathies, prions and similar entities (e.g. BSE, scrapie);
c) undesired pyrogenic, immunological or toxicological reactions.
1.3 This Part of EN 12442 does not stipulate levels of acceptability which, because they
are determined by a multiplicity of factors, cannot be set down in such a standard.
1.4 In addition, this Part of EN 12442 is intended to provide requirements and guidance
on risk management.
1.5 This Part of EN 12442 does not cover the utilization of human tissues in medical devices.
NOTE: There are materials which do not fall under the scope of this standard because these are not derived from animals. In this standard a specific definition of animal has been given.
1.6 This Part of EN 12442 does not describe a quality assurance system for the control of
all stages of manufacture.
NOTE: Attention is drawn to the standards for quality systems (see EN ISO 9001 and EN 46001 or EN ISO 9002 and EN 46002) which relate to all stages of manufacture.
It is not a requirement of this standard to have a complete quality system during manufacture but certain elements of such a system are required.
1.7 The principles of this Part of EN 12442 may also be applied by analogy to medical devices manufactured utilizing material derived from a non-vertebrate organism, in cases where the risks addressed in this standard are relevant.

Redline Standard: Standard Guide for Process Understanding Related to Pharmaceutical Manufacture and Control

Active Standard: Standard Guide for Process Understanding Related to Pharmaceutical Manufacture and Control

Redline Standard: Standard Test Methods for Determining Radiopacity for Medical Use