CEN/SS S99 - Health, environment and medical equipment - Undetermined

This International Standard specifies the nominal sizes, aim dimensions with tolerances, weights, and certain tests
for medical radiographic cassettes, screens, and films. It includes medical hard-copy imaging films in the form of
sheets, such as laser films and video.
This International Standard also includes information regarding the appropriate marking of these products, and
special attention is given to cassettes/screens/films used for mammography.
This International Standard does not include films in roll format (see informative annex A).

This CEN Report is designed to give a view of CEN Standards activity containing microbiological aspects.  It takes the form of a register of work items.  The register includes current work items and published Standards from TCs which are working on standards containing microbiological aspects.  The information in this register was produced on February 2001.
The intended audience of this Report is those people working in Standardization who have an interest in microbiological aspects.  It will be particularly useful for those people working on a subject with microbiological aspects, who wish to co-ordinate their efforts and therefore avoid duplication of work. In particular, this report is intended to assist in the evolution of common terms and definitions in standards that involve microbiological aspects.
The register is not exhaustive.  There may be other CEN TCs with microbiological aspects but these are not known at the time of writing this CEN Report.
Not all the information is available for all the work items listed.

This technical report provides recommendations for procedures that should be followed to establish, as far as possible, a traceability route for medical devices which have been placed on the market.
It is understood that the procedures to be described in this report will be more detailed in relation to high-risk devices when the need has been identified to trace devices as far as the actual patient.
For lower risk devices this report provides recommendations for elements of procedures to be transmitted by manufacturers to the members of a distribution chain, to achieve an appropriate level of traceability, perhaps of batches of products in some cases, sufficient to withdraw or inform purchasers or users of information regarding such identified products.

Few changes in the text, deletion of Annex A and changes in Annex ZA.1.

This standard specifies a procedure for the manufacturer to investigate, using available information, the safety of a medical device, including in vitro diagnostic devices or accessories, by identifying hazards and estimating the risks associated with the device. It is of particular assistance in areas where relevant standards are not available or not used.  This standard does not stipulate levels of acceptability, which because they are determined by a multiplicity of factors, cannot by their nature be set down in such a standard.  This standard is not intended to give detailed guidance on management of risks. Furthermore, it is not intended to cover decision-making processes regarding assessment of the indications  and contra-indications for the use of a particular device.