" Antiseptics and chemical disinfectants " - Basic bactericide activity
-> the standard applies in particular to the bactericide activity evaluated in relation to staphylococcus aureus strains - ATCC 6538

" Chemical disinfections and antiseptics " - Basic fungicide activity
-> Fungicide activity evaluated, in particular, on strains of Candida Albicans (ATCC 10231) and Aspergillus niger (ATCC 16404)

Information supplied by the manufacturer with the medical devices

Graphic symbols used for medical device labelling

Medical device sterilisation - Validation and routine inspection for sterilisation by ethylene oxide

Medical device sterilisation - Validation and routine inspection for sterilisation by irradiation

Medical device sterilisation - Validation and routine inspection for sterilisation by steam

Medical device sterilisation - Requirements for the medical devices labelled "sterile".

Medical device sterilisation - Estimation of the population of micro-organisms on a product - Part I: requirements

Medical device sterilisation - Estimation of the population of micro-organisms on a product - Part II: guidelines

Medical device sterilisation -Estimation of the population of micro-organisms on a product - Part III: guide lines concerning the validation methods for micro-biological techniques

Medical device packaging systems and materials to be used - Part I: general requirements and test methods

Biological evaluation of medical devices - Part I: Evaluation and tests

Biological evaluation of medical devices - Part V: Test concerning cytotoxicity: in vitro methods (ISO 10993-5: 1992)

Biological evaluation of medical devices - Part VII: sterilisation residues by ETO (ISO 10993-7: 1995)

Biological evaluation of medical devices - Part X: Irritation and sensitisation tests

Biological evaluation of medical devices - Part XI: Systemic toxicity tests (ISO 10993-11: 1993)

Biological evaluation of medical devices - Part XII: Preparation of reference materials and samples

Quality systems - MD - Special requirements relating to the application of EN ISO 9002

Quality systems - MD - Special requirements relating to the application of EN ISO 9001

Quality system - Model for quality assurance in production, installation and associated services.

Quality systems - MD - Model for quality assurance in design, development, production, installation and associated services.

Guide to application of EN 29001, En 46001, EN 29002 and EN 46002 for non-active MD

Clinical investigation concerning MD on human subjects

MD - Risk analysis