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De Bioenergiser voldoet aan onderstaande voorschriften, regels, standaarden en richtlijnen: Voorschriften: EEC Council Directive 93/42/EEC as published in the Journal of the European Communities L169, Vol. 36, 14th. June 1993. Consumer Protection Statutory Instrument No. 3017, The Medical Devices Regulations 1994. Standaarden: BS EN ISO 13485:2003 : Medical devices - Quality management Systems - requirements for regulatory purposes BS EN 14155 - 1:2003: Clinical Investigation of medical devices for human subjects - general BS EN 14155 - 2:2003 : Clinical Investigation of medical devices for human subjects - plans BS EN ISO 14971:2001 ; Medical devices - Application of risk management to medical devices BS EN 60601 - 1:1990 : Medical Electrical Equipment - General requirements for safety BS EN 60601 - l - 1:2001 ; Medical Electrical Equipment - Safety requirements for medical electrical systems BS EN 60601 - l - 2:2002 : Medical Electrical Equipment - General requirements for safety BS EN 60601 - 2 - 10:2001 : Medical Electrical Equipment Safety - Safety of nerve & muscle stimulators BS EN 980 : 2003 : Graphical Symbols for Labelling BS 6001-1:1999, ISO 2859-1:1999 : Sample Size Determination Conform Regels BS EN ISO 1385:2003 - BSI Registration Certificate Number MD 93061, October 2005 BS EN 60601: Electrical Safety - Intertek Certificate Number 05-5048, December 2005 BS EN 60601: Electromagnetic - Intertek Certificate Number EM 05017554, October 2005 EEC Council Directive 93/42/EEC: BSI Medical Device CE Mark Certificate Number CE 502302, December 2005
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