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