APPLICABLE STANDARDS FOR CYTOCARE (mandated by law)
European Union
Machinery Directive 98/37 CEE
Low Voltage Directive 73/23 CEE
EMC Directive 89/336 CEE
Directive 93/465/CEE on CE Mark labeling
USA
CDRH, Pharmacy Compounding Systems; Final Guidance for Industry & FDA
Worldwide
IECEE-CB Scheme (Worldwide System for Conformity Testing and Certification of Electrical Equipment, Covers UL)
European Union
Machinery Directive 98/37 CEE
Low Voltage Directive 73/23 CEE
EMC Directive 89/336 CEE
Directive 93/465/CEE on CE Mark labeling
USA
CDRH, Pharmacy Compounding Systems; Final Guidance for Industry & FDA
Worldwide
IECEE-CB Scheme (Worldwide System for Conformity Testing and Certification of Electrical Equipment, Covers UL)
PERTAINING STANDARDS FOR CYTOCARE (voluntarily adopted)
European Union
DIN 12980:2004 Safety cabinets for handling cytotoxic and highly active substances
EN 12469:2000 Performance criteria for microbiological safety cabinets
2003/94/EEC Principles and guidelines for GMP of medicinal products for human use
2003/94/EEC – Annex 1: Manufacture of sterile medicinal products
USA
USP – Chapter 797, Pharmaceutical Compounding: Sterile Preparations
European Union
DIN 12980:2004 Safety cabinets for handling cytotoxic and highly active substances
EN 12469:2000 Performance criteria for microbiological safety cabinets
2003/94/EEC Principles and guidelines for GMP of medicinal products for human use
2003/94/EEC – Annex 1: Manufacture of sterile medicinal products
USA
USP – Chapter 797, Pharmaceutical Compounding: Sterile Preparations
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