BC/CLC/09-89 - BC/CLC/09-89
General Information
Frequently Asked Questions
A European Standardization Mandate is a formal request from the European Commission to the European Standardization Organizations (CEN, CENELEC, and ETSI) to develop European standards (ENs) in support of EU legislation and policies. Mandates are issued under Regulation (EU) No 1025/2012 and help ensure that products and services meet the essential requirements set out in EU directives and regulations.
BC/CLC/09-89 is a European Standardization Mandate titled "undefined". BC/CLC/09-89 There are 6 standards developed under this mandate.
Standards developed in response to a mandate and cited in the Official Journal of the European Union become "harmonized standards". Products manufactured in compliance with harmonized standards benefit from a presumption of conformity with the essential requirements of the corresponding EU directive or regulation, facilitating CE marking and market access across the European Economic Area.
This is the major revised and updated baseline of standards for the safety of all medical electrical equipment used by or under the supervision of qualified personnel in the general medical and patient environment. lt also contains certain requirements for reliable operation to ensure safety. Note the change of title from the first (1977) edition. (For particular requirements see series 601-2 below.)
- Standard220 pagesEnglish languagee-Library read for1 day
- Standard – translation192 pagesSlovenian languagee-Library read for1 day
This is the major revised and updated baseline of standards for the safety of all medical electrical equipment used by or under the supervision of qualified personnel in the general medical and patient environment. lt also contains certain requirements for reliable operation to ensure safety. Note the change of title from the first (1977) edition. (For particular requirements see series 601-2 below.)
- Standard220 pagesEnglish languagee-Library read for1 day
- Standard – translation192 pagesSlovenian languagee-Library read for1 day
Corrigendum to EN/A12 issued July 1994
- Standard220 pagesEnglish languagee-Library read for1 day
Corrigendum to EN/A11 issued July 1994 * Superseded by A2:1995
- Standard220 pagesEnglish languagee-Library read for1 day
Corrigendum to EN/A11 issued July 1994 * Superseded by A2:1995
- Standard220 pagesEnglish languagee-Library read for1 day
Corrigendum to EN/A12 issued July 1994 * Superseded by A2:1995
- Standard220 pagesEnglish languagee-Library read for1 day