CR 14060:2000

CR 14060:2000 is a standardization document published by the European Committee for Standardization (CEN). Its full title is "Medical device traceability". This standard covers: This technical report provides recommendations for procedures that should be followed to establish, as far as possible, a traceability route for medical devices which have been placed on the market. It is understood that the procedures to be described in this report will be more detailed in relation to high-risk devices when the need has been identified to trace devices as far as the actual patient. For lower risk devices this report provides recommendations for elements of procedures to be transmitted by manufacturers to the members of a distribution chain, to achieve an appropriate level of traceability, perhaps of batches of products in some cases, sufficient to withdraw or inform purchasers or users of information regarding such identified products.

This technical report provides recommendations for procedures that should be followed to establish, as far as possible, a traceability route for medical devices which have been placed on the market. It is understood that the procedures to be described in this report will be more detailed in relation to high-risk devices when the need has been identified to trace devices as far as the actual patient. For lower risk devices this report provides recommendations for elements of procedures to be transmitted by manufacturers to the members of a distribution chain, to achieve an appropriate level of traceability, perhaps of batches of products in some cases, sufficient to withdraw or inform purchasers or users of information regarding such identified products.

CR 14060:2000 is classified under the following ICS (International Classification for Standards) categories: 11.040.01 - Medical equipment in general. The ICS classification helps identify the subject area and facilitates finding related standards.

CR 14060:2000 has the following relationships with other standards: It is inter standard links to CEN/CLC/TR 14060:2014. Understanding these relationships helps ensure you are using the most current and applicable version of the standard.

CR 14060:2000 is associated with the following European legislation: EU Directives/Regulations: 90/385/EEC, 93/42/EEC; Standardization Mandates: M/295. When a standard is cited in the Official Journal of the European Union, products manufactured in conformity with it benefit from a presumption of conformity with the essential requirements of the corresponding EU directive or regulation.

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