CEN/CLC/TC 3 - Quality management and corresponding general aspects for medical devices
The objective of the joint Technical Committee is to contribute to, and where necessary draft, suitable standards for "Quality management and corresponding general aspects for medical devices" that are applicable internationally and relevant to the essential requirements of EU Directives. The joint Technical Committee closely cooperates with ISO/TC 210 'Quality management and corresponding general aspects for medical devices' in the development of standards and revisions. The objective of the joint Technical Committee is to contribute to a further global harmonization of standards in close co-operation with ISO/TC 210. In principle the standards are drafted by ISO/TC 210 under the Vienna agreement with ISO-lead, including the joint work programme with IEC/SC 62. The joint Technical Committee will liaise with other Technical Committees - to achieve a coherent set of horizontal and product standards; - to minimize the necessity for additional European requirements; - to advise on aspects concerning quality management and risk management to ensure an optimal use of EN ISO 13485 and EN ISO 14971.
Quality management and corresponding general aspects for medical devices
The objective of the joint Technical Committee is to contribute to, and where necessary draft, suitable standards for "Quality management and corresponding general aspects for medical devices" that are applicable internationally and relevant to the essential requirements of EU Directives. The joint Technical Committee closely cooperates with ISO/TC 210 'Quality management and corresponding general aspects for medical devices' in the development of standards and revisions. The objective of the joint Technical Committee is to contribute to a further global harmonization of standards in close co-operation with ISO/TC 210. In principle the standards are drafted by ISO/TC 210 under the Vienna agreement with ISO-lead, including the joint work programme with IEC/SC 62. The joint Technical Committee will liaise with other Technical Committees - to achieve a coherent set of horizontal and product standards; - to minimize the necessity for additional European requirements; - to advise on aspects concerning quality management and risk management to ensure an optimal use of EN ISO 13485 and EN ISO 14971.
General Information
ISO 80369-20:2015 specifies the test methods to evaluate the performance requirements for small-bore connectors specified in the ISO 80369‑ series.
- Standard38 pagesEnglish languagesale 10% offe-Library read for1 day
ISO 80369-1:2010 specifies general requirements for small-bore connectors, which convey liquids or gases in healthcare applications. These small-bore connectors are used in medical devices or accessories intended for use with a patient. ISO 80369-1:2010 also specifies the healthcare fields in which these small-bore connectors are intended to be used. These healthcare fields of use include, but are not limited to, applications for: breathing systems and driving gases, enteral and gastric, urethral and urinary, limb cuff inflation, neuraxial devices, and intravascular or hypodermic. Small-bore connectors as specified in ISO 80369-1:2010 are non-interconnectable with: the cones and sockets of ISO 5356-1:2004 and ISO 5356-2:2006; the temperature sensor connector and mating ports specified in Annex DD of ISO 8185:2007; and the nipples of EN 13544-2:2002. ISO 80369-1:2010 provides the methodology to assess non-interconnectable characteristics of small-bore connectors based on their inherent design and dimensions in order to reduce the risk of misconnections between medical devices or between accessories for different applications and to reduce the risk of misconnections between medical devices with 6 % Luer connectors, and all other non-Luer (6 %) connectors that will be developed under future parts of this series of standards. It does not specify requirements for the medical devices or accessories that use these small-bore connectors. Such requirements are given in particular International Standards for specific medical devices or accessories.
- Standard28 pagesEnglish languagesale 10% offe-Library read for1 day