EN 46002:1996

EN 46002:1996 is a standard published by the European Committee for Standardization (CEN). Its full title is "Quality systems - Medical devices - Particular requirements for the application of EN ISO 9002". This standard covers: This European Standard specifies, in conjunction with EN ISO 9002, the quality system requirements for the production, and where relevant, installation of medical devices. The field of application of EN ISO 9002 applies. In addition, this European Standard, in conjunction with EN ISO 9002, is applicable when a medical device supplier's quality system is assessed in accordance with regulatory requirements. As part of an assessment by a third party for the purpose of regulatory requirements, the supplier may be required to provide access to confidential data in order to demonstrate compliance with this standard. The supplier may be required to exhibit these data but is not obliged to provide copies for retention.

This European Standard specifies, in conjunction with EN ISO 9002, the quality system requirements for the production, and where relevant, installation of medical devices. The field of application of EN ISO 9002 applies. In addition, this European Standard, in conjunction with EN ISO 9002, is applicable when a medical device supplier's quality system is assessed in accordance with regulatory requirements. As part of an assessment by a third party for the purpose of regulatory requirements, the supplier may be required to provide access to confidential data in order to demonstrate compliance with this standard. The supplier may be required to exhibit these data but is not obliged to provide copies for retention.

EN 46002:1996 is classified under the following ICS (International Classification for Standards) categories: 03.120.10 - Quality management and quality assurance; 11.040.01 - Medical equipment in general. The ICS classification helps identify the subject area and facilitates finding related standards.

EN 46002:1996 has the following relationships with other standards: It is inter standard links to EN 46002:1993/AC:1994, EN ISO 26945:2011, EN ISO 19598:2016, EN ISO 27874:2008, EN ISO 4042:2018, EN ISO 6158:2011, EN ISO 4526:2004, EN 14436:2004, EN ISO 2179:2016, EN ISO 2082:2017, EN ISO 2081:2008, EN ISO 1456:2009, EN ISO 4042:2022, EN ISO 3882:2003, EN ISO 4521:2008. Understanding these relationships helps ensure you are using the most current and applicable version of the standard.

EN 46002:1996 is associated with the following European legislation: EU Directives/Regulations: 90/385/EEC, 93/42/EEC; Standardization Mandates: M/BC/CEN/89/9. 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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