SIST EN 12006-3:2000/kprA1:2009

Overview

EN 12006-3:1998/prA1 is a CEN draft amendment to the European standard series EN 12006 covering non‑active surgical implants with a specific focus on cardiac and vascular implants - Part 3: Endovascular devices. The prA1 (2008) amendment replaces the original Annex C with an informative Annex ZA that maps the standard to the essential requirements of EU Medical Device Directive 93/42/EEC, providing a pathway to a presumption of conformity when implemented as a national standard.

Key topics and requirements

This document and its amendment emphasize regulatory alignment and device‑specific requirements for endovascular implants. Key topics addressed include:

• Regulatory relationship: Annex ZA establishes correspondence between clauses of EN 12006‑3 and the Essential Requirements of Directive 93/42/EEC, clarifying which ERs are covered and noting any limitations.
• Scope and applicability: Part 3 confines the EN 12006 series to endovascular cardiac and vascular implants (stents, grafts and similar non‑active intravascular devices).
• Standards structure and language: The amendment was prepared by CEN/TC 285 and published in official English, French and German versions; translated national versions have equivalent status.
• Conformity presumption: Once cited in the Official Journal and adopted nationally, compliance with the listed clauses affords a presumption of conformity with corresponding Directive requirements - within the standard’s scope.
• Limitations and warnings: The amendment explicitly warns that not all aspects (e.g., regulatory provisions for medicinal products associated with some devices) are addressed, and other EU Directives may apply.

Note: The published text is a draft amendment submitted for unique acceptance and is subject to change.

Applications and who uses it

EN 12006‑3:1998/prA1 is relevant to organizations involved in design, production, testing and regulation of non‑active endovascular implants:

• Medical device manufacturers (stents, endovascular grafts, occluders) for product design inputs and regulatory strategy
• Regulatory affairs and quality managers using the standard to demonstrate conformity with Directive 93/42/EEC
• Notified bodies and conformity assessment bodies when evaluating technical documentation
• Test laboratories and contract manufacturers performing verification activities
• Procurement and clinical engineering teams seeking assurance about standards compliance

Related standards

• EN 12006 series (general requirements for non‑active surgical implants)
• Other CEN standards referenced in technical documentation and Annex ZA
• EU Medical Device Directive 93/42/EEC (for regulatory conformity)

Keywords: EN 12006-3, endovascular devices, non-active surgical implants, cardiac and vascular implants, CEN, Directive 93/42/EEC, medical device standard, Annex ZA, presumption of conformity.