19/30385889 DC - BS EN ISO 25539-2. Cardiovascular implants. Endovascular devices. Part 2. Vascular stents

19/30385889 DC

BS EN ISO 25539-2. Cardiovascular implants. Endovascular devices. Part 2. Vascular stents

Status : Current, Draft for public comment   Published : May 2019

Format
PDF

Format
HARDCOPY



Part 2 of ISO 25539 specifies requirements for the evaluation of stent systems (vascular stents and delivery systems) and requirements with respect to nomenclature, design attributes and information supplied by the manufacturer, based upon current medical knowledge. Guidance for the development of in vitro test methods is included in an informative annex to this standard. This standard should be considered as a supplement to ISO 14630, which specifies general requirements for the performance of non-active surgical implants.

NOTE

Due to the variations in the design of implants covered by this part of ISO 25539 and in some cases due to the relatively recent development of some of these implants (e.g. absorbable stents, polymeric stents), acceptable standardized in vitro tests and clinical results are not always available. As further scientific and clinical data become available, appropriate revision of this part of ISO 25539 will be necessary.

The scope of this part of ISO 25539 is applicable to vascular stents and vascular scaffolds (e.g. absorbable vascular scaffolds) used to treat vascular stenoses or other vascular abnormalities or pathologies. Some of the requirements are specific to endovascular treatment of arterial stenoses. Although uses of stent systems other than treatment of arterial stenoses (e.g. venous stenting) are within the scope of this standard, comprehensive requirements and testing are not described for these uses. Similarly, specific stent configurations (e.g. bifurcation stents) are within the scope, but comprehensive requirements and testing are not described for these devices.

Stents used in combination with an endovascular prosthesis to complete the treatment of a lesion, including bridging stents (e.g. stents placed in the renal arteries after deployment of a fenestrated endovascular prosthesis), are within the scope of this standard, but test methods are not described for the combination. The preclinical in vivo and clinical evaluations of these stents may be addressed with the evaluations of the associated endovascular prosthesis in accordance with ISO 25539-1.

Vascular stents that have surface modifications, such as drug and/or other coatings, are within the scope of this standard. Stents covered with materials that significantly modify the permeability of the uncovered stent (e.g. by covering the stent-free-surface area) are within the scope of ISO 25539-1. The stent design or intended use might dictate the need to address functional requirements identified in both ISO 25539-1 and this part of ISO 25539 (e.g. stents used in combination with endovascular prostheses, stents used to treat aortic aneurysms).

Balloons integral to the stent system are within the scope of this standard. This part of ISO 25539 provides requirements beyond the requirements of ISO 10555-4Intravascular catheters — Sterile and single-use catheters, specific to the use of balloons with vascular stents.

This part of ISO 25539 is not applicable to procedures and devices used prior to the introduction of the vascular stent, such as balloon angioplasty devices.

Tacking devices intended to spot treat post-angioplasy dissections, coil supporting devices, and flow diverters are within the scope of this standard, but comprehensive requirements and testing are not described for these devices.

Although drug-eluting stents are within the scope of this standard, this standard is not comprehensive with respect to the drug-eluting properties of these devices.

NOTE

Vascular device-drug combination products are within the scope of ISO 12417-1Cardiovascular implants and extracorporeal systems – Vascular device-drug combination products.

Although absorbable stents and stents with absorbable coatings are within the scope of this standard, this standard in not comprehensive with respect to the absorbable properties of these devices.

NOTE

Absorbable implants are within the scope of ISO/TS 17137Cardiovascular implants and extracorporeal systems — Cardiovascular absorbable implants.

Although coated stents and coated stent systems are within the scope of this standard, this standard is not comprehensive with respect to coatings.

NOTE

Some coating properties are within the scope of ISO 17327-1Non-active surgical implants — Implant coating — Part 1: General requirements.

This standard does not address the requirements for, and the evaluation of, viable tissues and non-viable biologic materials used in the construction of vascular stents.




Standard Number19/30385889 DC
TitleBS EN ISO 25539-2. Cardiovascular implants. Endovascular devices. Part 2. Vascular stents
StatusCurrent, Draft for public comment
Publication Date13 May 2019
Normative References(Required to achieve compliance to this standard)ISO 14971:2007, ISO 14630:2012, ISO 17665-1, ISO 14937, ASTM F2503, ISO 10993-1, ISO 11135, ISO 13485, ISO 11137 (all parts), ISO 11607-1
Informative References(Provided for Information)ISO 14155, ASTM F3172, ASTM F2119, ISO 10555-1, ISO/TS 17137, AAMI TIR 42, ASTM F640, ASTM F2182, ISO 7198, ASTM F746, ASTM F2514, ASTM F2394, ASTM G71, ASTM G61, ASTM F2743, ISO 10555-4, ASTM F2914, ASTM G102, ASTM G5, ISO 17475, ASTM F3044, ISO 12417-1, ASTM F2477, ASTM F2052, ASTM F2081, ASTM F2079, ASTM F2213, ASME V&V40, ASTM F2942, ASTM F3211, ISO 16429, ISO 17327-1, ASTM F2129, ASTM F3067
International RelationshipsISO/DIS 25539-2
Draft Expiry Date30 June 2019
DescriptorsCardiovascular system, Surgical implants, Medical equipment, Blood vessels, Circulatory system
ICS11.040.40
Title in FrenchImplants cardiovasculaires — Dispositifs endovasculaires — Partie 2: Endoprothèses vasculaires Partie 2: Endoprothèses vasculaires
CommitteeCH/150/2
PublisherBSI
FormatA4
DeliveryYes
Pages124
File Size1.332 MB
NotesWarning: this draft is not current beyond its expiry date for comments.
Price£36.00


 Your basket
Your basket is empty

Multi-user access to over 3,500 medical device standards, regulations, expert commentaries and other documents


Develop a PAS

Develop a fast-track standardization document in 9-12 months


BSOL

The faster, easier way to work with standards


Worldwide Standards
We can source any standard from anywhere in the world