UNI EN 12006-2 : 2009

Name: UNI EN 12006-2 : 2009
Brand: UNI

Superseded

View Superseded by

NON ACTIVE SURGICAL IMPLANTS - PARTICULAR REQUIREMENTS FOR CARDIAC AND VASCULAR IMPLANTS - PART 2: VASCULAR PROSTHESES INCLUDING CARDIAC VALVE CONDUITS

Superseded date

19-10-2017

Published date

01-01-2009

Publisher

Ente Nazionale Italiano di Unificazione (UNI)

Foreword
Introduction
1 Scope
2 Normative references
3 Definitions
4 Intended performance
5 Design attributes
6 Materials
7 Design evaluation
8 Manufacturing
9 Sterilization
10 Packaging
11 Information supplied by the manufacturer
Annex A (normative) - Classification of prostheses
Annex B (informative) - Bibliography
Annex C (informative) - Reference table EN 12006-2 and
        ISO/DIS 7198
Annex ZA (informative) - Relationship between this European
         Standard and the Essential Requirements of EU
         Directive 93/42/EEC

Deals with specific requirements for vascular prostheses, including cardiac valve conduits, of synthetic or biological origin intended to replace, to reconstruct, to bypass or to form shunts between segments of the cardio-vascular system in humans.

DocumentType	Standard
PublisherName	Ente Nazionale Italiano di Unificazione (UNI)
Status	Superseded
SupersededBy	UNI EN ISO 7198 : 2017
Supersedes	UNI EN 12006-2 : 2000

Standards	Relationship
NEN EN 12006-2 : 1998 + A1 2009	Identical
NBN EN 12006-2 : 1998 + A1 2009	Identical
BS EN 12006-2 : 1998	Identical
NF EN 12006-2 : 1998 + A1 2009	Identical
SN EN 12006-2 : 1998 + A1 2009	Identical
UNE-EN 12006-2:1998	Identical
DIN EN 12006-2:2009-08	Identical
NS EN 12006-2 : 1998 + A1 2009	Identical
I.S. EN 12006-2:1998	Identical
EN 12006-2:1998+A1:2009	Identical

ISO 7198:2016	Cardiovascular implants and extracorporeal systems — Vascular prostheses — Tubular vascular grafts and vascular patches
EN 540 : 1993	CLINICAL INVESTIGATION OF MEDICAL DEVICES FOR HUMAN SUBJECTS
ISO 2960:1974	Textiles — Determination of bursting strength and bursting distension — Diaphragm method
ISO 5084:1996	Textiles Determination of thickness of textiles and textile products
ISO 2076:2013	Textiles Man-made fibres Generic names
ISO 2859-2:1985	Sampling procedures for inspection by attributes — Part 2: Sampling plans indexed by limiting quality (LQ) for isolated lot inspection
EN ISO 10993-7 : 2008 COR 2009	BIOLOGICAL EVALUATION OF MEDICAL DEVICES - PART 7: ETHYLENE OXIDE STERILIZATION RESIDUALS (ISO 10993-7:2008/COR 1:2009)
ISO 5081:1977	Textiles Woven fabrics Determination of breaking strength and elongation (Strip method)
ISO 14630:2012	Non-active surgical implants General requirements
ISO 472:2013	Plastics Vocabulary
ISO 10993-7:2008	Biological evaluation of medical devices Part 7: Ethylene oxide sterilization residuals
EN ISO 14630:2012	Non-active surgical implants - General requirements (ISO 14630:2012)