Back

EVS-EN 12006-1:2000

Non-active surgical implants - Particular requirements for cardiac and vascular implants - Part 1: Heart valve substitutes

General information

Valid from 01.01.2000
Base Documents
EN 12006-1:1999
ICS Groups
11.040.40 Implants for surgery, prosthetics and orthotics
Directives or regulations
None

Standard history

Status
Date
Type
Name
01.01.2000
Main
EVS-EN 12006-1:2000
This Standard specifies particular requirements for heart valve substitutes. With regard to safety, it gives requirements for intended performance, design attributes, materials, design evaluation, manufacturing and inspection, sterilization, packaging and information supplied by the manufacturer.

Required fields are indicated with *

*
*
*
PDF
26.84 € incl tax
Paper
26.84 € incl tax
Browse standard from 2.44 € incl tax
Standard monitoring
English (PDF 189 KB)

Related products

Main

EVS-EN ISO 14630:2012

Non-active surgical implants - General requirements (ISO 14630:2012)
Newest version Valid from 04.01.2013
Main

EVS-EN ISO 16061:2021

Instruments for use in association with non-active surgical implants - General requirements (ISO 16061:2021)
Newest version Valid from 15.04.2021
Main

EVS-EN ISO 15001:2011

Anaesthetic and respiratory equipment - Compatibility with oxygen (ISO 15001:2010)
Newest version Valid from 02.11.2011
Main

EVS-EN ISO 25539-1:2017

Cardiovascular implants - Endovascular devices - Part 1: Endovascular prostheses (ISO 25539-1:2017)
Newest version Valid from 04.04.2017

Customers who bought this item also bought

Main

EVS-EN ISO 14644-8:2013

Cleanrooms and associated controlled environments - Part 8: Classification of air cleanliness by chemical concentration (ISO 14644-8:2013)
Withdrawn from 15.07.2022
Main

EVS-EN 10204:2004

Metallic materials - Types of inspection documents
Newest version Valid from 05.01.2005
Main + amendment

EVS-EN 12006-2:1999+A1:2009

Non active surgical implants - Particular requirements for cardiac and vascular implants - Part 2: Vascular prostheses including cardiac valve conduits. CONSOLIDATED TEXT
Withdrawn from 04.04.2017
Main

EVS-EN 13549:2002

Cleaning services - Basic requirements and recommendations for quality measuring systems
Newest version Valid from 04.02.2002

Standards designation

EVS Estonian standard
EN European standard (published by an CEN or CENELEC)
EN ISO International standard adopted as an European standard
ISO International Organization for Standardization’s standard
IEC International Electrotechnical Commission’s standard
HD CENELEC’s harmonisation document
   
EVS-EN European standard implemented in Estonia
EVS-EN ISO International standard adopted in Europe and implemented in Estonia
EVS-EN ISO/IEC International standard/International electrotechnical standard adopted in Europe and implemented in Estonia
EVS-IEC International electrotechnical standard implemented in Estonia
EVS-ISO International standard implemented in Estonia
   
A, AMD amedment
+A a full standard plus the amendment
/A only amendment
COR, AC corrigendum
+COR a full standard plus the corrigendum
NA national annex
+NA a full standard plus the national annex
/NA only national annex
TS technical specification
TR technical report
CWA agreement, developed by a CEN or CENELEC
prEVS-EN (etc) draft standard
   
et the standard is in Estonian only
en the standard is in English only
et-en the standard is in Parallel text Estonian-English