Neurosurgical implants Sterile, single-use hydrocephalus shunts and components

Amended by

ISO 7197:2006/Cor 1:2007

Available format(s)

Hardcopy , PDF 1 User , PDF 3 Users , PDF 5 Users , PDF 9 Users

Published date

09-06-2006

Publisher

International Organization for Standardization

ISO 7197:2006 specifies safety and performance requirements for sterile, single-use non-active hydrocephalus shunts and components. This includes the components used in shunts, like valves, tubes and reservoirs.

For manufacturing, ISO 7197:2006 defines the mechanical and technical requirements. This International Standard defines the technical information of the valve, to be given by the manufacturer. In respect to the different principles of the valve types, specific characteristics are defined for each group as declared by the manufacturer.

The benefit of ISO 7197:2006 for the surgeon and the patient is to understand the information given by the manufacturer and to obtain standardized information about the performance of a well working product with new design characteristics. The benefit for the manufacturer is to define the important requirements for shunts as a basis for investigations during development as well as for quality control during manufacture.

DevelopmentNote	Supersedes ISO/DIS 7197 (06/2006)
DocumentType	Standard
Pages	7
PublisherName	International Organization for Standardization
Status	Current
Supersedes	ISO 7197:1997

Standards	Relationship
NBN EN ISO 7197 : 2009	Identical
NEN EN ISO 7197 : 2009	Identical
NS EN ISO 7197 : 2009	Identical
I.S. EN ISO 7197:2009	Identical
PN EN ISO 7197 : 2009	Identical
SN EN ISO 7197 : 2009	Identical
UNI EN ISO 7197 : 2009	Identical
UNE-EN ISO 7197:2009	Identical
BS EN ISO 7197:2009	Identical
EN ISO 7197:2009	Identical
NF EN ISO 7197 : 2009	Identical
DIN EN ISO 7197:2009-08	Identical
UNE-EN ISO 7197:2007	Identical
BS ISO 7197:1997	Identical
UNI ISO 7197 : 1990	Similar to

04/300654 DC : DRAFT JAN 2004	BS EN ISO 14630 - NON-ACTIVE SURGICAL IMPLANTS - GENERAL REQUIREMENTS
ISO 16142-1:2016	Medical devices — Recognized essential principles of safety and performance of medical devices — Part 1: General essential principles and additional specific essential principles for all non-IVD medical devices and guidance on the selection of standards
BS EN ISO 14630:2012	Non-active surgical implants. General requirements
ANSI/AAMI/ISO 16142-1:2016	MEDICAL DEVICES - RECOGNIZED ESSENTIAL PRINCIPLES OF SAFETY AND PERFORMANCE OF MEDICAL DEVICES - PART 1: GENERAL ESSENTIAL PRINCIPLES AND ADDITIONAL SPECIFIC ESSENTIAL PRINCIPLES FOR ALL NON-IVD MEDICAL DEVICES AND GUIDANCE ON THE SELECTION OF STANDARDS
I.S. EN ISO 14630:2012	NON-ACTIVE SURGICAL IMPLANTS - GENERAL REQUIREMENTS (ISO 14630:2012)
BS ISO 16142-1:2016	Medical devices. Recognized essential principles of safety and performance of medical devices General essential principles and additional specific essential principles for all non-IVD medical devices and guidance on the selection of standards
UNI EN ISO 14630 : 2013	NON-ACTIVE SURGICAL IMPLANTS - GENERAL REQUIREMENTS
DIN EN ISO 14630:2013-03	Non-active surgical implants - General requirements (ISO 14630:2012)
UNE-EN ISO 14630:2013	Non-active surgical implants - General requirements (ISO 14630:2012)
EN ISO 14630:2012	Non-active surgical implants - General requirements (ISO 14630:2012)
ISO 14630:2012	Non-active surgical implants General requirements

ISO 14155-2:2003	Clinical investigation of medical devices for human subjects Part 2: Clinical investigation plans
ISO 11135:2014	Sterilization of health-care products Ethylene oxide Requirements for the development, validation and routine control of a sterilization process for medical devices
ASTM F 2503 : 2013 : REDLINE	Standard Practice for Marking Medical Devices and Other Items for Safety in the Magnetic Resonance Environment
ISO 14155-1:2003	Clinical investigation of medical devices for human subjects Part 1: General requirements
ISO 14630:2012	Non-active surgical implants General requirements
ISO 10993-1:2009	Biological evaluation of medical devices Part 1: Evaluation and testing within a risk management process
ISO 11134:1994	Sterilization of health care products — Requirements for validation and routine control — Industrial moist heat sterilization
ISO 14971:2007	Medical devices Application of risk management to medical devices
ISO 11137:1995	Sterilization of health care products Requirements for validation and routine control Radiation sterilization
ASTM F 640 : 2012 : REDLINE	Standard Test Methods for Determining Radiopacity for Medical Use

View more information

$79.15

Including GST where applicable

Product format

I agree to the DRM document license rules apply against the PDF selection made.

Please confirm that you agree to the document license rules for this document.

I agree to the document license rules .

Please confirm that you agree to the document license rules for this document.

Access your standards online with a subscription

Features

Simple online access to standards, technical information and regulations.
Critical updates of standards and customisable alerts and notifications.
Multi-user online standards collection: secure, flexible and cost effective.

Learn more on subscription solutions

Get in touch with us

Log into your Account

ISO 7197:2006

Current

Abstract

General Product Information

International Equivalents

Standards Referenced By This Book

Standards Referencing This Book

Category

Subcategory

Access your standards online with a subscription