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BS ISO 7197:1997

BS ISO 7197:1997

Superseded

Superseded

A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.

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superseded

A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.

Neurosurgical implants. Sterile, single-use hydrocephalus shunts and components

Available format(s)

Hardcopy , PDF

Superseded date

12-31-2008

Language(s)

English

Published date

02-15-1998

Publisher

British Standards Institution

1 Scope
2 Normative references
3 Definitions
4 General requirements for hydrocephalus shunts and
    accessory devices
5 Test methods
6 Unit container packaging
7 Marking of devices and information supplied by the
    manufacturer
8 Accompanying documentation

Defines requirements for sterile, single-use hydrocephalus shunts and components. Applies to: complete sterile, single-use hydrocephalus shunts of one-piece type: complete sterile, single-use hydrocephalus shunts of multipiece type, either assembled by the manufacture or in kit form: or sterile, single-use shunt components which comprise shunt assemblies, eg valves, valved catheters (integral valves), inflow or outflow catheters (arterial, peritoneal, ventricular), connectors, implantable accessory devices eg siphoning-prevention, measuring and reservoirs/priming devices. Also for other applications.

Committee
CH/150/2
DevelopmentNote
Supersedes 96/561185 DC and BS 6788-1(1986). (07/2005)
DocumentType
Standard
Pages
20
PublisherName
British Standards Institution
Status
Superseded
SupersededBy
Supersedes

Standards Relationship
ISO 7197:2006 Identical

ISO 11138-3:2017 Sterilization of health care products — Biological indicators — Part 3: Biological indicators for moist heat sterilization processes
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
IEC 60601-1:2005+AMD1:2012 CSV Medical electrical equipment - Part 1: General requirements for basic safety and essential performance
ISO 10993-1:2009 Biological evaluation of medical devices Part 1: Evaluation and testing within a risk management process
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

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Hardcopy - English
PDF - English
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