BS ISO 7197:1997
Superseded
A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.
View Superseded by
Neurosurgical implants. Sterile, single-use hydrocephalus shunts and components
Hardcopy , PDF
English
15-02-1998
31-12-2008
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Superseded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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