I.S. EN ISO 7197:2009
Current
The latest, up-to-date edition.
NEUROSURGICAL IMPLANTS - STERILE, SINGLE-USE HYDROCEPHALUS SHUNTS AND COMPONENTS
Hardcopy , PDF
English
01-01-2009
For Harmonized Standards, check the EU site to confirm that the Standard is cited in the Official Journal.
Only cited Standards give presumption of conformance to New Approach Directives/Regulations.
Dates of withdrawal of national standards are available from NSAI.
Foreword
Introduction
1 Scope
2 Normative references
3 Terms and definitions
4 General requirements for shunts
5 Specific requirements for components
6 Marking and labeling for shunts
7 Packaging
8 Information supplied by the manufacturer
Annex ZA (informative) Relationship between this European
Standard and the Essential Requirements of EU
Directive 93/42/EEC
Bibliography
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