AAMI NS28 : 1988 : R2015
Withdrawn
INTRACRANIAL PRESSURE MONITORING DEVICES
English
01-01-2015
08-27-2017
Foreword
1 Scope
2 Applicable Documents
3 Requirements
4 Tests
5 Glossary
Appendix A - Rationale for the Development and Provisions
of This Standard
Describes minimum labeling, safety, and performance requirements for intracranial pressure (ICP) monitoring devices, whether percutaneous, fully implantable, or noninvasive.
| DocumentType |
Standard
|
| Pages |
22
|
| ProductNote |
Reconfirmed 2015
|
| PublisherName |
Association for the Advancement of Medical Instrumentation
|
| Status |
Withdrawn
|
| Supersedes |
| ASTM F 90 : 2014 : REDLINE | Standard Specification for Wrought Cobalt-20Chromium-15Tungsten-10Nickel Alloy for Surgical Implant Applications (UNS R30605) |
| ASTM F 469 : 1978 | Practice for Assessment of Compatibility of Nonporous Polymeric Materials for Surgical Implants with Regard to Effect of Materials on Tissue (Withdrawn 1987) |
| AAMI ES1 : 3ED 93 | SAFE CURRENT LIMITS FOR ELECTROMEDICAL APPARATUS |
| ASTM F 604 : 1994 | Specification for Silicone Elastomers Used in Medical Applications (Withdrawn 2001) |
| ASTM F 55 : 1982 | Specification for Stainless Steel Bar and Wire for Surgical Implants (Withdrawn 1989) |
| ASTM F 640 : 2012 : REDLINE | Standard Test Methods for Determining Radiopacity for Medical Use |
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