AAMI NS28 : 1988 : R2015
Withdrawn
A Withdrawn Standard is one, which is removed from sale, and its unique number can no longer be used. The Standard can be withdrawn and not replaced, or it can be withdrawn and replaced by a Standard with a different number.
INTRACRANIAL PRESSURE MONITORING DEVICES
27-08-2017
01-01-2015
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
|
| 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Withdrawn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of Compatibility of Nonporous Polymeric Materials for Surgical Implants with Regard to Effect of Materials on Tissue (Withdrawn 1987) |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| ASTM F 604 : 1994 | Specification for Silicone Elastomers Used in Medical Applications (Withdrawn 2001) |
| ASTM F 55 : 1982 | Specification for Stainless Steel Bar and Wire for Surgical Implants (Withdrawn 1989) |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 |
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.