AAMI ST72 : 2011 : R2016
Superseded
A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.
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BACTERIAL ENDOTOXIN - TEST METHODS, ROUTINE MONITORING AND ALTERNATIVES TO BATCH TESTING
Hardcopy , PDF
25-11-2019
English
01-01-2016
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Glossary of equivalent standards
Committee representation
Foreword
Introduction
1 Scope
2 Normative references
3 Definitions
4 Quality management system elements
5 Non-pyrogenic labeling
6 Selection of product units
7 Selection of technique
8 Validation of methodology
9 Use of technique
10 Alternatives to batch testing
Annex A - Background on the bacterial endotoxins test
Annex B - Guidance on test methods, routine monitoring, and
alternatives to batch testing
Annex C - Guidance on out of specification (OOS) and failure
investigation
Annex D - Bibliography
Describes general criteria to be applied in the determination of bacterial endotoxins on or in medical devices, components, or raw materials using bacterial endotoxin test methods.
| Committee |
WG 08
|
| DocumentType |
Standard
|
| Pages |
51
|
| ProductNote |
Reconfirmed 2016
|
| PublisherName |
Association for the Advancement of Medical Instrumentation
|
| Status |
Superseded
|
| SupersededBy | |
| Supersedes |
| ISO/IEC 17025:2005 | General requirements for the competence of testing and calibration laboratories |
| ISO 13488:1996 | Quality systems — Medical devices — Particular requirements for the application of ISO 9002 |
| ISO 13485:2016 | Medical devices Quality management systems Requirements for regulatory purposes |
| CFR 21(PTS800-1299) : 0 | FOOD AND DRUGS - FOOD AND DRUG ADMINISTRATION, CHAPTER 1 DEPARTMENT OF HEALTH AND HUMAN SERVICES - PARTS 800-1299 |
| AAMI ISO TIR 11139 : 2006 | STERILIZATION OF HEALTH CARE PRODUCTS - VOCABULARY |
| ISO 15798:2013 | Ophthalmic implants Ophthalmic viscosurgical devices |
| ASTM D 7102 : 2017 : REDLINE | Standard Guide for Determination of Endotoxin on Sterile Medical Gloves |
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